アステラス製薬　韓国の行政機関 「中小ベンチャー企業部」の傘… 2025年07月17日 13時00分

- 韓国スタートアップの創薬研究およびグローバル展開を支援 --本プログラムの運営に参画する初の日本製薬企業 -　アステラス製薬株式会社（本社：東京、代表取締役社長CEO：岡村 直樹、以下「アステラス製薬」）は、韓国の行政機関である中小ベンチャー企業部（Ministry of SMEs and Startups）の傘下機関である創業振興院（本部：韓国世宗市、代表：Jong-pil Yoo、The Korea Institute of Startup and Entrepreneurship Development、以下「KISED」）と、韓国の創薬スタートアップの発掘、事業拡大およびグローバル展開支援を目的とした「グローバル企業パートナーシッププログラム」の運営に関する基本合意書を締結しました。　本基本合意書に基づき、KISEDは「グローバル企業パートナーシッププログラム」の運営全般、および研究資金の提供を行います。アステラス製薬は、KISEDと共に選出した韓国創薬スタートアップに対し、つくば研究センター敷地内に設立されたSakuLabTM-Tsukuba内の研究スペースおよびオフィススペースの利用権を提供します。SakuLabTM-Tsukubaに入居した場合、アステラス製薬の各分野の専門家による相談対応の支援に加え、他の入居者やアステラス製薬の研究者とのネットワークを活用することで、創薬研究を加速させることが可能になります。　本プログラムを通じて、韓国の製薬およびバイオテクノロジースタートアップ2社、すなわち、次世代のT細胞免疫療法の開発を専門とするTCUBEiT Inc.およびAAV（アデノ随伴ウイルス）ベクターエンジニアリング技術に専門性を有するAAVATAR Therapeuticsが選出されました。両社はSakuLabTM-Tsukubaへ入居し、研究活動を加速させます。　アステラス製薬の研究開発担当CRDO（Chief Research & Development Officer）の谷口忠明は、「KISEDとグローバル企業パートナーシッププログラムの運営に関する基本合意書を締結できたことを大変嬉しく思います。新たな創薬アイデアや技術が次々に生まれる今日、それらを患者さんの「価値」に変えるためには、多様な価値観や専門性が交わり、互いの経験を活かし合うことが重要です。アステラス製薬がこれまで培ってきた知識・ノウハウや海外ネットワークを、イノベーションに挑むスタートアップのニーズに応じて提供し、芽吹いたアイデアや技術を共に育み、花開かせたいと考えています。今回の基本合意書の締結により、韓国のスタートアップと共に創薬研究がさらに強化、加速し、革新的な医療ソリューションの創出につながることを期待しています」と述べています。　KISEDの代表であるJong-pil Yoo氏は、「グローバル製薬企業であるアステラス製薬との今回の戦略的な提携は、バイオ・医薬品分野における有望な韓国スタートアップのグローバル展開を加速させる重要な契機となります。新薬の研究開発には高度な専門性とインフラが求められるなか、アステラス製薬の研究資産やグローバルネットワークをスタートアップが直接活用できる本プログラムは、彼らの成長を大きく後押しするものと期待しています。KISEDは、今後さらにグローバル企業との連携を強化し、韓国スタートアップのグローバル市場における競争力の向上に取り組んでいきます」と述べています。　本件によるアステラス製薬の通期（2026年3月期）連結業績への影響は軽微です。以上アステラス製薬株式会社についてアステラス製薬は、科学の進歩を患者さんの「価値」に変えることを目指すグローバルライフサイエンス企業です。私たちは、がんや、眼科・泌尿器疾患、免疫、ウィメンズヘルスなどの多様な領域において、革新的な治療法を提供しています。研究開発プログラムを通じて、アンメットメディカルニーズの高い疾患領域において新たなヘルスケアソリューションを開拓しています。アステラス製薬の詳細については、www.astellas.comをご覧ください。中小ベンチャー企業部について中小ベンチャー企業部は、中小企業とベンチャー企業の競争力を強化し、イノベーションを支援することを目指す韓国の中央政府機関です。 中小企業政策の遂行のため、1996年に中小企業庁として発足し、2017年にその重点分野と目標をより明確にするため、中小ベンチャー企業部に名称変更されました。中小ベンチャー企業部は、スタートアップ育成政策、企業成長のための政策、韓国国内市場における中小企業の競争力強化のための政策を重点的に推進しています。詳細な説明はこちらをご覧ください。創業振興院（KISED）について創業振興院は、韓国の中小ベンチャー企業部傘下の政府機関であり、韓国のスタートアップエコシステムの発展を推進するための戦略的な取り組みを実施しています。個々のニーズに応じて成功するスタートアップの創出、持続可能な未来の成長エンジンの確保、そして創造的かつ革新的なスマート経営の実現を目指しています。詳細な説明はこちらをご覧ください。注意事項（アステラス製薬）このプレスリリースに記載されている現在の計画、予想、戦略、想定に関する記述およびその他の過去の事実ではない記述は、アステラス製薬の業績等に関する将来の見通しです。これらの記述は経営陣の現在入手可能な情報に基づく見積りや想定によるものであり、既知および未知のリスクと不確実な要素を含んでいます。さまざまな要因によって、これら将来の見通しは実際の結果と大きく異なる可能性があります。その要因としては、（i）医薬品市場における事業環境の変化および関係法規制の改正、（ii）為替レートの変動、（iii）新製品発売の遅延、（iv）新製品および既存品の販売活動において期待した成果を得られない可能性、（v）競争力のある新薬を継続的に生み出すことができない可能性、（vi）第三者による知的財産の侵害等がありますが、これらに限定されるものではありません。また、このプレスリリースに含まれている医薬品（開発中のものを含む）に関する情報は、宣伝広告、医学的アドバイスを目的としているものではありません。 

Astellas Announces a Partnership with the “Korea Institute … 2025年07月17日 13時00分

- Supporting Korean Startups’ Drug Discovery Research and Global Expansion -- First Pharmaceutical Company from Japan to Actively Support the Operation of the Program -TOKYO, July 17, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it has agreed on a memorandum of understanding (“MoU”) with the Korea Institute of Startup and Entrepreneurship Development (President: Jong-pil Yoo, “KISED”), an umbrella organization of the Ministry of SMEs and Startups, a Korean Government Agency, for the operation of the Partnership with Global Companies Program, which aims to identify Korean drug-discovery startups and support their business growth and global expansion.Under the terms of the MoU, KISED will provide overall management and research funding for the Partnership with Global Companies Program. Astellas will provide Korean drug-discovery startups, which are selected together, with KISED with access to laboratory and office space at SakuLabTM-Tsukuba, located on the premises of the Astellas Tsukuba Research Center. Startups residing in SakuLabTM-Tsukuba will not only receive support through consultations with Astellas experts in various fields, but will also be able to accelerate their drug discovery research by leveraging networks with fellow residents and Astellas researchers.Through this program, two Korean pharmaceutical and biotech startups—TCUBEiT Inc. (a next-generation T-cell-based immunotherapy developer) and AAVATAR Therapeutics (specializing in AAV viral vector engineering technology)—have been selected. They will begin full-scale collaboration by moving into SakuLab™-Tsukuba.Tadaaki Taniguchi, M.D., Ph.D., Chief Research & Development Officer (CRDO) of Astellas“We are very pleased to agree on a MoU with KISED for the Operation of the Partnership with Global Companies Program. In today's world, where new drug discovery ideas and technologies are emerging one after another, Diverse perspectives, expertise and experiences are essential to turning innovative ideas and technologies into VALUE for patients. Astellas is committed to fostering innovation in collaboration with startups by providing knowledge and expertise we have gained through our research and global network. We expect that the signing of this MoU will further strengthen and accelerate drug discovery research together with Korean startups, ultimately contributing to the creation of innovative medical solutions.”Jong-pil Yoo, President of KISED“This agreement will serve as a significant opportunity to accelerate the global expansion of promising Korean startups in the bio and pharmaceutical sectors through strategic collaboration with Astellas, a global pharmaceutical company. In particular, as new drug development requires a high level of expertise and infrastructure, this program—enabling startups to leverage Astellas' research assets and global network directly—is expected to provide substantial support for their growth. KISED will continue to strengthen its partnerships with global corporations to ensure that Korean startups can enhance their competitiveness in the global market.”The impact of this partnership on Astellas’ financial results for the fiscal year ending March 31, 2026, is expected to be minor.About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.About Ministry of SMEs and StartupsThe Ministry of SMEs and Startups is a central government agency in South Korea, dedicated to enhancing the competitiveness and fostering innovation among small and medium-sized enterprises (SMEs) and venture businesses. Initially established in 1996 as the Ministry of SMEs, it was rebranded in 2017 as the Ministry of SMEs and Startups to more accurately reflect its expanded focus and objectives.MSS is committed to developing and implementing policies that support startup growth, promote corporate development, and strengthen the competitiveness of small businesses within the national and global markets. Learn more at https://www.mss.go.kr/site/eng/main.doAbout KISEDKISED carries out strategic initiatives aimed at advancing the startup ecosystem, enabling tailored and successful startups, securing sustainable future growth engines, and realizing creative and innovative smart management. Learn more at https://www.kised.or.kr/index.es?sid=a2Cautionary Notes (Astellas)In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release 

IZERVAY^TM (avacincaptad pegol) 米国売上（速報値… 2025年07月10日 08時30分

　アステラス製薬株式会社（本社：東京、代表取締役社長CEO：岡村 直樹、以下「当社」）は、地図状萎縮（Geographic Atrophy: GA）を伴う加齢黄斑変性（Age-related Macular Degeneration: AMD）の治療薬IZERVAY™（一般名：avacincaptad pegol）硝子体内注射液の2025年度第1四半期（2025年4月1日～6月30日）における米国での売上が、159億円/110百万米ドル（速報値）であったことをお知らせします。　当社は、本日開催された投資家向け説明会に合わせて、本情報を開示しました。IZERVAY™の売上を含む、当社の2026年3月期第1四半期連結業績の詳細については、2025年7月30日に予定している決算発表にて開示する予定です。以上アステラス製薬株式会社について当社は、科学の進歩を患者さんの「価値」に変えることを目指すグローバルライフサイエンス企業です。私たちは、がんや、眼科・泌尿器疾患、免疫、ウィメンズヘルスなどの多様な領域において、革新的な治療法を提供しています。研究開発プログラムを通じて、アンメットメディカルニーズの高い疾患領域において新たなヘルスケアソリューションを開拓しています。当社の詳細については、www.astellas.comをご覧ください。注意事項このプレスリリースに記載されている現在の計画、予想、戦略、想定に関する記述およびその他の過去の事実ではない記述は、当社の業績等に関する将来の見通しです。これらの記述は経営陣の現在入手可能な情報に基づく見積りや想定によるものであり、既知および未知のリスクと不確実な要素を含んでいます。さまざまな要因によって、これら将来の見通しは実際の結果と大きく異なる可能性があります。その要因としては、（i）医薬品市場における事業環境の変化および関係法規制の改正、（ii）為替レートの変動、（iii）新製品発売の遅延、（iv）新製品および既存品の販売活動において期待した成果を得られない可能性、（v）競争力のある新薬を継続的に生み出すことができない可能性、（vi）第三者による知的財産の侵害等がありますが、これらに限定されるものではありません。また、このプレスリリースに含まれている医薬品（開発中のものを含む）に関する情報は、宣伝広告、医学的アドバイスを目的としているものではありません。 

Sales of IZERVAY™ (Preliminary Figures) 2025年07月10日 08時30分

TOKYO, July 10, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the sales in the U.S. of the IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in the first quarter of FY2025 (April 1, 2025 – June 30, 2025) was ¥15.9 billion/ $110 million (preliminary figures).This information has been disclosed in conjunction with today's meeting for the investment community. Astellas’ financial results for the first quarter of FY2025, including IZERVAY’s sales, will be disclosed and explained at Astellas’ Q1 earnings call scheduled on July 30, 2025.About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.Cautionary NotesIn this press release, statements made concerning current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs considering the information currently available to it and involve known and unknown risks and uncertainties. Several factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development) included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release 

2025年3月期（第20期）　有価証券報告書を掲載しました。 2025年06月16日 14時30分

三菱総合研究所とアステラス製薬 MEDISO事業のうち、創薬スター… 2025年06月13日 14時00分

株式会社三菱総合研究所（代表取締役社長：籔田健二、以下 MRI）とアステラス製薬株式会社（代表取締役社長CEO：岡村直樹、以下 アステラス製薬）は、MRIが厚生労働省より委託を受けて実施する「医療系ベンチャー・トータルサポート事業（MEDISO: Medical Innovation Support Office）」における、創薬スタートアップ支援業務での提携に関する基本合意書を締結しました。背景日本政府は、昨今のドラッグ・ラグ／ドラッグ・ロス問題や医薬品産業の国際競争力の低下等の課題を受け、2023年12月に「創薬力の向上により国民に最新の医薬品を迅速に届けるための構想会議」を立ち上げました。2024年5月に公表された中間とりまとめでは、国内外の製薬企業やベンチャーキャピタル（VC）等のノウハウや資金を積極的に呼び込むことで、日本の創薬力の強化を図る方針が示されました。また、「経済財政運営と改革の基本方針2024　～賃上げと投資がけん引する成長型経済の実現～」（骨太方針2024）では、MEDISOの機能強化が明記されています。厚生労働省より委託を受けてMEDISOを運営しているMRIは、国内外のさまざまなステークホルダーと連携し、相談助言およびアクセラレーションプログラムを実施し、海外VCとのマッチングイベントの開催等を通じて、革新的な医療ソリューションの実用化を目指す医療系スタートアップ・アカデミアを支援しています。 提携の概要と見通し本提携は、MRIがMEDISOで提供する日本の医療系スタートアップやアカデミアのシーズの実用化支援において、日本を代表する製薬企業であるアステラス製薬の創薬開発における専門性を活かし、支援をより高度化させるものです。本契約に基づき、アステラス製薬は、MEDISOで実施する様々な支援プログラムのうち、創薬スタートアップに対するアクセラレーションプログラムにおいて、つくば研究センターの敷地内に設立されたSakuLabTM-Tsukuba内の研究スペースおよびオフィススペースの利用権の提供を行います。創薬スタートアップがSakuLabTM-Tsukubaに入居した場合、アステラス製薬の各分野の専門家による相談対応の支援に加え、他の入居者やアステラス製薬の研究者とのネットワークを活用することで、創薬研究を加速させることが可能になります。今回の提携について、MRIの執行役員 公共イノベーション部門長の鈴木啓史は「アステラス製薬と、MEDISOにおける創薬スタートアップ支援で提携できることを大変心強く思います。創薬スタートアップが研究シーズの実用化を進める上で、最新の知見やノウハウを外部に求めることは不可欠です。グローバルに活躍する製薬企業であるアステラス製薬の視点を早期に入れることで研究シーズの実用化が加速され、日本の創薬エコシステムに有効に作用することが期待できます。私たちは両社の強みを活かし、革新的な医療ソリューションを、日本そして世界の患者にいち早く届けられるようにしていきます。」と述べています。アステラス製薬の研究開発担当CRDO（Chief Research & Development Officer）の谷口忠明は、「MRIとMEDISOの創薬スタートアップ支援業務に関する基本合意書を締結できたことを大変嬉しく思います。アステラス製薬は、これまでの研究開発で培ってきた知識・経験や海外ネットワークを、イノベーションに挑戦するスタートアップやアカミデアのニーズに応じて提供することで、革新的なアイデアや技術を共に育み、花開かせたいと考えています。今回の基本合意書の締結により、日本の創薬スタートアップによる創薬研究がさらに強化、加速され、革新的な医療ソリューションの創出につながることを期待しています」と述べています。三菱総合研究所とアステラス製薬は、両社の協働を通じて、日本発の革新的な医薬品の創出を目指します。関連情報厚生労働省「医療系ベンチャー・トータルサポート事業（MEDISO）」を受託（ニュースリリース　2025.6.13） 

Mitsubishi Research Institute and Astellas Announce Collabo… 2025年06月13日 14時00分

Tokyo, 13 June 2025—Mitsubishi Research Institute, Inc. (“MRI”) and Astellas Pharma Inc. (“Astellas”) today announced that they have agreed on a memorandum of understanding to provide drug-discovery startups in Japan with support in their efforts to go global. The pair aims to strengthen Japan’s position as a global hub for drug discovery and foster the growth of its startups that can thrive globally.The new support represents multiple programs under the Ministry of Health, Labour and Welfare’s Medical Innovation Support Office (MEDISO), which looks to address the lack of practical application of Japan’s advanced life-sciences technologies. Mitsubishi Research Institute has been entrusted to operate MEDISO since 2018 and has been helping promising drug-discovery startups commercialize their intellectual property since.“When it comes to practical application, drug-discovery startups need external insights and expertise,” said Hirofumi Suzuki, Executive Officer and General Manager of the Public Innovation Unit at Mitsubishi Research Institute. “Promising startups can substantially speed up the commercialization of their offerings by engaging with globally active pharmaceutical companies early.”The new partnership looks to leverage the strengths of both companies. MRI will draw from its previous MEDISO work—supporting over twelve hundred startup and academic ventures—and design specific support programs for participants. Astellas Pharma will provide drug-discovery startups participating in the acceleration program conducted through MEDISO with access to laboratory and office space at SakuLabTM -Tsukuba, located on the premises of the Astellas Tsukuba Research Center. Startups residing in SakuLabTM-Tsukuba will not only receive support through consultations with Astellas experts in various fields, but will also be able to accelerate their drug discovery research by leveraging networks with fellow residents and Astellas researchers.“We are very pleased to agree on a memorandum of understanding with MRI. Astellas Pharma is committed to growing and developing innovative ideas and technologies with academia and startups by providing knowledge and experience gained through research and our global network,” said Tadaaki Taniguchi, M.D., Ph.D., Chief Research & Development Officer (CRDO) of Astellas Pharma. “We expect that the signing of this MoU will further strengthen and accelerate drug discovery research by Japanese startups, ultimately leading to the creation of innovative medical solutions.”The new support will provide Japanese drug-discovery startups with early access to pharmaceutical-industry insights, enabling them to chart a path toward successful global development and potential out-licensing. This aligns with the Basic Policy on Economic and Fiscal Management and Reform 2024, which aims to improve domestic research and development environments while encouraging the participation of global pharmaceutical companies and venture capitalists in building a robust drug discovery ecosystem.“We are pleased to partner with Astellas Pharma to support startups under the MEDISO initiative, and we are sure that this will be a groundbreaking step for Japan’s drug discovery ecosystem,” said Suzuki. “We are committed to leveraging the strengths of both companies to swiftly deliver innovative pharmaceuticals to patients in Japan and globally.”Moving forward, MEDISO as a whole aims to collaborate with domestic and international business partners to support the global expansion of Japanese drug- discovery startups while encouraging global investors to invest in Japan’s burgeoning drug discovery field.About Mitsubishi Research Institute, Inc.Mitsubishi Research Institute is one of Japan’s foremost think tanks. For over five decades, it has provided the public and private sectors with research and consulting services in fields spanning healthcare, the environment, energy, and digital transformation. This is accompanied by policy recommendations and the real-world application of solutions. Mitsubishi Research Institute will continue to envision the future, resolve societal issues, and lead change to build a sustainable and prosperous world. For more information, please visit: www.mri.co.jp/en/About Astellas Pharma Inc.Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com. Click below for a copy of the full press release 

アステラス製薬とEvopoint Biosciences CLDN18.2を標的とした抗… 2025年05月30日 08時45分

- アステラス製薬は、全世界（中国本土、香港、マカオ、台湾を除く）においてXNW27011を独占的に開発および商業化する権利を取得 -- XNW27011は、胃がん、胃食道がんおよび膵臓がん等の固形がんを対象とした進行中の第I/II相試験において、単剤療法として良好な有効性を確認 -　アステラス製薬株式会社（本社：東京、代表取締役社長CEO：岡村 直樹、以下「アステラス製薬」）は、バイオ医薬品企業であるEvopoint Biosciences Co., Ltd.（本社：中国蘇州市、Chairman：Arthur Qiang、以下「Evopoint」）と、本日、CLDN18.2を標的とした臨床段階にある新規の抗体-薬物複合体（antibody-drug conjugate：ADC）XNW27011の独占的なライセンス契約を締結しました。本契約により、アステラス製薬は、XNW27011の全世界（中国本土、香港、マカオ、台湾を除く）における開発および商業化に関するライセンスを取得します。　XNW27011は、胃がん、胃食道がんおよび膵臓がんを含む、CLDN18.2陽性の固形がん患者を対象として、中国で第I/II相試験を実施中です。本プログラムは、既存のがん治療において、すでに有効性が確認されている独自のペイロード（トポイソメラーゼ I 阻害剤）とリンカー技術を採用しています。　アステラス製薬は、世界で唯一承認されている抗CLDN18.2モノクローナル抗体であるVYLOYTM をはじめ、CLDN18.2を標的とする複数のがん免疫療法の研究開発において高い専門性を有しています。XNW27011はアンメットメディカルニーズを満たす可能性があり、CLDNを標的とするプログラム、および他の標的に対する複数のADCを有するアステラスのがん治療パイプラインを強化します。　本契約に基づきEvopointは、1億3,000万米ドルを契約一時金として受け取ります。Evopointは、近い将来に支払われる開発マイルストンとして最大7,000万米ドルを受け取る可能性があります。さらに、薬事申請、販売、および開発の進捗に応じたマイルストンとして、最大総額13億4,000万米ドルに加え、承認された場合はXNW27011の売上高に応じたロイヤルティを受け取る可能性があります。　今回の契約について、アステラス製薬の経営戦略担当CStO（Chief Strategy Officer）のAdam Pearsonは、「アステラス製薬は、胃がんや膵臓がんをはじめとする治療が困難ながんに対する革新的な治療法の研究開発に注力しています。XNW27011は、アステラス製薬のパイプラインを拡充し、精密がん医療におけるリーディングポジションをさらに強化することが期待される有望なプログラムです。CLDN18.2および消化器がんに対する私たちの高い専門性を活かし、XNW27011の開発を加速し、患者さんに意義のある治療効果を提供できることを期待しています」と述べています。　また、EvopointのChairmanであるArthur Qiangは、「XNW27011は、臨床において大きな期待が寄せられている革新的なADCです。アステラス製薬は、革新的ながん治療プログラムの研究開発において豊富な実績があり、商業化においても強固ながん領域の事業基盤を構築しています。治療を必要としている世界中の患者さんに新たな治療選択肢を提供するという、私たち共通の目標の達成に向けて、今回のライセンス契約を締結できることを嬉しく思います」と述べています。　本件によるアステラス製薬の通期（2026年3月期）連結業績への影響は軽微です。以上アステラス製薬株式会社についてアステラス製薬は、科学の進歩を患者さんの「価値」に変えることを目指すグローバルライフサイエンス企業です。私たちは、がんや、眼科・泌尿器疾患、免疫、ウィメンズヘルスなどの多様な領域において、革新的な治療法を提供しています。研究開発プログラムを通じて、アンメットメディカルニーズの高い疾患領域において新たなヘルスケアソリューションを開拓しています。アステラス製薬の詳細については、www.astellas.comをご覧ください。Evopoint BiosciencesについてEvopointは、研究開発および商業化において卓越した専門性を有する革新的なバイオ医薬品企業です。会社設立以来、Evopointは、世界中の重要なアンメットメディカルニーズに応える最先端の医療ソリューションの発見と開発を通じて、人々の健康に貢献するために尽力してきました。標的療法、ADC、標的タンパク質分解誘導における多様な創薬プラットフォームを活用し、腫瘍、感染症、代謝性疾患にフォーカスした強固なパイプラインを構築してきました。詳細については、https://www.evopointbio.com/enをご覧ください。注意事項（アステラス）このプレスリリースに記載されている現在の計画、予想、戦略、想定に関する記述およびその他の過去の事実ではない記述は、アステラス製薬の業績等に関する将来の見通しです。これらの記述は経営陣の現在入手可能な情報に基づく見積りや想定によるものであり、既知および未知のリスクと不確実な要素を含んでいます。さまざまな要因によって、これら将来の見通しは実際の結果と大きく異なる可能性があります。その要因としては、（i）医薬品市場における事業環境の変化および関係法規制の改正、（ii）為替レートの変動、（iii）新製品発売の遅延、（iv）新製品および既存品の販売活動において期待した成果を得られない可能性、（v）競争力のある新薬を継続的に生み出すことができない可能性、（vi）第三者による知的財産の侵害等がありますが、これらに限定されるものではありません。また、このプレスリリースに含まれている医薬品（開発中のものを含む）に関する情報は、宣伝広告、医学的アドバイスを目的としているものではありません。 

Astellas Enters Exclusive License Agreement with Evopoint B… 2025年05月30日 08時45分

- Agreement grants Astellas exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macao and Taiwan region) to develop and commercialize XNW27011 -- XNW27011 has demonstrated encouraging monotherapy efficacy in an ongoing Phase 1/2 study of patients with solid tumors, including gastric cancer, gastroesophageal cancer and pancreatic cancer -- Evopoint to receive a $130 million upfront payment and is eligible to receive up to $70 million near-term payments, and additional milestone payments associated with development, regulatory and commercialization milestones totaling up to $1.34 billion, as well as royalties on net sales of XNW27011, if approved -TOKYO, Japan and SUZHOU, China, May 30, 2025, Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Evopoint Biosciences (Evopoint Biosciences Co., Ltd.) today announced they have entered into an exclusive license agreement for XNW27011, a novel investigational clinical-stage antibody-drug conjugate (ADC) targeting CLDN18.2. The agreement grants Astellas a worldwide (excluding China’s mainland, Hong Kong, Macao and Taiwan region) exclusive license to develop and commercialize XNW27011.XNW27011 is currently being evaluated in a Phase 1/2 study in China in patients with CLDN18.2-expressing solid tumors, including gastric cancer, gastroesophageal cancer and pancreatic cancer. It uses a proprietary topoisomerase I inhibitor payload and linker technology, an approach that has demonstrated clinical success in other approved cancer therapies.Astellas has significant expertise in developing therapies that target CLDN18.2, including VYLOYTM, the first CLDN18.2-targeted therapy approved in the world. XNW27011 has the potential to address currently unmet patient need and will expand Astellas’ oncology pipeline which currently contains CLDN-targeting therapies utilizing different approaches, as well as ADC’s directed to other targets.Under the terms of the agreement, Evopoint will receive a $130 million upfront payment and is eligible to receive up to $70 million near-term payments, and additional milestone payments associated with development, regulatory and commercialization milestones totaling up to $1.34 billion, as well as royalties on net sales of XNW27011, if approved.Adam Pearson, Chief Strategy Officer, Astellas“Astellas is dedicated to advancing innovative therapies for some of the most challenging-to-treat cancers, such as gastric and pancreatic cancer. XNW27011 is a promising new asset that complements Astellas’ pipeline and enhances our leading position in precision oncology. We look forward to harnessing our expertise in targeting CLDN18.2 and specialized knowledge in GI cancers to advance XNW27011 and deliver meaningful outcomes to patients.”Arthur Qiang, Chairman, Evopoint“XNW27011 is a novel investigational antibody-drug conjugate that has shown great promise in the clinic. Astellas has a proven history of developing and commercializing a strong franchise of innovative cancer therapies. We are pleased to enter into this new license agreement to further our collective goals of bringing new treatment options for patients in need worldwide.”About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com. About Evopoint BiosciencesEvopoint Biosciences is an innovative biopharmaceutical company with exceptional capabilities in R&D and commercialization. Since its inception, Evopoint has been committed to improving human health by discovering and developing cutting-edge pharmaceutical solutions that address significant unmet medical needs worldwide.  Leveraging diverse discovery platforms in targeted therapy, ADC, and targeted protein degradation (TPD), the company has built a robust pipeline focused on oncology, infectious diseases and metabolic diseases. Learn more at www.evopointbio.com.Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release 

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Shaping the Future with Pompe Patients 2025年05月27日 10時00分

DTx流通プラットフォームの開発・運用に向けた3社間基本合意書… 2025年05月26日 13時00分

塩野義製薬株式会社（本社：大阪市中央区、代表取締役会長兼社長CEO：手代木 功、以下「塩野義製薬」）、アステラス製薬株式会社（本社：東京都中央区、代表取締役社長 CEO：岡村 直樹、以下「アステラス製薬」）、および株式会社NTTデータ（本社：東京都江東区、代表取締役社長：佐々木 裕、以下「NTTデータ」）は、デジタル治療サービス（以下「DTx注1」）の普及を目指し、「DTx流通プラットフォーム」（以下「本プラットフォーム」）の開発・運用に向けた検討を開始する基本合意書を締結しました。DTxとは、モバイルアプリケーションなどを通じて「疾患等を治療、管理、予防するため、エビデンスに基づいた治療介入を提供するデジタル治療サービス」であり、新たなモダリティ注2（治療手段）として注目されています。米国やドイツなどの海外では既に普及が進んでおり、日本でも今後の発展が期待されています。しかし、日本のDTx市場はまだ発展途上であり、認知度の向上、製品開発や承認モデルケースの確立、流通プロセスの整備など、個社単独では解決が難しい課題が多く存在しています。これらは、多くの企業が連携・協力して取り組むべき共通の課題です。本プラットフォームの構想は、各事業者の協力によるDTx市場の「共創」を理念として取り組みます。DTxの開発に関する知見を有する塩野義製薬およびアステラス製薬、ならびにITサービスを提供するNTTデータが、各領域の知見を集約し、業界標準に資するプラットフォーム提供を実現することで国内DTxのスムーズな普及と発展を目指します。具体的には、DTx流通プロセスの標準化・医療機関の利用環境の一元化など、DTxの利用に必要な機能を統一することで、医療機関やDTx開発企業の負担を減らし、患者さんの医療アクセス向上に寄与していきます。加えて、こうした取り組みを推進する活動として、ヘルスケア企業が参画するコンソーシアムの設立についても検討を進めてまいります。  図1：DTx市場における「共創」イメージ  図2：DTx流通プラットフォーム概要各社コメント塩野義製薬株式会社 三春 洋介 （執行役員 DX推進本部長）このたびの基本合意書の締結により3社でDTx流通プラットフォームの構想検討に取り組めることを大変うれしく思います。各社の強みやノウハウを活かした「共創」に取り組むことで、国内DTxのスムーズな普及につながる価値の高いプラットフォームが提供できると確信しています。引き続き、患者さまや社会の抱える困り事の解決に向けた新たなソリューションの提供に取り組んでまいります。アステラス製薬株式会社 Adam Pearson （経営戦略担当）アステラス製薬は、医薬品に留まらず、ペイシェントジャーニー（診断、予防、治療および予後管理を含む医療シーン全般）全体を通じて、様々なアプローチで患者さんに「価値」を届けることを目指しています。DTxはそうした取り組みの一つです。DTx流通プラットフォームを実現する方法を探索し、患者さんにベネフィットをもたらすために、3社でこの基本合意書を締結できることを嬉しく思います。株式会社NTTデータ 安地 亮一 (執行役員　第二インダストリ統括事業本部長)デジタルの力で患者に新たな治療手段を提供するDTxに期待が高まっている今、医療・ヘルスケア産業のリーディングカンパニーである塩野義製薬、アステラス製薬と共に、DTxの社会実装に挑戦する機会を得られたことを光栄に思います。DTx普及がわが国の健康増進や医療費の抑制といった重要な社会課題の解決に資する営みであると確信し、患者様や医療機関様にとって使いやすく、安心してお使いいただけるプラットフォームづくりに取り組んで参ります。3社は基本合意契約に基づき、2026年3月を目標として本プラットフォームの具体的な構想をまとめ、その後の社会実装を目指します。今後DTxの上市注3を予定している企業や関連企業との連携も視野に入れており、この取り組みに賛同いただける方々からのご意見をお待ちしています。【注釈】(注1)DTx ： Digital Therapeuticsの略(注2)モダリティ ： 創薬基盤技術の方法や手段、または各方法や手段に基づいて製造された医薬品の種別を示す用語(注3)上市 ： 承認された新薬が市場で販売開始されること 塩野義製薬株式会社について塩野義製薬は、「新たなプラットフォームでヘルスケアの未来を創り出す」ことを SHIONOGI Group Visionとして掲げ、薬の提供にとどまらない未病から予後に至るヘルスケアサービスによるトータルケアを実現し、患者さまや社会の困りごとに対する包括的な解決に取り組んでいます。URL：https://www.shionogi.com/jp/ja/アステラス製薬株式会社についてアステラス製薬は、科学の進歩を患者さんの「価値」に変えることを目指すグローバルライフサイエンス企業です。私たちは、がんや、眼科・泌尿器疾患、免疫、ウィメンズヘルスなどの多様な領域において、革新的な治療法を提供しています。研究開発プログラムを通じて、アンメットメディカルニーズの高い疾患領域において新たなヘルスケアソリューションを開拓しています。アステラス製薬の詳細については、www.astellas.comをご覧ください。株式会社NTTデータについてNTTデータは、豊かで調和のとれた社会づくりを目指し、世界50カ国以上でITサービスを提供しています。デジタル技術を活用したビジネス変革や社会課題の解決に向けて、お客さまとともに未来を見つめ、コンサルティングからシステムづくり、システムの運用に至るまで、さまざまなサービスを提供します。ＮＴＴデータの製薬・ライフサイエンスに関する取り組み：https://www.nttdata.com/jp/ja/industries/lifescience/ 

前立腺がん治療剤エンザルタミド 第III相ARCHES試験の追跡調査… 2025年05月23日 09時00分

- 第III相ARCHES試験の5年間の追跡調査のデータにおいてエンザルタミド＋アンドロゲン除去療法（ADT）群がプラセボ＋ADT群と比較して死亡リスクを30%減少 -- 中央値61.4カ月間の追跡調査後の5年生存率はエンザルタミド＋ADT群で66%プラセボ＋ADT群で53% -- 転移性ホルモン感受性前立腺がんを対象として、投与後5年時点で、統計学的に有意な全生存率の改善を示した唯一のアンドロゲン受容体阻害剤 -　アステラス製薬株式会社（本社：東京、代表取締役社長CEO：岡村 直樹、以下「アステラス製薬」）は、Pfizer Inc.（本社：米国ニューヨーク州）と共同で開発、商業化を進めている経口アンドロゲン受容体阻害剤であるXTANDITM（製品名、一般名：エンザルタミド）が、転移性ホルモン感受性前立腺がん（metastatic hormone-sensitive prostate cancer：mHSPC）患者を対象とした第III相ARCHES試験（NCT02677896）の非盲検継続試験における長期追跡調査の結果、エンザルタミド＋アンドロゲン除去療法（androgen-deprivation therapy：ADT）群では、プラセボ＋ADT群と比較して、全生存期間（Overall Survival：OS）が延長し、死亡リスクが30%減少したことをお知らせします。　これらのデータは、米国イリノイ州シカゴで開催される2025年米国臨床腫瘍学会（American Society of Clinical Oncology：ASCO）年次総会（6月3日（火）午前9時45分～午後12時45分、米国中部時間）において、口頭発表される予定です（抄録番号：5005）。　ARCHES試験の5年間の追跡調査におけるOSについて、高腫瘍量病変を有する患者（ハザード比 [Hazard Ratio：HR = 0.70, 95%信頼区間 [Confidence Interval：CI]：0.56-0.88）、低腫瘍量病変を有する患者（HR = 0.71, 95%CI：0.49-1.05）、ドセタキセル療法の前治療歴がある患者（HR = 0.67, 95%CI：0.43-1.05）、およびドセタキセル療法の前治療歴が無い患者（HR = 0.71, 95%CI：0.57-0.88）のいずれにおいても同様の結果が得られました。また、高腫瘍量病変を有する患者ではOSの中央値が36カ月延長しました。5年間の追跡調査における治療に関連する有害事象の発現率は、これまでのARCHES試験と同様の結果であり、新たな安全性シグナルは認められませんでした。 　今回のARCHES試験の5年間にわたる追跡調査の詳細な結果については、近日中に査読付きの学術誌に投稿予定です。　上記、ARCHES試験の5年間の長期追跡調査データに加え、mHSPC患者を対象に、エンザルタミドと非ステロイド性抗アンドロゲン治療剤（non-steroidal anti-androgen：NSAA）（両剤に、ドセタキセルを併用あるいは非併用したADTを実施）を比較、評価したEMZAMET試験（NCT02446405）の8年間にわたる追跡調査のデータも、ASCO年次総会のポスターセッション（6月2日（月）午前9時、米国中部時間）で発表される予定です。シドニー大学がスポンサーになり、オーストラリア・ニュージーランド泌尿器・生殖器および前立腺がん試験グループ（Australian and New Zealand Urogenital and Prostate Cancer Trials Group Limited：ANZUP）が主導する独立した第III相EMZAMET試験では、mHSPCの患者における死亡リスクが低下しました。　ENZAMET試験ではmHSPCの患者にエンザルタミド＋ADT（ドセタキセル併用または非併用）（エンザルタミド群）あるいは、NSAA＋ADT（ドセタキセル併用または非併用）（NSAA群）の投与がなされ、がなされ， 追跡期間の中央値98カ月におけるOS中央値は、エンザルタミド群で8年、NSAA群で5.8年でした（HR = 0.73, 95%CI：0.63-0.86）。投与後96カ月時点での全生存率は、エンザルタミド群で50%、NSAA群で40%でした。また、無増悪生存率（progression-free survival：PFS）についても、エンザルタミド群がNSAA群よりも良好な結果を示しました（HR = 0.49, 95%CI：0.42-0.57）。全死亡者622名のうち468名が前立腺がんによるものであり、エンザルタミド群（207名）、NSAA群（261名）でした。その他の原因による死亡者数は合計154名であり、エンザルタミド群（78名）とNSAA群（76名）において同程度でした。平均治療期間については、エンザルタミド群（58カ月）がNSAA群（36カ月）よりも長く、33%の患者において、エンザルタミドが160 mg常用量で投与継続されていました。　XTANDITMは、現在、米国、欧州連合、日本を含む90カ国以上で承認されています。2012年に最初に承認を取得して以来、世界中で100万人以上の患者さんがXTANDITMによる治療を受けています。以上転移性ホルモン感受性前立腺がん（metastatic Hormone-Sensitive Prostate Cancer：mHSPC）について転移性ホルモン感受性前立腺がんは、転移性去勢感受性前立腺がんとも呼ばれ、ホルモン療法に反応を示しながらも前立腺以外の部位（リンパ節、骨、肺、肝臓など）に転移した前立腺がんを指します。ARCHES試験についてARCHES試験（NCT02677896）は、国際共同無作為化二重盲検プラセボ対照第III相試験です。1,150名の転移性mHSPC患者を対象として、米国、カナダ、欧州、南米およびアジア太平洋地域において実施しました。本試験は、黄体化ホルモン放出ホルモン（LHRH）作動薬または拮抗薬による治療を継続している、あるいは精巣摘除術の既往例を有する患者を対象に、エンザルタミド1日160 mg群またはプラセボ群に無作為に割り付けられました。本試験には、低腫瘍量病変と高腫瘍量病変の両方の患者、新たにmHSPCと診断された患者と、および根治的治療を受けた後に転移した患者が対象となりました。また、mHSPCに対して最近ドセタキセルによる治療を受け、病勢進行が認められなかった患者も対象となりました。本試験の主要評価項目は、画像診断上の無増悪生存期間（radiographic progression-free survival：rPFS）であり、これは無作為化から、中央判定による画像診断上の病勢進行が初めて客観的に確認された時点、または治療中止後24週間以内の死亡のいずれか早い時点までの期間として定義されました。最終解析における主要な副次的評価項目である全生存率に加えて、5年間の臨床的に意義のあるフォローアップで長期の全生存率をさらに定量化することを目的に5年間の事後解析が実行されました。ARCHES試験の詳細については、www.clinicaltrials.govをご覧くださいENZAMET試験についてENZAMET試験は、ANZUP Cancer Trials Group Limitedがシドニー大学NHMRC（National Health and Medical Research Council）臨床試験センターと共同で主導する試験で、オーストラリア、カナダ、アイルランド、ニュージーランド、英国、米国において実施されました。本試験では、mHSPC患者1,125名を対象に、エンザルタミドとアンドロゲン除去療法（ADT）の併用療法、または従来の非ステロイド性抗アンドロゲン剤（NSAA）とADTの併用療法を比較評価しています。本試験の主要評価項目は全生存期間（OS）です。ENZAMET試験（NCT02446405）の詳細については、www.clinicaltrials.govをご覧ください。アステラス製薬は、ENZAMET試験実施のために、資金やサポートを提供しました。アステラス製薬株式会社についてアステラス製薬は、科学の進歩を患者さんの「価値」に変えることを目指すグローバルライフサイエンス企業です。私たちは、がんや、眼科・泌尿器疾患、免疫、ウィメンズヘルスなどの多様な領域において、革新的な治療法を提供しています。研究開発プログラムを通じて、アンメットメディカルニーズの高い疾患領域において新たなヘルスケアソリューションを開拓しています。アステラス製薬の詳細については、www.astellas.comをご覧ください。XTANDIに関するPfizerとアステラス製薬の提携について2009年10月、現在はPfizerの子会社である Medivation, Inc.とアステラス製薬は、米国でXTANDITM(エンザルタミド)を共同で開発および商業化するための商業契約を締結しました。アステラス製薬は、米国外での商業化と、グローバルでの製造およびすべての追加の規制当局への申請を担っています。Pfizerは、米国での利益の一部であるアライアンス収益として受け取り、米国外での販売に対してはロイヤリティを受け取っています。注意事項このプレスリリースに記載されている現在の計画、予想、戦略、想定に関する記述およびその他の過去の事実ではない記述は、アステラス製薬の業績等に関する将来の見通しです。これらの記述は経営陣の現在入手可能な情報に基づく見積りや想定によるものであり、既知および未知のリスクと不確実な要素を含んでいます。さまざまな要因によって、これら将来の見通しは実際の結果と大きく異なる可能性があります。その要因としては、（i）医薬品市場における事業環境の変化および関係法規制の改正、（ii）為替レートの変動、（iii）新製品発売の遅延、（iv）新製品および既存品の販売活動において期待した成果を得られない可能性、（v）競争力のある新薬を継続的に生み出すことができない可能性、（vi）第三者による知的財産の侵害等がありますが、これらに限定されるものではありません。また、このプレスリリースに含まれている医薬品（開発中のものを含む）に関する情報は、宣伝広告、医学的アドバイスを目的としているものではありません。 

Astellas and Pfizer’s XTANDI™ (enzalutamide) Shows Long-Ter… 2025年05月23日 09時00分

Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30%After a median follow-up of 61.4 months, treatment with (XTANDI) enzalutamide plus ADT was associated with a 66% probability of survival at five years compared to 53% probability of survival with placebo plus ADTXTANDI (enzalutamide) is the first and only androgen receptor inhibitor to demonstrate an overall survival benefit at five years in men with metastatic hormone-sensitive prostate cancerData continue to show wide-ranging effect of treatment with XTANDI (enzalutamide) plus ADT across various patient subgroups, notably those with high-volume disease, no prior docetaxel use, and synchronous diseaseLong-term data reinforce XTANDI (enzalutamide) plus ADT as a standard of care TOKYO and NEW YORK, May 22, 2025 — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced longer-term follow-up results from an open-label extension of the Phase 3 ARCHES (NCT02677896) study, reporting a five-year follow up of overall survival (OS) benefits and a 30% reduction in the risk of death in men with metastatic hormone-sensitive prostate cancer (mHSPC) treated with XTANDI™ (enzalutamide), an androgen receptor pathway inhibitor (ARPI), plus androgen deprivation therapy (ADT) compared to placebo plus ADT. These data will be presented during an oral presentation (Abstract #5005) at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Tuesday, June 3, 9:45 a.m.- 12:45 p.m. US CT).“Historically, the likelihood of survival at five years for men with metastatic hormone-sensitive prostate cancer was low, but with advancements in initial treatment intensification like what we’ve seen with XTANDI, this is now becoming the standard,” said Andrew J. Armstrong, MD, ScM, Director of Research at the Center for Prostate & Urologic Cancers, Duke Cancer Institute, Durham, NC, and ARCHES primary investigator. “In our five-year follow up of the global ARCHES trial, two-thirds of men are now surviving five years, representing a 13% absolute and 30% relative improvement over standard hormonal therapy alone, with benefits in patients with high and low disease burden that are meaningful to our patients.”In patients with high-volume disease (HR: 0.70; 95% CI: 0.56-0.88) a 36-month improvement in median OS was observed. Additional clinically relevant subgroups of patients were evaluated, showing consistently improved survival: low-volume disease (HR: 0.71; 95% CI, 0.49-1.05); patients who had previously received docetaxel therapy (HR: 0.67; 95% CI, 0.43- 1.05) and those who had not received prior docetaxel therapy (HR: 0.71; 95% CI, 0.57-0.88). The incidence of treatment-emergent adverse events in the five-year follow-up is consistent with prior ARCHES analyses and no new safety signals were identified.“The survival benefits of intervention with XTANDI in advanced prostate cancer are well-recognized,” added Shontelle Dodson, Executive Vice President, Head of Medical Affairs, Astellas. “The collective – and growing – body of data for XTANDI continues to reinforce its long-term efficacy and patient impact in prostate cancer, including in the metastatic setting, and shows that XTANDI is changing the trajectory of those living with the disease.”These results of the five-year follow-up from the ARCHES study will be submitted for publication in a peer-reviewed journal in the near future.“Until recently, patients with metastatic hormone-sensitive prostate cancer faced a poor prognosis, particularly in advanced stages, often due to treatment resistance,” said Johanna Bendell, M.D., Oncology Chief Development Officer, Pfizer. “As the only androgen receptor inhibitor demonstrating sustained five-year survival in this patient population, these data further reinforce XTANDI combined with androgen deprivation therapy as the standard-of-care for treating this advanced disease.”In addition to five-year data from the follow-up ARCHES study, eight-year data from the ENZAMET study assessing outcomes of enzalutamide versus non-steroidal anti-androgen (NSAA) – both plus testosterone suppression with or without docetaxel – in mHSPC will also be presented during a poster session at ASCO (Monday, June 2, 9:00 a.m. US CT). This independent, Phase 3 trial sponsored by the University of Sydney (NCT02446405), led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP), demonstrated a reduction in risk of death in men with mHSPC.“Data from the eight-year follow-up of XTANDI are highly encouraging, as they show the progression-free survival and overall survival benefits are sustained out to at least eight years,” said Christopher Sweeney, MBBS, DHS, FRACP, ANZUP Cancer Trials Group Limited, Sydney, Australia, and ENZAMET follow-up primary investigator. “These results further support the value of XTANDI as a treatment regimen for metastatic hormone-sensitive prostate cancer.”With a median follow-up of 98 months, patients with mHSPC were treated with XTANDI plus testosterone suppression or NSAA plus testosterone suppression, each group with or without docetaxel. The median OS in the XTANDI group was 8.0 years and 5.8 years in the NSAA group (HR: 0.73; 95% CI, 0.63-0.86). OS at 96 months was 50% with XTANDI and 40% for NSAA; progression-free survival (PFS) also favored XTANDI over NSAA (HR: 0.49; 95% CI, 0.42-0.57). Prostate cancer accounted for 468 of all 622 deaths and were less frequent among those assigned XTANDI than NSAA (207 versus 261). Other causes accounted for a total of 154 deaths and were similarly frequent among those assigned XTANDI versus NSAA (78 versus 76). Mean duration of treatment was longer for XTANDI (58 months) than NSAA (36 months), with 33% remaining on XTANDI and 88% of these patients remained at the full dose of 160 mg.XTANDI is currently approved in more than 90 countries, including in the United States, European Union and Japan. Since its initial approval in 2012, over one million patients have been treated with XTANDI globally.1 About Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Metastatic hormone-sensitive prostate cancer, also known as metastatic castration-sensitive prostate cancer, refers to prostate cancer that still responds to hormonal therapy and has spread outside of the prostate gland to other parts of the body, such as the lymph nodes, bones, lungs and liver.2About the ARCHES StudyThe Phase 3, randomized, double-blind, placebo-controlled, multi-national trial enrolled 1,150 patients with metastatic hormone-sensitive prostate cancer (mHSPC) at sites in the United States, Canada, Europe, South America and the Asia-Pacific region. Patients in the ARCHES trial were randomized to receive XTANDI 160 mg daily or placebo and continued on a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist or had a history of bilateral orchiectomy. The ARCHES trial included patients with both low- and high-volume disease and both newly diagnosed patients with mHSPC and patients who had prior definitive therapy and subsequently developed metastatic disease. The trial also included some patients who had received recent treatment with docetaxel for mHSPC, but whose disease had not progressed. The primary endpoint of the trial was radiographic progression-free survival (rPFS), defined as the time from randomization to the first objective evidence of radiographic disease progression as assessed by central review, or death within 24 weeks of treatment discontinuation.In addition to the key secondary endpoint of overall survival at final analysis, a post hoc 5-year analysis was executed with the intent to further quantify long-term overall survival at a clinically meaningful landmark follow-up of five years.For more information on the global ARCHES trial, go to www.clinicaltrials.gov.About ENZAMETENZAMET is a trial led by ANZUP Cancer Trials Group Limited in collaboration with the NHMRC (National Health and Medical Research Council) Clinical Trials Centre at the University of Sydney with trial sites in Australia, Canada, Ireland, New Zealand, UK and United States. The trial evaluates the potential of enzalutamide plus androgen deprivation therapy (ADT) versus a conventional non-steroidal anti androgen (NSAA) plus ADT in 1,125 men with mHSPC. The primary endpoint for the trial is overall survival (OS). Additional details about ENZAMET (NCT02446405) are available on www.clinicaltrials.gov. Astellas provided funding and support for the ENZAMET trial.About XTANDI™ (enzalutamide)XTANDI (enzalutamide) is an androgen receptor signaling inhibitor. XTANDI is a standard of care and has received regulatory approvals in one or more countries around the world for use in men with metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC) and non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). XTANDI is currently approved for one or more of these indications in more than 90 countries, including in the United States, European Union and Japan. Over one million patients have been treated with XTANDI globally.1About XTANDI (enzalutamide) and Important Safety InformationXTANDI (enzalutamide) is indicated for the treatment of patients with:• castration-resistant prostate cancer (CRPC)• metastatic castration-sensitive prostate cancer (mCSPC)• nonmetastatic castration sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR)Important Safety InformationWarnings and PrecautionsSeizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo.Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI.Dysphagia or Choking Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets.Adverse Reactions (ARs)In the data from the five randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher ARs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to ARs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients.Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia.Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.Drug InteractionsEffect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI.Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI.Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites.About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.About Pfizer OncologyAt Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives.About the Pfizer/Astellas CollaborationIn October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize XTANDI (enzalutamide). The companies jointly commercialize XTANDI in the United States, and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.Astellas Forward-Looking StatementIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.Pfizer Disclosure NoticeThe information contained in this release is as of May 22, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.This release contains forward-looking information about XTANDI (enzalutamide) and a new indication in the U.S. for the treatment of patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis (high-risk BCR), including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of XTANDI; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether the EMBARK trial will meet the secondary endpoint of overall survival; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications for XTANDI may be filed in other jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be pending or filed for XTANDI (including the application pending with the European Medicines Agency), which will depend on a myriad of factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether XTANDI for any potential indication will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety, and/or other matters that could affect the availability or commercial potential of XTANDI, including for the new indication; dependence on the efforts and funding by Astellas Pharma Inc. for the development, manufacturing and commercialization of XTANDI; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.1 Astellas. Data on File. XTANDI patient. January 2023.2 Sartor, O., de Bono, J., Chi, K. N., Fizazi, K., Herrmann, K., Piulats, J. M., ... & Hussain, M. (2021). Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. New England Journal of Medicine, 385(12), 1091-1103. Click below for a copy of the full press release 

2025年米国臨床腫瘍学会（ASCO）年次総会においてがん領域ポー… 2025年05月20日 09時00分

　アステラス製薬株式会社（本社：東京、代表取締役社長CEO：岡村 直樹、以下「アステラス製薬」）は、5月30日から6月3日にかけて開催される2025年米国臨床腫瘍学会（American Society of Clinical Oncology：ASCO）年次総会において、承認取得済みのがん治療薬を含む革新的ながん領域ポートフォリオ全体に関する新たなデータを発表します。口頭発表2件を含む全16件の発表は、アステラス製薬ががん領域の未来を切り拓くことに注力し、患者さんにとって真に価値のある成果に焦点を当てている姿勢を示すものです。　今回の発表には、エンザルタミドの全生存期間（Overall Survival：OS）に関する新たな解析データと、エンホルツマブ　ベドチンに関する2つの解析データが含まれており、発表データは、それぞれ転移性、非転移性、去勢抵抗性、またはホルモン感受性の前立腺がん患者さん、ならびに切除不能な局所進行性または転移性尿路上皮がん患者さんにおける、これら治療薬による治療継続の可能性を示すものです。主な発表は以下の通りです。OSデータの最新情報にフォーカスし、エンザルタミドおよびエンホルツマブ　ベドチンが患者さんにもたらす価値を紹介します。■エンザルタミド転移性ホルモン感受性前立腺がん（metastatic hormone sensitive prostate cancer ：mHSPC）患者を対象とした、エンザルタミド＋アンドロゲン除去療法に関するARCHES試験のOS解析について口頭発表を行います。アステラス製薬は、エンザルタミドの医師主導治験も支援しており、ARCHES試験の5年間の追跡調査に加え、オーストラリア・ニュージーランド泌尿器・生殖器および前立腺がん治験グループ（Australian and New Zealand Urogenital and Prostate Cancer Trials Group：ANZUP）が主導する独立した医師主導治験（ENZAMET試験）から得られたmHSPCにおけるエンザルタミドと、非ステロイド性抗アンドロゲン治療剤の転帰を比較した8年間のデータも発表します。■エンホルツマブ　ベドチン尿路上皮がん治療歴のない局所進行性または転移性尿路上皮がん（locally advanced or metastatic urothelial cancer: la/mUC）患者を対象として、エンホルツマブ　ベドチンとペムブロリズマブの併用療法と化学療法を比較する第III相EV-302試験における2つの解析：奏効例の探索的解析に関する口頭発表長期間に及ぶサブグループ解析に関するポスター発表膀胱がん筋層浸潤性膀胱がんの臨床試験における代替エンドポイントに関する系統的なレビュー、およびメタ分析の結果を紹介するポスター発表2025年ASCO年次総会におけるアステラス製薬の発表演題（現地時間）エンザルタミド Presentation TitleLead AuthorPresentation DetailsARCHES 5-year follow-up overall survival analysis of enzalutamide plus androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer A. ArmstrongType: Oral PresentationAbstract Number: 5005Date: June 3, 2025, 9:45am – 12:45pm CDTCardiovascular event risk in patients with metastatic castration-resistant prostate cancer treated with enzalutamide or abiraterone acetate in the United States A. BryceType: Poster PresentationAbstract Number: 5041Date: June 2, 2025, 9:00am – 12:00pm CDTSecondary outcomes by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer treated with enzalutamide monotherapy: EMBARK post hoc analysisS. FreedlandType: Poster PresentationAbstract Number: 5103Date: June 2, 2025, 9:00am – 12:00pm CDTHow low do you need to go? Association between various prostate-specific antigen response measures and clinical outcomes in metastatic castration‑sensitive prostate cancer in the Veteran Health Administration dataS. FreedlandType: Poster PresentationAbstract Number: 5092Date: June 2, 2025, 9:00am – 12:00pm CDTAbiraterone acetate is associated with shorter overall survival than enzalutamide in patients with chemotherapy naïve metastatic castration-resistant prostate cancer: Real world data from the Flatiron electronic health records databaseD. GeorgeType: E-Publication OnlyAbstract Number for Publication: e17033Secondary outcomes by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer (treated with enzalutamide plus leuprolide (combo): EMBARK post hoc analysisN. ShoreType: E-Publication OnlyAbstract Number for Publication: e17127Corticosteroid Use and Risk of Adverse Events in Patients Treated for Metastatic Hormone-Sensitive Prostate CancerU. SwamiType: E-Publication OnlyAbstract Number for Publication: e17097エンホルツマブ　ベドチンPresentation TitleLead AuthorPresentation DetailsEV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab vs chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma J. BedkeType: Poster PresentationAbstract Number: 4571Date: June 2, 2025, 9:00am – 12:00pm CDTExploratory analysis of responders from the phase 3 EV-302 trial of enfortumab vedotin plus pembrolizumab vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma S. GuptaType: Oral PresentationAbstract Number: 4502Date: June 1, 2025, 9:45am – 12:45pm CDTEvaluation of surrogate endpoints in muscle-invasive bladder cancer: A systematic review and meta-analysisM. GalskyType: Poster PresentationAbstract Number: 4580Date: June 2, 2025, 9:00am – 12:00pm CDTStudy EV-103 Cohort H: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle-invasive bladder cancer: 3-year efficacy resultsN. MarType: Poster PresentationAbstract Number: 4583Date: June 2, 2025, 9:00am – 12:00pm CDTRecent trends in US real-world first-line treatment patterns for patients with locally advanced or metastatic urothelial carcinoma G. SonpavdeType: E-Publication OnlyAbstract Number for Publication: e16556Patient and clinician expert perspectives on the impactful symptoms of head and neck squamous cell carcinoma and its treatmentE. TheodorouType: E-Publication OnlyAbstract Number for Publication: e18001ゾルベツキシマブPresentation TitleLead AuthorPresentation DetailsA real-world study on epidemiology, biomarker test results, clinical characteristics, and treatment patterns of unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma in ChinaY. ChenType: E-Publication OnlyAbstract Number for Publication: e16013ギルテリチニブPresentation TitleLead AuthorPresentation DetailsReal-world adherence and tolerability of FLT3 inhibitors s post-allogeneic transplant maintenance therapy in older adults with AML: A Medicare claims cohort studyV. KennedyType: E-Publication OnlyAbstract Number: e18505パイプラインPresentation TitleLead AuthorPresentation DetailsTrial in progress: Phase 1 study of the selective protein degrader ASP4396 in patients with locally advanced or metastatic solid tumors with KRAS G12D mutationShiraj SenType: Poster PresentationAbstract Number: TPS3178Date: June 2, 2025, 1:30 – 4:30pm CDT 以上 アステラス製薬株式会社についてアステラス製薬は、科学の進歩を患者さんの「価値」に変えることを目指すグローバルライフサイエンス企業です。私たちは、がんや、眼科・泌尿器疾患、免疫、ウィメンズヘルスなどの多様な領域において、革新的な治療法を提供しています。研究開発プログラムを通じて、アンメットメディカルニーズの高い疾患領域において新たなヘルスケアソリューションを開拓しています。アステラス製薬の詳細については、www.astellas.comをご覧ください。PADCEVに関するPfizer、Merck & Co., Inc., Rahway, NJ, USAとの提携についてPfizerとアステラス製薬は、治療歴のない転移性尿路上皮がん患者を対象に、PADCEVTM（エンホルツマブ　ベドチン）とMerck & Co., Inc., Rahway, NJ, USA（米国とカナダ以外ではMSD）のKEYTRUDA®（ペムブロリズマブ）の併用療法を評価するために、臨床開発の提携契約を締結しています。KEYTRUDA®はMerck & Co., Inc., Rahway, NJ, USAの子会社であるMerck Sharp & Dohme Corp.の登録商標です。XTANDIに関するPfizer とアステラス製薬の提携について2009 年 10 月、現在は Pfizer(NYSE:PFE)の子会社である Medivation, Inc.とアステラス製薬(TSE:4503)は、米国で XTANDI®(エンザルタミド)を共同で開発および商業化するための商業契約を締結しました。アステラス製薬は、米国外での商業化と、グローバルでの製造およびすべての追加の規制当局への申請を担っています。Pfizerは、米国での利益の一部であるアライアンス収益として受け取り、米国外での販売に対してはロイヤリティを受け取っています。注意事項このプレスリリースに記載されている現在の計画、予想、戦略、想定に関する記述およびその他の過去の事実ではない記述は、アステラス製薬の業績等に関する将来の見通しです。これらの記述は経営陣の現在入手可能な情報に基づく見積りや想定によるものであり、既知および未知のリスクと不確実な要素を含んでいます。さまざまな要因によって、これら将来の見通しは実際の結果と大きく異なる可能性があります。その要因としては、（i）医薬品市場における事業環境の変化および関係法規制の改正、（ii）為替レートの変動、（iii）新製品発売の遅延、（iv）新製品および既存品の販売活動において期待した成果を得られない可能性、（v）競争力のある新薬を継続的に生み出すことができない可能性、（vi）第三者による知的財産の侵害等がありますが、これらに限定されるものではありません。また、このプレスリリースに含まれている医薬品（開発中のものを含む）に関する情報は、宣伝広告、医学的アドバイスを目的としているものではありません。 

Astellas Presents New Data that Explores Potential of its C… 2025年05月20日 09時00分

16 abstracts, including two oral presentations, feature new clinical data from Astellas’ oncology portfolioTOKYO, May 19, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) will present 16 abstracts featuring new data across its approved cancer therapies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3). The research underscores Astellas’ dedication as a pioneer in oncology and focus on clinical outcomes that matter to patients.The abstracts include new post hoc analyses of long-term overall survival (OS) data for XTANDI (enzalutamide) and two analyses for PADCEV (enfortumab vedotin), which demonstrate how these standard-of-care medicines can continue to treat patients in metastatic, non-metastatic, castration-resistant, or hormone-sensitive prostate cancer patients and unresectable, locally advanced or metastatic urothelial cancer patients, respectively.Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas“At Astellas, we are dedicated to transforming cancer care through innovative treatment approaches. The data we will present at ASCO this year, including new long-term follow-up data for advanced prostate and bladder cancers, reflect the pioneering role we continue to play in delivering outcomes that matter to patients. We continue to push the boundaries of cancer treatment with our growing pipeline, using novel modalities and precision medicine approaches, to benefit all eligible patients now and in the future.” Highlights from Astellas at the 2025 ASCO Annual Meeting will include a strong focus on Overall Survival (OS) data updates, confirming the value that these therapies bring to patients:Enzalutamide:The ARCHES five-year follow-up OS analysis of enzalutamide plus androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) will be featured in an oral presentationIn addition to the ARCHES five-year follow-up presentation, Astellas is supporting investigator-sponsored studies. Eight-year data assessing outcomes of enzalutamide vs non-steroidal anti-androgen (NSAA) in mHSPC will be presented from an independent, investigator-sponsored trial (ENZAMET) led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP).Enfortumab vedotinUrothelial carcinomaTwo analyses of the phase 3 EV-302 study of enfortumab vedotin in combination with pembrolizumab vs chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC)Exploratory analysis of responders will be presented in an oral presentationPoster presentation featuring long-term subgroup analysisBladder cancerA systematic review and meta-analysis of surrogate endpoints in muscle-invasive bladder cancer trials will be featured in a poster presentation.Shontelle Dodson, Executive Vice President, Head of Medical Affairs, Astellas “Long-term overall survival is the gold standard endpoint in cancer research. New post hoc analysis data from the ARCHES enzalutamide trial demonstrates our mission to help patients live longer, healthier lives. We are committed to maximizing the impact of our therapies as we continue to pioneer the oncology medicines of tomorrow.”Astellas Presentations at 2025 ASCO Annual MeetingEnzalutamide Presentation TitleLead AuthorPresentation DetailsARCHES 5-year follow-up overall survival analysis of enzalutamide plus androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancerA. ArmstrongType: Oral PresentationAbstract Number: 5005Date: June 3, 2025, 9:45am – 12:45pm CDT Cardiovascular event risk in patients with metastatic castration-resistant prostate cancer treated with enzalutamide or abiraterone acetate in the United States A. BryceType: Poster PresentationAbstract Number: 5041Date: June 2, 2025, 9:00am – 12:00pm CDTSecondary outcomes by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer treated with enzalutamide monotherapy: EMBARK post hoc analysisS. FreedlandType: Poster PresentationAbstract Number: 5103Date: June 2, 2025, 9:00am – 12:00pm CDTHow low do you need to go? Association between various prostate-specific antigen response measures and clinical outcomes in metastatic castration‑sensitive prostate cancer in the Veteran Health Administration dataS. FreedlandType: Poster PresentationAbstract Number: 5092Date: June 2, 2025, 9:00am – 12:00pm CDTAbiraterone acetate is associated with shorter overall survival than enzalutamide in patients with chemotherapy naïve metastatic castration-resistant prostate cancer: Real world data from the Flatiron electronic health records databaseD. GeorgeType: E-Publication OnlyAbstract Number for Publication: e17033Secondary outcomes by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer (treated with enzalutamide plus leuprolide (combo): EMBARK post hoc analysisN. ShoreType: E-Publication OnlyAbstract Number for Publication: e17127Corticosteroid Use and Risk of Adverse Events in Patients Treated for Metastatic Hormone-Sensitive Prostate CancerU. SwamiType: E-Publication OnlyAbstract Number for Publication: e17097Enfortumab vedotinPresentation TitleLead AuthorPresentation DetailsEV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab vs chemotherapy in previously untreated locally advanced or metastatic urothelial carcinomaJ. BedkeType: Poster PresentationAbstract Number: 4571Date: June 2, 2025, 9:00am – 12:00pm CDTExploratory analysis of responders from the phase 3 EV-302 trial of enfortumab vedotin plus pembrolizumab vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma S. GuptaType: Oral PresentationAbstract Number: 4502Date: June 1, 2025, 9:45am – 12:45pm CDTEvaluation of surrogate endpoints in muscle-invasive bladder cancer: A systematic review and meta-analysisM. GalskyType: Poster PresentationAbstract Number: 4580Date: June 2, 2025, 9:00am – 12:00pm CDTStudy EV-103 Cohort H: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle-invasive bladder cancer: 3-year efficacy resultsN. MarType: Poster PresentationAbstract Number: 4583Date: June 2, 2025, 9:00am – 12:00pm CDTRecent trends in US real-world first-line treatment patterns for patients with locally advanced or metastatic urothelial carcinoma G. SonpavdeType: E-Publication OnlyAbstract Number for Publication: e16556Patient and clinician expert perspectives on the impactful symptoms of head and neck squamous cell carcinoma and its treatmentE. TheodorouType: E-Publication OnlyAbstract Number for Publication: e18001ZolbetuximabPresentation TitleLead AuthorPresentation DetailsA real-world study on epidemiology, biomarker test results, clinical characteristics, and treatment patterns of unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma in ChinaY. ChenType: E-Publication OnlyAbstract Number for Publication: e16013GilteritinibPresentation TitleLead AuthorPresentation DetailsReal-world adherence and tolerability of FLT3 inhibitors s post-allogeneic transplant maintenance therapy in older adults with AML: A Medicare claims cohort studyV. KennedyType: E-Publication OnlyPipelinePresentation TitleLead AuthorPresentation DetailsTrial in progress: Phase 1 study of the selective protein degrader ASP4396 in patients with locally advanced or metastatic solid tumors with KRAS G12D mutationShiraj SenType: Poster PresentationAbstract Number: TPS3178Date: June 2, 2025, 1:30 – 4:30pm CDT About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.About PADCEV and the Astellas, Pfizer and Merck CollaborationAstellas and Pfizer have a clinical collaboration agreement with Merck to evaluate the combination of Astellas' and Pfizer's PADCEV (enfortumab vedotin) and Merck's KEYTRUDA (pembrolizumab) in patients with previously untreated metastatic urothelial cancer. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada).About XTANDI and the Pfizer/Astellas CollaborationIn October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a commercial agreement to jointly develop and commercialize XTANDI® (enzalutamide) in the United States, while Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing the product outside the United States. Pfizer receives alliance revenues as a share of U.S. profits and receives royalties on sales outside the U.S.XTANDI Important Safety InformationWarnings and PrecautionsSeizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo.Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females.XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI.Dysphagia or Choking Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets.Adverse Reactions (ARs)In the data from the five randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.In AFFIRM, the placebo-controlled study of metastatic CRPC (mCRPC) patients who previously received docetaxel, Grade 3 and higher ARs were reported among 47% of XTANDI-treated patients.Discontinuations due to ARs were reported for 16% of XTANDI-treated patients. In PREVAIL, the placebo-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to ARs were reported for 6% of XTANDI-treated patients. In TERRAIN, the bicalutamide-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 39% of XTANDI patients and 38% of bicalutamide patients. Discontinuations with an AR as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients.In PROSPER, the placebo-controlled study of nonmetastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients.Discontinuations with an AR as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients.In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher ARs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to ARs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients.In EMBARK, the placebo-controlled study of nonmetastatic CSPC (nmCSPC) with high-risk biochemical recurrence (BCR) patients, Grade 3 or higher adverse reactions during the total duration of treatment were reported in 46% of patients treated with XTANDI plus leuprolide, 50% of patients receiving XTANDI as a single agent, and 43% of patients receiving placebo plus leuprolide. Permanent treatment discontinuation due to adverse reactions during the total duration of treatment as the primary reason was reported in 21% of patients treated with XTANDI plus leuprolide, 18% of patients receiving XTANDI as a single agent, and 10% of patients receiving placebo plus leuprolide.Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia.Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14% of XTANDI patients and 7% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.Drug InteractionsEffect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI.Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI.Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites.Full Prescribing InformationPADCEV Important Safety InformationWarnings and PrecautionsSkin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV. SJS and TEN occurred predominantly during the first cycle of treatment but may occur later. Skin reactions occurred in 70% (all grades) of the 564 patients treated with PADCEV in combination with pembrolizumab in clinical trials. When PADCEV was given in combination with pembrolizumab, the incidence of skin reactions, including severe events, occurred at a higher rate compared to PADCEV as a single agent. The majority of the skin reactions that occurred with combination therapy included maculo-papular rash, macular rash and papular rash. Grade 3-4 skin reactions occurred in 17% of patients (Grade 3: 16%, Grade 4: 1%), including maculo-papular rash, bullous dermatitis, dermatitis, exfoliative dermatitis, pemphigoid, rash, erythematous rash, macular rash, and papular rash. A fatal reaction of bullous dermatitis occurred in one patient (0.2%). The median time to onset of severe skin reactions was 1.7 months (range: 0.1 to 17.2 months). Skin reactions led to discontinuation of PADCEV in 6% of patients.Skin reactions occurred in 58% (all grades) of the 720 patients treated with PADCEV as a single agent in clinical trials. Twenty-three percent (23%) of patients had maculo-papular rash and 34% had pruritus. Grade 3-4 skin reactions occurred in 14% of patients, including maculo-papular rash, erythematous rash, rash or drug eruption, symmetrical drug-related intertriginous and flexural exanthema (SDRIFE), bullous dermatitis, exfoliative dermatitis, and palmar-plantar erythrodysesthesia. The median time to onset of severe skin reactions was 0.6 months (range: 0.1 to 8 months). Among patients experiencing a skin reaction leading to dose interruption who then restarted PADCEV (n=75), 24% of patients restarting at the same dose and 24% of patients restarting at a reduced dose experienced recurrent severe skin reactions. Skin reactions led to discontinuation of PADCEV in 3.1% of patients.Monitor patients closely throughout treatment for skin reactions. Consider topical corticosteroids and antihistamines, as clinically indicated. For persistent or recurrent Grade 2 skin reactions, consider withholding PADCEV until Grade ≤1. Withhold PADCEV and refer for specialized care for suspected SJS, TEN or for Grade 3 skin reactions. Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions.Hyperglycemia and diabetic ketoacidosis (DKA), including fatal events, occurred in patients with and without pre-existing diabetes mellitus, treated with PADCEV. Patients with baseline hemoglobin A1C ≥8% were excluded from clinical trials. In clinical trials of PADCEV as a single agent, 17% of the 720 patients treated with PADCEV developed hyperglycemia of any grade; 7% of patients developed Grade 3-4 hyperglycemia (Grade 3: 6.5%, Grade 4: 0.6%). Fatal events of hyperglycemia and DKA occurred in one patient each (0.1%). The incidence of Grade 3-4 hyperglycemia increased consistently in patients with higher body mass index and in patients with higher baseline A1C. The median time to onset of hyperglycemia was 0.5 months (range: 0 to 20 months). Hyperglycemia led to discontinuation of PADCEV in 0.7% of patients. Five percent (5%) of patients required initiation of insulin therapy for treatment of hyperglycemia. Of the patients who initiated insulin therapy for treatment of hyperglycemia, 66% (23/35) discontinued insulin at the time of last evaluation. Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. If blood glucose is elevated (>250 mg/dL), withhold PADCEV.Pneumonitis/Interstitial Lung Disease (ILD) Severe, life-threatening or fatal pneumonitis/ILD occurred in patients treated with PADCEV. When PADCEV was given in combination with pembrolizumab, 10% of the 564 patients treated with combination therapy had pneumonitis/ILD of any grade and 4% had Grade 3-4. A fatal event of pneumonitis/ILD occurred in two patients (0.4%). The incidence of pneumonitis/ILD, including severe events, occurred at a higher rate when PADCEV was given in combination with pembrolizumab compared to PADCEV as a single agent. The median time to onset of any grade pneumonitis/ILD was 4 months (range: 0.3 to 26 months).In clinical trials of PADCEV as a single agent, 3% of the 720 patients treated with PADCEV had pneumonitis/ILD of any grade and 0.8% had Grade 3-4. The median time to onset of any grade pneumonitis/ILD was 2.9 months (range: 0.6 to 6 months).Monitor patients for signs and symptoms indicative of pneumonitis/ILD such as hypoxia, cough, dyspnea or interstitial infiltrates on radiologic exams. Evaluate and exclude infectious, neoplastic and other causes for such signs and symptoms through appropriate investigations. Withhold PADCEV for patients who develop Grade 2 pneumonitis/ILD and consider dose reduction. Permanently discontinue PADCEV in all patients with Grade 3 or 4 pneumonitis/ILD.Peripheral neuropathy (PN) When PADCEV was given in combination with pembrolizumab, 67% of the 564 patients treated with combination therapy had PN of any grade, 36% had Grade 2 neuropathy, and 7% had Grade 3 neuropathy. The incidence of PN occurred at a higher rate when PADCEV was given in combination with pembrolizumab compared to PADCEV as a single agent. The median time to onset of Grade ≥2 PN was 6 months (range: 0.3 to 25 months).PN occurred in 53% of the 720 patients treated with PADCEV as a single agent in clinical trials including 38% with sensory neuropathy, 8% with muscular weakness and 7% with motor neuropathy. Thirty percent of patients experienced Grade 2 reactions and 5% experienced Grade 3-4 reactions. PN occurred in patients treated with PADCEV with or without preexisting PN. The median time to onset of Grade ≥2 PN was 4.9 months (range: 0.1 to 20 months). Neuropathy led to treatment discontinuation in 6% of patients.Monitor patients for symptoms of new or worsening PN and consider dose interruption or dose reduction of PADCEV when PN occurs. Permanently discontinue PADCEV in patients who develop Grade ≥3 PN.Ocular disorders were reported in 40% of the 384 patients treated with PADCEV as a single agent in clinical trials in which ophthalmologic exams were scheduled. The majority of these events involved the cornea and included events associated with dry eye such as keratitis, blurred vision, increased lacrimation, conjunctivitis, limbal stem cell deficiency, and keratopathy. Dry eye symptoms occurred in 30% of patients, and blurred vision occurred in 10% of patients, during treatment with PADCEV. The median time to onset to symptomatic ocular disorder was 1.7 months (range: 0 to 30.6 months). Monitor patients for ocular disorders. Consider artificial tears for prophylaxis of dry eyes and ophthalmologic evaluation if ocular symptoms occur or do not resolve. Consider treatment with ophthalmic topical steroids, if indicated after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV for symptomatic ocular disorders.Infusion site extravasation Skin and soft tissue reactions secondary to extravasation have been observed after administration of PADCEV. Of the 720 patients treated with PADCEV as a single agent in clinical trials, 1% of patients experienced skin and soft tissue reactions, including 0.3% who experienced Grade 3-4 reactions. Reactions may be delayed. Erythema, swelling, increased temperature, and pain worsened until 2-7 days after extravasation and resolved within 1-4 weeks of peak. Two patients (0.3%) developed extravasation reactions with secondary cellulitis, bullae, or exfoliation. Ensure adequate venous access prior to starting PADCEV and monitor for possible extravasation during administration. If extravasation occurs, stop the infusion and monitor for adverse reactions.Embryo-fetal toxicity PADCEV can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during PADCEV treatment and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose.ADVERSE REACTIONSMost common adverse reactions, including laboratory abnormalities (≥20%) (PADCEV in combination with pembrolizumab)Increased aspartate aminotransferase (AST), increased creatinine, rash, increased glucose, PN, increased lipase, decreased lymphocytes, increased alanine aminotransferase (ALT), decreased hemoglobin, fatigue, decreased sodium, decreased phosphate, decreased albumin, pruritus, diarrhea, alopecia, decreased weight, decreased appetite, increased urate, decreased neutrophils, decreased potassium, dry eye, nausea, constipation, increased potassium, dysgeusia, urinary tract infection and decreased platelets.Most common adverse reactions, including laboratory abnormalities (≥20%) (PADCEV monotherapy)Increased glucose, increased AST, decreased lymphocytes, increased creatinine, rash, fatigue, PN, decreased albumin, decreased hemoglobin, alopecia, decreased appetite, decreased neutrophils, decreased sodium, increased ALT, decreased phosphate, diarrhea, nausea, pruritus, increased urate, dry eye, dysgeusia, constipation, increased lipase, decreased weight, decreased platelets, abdominal pain, dry skin.EV-302 Study: 440 patients with previously untreated la/mUC (PADCEV in combination with pembrolizumab)Serious adverse reactions occurred in 50% of patients treated with PADCEV in combination with pembrolizumab. The most common serious adverse reactions (≥2%) were rash (6%), acute kidney injury (5%), pneumonitis/ILD (4.5%), urinary tract infection (3.6%), diarrhea (3.2%), pneumonia (2.3%), pyrexia (2%), and hyperglycemia (2%). Fatal adverse reactions occurred in 3.9% of patients treated with PADCEV in combination with pembrolizumab including acute respiratory failure (0.7%), pneumonia (0.5%), and pneumonitis/ILD (0.2%).Adverse reactions leading to discontinuation of PADCEV occurred in 35% of patients. The most common adverse reactions (≥2%) leading to discontinuation of PADCEV were PN (15%), rash (4.1%) and pneumonitis/ILD (2.3%). Adverse reactions leading to dose interruption of PADCEV occurred in 73% of patients. The most common adverse reactions (≥2%) leading to dose interruption of PADCEV were PN (22%), rash (16%), COVID 19 (10%), diarrhea (5%), pneumonitis/ILD (4.8%), fatigue (3.9%), hyperglycemia (3.6%), increased ALT (3%) and pruritus (2.5%). Adverse reactions leading to dose reduction of PADCEV occurred in 42% of patients. The most common adverse reactions (≥2%) leading to dose reduction of PADCEV were rash (16%), PN (13%) and fatigue (2.7%).EV-103 Study: 121 patients with previously untreated la/mUC who were not eligible for cisplatin-containing chemotherapy (PADCEV in combination with pembrolizumab)Serious adverse reactions occurred in 50% of patients treated with PADCEV in combination with pembrolizumab; the most common (≥2%) were acute kidney injury (7%), urinary tract infection (7%), urosepsis (5%), sepsis (3.3%), pneumonia (3.3%), hematuria (3.3%), pneumonitis/ILD (3.3%), urinary retention (2.5%), diarrhea (2.5%), myasthenia gravis (2.5%), myositis (2.5%), anemia (2.5%), and hypotension (2.5%). Fatal adverse reactions occurred in 5% of patients treated with PADCEV in combination with pembrolizumab, including sepsis (1.6%), bullous dermatitis (0.8%), myasthenia gravis (0.8%), and pneumonitis/ILD (0.8%). Adverse reactions leading to discontinuation of PADCEV occurred in 36% of patients; the most common (≥2%) were PN (20%) and rash (6%). Adverse reactions leading to dose interruption of PADCEV occurred in 69% of patients; the most common (≥2%) were PN (18%), rash (12%), increased lipase (6%), pneumonitis/ILD (6%), diarrhea (4.1%), acute kidney injury (3.3%), increased ALT (3.3%), fatigue (3.3%), neutropenia (3.3%), urinary tract infection (3.3%), increased amylase (2.5%), anemia (2.5%), COVID 19 (2.5%), hyperglycemia (2.5%), and hypotension (2.5%). Adverse reactions leading to dose reduction of PADCEV occurred in 45% of patients; the most common (≥2%) were PN (17%), rash (12%), fatigue (5%), neutropenia (5%), and diarrhea (4.1%).EV-301 Study: 296 patients previously treated with a PD-1/L1 inhibitor and platinum-based chemotherapy (PADCEV monotherapy)Serious adverse reactions occurred in 47% of patients treated with PADCEV; the most common (≥2%) were urinary tract infection, acute kidney injury (7% each), and pneumonia (5%). Fatal adverse reactions occurred in 3% of patients, including multiorgan dysfunction (1%), hepatic dysfunction, septic shock, hyperglycemia, pneumonitis/ILD, and pelvic abscess (0.3% each). Adverse reactions leading to discontinuation occurred in 17% of patients; the most common (≥2%) were PN (5%) and rash (4%). Adverse reactions leading to dose interruption occurred in 61% of patients; the most common (≥4%) were PN (23%), rash (11%), and fatigue (9%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common (≥2%) were PN (10%), rash (8%), decreased appetite, and fatigue (3% each).EV-201, Cohort 2 Study: 89 patients previously treated with a PD-1/L1 inhibitor and not eligible for cisplatin-based chemotherapy (PADCEV monotherapy)Serious adverse reactions occurred in 39% of patients treated with PADCEV; the most common (≥3%) were pneumonia, sepsis, and diarrhea (5% each). Fatal adverse reactions occurred in 8% of patients, including acute kidney injury (2.2%), metabolic acidosis, sepsis, multiorgan dysfunction, pneumonia, and pneumonitis/ILD (1.1% each). Adverse reactions leading to discontinuation occurred in 20% of patients; the most common (≥2%) was PN (7%). Adverse reactions leading to dose interruption occurred in 60% of patients; the most common (≥3%) were PN (19%), rash (9%), fatigue (8%), diarrhea (5%), increased AST, and hyperglycemia (3% each). Adverse reactions leading to dose reduction occurred in 49% of patients; the most common (≥3%) were PN (19%), rash (11%), and fatigue (7%).DRUG INTERACTIONSEffects of other drugs on PADCEV (Dual P-gp and Strong CYP3A4 Inhibitors)Concomitant use with dual P-gp and strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E exposure, which may increase the incidence or severity of PADCEV toxicities. Closely monitor patients for signs of toxicity when PADCEV is given concomitantly with dual P-gp and strong CYP3A4 inhibitors.SPECIFIC POPULATIONSLactation Advise lactating women not to breastfeed during treatment with PADCEV and for 3 weeks after the last dose.Hepatic impairment Avoid the use of PADCEV in patients with moderate or severe hepatic impairment.Full Prescribing InformationVYLOY Important Safety InformationWarnings and PrecautionsHypersensitivity reactions, including serious anaphylaxis reactions, and serious and fatal infusion-related reactions (IRR) have been reported in clinical studies when VYLOY has been administered. Any grade hypersensitivity reactions, including anaphylactic reactions, occurring with VYLOY in combination with mFOLFOX6 or CAPOX was 18%. Severe (Grade 3 or 4) hypersensitivity reactions, including anaphylactic reactions, occurred in 2% of patients. Seven patients (1.3%) permanently discontinued VYLOY for hypersensitivity reactions, including two patients (0.4%) who permanently discontinued VYLOY due to anaphylactic reactions. Seventeen (3.2%) patients required dose interruption, and three patients (0.6%) required infusion rate reduction due to hypersensitivity reactions. All grade IRRs occurred in 3.2% in patients administered VYLOY in combination with mFOLFOX6 or CAPOX. Severe (Grade 3) IRRs occurred in 2 (0.4%) patients who received VYLOY. An IRR led to permanent discontinuation of VYLOY in 2 (0.4%) patients and dose interruption in 7 (1.3%) patients. The infusion rate was reduced for VYLOY for 2 (0.4%) patients due to an IRR. Monitor patients during infusion with VYLOY and for 2 hours after completion of infusion or longer if clinically indicated, for hypersensitivity reactions with symptoms and signs that are highly suggestive of anaphylaxis (urticaria, repetitive cough, wheeze and throat tightness/change in voice). Monitor patients for signs and symptoms of IRRs including nausea, vomiting, abdominal pain, salivary hypersecretion, pyrexia, chest discomfort, chills, back pain, cough and hypertension. If a severe or life-threatening hypersensitivity or IRR reaction occurs, discontinue VYLOY permanently, treat symptoms according to standard medical care, and monitor until symptoms resolve. For any Grade 2 hypersensitivity or IRR, interrupt the VYLOY infusion until Grade ≤1, then resume at a reduced infusion rate for the remaining infusion. Follow Grade 2 management for Grade 3 infusion-related nausea and vomiting. Premedicate the patient with antihistamines for the subsequent infusions, and closely monitor the patient for symptoms and signs of a hypersensitivity reaction. The infusion rate may be gradually increased as tolerated.Severe Nausea and Vomiting. VYLOY is emetogenic. Nausea and vomiting occurred more often during the first cycle of treatment. All grade nausea and vomiting occurred in 82% and 67% respectively of patients treated with VYLOY in combination with mFOLFOX6 and 69% and 66% in combination with CAPOX, respectively. Severe (Grade 3) nausea occurred in 16% and 9% of patients treated with VYLOY in combination with mFOLFOX6 or CAPOX respectively. Severe (Grade 3) vomiting occurred in 16% and 12% of patients treated with VYLOY in combination with mFOLFOX6 or CAPOX. Nausea led to permanent discontinuation of VYLOY in combination with mFOLFOX6 or CAPOX in 18 (3.4%) patients and dose interruption in 147 (28%) patients. Vomiting led to permanent discontinuation of VYLOY in combination with mFOLFOX6 or CAPOX in 20 (3.8%) patients and dose interruption in 150 (28%) patients. Pretreat with antiemetics prior to each infusion of VYLOY. Manage patients during and after infusion with antiemetics or fluid replacement. Interrupt the infusion, or permanently discontinue VYLOY based on severity.ADVERSE REACTIONSMost common adverse reactions (≥15%): Nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, decreased weight, hypersensitivity reactions, and pyrexia.Most common laboratory abnormalities (≥15%): Decreased neutrophil count, decreased leucocyte count, decreased albumin, increased creatinine, decreased hemoglobin, increased glucose, decreased lymphocyte count, increased aspartate aminotransferase, decreased platelets, increased alkaline phosphatase, increased alanine aminotransferase, decreased glucose, decreased sodium, increased phosphate, decreased potassium, and decreased magnesium.SPOTLIGHT Study: 279 patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive who received at least one dose of VYLOY in combination with mFOLFOX6Serious adverse reactions occurred in 45% of patients treated with VYLOY in combination with mFOLFOX6; the most common serious adverse reactions (≥2%) were vomiting (8%), nausea (7%), neutropenia (2.9%), febrile neutropenia (2.9%), diarrhea (2.9%), intestinal obstruction (3.2%), pyrexia (2.5%), pneumonia (2.5%), respiratory failure (2.2%), pulmonary embolism (2.2%), decreased appetite (2.1%) and sepsis (2.0%). Fatal adverse reactions occurred in 5% of patients who received VYLOY in combination with mFOLFOX6 including sepsis (1.4%), pneumonia (1.1%), respiratory failure (1.1%), intestinal obstruction (0.7%), acute hepatic failure (0.4%), acute myocardial infarction (0.4%), death (0.4%), disseminated intravascular coagulation (0.4%), encephalopathy (0.4%), and upper gastrointestinal hemorrhage (0.4%). Permanent discontinuation of VYLOY due to an adverse reaction occurred in 20% of patients; the most common adverse reactions leading to discontinuation (≥2%) were nausea and vomiting. Dosage interruptions of VYLOY due to an adverse reaction occurred in 75% of patients; the most common adverse reactions leading to dose interruption (≥5%) were nausea, vomiting, neutropenia, abdominal pain, fatigue, and hypertension.GLOW Study: 254 patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive who received at least one dose of VYLOY in combination with CAPOXSerious adverse reactions occurred in 47% of patients treated with VYLOY in combination with CAPOX; the most common serious adverse reactions (≥2%) were vomiting (6%), nausea (4.3%), decreased appetite (3.9%), decreased platelet count (3.1%), upper gastrointestinal hemorrhage (2.8%), diarrhea (2.8%), pneumonia (2.4%), pulmonary embolism (2.3%), and pyrexia (2.0%). Fatal adverse reactions occurred in 8% of patients who received VYLOY in combination with CAPOX including sepsis (1.2%), pneumonia (0.4%), death (0.8%), upper gastrointestinal hemorrhage (0.8%), cerebral hemorrhage (0.8%), abdominal infection (0.4%), acute respiratory distress syndrome (0.4%), cardio-respiratory arrest (0.4%), decreased platelet count (0.4%), disseminated intravascular coagulation (0.4%), dyspnea (0.4%), gastric perforation (0.4%), hemorrhagic ascites (0.4%), procedural complication (0.4%), sudden death (0.4%), and syncope (0.4%). Permanent discontinuation of VYLOY due to an adverse reaction occurred in 19% of patients; the most common adverse reaction leading to discontinuation (≥2%) was vomiting. Dosage interruption of VYLOY due to an adverse reaction occurred in 55% of patients; the most common adverse reactions leading to dose interruption (≥2%) were nausea, vomiting, neutropenia, thrombocytopenia, anemia, fatigue, infusion-related reaction, and abdominal pain.SPECIFIC POPULATIONSLactation Advise lactating women not to breastfeed during treatment with VYLOY and for 8 months after the last dose.Full Prescribing InformationXOSPATA Important Safety InformationContraindicationsXOSPATA is contraindicated in patients with hypersensitivity to gilteritinib or any of the excipients. Anaphylactic reactions have been observed in clinical trials.Warnings and PrecautionsDifferentiation Syndrome (See BOXED WARNING) 3% of 319 patients treated with XOSPATA in the clinical trials experienced differentiation syndrome. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated. Symptoms and other clinical findings of differentiation syndrome in patients treated with XOSPATA included fever, dyspnea, pleural effusion, pericardial effusion, pulmonary edema, hypotension, rapid weight gain, peripheral edema, rash, and renal dysfunction. Some cases had concomitant acute febrile neutrophilic dermatosis. Differentiation syndrome occurred as early as 1 day and up to 82 days after XOSPATA initiation and has been observed with or without concomitant leukocytosis. If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. Taper corticosteroids after resolution of symptoms and administer corticosteroids for a minimum of 3 days. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid treatment. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt XOSPATA until signs and symptoms are no longer severe.Posterior Reversible Encephalopathy Syndrome (PRES) 1% of 319 patients treated with XOSPATA in the clinical trials experienced posterior reversible encephalopathy syndrome (PRES) with symptoms including seizure and altered mental status. Symptoms have resolved after discontinuation of XOSPATA. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). Discontinue XOSPATA in patients who develop PRES.Prolonged QT Interval XOSPATA has been associated with prolonged cardiac ventricular repolarization (QT interval). 1% of the 317 patients with a post-baseline QTc measurement on treatment with XOSPATA in the clinical trial were found to have a QTc interval greater than 500 msec and 7% of patients had an increase from baseline QTc greater than 60 msec. Perform electrocardiogram (ECG) prior to initiation of treatment with XOSPATA, on days 8 and 15 of cycle 1, and prior to the start of the next two subsequent cycles. Interrupt and reduce XOSPATA dosage in patients who have a QTcF >500 msec. Hypokalemia or hypomagnesemia may increase the QT prolongation risk. Correct hypokalemia or hypomagnesemia prior to and during XOSPATA administration.Pancreatitis 4% of 319 patients treated with XOSPATA in the clinical trials experienced pancreatitis. Evaluate patients who develop signs and symptoms of pancreatitis. Interrupt and reduce the dose of XOSPATA in patients who develop pancreatitis.Embryo-Fetal Toxicity XOSPATA can cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with XOSPATA and for 6 months after the last dose of XOSPATA. Advise males with female partners of reproductive potential to use effective contraception during treatment with XOSPATA and for 4 months after the last dose of XOSPATA. Pregnant women, patients becoming pregnant while receiving XOSPATA or male patients with pregnant female partners should be apprised of the potential risk to the fetus.Adverse ReactionsFatal adverse reactions occurred in 2% of patients receiving XOSPATA. These were cardiac arrest (1%) and one case each of differentiation syndrome and pancreatitis. The most frequent (≥5%) nonhematological serious adverse reactions reported in patients were fever (13%), dyspnea (9%), renal impairment (8%), transaminase increased (6%) and noninfectious diarrhea (5%).7% discontinued XOSPATA treatment permanently due to an adverse reaction. The most common (>1%) adverse reactions leading to discontinuation were aspartate aminotransferase increased (2%) and alanine aminotransferase increased (2%).The most frequent (≥5%) grade ≥3 nonhematological adverse reactions reported in patients were transaminase increased (21%), dyspnea (12%), hypotension (7%), mucositis (7%), myalgia/arthralgia (7%), and fatigue/malaise (6%).Other clinically significant adverse reactions occurring in ≤10% of patients included: electrocardiogram QT prolonged (9%), hypersensitivity (8%), pancreatitis (5%), cardiac failure (4%), pericardial effusion (4%), acute febrile neutrophilic dermatosis (3%), differentiation syndrome (3%), pericarditis/myocarditis (2%), large intestine perforation (1%), and posterior reversible encephalopathy syndrome (1%).Lab Abnormalities Shifts to grades 3-4 nonhematologic laboratory abnormalities in XOSPATA treated patients included phosphate decreased (14%), alanine aminotransferase increased (13%), sodium decreased (12%), aspartate aminotransferase increased (10%), calcium decreased (6%), creatine kinase increased (6%), triglycerides increased (6%), creatinine increased (3%), and alkaline phosphatase increased (2%).Drug InteractionsCombined P-gp and Strong CYP3A Inducers Concomitant use of XOSPATA with a combined P-gp and strong CYP3A inducer decreases XOSPATA exposure which may decrease XOSPATA efficacy. Avoid concomitant use of XOSPATA with combined P-gp and strong CYP3A inducers.Strong CYP3A inhibitors Concomitant use of XOSPATA with a strong CYP3A inhibitor increases XOSPATA exposure. Consider alternative therapies that are not strong CYP3A inhibitors. If the concomitant use of these inhibitors is considered essential for the care of the patient, monitor patient more frequently for XOSPATA adverse reactions. Interrupt and reduce XOSPATA dosage in patients with serious or life-threatening toxicity.Drugs that Target 5HT2B Receptor or Sigma Nonspecific Receptor Concomitant use of XOSPATA may reduce the effects of drugs that target the 5HT2B receptor or the sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline). Avoid concomitant use of these drugs with XOSPATA unless their use is considered essential for the care of the patient.P-gp, BCRP, and OCT1 Substrates Based on in vitro data, gilteritinib is a P-gp, breast cancer resistant protein (BCRP), and organic cation transporter 1 (OCT1) inhibitor. Coadministration of gilteritinib may increase the exposure of P-gp, BCRP, and OCT1 substrates, which may increase the incidence and severity of adverse reactions of these substrates. For P-gp, BCRP, or OCT1 substrates where small concentration changes may lead to serious adverse reactions, decrease the dose or modify the dosing frequency of such substrate and monitor for adverse reactions as recommended in the respective prescribing information.Specific PopulationsLactation Advise women not to breastfeed during treatment with XOSPATA and for 2 months after the last dose.Full Prescribing InformationCautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release

新しいストーリー「グローバルヘルスへの取り組み」を公開しま… 2025年05月19日 10時00分

Addressing Global Health Challenges 2025年05月19日 10時00分

国内外の当社グループ幹部に対する業績連動型株式報酬制度およ… 2025年05月15日 16時00分

　アステラス製薬株式会社（本社：東京、以下「当社」）は、本日開催の取締役会において、当社の担当役員を対象とする業績連動型株式報酬制度および国内外の当社グループ幹部を対象とする業績連動型株式交付制度（以下両制度併せて「本制度」）を継続すること、および本制度に基づく、2025年度に実施するインセンティブプラン（以下「本プラン」）の詳細を決議しましたので、下記の通りお知らせいたします。記1. 本制度の目的(1) 本制度は、当社の担当役員および国内外の当社グループ幹部を対象とした、当社グループの中長期的な企業価値・株主価値の向上を重視した経営を推進することを目的とする、企業価値・株主価値との連動性が高く、かつ、透明性・客観性の高いグローバル共通の中長期インセンティブプランです。(2) 当社の担当役員を対象とした業績連動型株式報酬制度は、役員報酬BIP（Board Incentive Plan）信託（以下「BIP信託」）と称される仕組みを採用します。BIP信託とは、米国のパフォーマンス・シェア（Performance Share）制度および譲渡制限付株式報酬（Restricted Stock）制度を参考にした役員インセンティブプランであり、BIP信託が当社株式を取得し、企業価値・株主価値の成長度等に応じて担当役員に当該信託から「当社株式の交付等」（下記3．（5）で定義する。以下同じ）を行うものです。　また、国内外の当社グループ幹部を対象とする業績連動型株式交付制度は、株式付与ESOP（Employee Stock Ownership Plan）信託（以下「ESOP信託」）と称される仕組みを採用します。ESOP信託とは、米国のESOP制度を参考にした従業員インセンティブプランであり、ESOP信託が当社株式を取得し、企業価値・株主価値の成長度等に応じて国内外の当社グループ幹部に当該信託から「当社株式の交付等」を行うものです。 2. BIP信託・ESOP信託の仕組み ① 当社および当社グループ会社は、業績連動型株式報酬制度および業績連動型株式交付制度の継続、本制度に基づく本プランの実施および内容に関して取締役会等必要な手続を行います。② 当社は金銭を信託し、受益者要件を充足する当社の担当役員を受益者とする信託「BIP信託」および受益者要件を充足する国内外の当社グループ幹部を受益者とする信託「ESOP信託」（以下「BIP信託」と「ESOP信託」を併せて「本信託」）を設定します。なお、国内外の当社グループ会社は各社の対象人数等に応じて信託金相当額を拠出します。③ 本信託は、信託管理人の指図に従い、②で拠出された金銭を原資として当社株式を株式市場から取得します。④ 本信託内の当社株式に対しても、他の当社株式と同様に配当が行われます。⑤ 本信託内の当社株式については、信託期間を通じ、議決権を行使しないものとします。⑥ 信託期間中、受益者は、当社の株式交付規程に従い、当社株式の交付等を受けます。⑦ 信託期間中の企業価値・株主価値の成長度等により、信託期間の満了時に残余株式が生じた場合、信託契約の変更および追加信託を行うことにより、本制度に基づくインセンティブプランとして本信託を継続利用するか（※1）、または、本信託から当社に当該残余株式を無償譲渡し、当社はこれを無償で取得した上で、取締役会決議によりその消却を行う予定です。⑧ 本信託の終了時に、受益者に分配された後の残余財産は、信託金から株式取得資金を控除した信託費用準備金の範囲内で当社に帰属する予定です。また、信託費用準備金を超過する部分については、当社および当社役員と利害関係のない団体への寄附を行う予定です。（※1）当社の担当役員を対象とした本プランは、2015年度から導入している業績連動型株式報酬制度と同種のインセンティブプランであることから、2022年度に設定した担当役員を対象とする既存の役員報酬BIP信託を継続利用いたします。また、国内外の当社グループ幹部を対象とした本プランは、2020年度から導入している業績連動型株式報酬制度と同種のインセンティブプランであることから、2022年度に設定した国内外の当社グループ幹部を対象とする既存の株式付与ESOP信託を継続利用いたします。 3. 本プランの内容(1) 本プランの概要　本プランは、2026年3月末日で終了する事業年度から2028年3月末日で終了する事業年度までの3年間（以下「対象期間」）を対象として、対象期間を通じた企業価値・株主価値の成長度等に応じて当社株式の交付等を行うインセンティブプランです。　当社は、次年度以降も毎年、新たなBIP信託もしくはESOP信託を設定し、または信託期間の満了した既存のBIP信託もしくはESOP信託の変更および追加信託を行うことにより、本プランと同種のインセンティブプランを継続的に実施することを予定しています。次年度以降に実施するインセンティブプランの内容については、都度、取締役会の決議によって決定します。(2) 本プランの対象者（受益者要件）　2025年4月1日時点に在任する当社の担当役員および国内外の当社グループ幹部（以下「制度対象者」）は、原則として、以下の受益者要件を充足していることを条件に、下記(4)に定めるポイントに応じた数の当社株式の交付等を本信託から受けるものとします。受益者要件は以下の通りです。①対象期間満了日において制度対象者であること②その他本制度の趣旨を達成するために必要と認められる要件を満たしていること(3) 信託期間　本信託の信託期間は2025年5月21日（予定）から2028年8月末日（予定）までとします。なお、信託期間の満了時において、信託契約の変更および追加信託を行うことにより、本プランと同種のインセンティブプランとして本信託を継続することがあります。(4) 制度対象者に交付される当社株式　制度対象者に対して交付される当社株式の数（下記(5)により換価処分の対象となる当社株式の数を含む）は、以下に従って付与されるポイントにより、1ポイント＝当社株式1株(※2)として定まります。（※2）本信託に属する当社株式が株式の分割、株式の無償割当て、株式の併合等によって増加または減少した場合は、当社は1ポイント当たりに交付される当社株式の数を合理的な方法により調整します。　まず、2025年4月1日に制度対象者として在任する者には、以下の算定式に従って基準ポイントが付与されます。（基準ポイントの算定式）　役位・グローバルグレード等に応じ個別に定める基準金額(※3)÷2025年3月の東京証券取引所における当社株式の終値の平均値　*小数点以下の端数は切捨（※3）基準金額の水準は、優秀な人材の獲得・保持が可能となる競争力のある報酬水準となるよう、外部専門機関の客観的な報酬調査データ等を参考に職責等に応じて適切に設定します。 　2028年3月31日に制度対象者として在任する者は、以下の算定式に従って算出されるポイントに応じた数の当社株式の交付等を本信託から受けるものとします。基準ポイント×業績連動係数(※4)　*小数点以下の端数は切捨（※4）本プランの業績連動係数は、対象期間における当社株主総利回り（Total Shareholder Return。以下「TSR*」）と東証株価指数の成長率およびグローバル製薬企業（以下「TSR Peer Group」）のTSRとの比較結果に基づき、0％～200％の範囲で決定します。TSR Peer Groupは、報酬委員会の審議を経た上で取締役会に答申され、2025年6月末日までに決定されます。　*TSR：キャピタルゲインと配当を合わせた株主にとっての総合投資利回り(5) 制度対象者に対する当社株式の交付等の方法および時期　「当社株式の交付等」とは、ある時点において、付与されているポイントに対応する当社株式の数の半数について本信託から株式の交付を受け（ただし、単元未満株数については、本信託内で換価した上、その換価処分金相当額の金銭の給付を受け）、残りの半数については本信託内で換価した上で、その換価処分金相当額の金銭の給付を受けることをいいます。　受益者要件を充足した制度対象者は、2028年6月頃に、当社株式の交付等を受けるものとします。(6) マルス条項およびクローバック条項について　当社および当社グループ会社は、制度対象者による不正行為等があった場合には、当社および当社グループ会社の決定により、株式交付等を受ける権利を喪失させるマルス条項、および当社が予め定めた一部の制度対象者（トップマネジメント等の上位の役職に限る。以下同じ）に対して、重大な会計上の誤りや不正による決算の事後修正が行われた場合または制度対象者による不正行為等があった場合に、当社取締役会の決議により、制度対象者に交付等した当社株式数に相当する金銭の返還を要求することができるクローバック条項を定めています。返還の対象となり得る報酬は、当該事象が発生した事業年度およびその前の3事業年度を対象期間に含む、交付等した当社株式数に相当する金銭の一部または全部です。(7) 本信託による当社株式の取得　本制度の継続にあたり、本信託による株式市場からの当社株式の追加取得は行いません。(8) 本信託内の当社株式に関する議決権行使　本信託内にある当社株式については、経営への中立性を確保するため、信託期間中、議決権を行使しないものとします。(9) 本信託内の当社株式に係る配当の取扱い　本信託内の当社株式に係る配当は、本信託が受領し、本信託の信託報酬および信託費用に充てられます。(10) 信託期間満了時の取扱い　対象期間における企業価値・株主価値の成長度等により、信託期間満了時に残余株式が生じた場合は、信託契約の変更および追加信託を行うことにより、本プランと同種のインセンティブプランとして本信託を継続することがあります。信託期間満了により本信託を終了させる場合には、本信託から当社に当該残余株式の無償譲渡を行い、当社はこれを取締役会決議により消却することを予定しています。　また、信託期間満了時における本信託内の当社株式に係る配当の残余は、本信託を継続利用する場合には株式取得資金として活用されますが、信託期間満了により本信託を終了させる場合には、当社および当社役員と利害関係のない団体への寄附を行う予定です。以上（ご参考）【2025年度インセンティブプランのための信託の内容】 ｢BIP信託｣｢ESOP信託｣① 信託の種類特定単独運用の金銭信託以外の金銭の信託（他益信託）② 信託の目的当社担当役員に対するインセンティブの付与国内外の当社グループ幹部に対するインセンティブの付与③ 委託者当社④ 受託者三菱ＵＦＪ信託銀行株式会社（予定）（共同受託者　日本マスタートラスト信託銀行株式会社）⑤ 受益者当社担当役員のうち受益者要件を充足する者国内外の当社グループ幹部のうち受益者要件を充足する者⑥ 信託管理人当社と利害関係のない第三者（公認会計士）⑦ 信託契約日2025年5月21日（予定）⑧ 信託の期間2025年5月21日（予定）～2028年8月末日（予定）⑨ 本プラン開始日2025年4月1日⑩ 議決権行使行使しないものとします⑪ 取得株式の種類当社普通株式⑫ 信託金の金額378百万円（予定）（信託報酬および信託費用を含む。）（※5）3,750百万円（予定）（同左）（※6）⑬ 帰属権利者当社⑭ 残余財産帰属権利者である当社が受領できる残余財産は、信託金から株式取得資金を控除した信託費用準備金の範囲内とします。（※5）上記の信託金の金額には、既存のBIP信託から承継する残余財産を含みます。（※6）上記の信託金の金額には、既存のESOP信託から承継する残余財産を含みます。*本制度の継続にあたり、BIP信託およびESOP信託への信託金の追加拠出、ならびに株式市場からの当社株式の追加取得は行いません。アステラス製薬株式会社についてアステラス製薬は、科学の進歩を患者さんの「価値」に変えることを目指すグローバルライフサイエンス企業です。私たちは、がんや、眼科・泌尿器疾患、免疫、ウィメンズヘルスなどの多様な領域において、革新的な治療法を提供しています。研究開発プログラムを通じて、アンメットメディカルニーズの高い疾患領域において新たなヘルスケアソリューションを開拓しています。アステラス製薬の詳細については、www.astellas.comをご覧ください。注意事項このプレスリリースに記載されている現在の計画、予想、戦略、想定に関する記述およびその他の過去の事実ではない記述は、アステラス製薬の業績等に関する将来の見通しです。これらの記述は経営陣の現在入手可能な情報に基づく見積りや想定によるものであり、既知および未知のリスクと不確実な要素を含んでいます。さまざまな要因によって、これら将来の見通しは実際の結果と大きく異なる可能性があります。その要因としては、（i）医薬品市場における事業環境の変化および関係法規制の改正、（ii）為替レートの変動、（iii）新製品発売の遅延、（iv）新製品および既存品の販売活動において期待した成果を得られない可能性、（v）競争力のある新薬を継続的に生み出すことができない可能性、（vi）第三者による知的財産の侵害等がありますが、これらに限定されるものではありません。また、このプレスリリースに含まれている医薬品（開発中のものを含む）に関する情報は、宣伝広告、医学的アドバイスを目的としているものではありません。 

Notice Regarding Continuation of the Performance-linked Sto… 2025年05月15日 16時00分

TOKYO, May 15, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “the Company”) announced that at the meeting of the Board of Directors held today, a resolution was passed to continue the Performance-linked Stock Compensation Scheme for the Corporate Executives (Tantou-Yakuin) of the Company and the Performance-linked Stock Delivery Scheme for the domestic and global Astellas Group executives (both schemes hereinafter referred to as the “Schemes”). The Board of Directors also passed a resolution of the details of the incentive plan to be implemented in fiscal year 2025 based on the Schemes (hereinafter the “Plan”) as described below.1. Objective for the Schemes(1) The Schemes are medium- to long-term-based incentive plan, common on a global basis, for the Corporate Executives (Tantou-Yakuin) of the Company and the domestic and global Astellas Group executives that is highly transparent and objective, and closely linked with the Company’s enterprise and shareholder value with the aim of promoting management focused on increasing enterprise and shareholder value over the medium- to long-term.(2) The Performance-linked Stock Compensation Scheme for Corporate Executives (Tantou-Yakuin) of the Company adopts a structure called the executive compensation BIP (Board Incentive Plan) trust (“BIP Trust”). BIP Trust is an executive incentive plan modeled on Performance Share and Restricted Stock systems in the U.S. The BIP Trust acquires the Company’s shares and conducts a “delivery of the Company’s shares” (as set forth in 3. (5) below; hereinafter the same) to the Corporate Executives (Tantou-Yakuin) based on the level of growth of enterprise and shareholder value, etc.The Performance-linked Stock Delivery Scheme for the domestic and global Astellas Group executives adopts a structure called the stock-delivery ESOP (Employee Stock Ownership Plan) trust (“ESOP Trust”). ESOP Trust is an employee incentive plan modeled on the ESOP scheme in the U.S. The ESOP Trust acquires the Company’s shares and conducts a “delivery of the Company’s shares” to the domestic and global Astellas Group executives based on the level of growth of enterprise and shareholder value, etc. 2. The Structure of the BIP Trust and ESOP Trust 1) The Company and the Astellas Group companies shall carry out necessary processes such as holding meetings of the Board of Directors, for continuing the Performance-linked Stock Compensation Scheme and the Performance-linked Stock Delivery Scheme, and the implementation and details of the Plan based on the Schemes.2) The Company shall put money in trust, to establish the BIP Trust, which shall be the trust in which the beneficiaries shall be the Corporate Executives (Tantou-Yakuin)  of the Company who have satisfied the beneficiary conditions, and the ESOP Trust, which shall be the trust in which the beneficiaries shall be the domestic and global Astellas Group executives who have satisfied the beneficiary conditions (BIP Trust and ESOP Trust hereinafter collectively referred to as the “Trust.”) The Company and the domestic and global Astellas Group companies shall contribute a suitable amount to the trust based on the number of eligible persons in the respective company.3) The Trust, in accordance with the instructions of the trust administrator, will use the money entrusted in 2) to acquire the Company’s shares on the stock market.4) Dividends for the Company’s shares in the Trust will be paid in the same way as with other shares of the Company.5) Voting rights are not to be exercised on the Company’s shares within the Trust throughout the trust period.6) During the trust period, beneficiaries will receive delivery of the Company’s shares in accordance with the Company’s Share Delivery Policy.7) In the event that residual shares remain at the expiration of the trust period mainly due to the extent to which enterprise and shareholder value have achieved growth during the trust period, the Trust will continue to be used as an incentive plan based on the Schemes by making changes to the trust agreement and additional entrustments (*1), or otherwise a gratis transfer of these residual shares will be made from the Trust to the Company, and upon acquiring these shares the Company plans to implement the cancellation of them by resolution of the Board of Directors.8) Upon conclusion of the Trust, the residual assets remaining after allocation to the beneficiaries are to belong to the Company within the scope of the reserve fund for trust expenses after deductions for stock purchases from trust money. In the event that there remain residual assets beyond the scope of the reserve fund for trust expenses, such assets are to be donated to an organization having no relationship of interest with the Company or Corporate Executives (Tantou-Yakuin) and executives of the Company.(*1) As the Plan for which Corporate Executives (Tantou-Yakuin) of the Company are eligible are the same kind of incentive plan as the Performance-linked Stock Compensation Scheme introduced in fiscal year 2015, the existing executive compensation BIP for the Corporate Executives (Tantou-Yakuin) that was established in fiscal year 2022 shall continue to be used. In addition, since this plan is an incentive plan similar to the Performance-linked Stock Compensation Scheme that has been implemented since the fiscal year 2020, we will continue to utilize the existing ESOP trust established for domestic and global Astellas Group executives in the fiscal year 2022. 3. Details of the Plan(1) Overview of the PlanThe Plan is an incentive plan, under which delivery of the Company’s shares will be conducted during the three-year period from the fiscal year ending March 31, 2026 to the fiscal year ending March 31, 2028 (“Applicable Period”), based on the level of growth of enterprise and shareholder value, etc.The Company intends to continue implementing incentive plans which are similar to the Plan in each year in and after the following fiscal year by establishing new BIP Trusts or ESOP Trusts, or by making changes or additional entrustments to the existing BIP Trusts or ESOP Trusts that have expired. The details of incentive plans put into effect next fiscal year or later shall be determined at the appropriate time by resolution of the Board of Directors.(2) Individuals eligible under the Plan (Beneficiary Conditions)The Corporate Executives (Tantou-Yakuin) of the Company and the domestic and global Astellas Group executives in office as of April 1, 2025 (“Eligible Individuals”) shall, in principle, receive delivery of a certain number of the Company’s shares based on the points provided for below in (4) subject to the condition that the Beneficiary Conditions set forth below are satisfied.The Beneficiary Conditions are as follows:1) Such person shall be an Eligible Individual at the expiration date of the Applicable Period.2) Such person shall have met other criteria which are deemed necessary for achieving the purpose of the Schemes.(3) Trust periodThe trust period of this trust shall be from May 21, 2025 (planned) to August 31, 2028 (planned). At the expiration of the trust periods, the Company may continue the Trust in the form of incentive plans which are similar to the Plan by making changes to the trust agreements and making additional entrustments.(4) Number of the Company’s shares to be delivered to Eligible IndividualsThe number of the Company’s shares to be delivered to Eligible Individuals (including the number of the Company’s shares to be converted into cash in accordance with (5) below) shall be determined on the basis of the points, which have been allocated in accordance with the following, with 1 point corresponding to 1 share of the Company’s share (*2).(*2) In the event that the number of the Company’s shares belonging to the Trust increases or decreases due to stock split, gratis allotment or stock consolidation, etc., the number of the Company’s shares to be delivered per point shall be adjusted by means of a reasonable method.Basic points shall be allocated to the Eligible Individuals who are in office as of April 1, 2025 in accordance with the following formula.(Formula for the calculation of basic points)Basic amount (*3) individually determined based on rank, global grade, etc. divided by the Average closing price of the Company’s shares on the Tokyo Stock Exchange in March 2025* Any fractions of less than one shall be discarded.(*3) The basic amount levels shall be set appropriately in accordance with responsibilities and other factors in reference particularly to objective remuneration survey data of an external expert organization in order to ensure competitive remuneration levels that enable the Company to recruit and retain talents.Eligible Individuals who are in office as of March 31, 2028 shall receive delivery of the Company’s shares from the Trust in numbers corresponding to the points calculated according to the formula below.Basic points × Performance-linked coefficient (*4)* Any fractions of less than one shall be discarded.(*4) The performance-linked coefficient of the Plan shall be determined within a range from 0% to 200% based on results of comparing the Company’s total shareholder return (“TSR*”) during the applicable period, against both the growth rate of Tokyo Stock Price Index (TOPIX) and the TSR of global pharmaceutical companies (“TSR Peer Group”). The list of the TSR Peer Group shall be proposed to the Board of Directors after deliberation by the Compensation Committee, and accordingly determined by June 30, 2025.* TSR refers to shareholders’ total return on investment, encompassing both capital gains and dividends.(5) Method and timing for delivering the Company’s shares to the Eligible Individuals“Delivery of the Company’s shares” refers to, at a given time, the receipt of half of the number of the Company’s shares corresponding to the allocated points from the Trust (provided that shares less than one unit shall be converted into cash within the Trust and the cash equivalent to the amount of conversion will be received), and the receipt of the cash equivalent to the remaining half after conversion into cash within the Trust.Eligible Individuals who have met the Beneficiary Conditions shall receive delivery of the Company’s shares around June 2028.(6) Malus Clause and Clawback ClauseThe Company and its Group companies stipulate a Malus Clause that forfeits the right to receive delivery of the Company’s shares, by resolution of the Company and its Group companies in the event of misconduct, etc., by Eligible Individuals and the Company stipulates a Clawback Clause which allows to demand the return of the amount equivalent to the number of Company’s shares delivered to Eligible Individuals who are pre-defined by the Company (limited to high-level positions, such as Top Management, etc.), in the event of post-financial restatement due to material accounting errors or fraud, or in the event of misconduct, etc., by Eligible Individuals, by resolution of Board of Directors. The remuneration that may be subject to reimbursement are part or all of the amount equivalent to the number of Company’s shares delivered for the target period that includes the fiscal year in which such event occurred and the three preceding fiscal years.(7) Acquiring the Company’s shares by the TrustIn continuing this Schemes, no additional acquisition of the Company’s shares from the stock market will be made by the Trust.(8) Exercise of voting rights of the Company’s shares within the TrustIn order to maintain a neutral position vis-a-vis management, no voting rights shall be exercised on the Company’s shares within the Trust during the trust period.(9) Handling of dividends on the Company’s shares within the TrustDividends on the Company’s shares within the Trust shall be received by the Trust and applied to trust fees and trust expenses for the Trust.(10) Handling at the expiration of the trust periodIn the event that residual shares remain at the expiration of the trust period due to factors such as the extent to which enterprise and shareholder value have achieved growth during the applicable period, the Company may continue the Trust in the form of incentive plans which are similar to the Plan by making changes to the trust agreement and additional entrustments. If the Trust is to be terminated due to the expiration of the trust period, gratis transfer of these residual shares will be made from the Trust to the Company, and the Company plans to implement the cancellation of them by resolution of the Board of Directors.Additionally, in the event that residual dividends on the Company’s shares within the Trust remain at the expiration of the trust period and the Company continues to use the Trust, such residual assets shall be applied towards the acquisition of shares. However, if the Company concludes the Trust due to the expiration of the trust period, such assets are planned to be donated to an organization having no relationship of interest with the Company or Corporate Executives (Tantou-Yakuin) and executives of the Company.(Reference)[Contents of the Trust for the Incentive Plan in fiscal year 2025] “BIP Trust”“ESOP Trust”1) Trust categoryMonetary trust other than a specific individually operated monetary trust (third-party benefit trust)2) Trust objectiveTo provide incentive to Corporate Executives (Tantou-Yakuin) of the CompanyTo provide incentive to the domestic and global Astellas Group executives3) SettlorThe Company4) TrusteeMitsubishi UFJ Trust and Banking Corporation (planned)(Joint Trustee: The Master Trust Bank of Japan, Ltd.)5) BeneficiariesCorporate Executives (Tantou-Yakuin) of the Company who have satisfied the Beneficiary ConditionsThe domestic and global Astellas Group executives who have satisfied the Beneficiary Conditions6) Trust administratorThird party with no relationship of interest with the Company (certified public accountant)7) Date of trust agreementMay 21, 2025 (planned)8) Trust periodMay 21, 2025 (planned) to August 31, 2028 (planned)9) Start of the PlanApril 1, 202510) Exercise of voting rightsNot to be exercised11) Type of shares to be acquiredCommon stock of the Company12) Amount of entrustment¥378 million (planned)(Including trust fees and trust expenses) (*5)¥3,750 million (planned)(Same as on the left) (*6)13) Rights holderThe Company14) Residual assetsThe Company, the rights holder, shall receive residual assets within the scope of the reserve fund for trust expenses after deductions of stock purchases from trust money.(*5) The above amount of trust includes the residual assets succeeded from the existing BIP Trust.(*6) The above amount of trust includes the residual assets succeeded from the existing ESOP Trust.*In continuing this Schemes, no additional contributions to the BIP trust and ESOP trust, nor additional acquisitions of the company’s shares from the stock market will be made.About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release 

業績連動型株式報酬制度の継続に関するお知らせ 2025年05月15日 16時00分

　アステラス製薬株式会社（本社：東京、以下「当社」）は、本日開催の取締役会において、当社の取締役（社外取締役および監査等委員である取締役を除く。以下「取締役」）を対象とする業績連動型株式報酬制度（以下「本制度」）に基づき、2025年度に実施するインセンティブプラン（以下「本プラン」）の詳細を決議しましたので、以下の通りお知らせいたします。記本制度の目的(1) 本制度は、取締役を対象とした、中長期的な企業価値・株主価値の向上を重視した経営を推進することを目的とする、企業価値・株主価値との連動性が高く、かつ透明性・客観性の高い中長期インセンティブプランです。(2) 本制度は、役員報酬BIP（Board Incentive Plan）信託（以下「BIP信託」）と称される仕組みを採用しています。BIP信託とは、米国のパフォーマンス・シェア（Performance Share）制度および譲渡制限付株式報酬（Restricted Stock）制度を参考にした役員インセンティブプランであり、BIP信託が当社株式を取得し、企業価値・株主価値の成長度等に応じて取締役に当該信託から「当社株式の交付等」（下記3. (5)で定義する。以下同じ）を行うものです。 BIP信託の仕組み ① 当社は本制度に基づき、本プランの実施および内容を取締役会において決議します。② 当社は金銭を信託し、受益者要件を充足する当社取締役を受益者とする信託「BIP信託」（以下「本信託」）を設定します。なお、本信託へ信託する金銭は、第14期定時株主総会で承認を受けた範囲内とします。③ 本信託は、信託管理人の指図に従い、②で拠出された金銭を原資として当社株式を株式市場から取得します。④ 本信託内の当社株式に対しても、他の当社株式と同様に配当が行われます。⑤ 本信託内の当社株式については、信託期間を通じ、議決権を行使しないものとします。⑥ 信託期間中、受益者は、当社の株式交付規程に従い、当社株式の交付等を受けます。⑦ 信託期間中の企業価値・株主価値の成長度等により、信託期間の満了時に残余株式が生じた場合、信託契約の変更および追加信託を行うことにより、本制度に基づくインセンティブプランとして本信託を継続利用するか（※1）、または、本信託から当社に当該残余株式を無償譲渡し、当社はこれを無償で取得した上で、取締役会決議によりその消却を行う予定です。⑧ 本信託の終了時に、受益者に分配された後の残余財産は、信託金から株式取得資金を控除した信託費用準備金の範囲内で当社に帰属する予定です。また、信託費用準備金を超過する部分については、当社および当社役員と利害関係のない団体への寄附を行う予定です。（※1）本プランは、2015年度から導入している業績連動型株式報酬制度と同種のインセンティブプランであることから、2022年度に設定した取締役を対象とする既存のBIP信託を継続利用いたします。 本プランの内容(1) 本プランの概要　本プランは、2026年3月末日で終了する事業年度から2028年3月末日で終了する事業年度までの3年間（以下「対象期間」）を対象として、対象期間を通じた企業価値・株主価値の成長度等に応じて当社株式の交付等を行うインセンティブプランです。　当社は、次年度以降も毎年、新たなBIP信託を設定し、または信託期間の満了した既存のBIP信託の変更および追加信託を行うことにより、本プランと同種のインセンティブプランを継続的に実施することを予定しています。次年度以降に実施するインセンティブプランの内容については、都度、取締役会の決議によって決定します。(2) 本プランの対象者（受益者要件）　2025年7月1日時点に在任する取締役（以下「制度対象者」）は、原則として、以下の受益者要件を充足していることを条件に、下記(4)に定めるポイントに応じた数の当社株式の交付等を本信託から受けるものとします。　受益者要件は以下の通りです。① 2028年6月1日まで、取締役として、引き続き在任していること② その他株式報酬制度としての趣旨を達成するために必要と認められる要件を満たしていること(3) 信託期間　2025年5月21日（予定）から2028年8月末日（予定）までとします。　なお、信託期間の満了時において、信託契約の変更および追加信託を行うことにより、本プランと同種のインセンティブプランとして本信託を継続することがあります。(4) 制度対象者に交付される当社株式　制度対象者に対して交付される当社株式の数（下記(5)により換価処分の対象となる当社株式の数を含む）は、以下に従って付与されるポイントにより、1ポイント＝当社株式1株(※2)として定まります。（※2）本信託に属する当社株式が株式の分割、株式の無償割当て、株式の併合等によって増加または減少した場合は、当社は1ポイント当たりに交付される当社株式の数を合理的な方法により調整します。　まず、2025年7月1日に制度対象者として在任する者には、以下の算定式に従って基準ポイントが付与されます。（基準ポイントの算定式）　役位別に定める基準金額(※3)÷2025 年3月の東京証券取引所における当社株式の終値の平均値　*小数点以下の端数は切捨（※3）基準金額の水準は、優秀な人材の獲得・保持が可能となる競争力のある報酬水準となるよう、外部専門機関の客観的な報酬調査データ等を参考に職責等に応じて適切に設定します。　2028年6月1日に制度対象者として在任する者は、以下の算定式に従って算出されるポイントに応じた数の当社株式の交付等を本信託から受けるものとします。基準ポイント×業績連動係数(※4)  　*小数点以下の端数は切捨（※4）本プランの業績連動係数は、対象期間における当社株主総利回り（Total Shareholder Return。以下「TSR*」）と東証株価指数の成長率およびグローバル製薬企業（以下「TSR Peer Group」）のTSRとの比較結果に基づき、0% ~ 200%の範囲で決定します。TSR Peer Groupは、報酬委員会の審議を経た上で取締役会に答申され、2025年6月末日までに決定されます。 　*TSR：キャピタルゲインと配当を合わせた株主にとっての総合投資利回り(5) 取締役に対する当社株式の交付等の方法および時期　「当社株式の交付等」とは、ある時点において、付与されているポイントに対応する当社株式の数の半数について本信託から株式の交付を受け（ただし、単元未満株数については、本信託内で換価した上、その換価処分金相当額の金銭の給付を受け）、残りの半数については本信託内で換価した上で、その換価処分金相当額の金銭の給付を受けることをいいます。　受益者要件を充足した制度対象者は、2028年6月頃に、当社株式の交付等を受けるものとします。　信託期間中に制度対象者が退任する場合（自己都合により退任する場合および解任される場合を除く）は、原則としてその時点で付与されているポイントに応じた数の当社株式の交付等を受けるものとします。　信託期間中に制度対象者が死亡した場合は、原則としてその時点で付与されているポイントに応じた数の当社株式について、本信託内で換価した上で、その換価処分金相当額の金銭について、制度対象者の相続人が本信託から給付を受けるものとします。(6) 本信託に拠出される信託金の予定額および本信託から交付される当社株式の予定株数（上記(5)により換価処分の対象となる当社株式の数を含む。）　当社は、本信託に1,040百万円の信託金を拠出することを予定しています。(※5)（※5）信託期間中の本信託による株式取得資金ならびに信託報酬および信託費用の合算金額であり、既存のBIP信託から承継する残余財産を含みます。なお、第14期定時株主総会において、本制度について事業年度毎に拠出することのできる金額の上限を1,640百万円として承認決議を行っており、各事業年度において当社がBIP信託に拠出できる信託金の金額は決議された上限に服することになります。　本信託において信託期間中、上記(4)により交付される当社株式の数は、本信託に拠出される信託金の上限である1,640百万円を2025年3月の東京証券取引所における当社株式の終値の平均値をもって除して得られる数を上限とします。(7) マルス条項およびクローバック条項について     当社は、制度対象者による不正行為等があった場合には、取締役会の決議により、株式交付等を受ける権利を喪失させるマルス条項、および重大な会計上の誤りや不正による決算の事後修正が行われた場合または制度対象者による不正行為等があった場合に、取締役会の決議により、制度対象者に交付等した当社株式数に相当する金銭の返還を求めることができるクローバック条項を役員の報酬等に関する規程に定めています。返還の対象となり得る報酬は、当該事象が発生した事業年度及びその前の3事業年度を対象期間に含む、交付等した当社株式数に相当する金銭の一部または全部です。(8) 本信託による当社株式の取得方法　本信託による当社株式の取得は、株式市場からの取得を予定しています。(9) 本信託内の当社株式に関する議決権行使　本信託内にある当社株式については、経営への中立性を確保するため、信託期間中、議決権を行使しないものとします。(10) 本信託内の当社株式に係る配当の取扱い　本信託内の当社株式に係る配当は、本信託が受領し、本信託の信託報酬および信託費用に充てられます。(11) 信託期間満了時の取扱い　対象期間における企業価値・株主価値の成長度等により、信託期間満了時に残余株式が生じた場合は、信託契約の変更および追加信託を行うことにより、本プランと同種のインセンティブプランとして本信託を継続することがあります。信託期間満了により本信託を終了させる場合には、本信託から当社に当該残余株式の無償譲渡を行い、当社はこれを取締役会決議により消却することを予定しています。　また、信託期間満了時における本信託内の当社株式に係る配当の残余は、本信託を継続利用する場合には株式取得資金として活用されますが、信託期間満了により本信託を終了させる場合には、当社および当社役員と利害関係のない団体への寄附を行う予定です。 （ご参考）【2025年度インセンティブプランのための信託の内容】①    信託の種類特定単独運用の金銭信託以外の金銭の信託（他益信託）②    信託の目的取締役に対するインセンティブの付与③    委託者当社④    受託者三菱ＵＦＪ信託銀行株式会社（予定）（共同受託者　日本マスタートラスト信託銀行株式会社）⑤    受益者取締役のうち受益者要件を充足する者⑥    信託管理人当社と利害関係のない第三者（公認会計士）⑦    信託契約日2025年5月21日（予定）⑧    信託の期間2025年5月21日（予定）～2028年8月末日（予定）⑨    本プラン開始日2025年7月1日（予定）⑩    議決権行使行使しないものとします⑪    取得株式の種類当社普通株式⑫    信託金の金額1,040百万円（予定）（信託報酬および信託費用を含む。）(※6)⑬    株式の取得時期2025年5月23日（予定）～2025年6月末日（予定）⑭    株式の取得方法株式市場から取得⑮    帰属権利者当社⑯    残余財産帰属権利者である当社が受領できる残余財産は、信託金から株式取得資金を控除した信託費用準備金の範囲内とします。（※6）上記の信託金の金額には、既存のBIP信託から承継する残余財産を含みますアステラス製薬株式会社についてアステラス製薬は、科学の進歩を患者さんの「価値」に変えることを目指すグローバルライフサイエンス企業です。私たちは、がんや、眼科・泌尿器疾患、免疫、ウィメンズヘルスなどの多様な領域において、革新的な治療法を提供しています。研究開発プログラムを通じて、アンメットメディカルニーズの高い疾患領域において新たなヘルスケアソリューションを開拓しています。 アステラス製薬の詳細については、www.astellas.comをご覧ください。注意事項このプレスリリースに記載されている現在の計画、予想、戦略、想定に関する記述およびその他の過去の事実ではない記述は、アステラス製薬の業績等に関する将来の見通しです。これらの記述は経営陣の現在入手可能な情報に基づく見積りや想定によるものであり、既知および未知のリスクと不確実な要素を含んでいます。さまざまな要因によって、これら将来の見通しは実際の結果と大きく異なる可能性があります。その要因としては、（i）医薬品市場における事業環境の変化および関係法規制の改正、（ii）為替レートの変動、（iii）新製品発売の遅延、（iv）新製品および既存品の販売活動において期待した成果を得られない可能性、（v）競争力のある新薬を継続的に生み出すことができない可能性、（vi）第三者による知的財産の侵害等がありますが、これらに限定されるものではありません。また、このプレスリリースに含まれている医薬品（開発中のものを含む）に関する情報は、宣伝広告、医学的アドバイスを目的としているものではありません。 

Notice Regarding Continuation of the Performance-linked St… 2025年05月15日 16時00分

TOKYO, May 15, 2025– Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “the Company”) today announced that at the meeting of the Board of Directors held today, a resolution was passed to approve the details of the incentive plan (“Plan”) to be implemented in fiscal year 2025 based on the Performance-linked Stock Compensation Scheme (“Scheme”) for the Company’s Directors (excluding outside Directors and Directors who are Audit & Supervisory Committee Members; hereinafter “Directors”) as described below.Objective for the Scheme(1) The Scheme is a medium- to long-term-based incentive plan, for the Directors that is highly transparent and objective, and closely linked with the Company’s enterprise and shareholder value with the aim of promoting management focused on increasing enterprise and shareholder value over the medium- to long-term.(2) The Scheme adopts a structure called the executive compensation BIP (Board Incentive Plan) trust (“BIP Trust”). BIP Trust is an executive incentive plan modeled on Performance Share and Restricted Stock systems in the U.S. The BIP Trust acquires the Company’s shares and conducts a “delivery of the Company’s shares” (as set forth in 3. (5) below; hereinafter the same) to the Directors based on the level of growth of enterprise and shareholder value, etc. The Structure of the BIP Trust 1) Based on the Scheme, the Company shall resolve on the implementation and content of the Plan at the meeting of the Board of Directors.2) The Company will put money in trust, to establish the BIP Trust, which will be the trust in which the beneficiaries shall be the Directors who have satisfied the beneficiary conditions (“Trust”). The money entrusted in the Trust shall be within the scope of approval of the 14th Term Annual Shareholders Meeting. 3) The Trust, in accordance with the instructions of the trust administrator, will use the money entrusted in 2) to acquire the Company’s shares on the stock market.4) Dividends for the Company’s shares in the Trust will be paid in the same way as with other shares of the Company.5) Voting rights are not to be exercised on the Company’s shares within the Trust throughout the trust period.6) During the trust period, beneficiaries will receive delivery of the Company’s shares in accordance with the Company’s Share Delivery Policy.7) In the event that residual shares remain at the expiration of the trust period mainly due to the extent to which enterprise and shareholder value have achieved growth during the trust period, the Trust will continue to be used as an incentive plan based on the Scheme by making changes to the trust agreement and additional entrustments (*1), or otherwise a gratis transfer of these residual shares will be made from the Trust to the Company, and upon acquiring these shares the Company plans to implement the cancellation of them by resolution of the Board of Directors.8) Upon conclusion of the Trust, the residual assets remaining after allocation to the beneficiaries are to belong to the Company within the scope of the reserve fund for trust expenses after deductions for stock purchases from trust money. In the event that there remain residual assets beyond the scope of the reserve fund for trust expenses, such assets are to be donated to an organization having no relationship of interest with the Company or Directors and Corporate Executives of the Company.(*1) As the Plan are the same kind of incentive plan as the Performance-linked Stock Compensation Scheme introduced in fiscal year 2015, the existing BIP for the Company’s Directors that was established in fiscal year 2022 will continue to be used. Details of the Plan(1) Overview of the PlanThe Plan is an incentive plan, under which delivery of the Company’s shares will be conducted during the three-year period from the fiscal year ending March 31, 2026 to the fiscal year ending March 31, 2028 (“Applicable Period”), based on the level of growth of enterprise and shareholder value, etc.The Company intends to continue implementing incentive plans which are similar to the Plan in each year in and after the following fiscal year by establishing new BIP Trusts, or by making changes or additional entrustments to the existing BIP Trusts that have expired. The details of incentive plans put into effect next fiscal year or later shall be determined at the appropriate time by resolution of the Board of Directors.(2) Individuals eligible under the Plan (Beneficiary Conditions)The Directors who are in office as of July 1, 2025 (“Eligible Individuals”) will, in principle, receive delivery of a certain number of the Company’s shares based on the points provided for below in (4) subject to the condition that the Beneficiary Conditions set forth below are satisfied.The Beneficiary Conditions are as follows:1) Such person shall continue to serve as the Director until June 1, 2028;2) Such person shall have met other criteria which are deemed necessary for achieving the purpose of the stock compensation scheme.(3) Trust periodThe trust period shall be from May 21, 2025 (planned) to August 31, 2028 (planned).At the expiration of the trust period, the Company may continue the Trust in the form of incentive plans which are similar to the Plan by making changes to the trust agreements and making additional entrustments.(4) Number of the Company’s shares to be delivered to Eligible IndividualsThe number of the Company’s shares to be delivered to Eligible Individuals (including the number of the Company’s shares to be converted into cash in accordance with (5) below) shall be determined on the basis of the points, which have been allocated in accordance with the following, with 1 point corresponding to 1 share of the Company’s share (*2).(*2) In the event that the number of the Company’s shares belonging to the Trust increases or decreases due to stock split, gratis allotment or stock consolidation, etc., the number of the Company’s shares to be delivered per point shall be adjusted by means of a reasonable method.Basic points shall be allocated to the Eligible Individuals who are in office as of July 1, 2025 in accordance with the following formula.(Formula for the calculation of basic points)Basic amount (*3) determined based on rank divided by the Average closing price of the Company’s shares on the Tokyo Stock Exchange in March 2025* Any fractions of less than one shall be discarded.(*3) The basic amount levels shall be set appropriately in accordance with responsibilities and other factors in reference particularly to objective remuneration survey data of an external expert organization in order to ensure competitive remuneration levels that enable the Company to recruit and retain talents.Eligible Individuals who are in office as of June 1, 2028 will receive delivery of the Company’s shares from the Trust in numbers corresponding to the points calculated according to the formula below.Basic points × Performance-linked coefficient (*4)* Any fractions of less than one shall be discarded.(*4) The performance-linked coefficient of the Plan shall be determined within a range from 0% to 200% based on results of comparing the Company’s total shareholder return (“TSR*”) during the applicable period, against both the growth rate of Tokyo Stock Price Index (TOPIX) and the TSR of global pharmaceutical companies (“TSR Peer Group”). The list of the TSR Peer Group shall be proposed to the Board of Directors after deliberation by the Compensation Committee, and accordingly determined by June 30, 2025.*    TSR refers to shareholders’ total return on investment, encompassing both capital gains and dividends.(5) Method and timing for delivering the Company’s shares to the Directors“Delivery of the Company’s shares” refers to, at a given time, the receipt of half of the number of the Company’s shares corresponding to the allocated points from the Trust (provided that shares less than one unit shall be converted into cash within the Trust and the cash equivalent to the amount of conversion will be received), and the receipt of the cash equivalent to the remaining half after conversion into cash within the Trust.Eligible Individuals who have met the Beneficiary Conditions will receive delivery of the Company’s shares around June 2028.In the event that an Eligible Individual retires during the trust period (excluding voluntary retirement and dismissal), as a general rule, such individual will receive the delivery of the Company’s shares in numbers corresponding to the points that have been allocated up to the time of retirement.In the event that an Eligible Individual becomes deceased during the trust period, as a general rule, the Company’s shares shall be converted into cash in numbers corresponding to the points which have been allocated to such individual up to that time within the Trust, and the cash equivalent to the amount of conversion will be received by such individual’s heir from the Trust.(6) Amount expected to be entrusted to the Trust and the number of the Company’s shares expected to be delivered from the Trust (including the number of the Company’s shares to be converted into cash in accordance with (5) above).The Company intends to entrust ¥1,040 million to the Trust (*5).(*5) Equivalent to the total amount of stock purchases, trust fees and trust expenses during the trust period, and inclusive of the residual assets succeeded from the existing BIP Trust. At the 14th Term Annual Shareholders Meeting, it was approved and resolved the maximum amount of contribution to the Scheme to be ¥1,640 million per fiscal year, and the amount to be entrusted by the Company to BIP Trust in each fiscal year shall be within the amount thus resolved.The maximum number of the Company’s shares to be delivered by the Trust during the trust period in accordance with (4) above shall be the number derived by dividing maximum amount of ¥1,640 million entrusted to the Trust by the average closing price of the Company’s shares on the Tokyo Stock Exchange in March 2025.(7) Malus Clause and Clawback ClauseThe Company stipulates in the rules regarding remunerations for Directors a Malus Clause that forfeits the right to receive delivery of the Company’s shares by resolution of the Board of Directors in the event of misconduct, etc. by Eligible Individuals and the Company stipulates a Clawback Clause in the rules regarding remunerations for Directors, which allows the Company to demand the return of the amount equivalent to the number of Company’s shares delivered to Eligible Individuals by resolution of the Board of Directors in the event of post-financial restatement due to material accounting errors or fraud, or in the event of misconduct, etc., by Eligible Individuals. The remuneration that may be subject to reimbursement are part or all of the amount equivalent to the number of Company’s shares delivered, for the target period that includes the fiscal year in which such event occurred and the three preceding fiscal years. (8) Method for acquiring the Company’s shares by the TrustThe acquisition of the Company’s shares by the Trust is planned to be made on the stock market.(9) Exercise of voting rights of the Company’s shares within the TrustIn order to maintain a neutral position vis-a-vis management, no voting rights shall be exercised on the Company’s shares within the Trust during the trust period.(10) Handling of dividends on the Company’s shares within the TrustDividends on the Company’s shares within the Trust shall be received by the Trust and applied to trust fees and trust expenses for the Trust.(11) Handling at the expiration of the trust periodIn the event that residual shares remain at the expiration of the trust period due to factors such as the extent to which enterprise and shareholder value have achieved growth during the applicable period, the Company may continue the Trust in the form of incentive plans which are similar to the Plan by making changes to the trust agreement and additional entrustments. If the Trust is to be terminated due to the expiration of the trust period, gratis transfer of these residual shares will be made from the Trust to the Company, and the Company plans to implement the cancellation of them by resolution of the Board of Directors.Additionally, in the event that residual dividends on the Company’s shares within the Trust remain at the expiration of the trust period and the Company continues to use the Trust, such residual assets shall be applied towards the acquisition of shares. However, if the Company concludes the Trust due to the expiration of the trust period, such assets are planned to be donated to an organization having no relationship of interest with the Company or Directors and Corporate Executives of the Company.  (Reference)[Contents of the Trust for the Incentive Plan in fiscal year 2025]1) Trust categoryMonetary trust other than a specific individually operated monetary trust (third-party benefit trust)2) Trust objectiveTo provide incentive to the Directors3) SettlorThe Company4) TrusteeMitsubishi UFJ Trust and Banking Corporation (planned)(Joint Trustee: The Master Trust Bank of Japan, Ltd.)5) BeneficiariesThe Directors who have satisfied the Beneficiary Conditions6) Trust     administratorThird party with no relationship of interest with the Company (certified public accountant)7) Date of trust agreementMay 21, 2025 (planned)8) Trust periodMay 21, 2025 (planned) to August 31, 2028 (planned)9) Start of the PlanJuly 1, 2025 (planned)10) Exercise of voting rightsNot to be exercised11) Type of shares to be acquiredCommon stock of the Company12) Amount of entrustment¥1,040 million (planned)(Including trust fees and trust expenses) (*6)13) Acquisition period of sharesMay 23, 2025 (planned) to June 30, 2025 (planned)14) Method of acquiring sharesAcquisition on the stock market15) Rights holderThe Company16) Residual assetsThe Company, the rights holder, will receive residual assets within the scope of the reserve fund for trust expenses after deductions of stock purchases from trust money.(*6) The above amount of trust includes the residual assets succeeded from the existing BIP Trust.About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release 

新しいストーリー「 膀胱がんの早期診断の鍵を解明する」を公開… 2025年05月15日 10時00分

Cracking the Code to Earlier Bladder Cancer Diagnosis 2025年05月15日 10時00分

役員人事に関するお知らせ 2025年05月07日 18時30分

　アステラス製薬株式会社（本社：東京、以下「当社」）は、本日開催した取締役会において、下記のとおり、役員人事について内定いたしました。2025年6月19日に開催予定の第20期定時株主総会に新任候補者として付議する予定の Andreas Busch氏およびMark Enyedy氏の選任は、当社の取締役会の多様性を拡充することによる持続的な発展への重要な一歩となります。彼らのグローバルな視点と製薬業界における豊富な経験と見識は、取締役会の監督機能および実効性のさらなる強化につながると考えています。この決定は、株主を含むステークホルダーの皆様との対話の結果を踏まえたものです。なお、下記の役員人事は、第20期定時株主総会および同日開催予定の取締役会にて決定される予定です。記1. 取締役（監査等委員である取締役を除く）候補者氏名 現役職 (5月7日時点)安川　健司再任代表取締役会長岡村　直樹再任代表取締役社長CEO杉田　勝好再任代表取締役副社長 人事担当田中　孝司社外再任KDDI株式会社 取締役相談役沖縄セルラー電話株式会社 取締役桜井　恵理子社外再任株式会社三井住友フィナンシャルグループ 社外取締役花王株式会社 社外取締役日本板硝子株式会社 社外取締役宮﨑　正啓社外再任栗田工業株式会社 社外取締役大野　洋一社外再任埼玉医科大学 社会医学 兼 リサーチアドミニストレーションセンター 兼 医学教育センター 客員教授Andreas Busch社外新任Absci Corporation, Chief Innovation OfficerMark Enyedy社外新任BioMarin Pharmaceutical Inc., 社外取締役社外取締役候補者の現役職については会社法上の重要な兼職を記載しています2. 監査等委員である取締役候補者氏名 現役職(5月7日時点)秋山　里絵社外再任馬場・澤田法律事務所 弁護士株式会社ゴールドウイン 社外取締役社外取締役候補者の現役職については会社法上の重要な兼職を記載しています3. 定時株主総会承認後の取締役会の構成（予定）代表取締役会長    安川　健司（取締役会議長）代表取締役社長CEO    岡村　直樹代表取締役副社長    杉田　勝好社外取締役    田中　孝司社外取締役    桜井　恵理子社外取締役    宮﨑　正啓社外取締役    大野　洋一社外取締役    Andreas Busch社外取締役    Mark Enyedy取締役 （監査等委員）    廣田　里香社外取締役 （監査等委員）    中山　美加社外取締役 （監査等委員）    秋山　里絵社外取締役 （監査等委員）    荒牧　知子以上（参考）新任の取締役候補者の略歴氏名 Andreas Busch生年月日 1963年8月26日略歴1997年10月Head of DG Cardiovascular Diseases, Hoechst Marion Roussel (現 Sanofi S.A.)1999年1月Vice President, Head of DG Cardiovascular Diseases, Aventis (現 Sanofi S.A.)2004年7月Global Head of Cardiovascular Research, Sanofi- Aventis (現 Sanofi S.A.) 2005年5月Senior Vice President, Head of Discovery Europe, Bayer HealthCare AG (現 Bayer AG)2016年1月Head of Drug Discovery, Bayer Pharma AG (現 Bayer AG) 2018年1月Head of R&D and CSO, Shire plc2019年4月Chief Innovation Officer and CSO, Cyclerion Inc. (現 Cyclerion Therapeutics Inc.)2022年2月社外取締役, Centogene N.V. (現 Crown LiquidationCo N.V.)2022年10月Chief Innovation Officer, Absci Corporation (現任) 氏名 Mark Enyedy生年月日 1963年12月27日略歴1990年9月Associate, Palmer & Dodge, LLP (現 Locke Lord LLP)1996年2月Corporate Counsel, Genzyme Corporation (現 Sanofi S.A.)1999年11月Vice President, Oncology, Business Development, Genzyme Corporation (現 Sanofi S.A.) 2008年7月President, Transplant, Oncology, and Multiple Sclerosis, Genzyme Corporation (現 Sanofi S.A.)2011年9月取締役, Chief Executive Officer, Proteostasis Therapeutics, Inc. (現 Janssen Pharmaceutica N.V.)2012年7月社外取締役, Fate Therapeutics, Inc.2013年8月Head of Business Unit, Internal Medicine, Shire plc2014年5月Head of Corporate Development, Shire plc2016年5月取締役, President and Chief Executive Officer, ImmunoGen Inc. (現 AbbVie Inc.)2017年9月社外取締役, Keryx Biopharmaceuticals, Inc. (現 Akebia Therapeutics, Inc.)2020年3月社外取締役, LogicBio Therapeutics, Inc. (現 Alexion Pharmaceuticals, Inc.)2021年5月社外取締役, Ergomed Group Limited (現任)2023年12月社外取締役, BioMarin Pharmaceutical Inc. (現任) アステラス製薬株式会社についてアステラス製薬は、科学の進歩を患者さんの「価値」に変えることを目指すグローバルライフサイエンス企業です。私たちは、がんや、眼科・泌尿器疾患、免疫、ウィメンズヘルスなどの多様な領域において、革新的な治療法を提供しています。研究開発プログラムを通じて、アンメットメディカルニーズの高い疾患領域において新たなヘルスケアソリューションを開拓しています。アステラス製薬の詳細については、www.astellas.comをご覧ください。注意事項このプレスリリースに記載されている現在の計画、予想、戦略、想定に関する記述およびその他の過去の事実ではない記述は、アステラス製薬の業績等に関する将来の見通しです。これらの記述は経営陣の現在入手可能な情報に基づく見積りや想定によるものであり、既知および未知のリスクと不確実な要素を含んでいます。さまざまな要因によって、これら将来の見通しは実際の結果と大きく異なる可能性があります。その要因としては、（i）医薬品市場における事業環境の変化および関係法規制の改正、（ii）為替レートの変動、（iii）新製品発売の遅延、（iv）新製品および既存品の販売活動において期待した成果を得られない可能性、（v）競争力のある新薬を継続的に生み出すことができない可能性、（vi）第三者による知的財産の侵害等がありますが、これらに限定されるものではありません。また、このプレスリリースに含まれている医薬品（開発中のものを含む）に関する情報は、宣伝広告、医学的アドバイスを目的としているものではありません。 

Notice of Nominees for Directors 2025年05月07日 18時30分

TOKYO, May 7, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that during a meeting of its Board of Directors held today, it decided a change in Directors as outlined below. The appointment of Andreas Busch and Mark Enyedy as new candidates to be proposed at the 20th Term Annual Shareholders Meeting scheduled for June 19, 2025, represents a significant move in the company's continuous evolution, aimed at enhancing the diverse composition of our Board of Directors. Their extensive experience and insight into the global pharmaceutical industry will further strengthen the board's supervisory function and effectiveness. This decision reflects the voices from stakeholders, including shareholders. The change is subject to approval at the 20th Term Annual Shareholders Meeting and a subsequent decision at the Board of Directors meeting scheduled for the same day.1. Candidates for Directors (excluding Directors who Are Audit & Supervisory Committee Members)Name Current Position (As of May 7)Kenji YasukawaReelectionRepresentative Director, Chairman of the BoardNaoki OkamuraReelectionRepresentative Director, President and CEOKatsuyoshi SugitaReelectionRepresentative Director, Executive Vice President, Chief People OfficerTakashi TanakaOutsideReelectionDirector, Senior Advisor, KDDI CORPORATIONDirector, Okinawa Cellular Telephone CompanyEriko SakuraiOutsideReelectionOutside Director, Sumitomo Mitsui Financial Group, Inc. Outside Director, Kao CorporationOutside Director, Nippon Sheet Glass Company, LtdMasahiro MiyazakiOutsideReelectionOutside Director, Kurita Water Industries Ltd.Yoichi OhnoOutsideReelectionVisiting Professor, Social Medicine, Research Administration Center and Medical Education Center, Saitama Medical UniversityAndreas BuschOutside New CandidateChief Innovation Officer, Absci CorporationMark EnyedyOutside New CandidateNon-Executive Director, BioMarin Pharmaceutical Inc.The current position of the candidates for outside Directors describes significant concurrent positions at other organizations pursuant to the Companies Act.2. Candidates for Directors who Are Audit & Supervisory Committee MembersName Current Position (As of May 7)Rie AkiyamaOutsideReelectionLawyer, Baba & Sawada Law OfficeOutside Director, GOLDWIN INC.The current position of the candidates for outside Directors describes significant concurrent positions at other organizations pursuant to the Companies Act.3. The Board of Directors as from June 19, 2025 (planned)Kenji Yasukawa (Representative Director, Chairman of the Board)Naoki Okamura (Representative Director, President and CEO)Katsuyoshi Sugita (Representative Director, Executive Vice President)Takashi Tanaka (Outside Director)Eriko Sakurai (Outside Director)Masahiro Miyazaki (Outside Director)Yoichi Ohno (Outside Director)Andreas Busch (Outside Director)Mark Enyedy (Outside Director)Rika Hirota (Director, Audit & Supervisory Committee Member)Mika Nakayama (Outside Director, Audit & Supervisory Committee Member) Rie Akiyama (Outside Director, Audit & Supervisory Committee Member)Tomoko Aramaki (Outside Director, Audit & Supervisory Committee Member)<Reference>Brief Biographies of New Candidates for Outside DirectorName: Andreas BuschDate of birth: August 26, 1963Resume, position and responsibilities at the Company:October 1997Head of DG Cardiovascular Diseases, Hoechst Marion Roussel (current Sanofi S.A.)January 1999Vice President, Head of DG Cardiovascular Diseases, Aventis (current Sanofi S.A.),July 2004Global Head of Cardiovascular Research, Sanofi- Aventis (current Sanofi S.A.)May 2005Senior Vice President, Head of Discovery Europe, Bayer HealthCare AG (current Bayer AG)January 2016Head of Drug Discovery, Bayer Pharma AG (current Bayer AG)January 2018Head of R&D and CSO, Shire plcApril 2019Chief Innovation Officer and CSO, Cyclerion Inc. (current Cyclerion Therapeutics Inc.)February 2022Non-Executive Director, Centogene N.V. (current Crown LiquidationCo N.V.)October 2022Chief Innovation Officer, Absci Corporation, (present post)Name: Mark EnyedyDate of birth: December 27, 1963Resume, position and responsibilities at the Company:September 1990Associate, Palmer & Dodge, LLP (current Locke Lord LLP)February 1996Corporate Counsel, Genzyme Corporation (current Sanofi S.A.)November 1999Vice President, Oncology, Business Development, Genzyme Corporation (current Sanofi S.A.)July 2008President, Transplant, Oncology, and Multiple Sclerosis, Genzyme Corporation (current Sanofi S.A.)September 2011Director, Chief Executive Officer, Proteostasis Therapeutics, Inc. (current Janssen Pharmaceutica N.V.)July 2012Non-Executive Director, Fate Therapeutics, Inc.August 2013Head of Business Unit, Internal Medicine, Shire plcMay 2014Head of Corporate Development, Shire plcMay 2016Director, President and Chief Executive Officer, ImmunoGen Inc. (current AbbVie Inc.)September 2017Non-Executive Director, Keryx Biopharmaceuticals, Inc. (current Akebia Therapeutics, Inc.)March 2020Non-Executive Director, LogicBio Therapeutics, Inc. (current Alexion Pharmaceuticals, Inc.)May 2021Non-Executive Director, Ergomed Group Limited (present post)December 2023Non-Executive Director, BioMarin Pharmaceutical Inc. (present post) About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release 

Astellas to Present New Data in Geographic Atrophy at Upcom… 2025年05月07日 09時00分

ARVO and RWC abstracts feature analyses on biomarkers, mechanism of disease,patient experience and other data from IZERVAYTM (avacincaptad pegol intravitreal solution) pivotal studiesTOKYO, May 1, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”), maker of IZERVAYTM (avacincaptad pegol intravitreal solution), a C5 inhibitor for the treatment of geographic atrophy (GA)*, will highlight new data that enhances continued understanding of the science of GA, and the experience of patients living with the progressive disease at the Association for Research in Vision and Ophthalmology Annual Meeting (ARVO), May 4-8, Salt Lake City, Utah, and Retina World Congress (RWC), May 8-11, Fort Lauderdale, Florida.The data comprises nine abstracts, including two oral presentations, featuring analyses on biomarkers, patient experience, mechanism of disease and other insights from the GATHER Phase 3 studies of IZERVAY for the treatment of GA secondary to age-related macular degeneration (AMD).Marci English, Senior Vice President, Biopharma and Ophthalmology Development, Astellas Pharma“Recognizing the early indicators and disease pathways of geographic atrophy are critical to helping patients preserve their existing vision for longer. We look forward to engaging with the retina community at ARVO and RWC to discuss the latest scientific insights in early diagnosis and effective management of GA.”Research highlights include:An oral presentation on the structure-function relationship between baseline central subfield ellipsoid zone (EZ) integrity and visual acuity at baseline and future vision lossAn oral presentation on baseline EZ integrity features linked to GA progression in eyes with differential shifts in GA growth rateMultiple posters evaluating imaging data from the GATHER1 and GATHER2 studies, which link structure and function in GATwo preclinical posters with structural insights refining the mechanism of action, as well as pharmacokinetics and pharmacodynamics, of avacincaptad pegol (ACP)Data from qualitative studies assessing the experience of patients with GA in the U.S., Spain, Germany and France, including the impact of disease symptoms on health-related quality of life (HRQoL) and coping mechanisms used to manage symptoms of GAAstellas Presentations at 2025 ARVO Annual MeetingPresentation TitlePresenterPresentation DetailsAssociation of baseline central subfield ellipsoid zone integrity with baseline visual acuity and future vision loss in the GATHER clinical trialsR. AmineType: OralPresentation Number: 4594Date: May 7, 2025 3:30-3:45 PM MTUnderstanding the experience of people living with geographic atrophy in the United States, Spain, France and GermanyN. GenovaType: PosterPosterboard Number: 807 - B0259Date: May 4, 2024 1:00-2:45 PM MTStructural insights into the mechanism of inhabitation of C5 activation by avacincaptad pegol, an aptamer approved for the treatment of geographic atrophy secondary to age-related macular degermationG. MusadaType: PosterPresentation Posterboard Number: 2522 - B0235Date: May 5, 2025 3:00 – 4:45 PM MTNonclinical pharmacology and pharmacokinetic properties of avacincaptad pegol, an aptamer against C5 approved for the treatment of geographic atrophy secondary to age-related macular degenerationN. LombardiType: PosterPosterboard Number: 2539 - B0252Date: May 5, 2025 3:00 – 4:45 PM MTiRORA phenotype characterization using fundus autofluorescence: GATHER2 post-hoc analysis for geographic atrophy secondary to AMDG. CorradettiType: PosterPosterboard Number: 3468 - B0031Date: May 6, 2025 1:15 – 3:00 PM MTAssociation of ellipsoid zone integrity features with diffuse trickling fundus autofluorescence patterns in the GATHER1/GATHER2 clinical trialsL. Della VecchiaType: PosterPosterboard Number: 3512 - B0075Date: May 6, 2025 1:15 – 3:00 PM MTStructure-function link between ellipsoid zone integrity features and visual acuity in eyes with geographic atrophy in the GATHER1 and GATHER2 clinical trialsK. MatarType: PosterPosterboard Number: 4123 - A0121Date: May 7, 2025 10:15 AM – 12:00 PM MTEllipsoid zone integrity features linked to differential shifts in geographic atrophy growth rate in the GATHER1 and GATHER2 clinical trialsA. IndurkarType: PosterPosterboard Number: 4220 - A0218Date: May 7, 2025 10:15 AM – 12:00 PM MT Astellas Presentations at RWC 2025 MeetingPresentation TitlePresenterPresentation DetailsEllipsoid zone integrity features linked to differential shifts in geographic atrophy growth rate in the GATHER1 and GATHER2 clinical trialsR. DownesType: OralDate: May 9, 2025 2:38 – 2:43 pm ET *avacincaptad pegol intravitreal solution (ACP) is approved for use as IZERVAYTM only in the U.S.About IZERVAYTM (avacincaptad pegol intravitreal solution)INDICATION AND IMPORTANT SAFETY INFORMATIONWhat is IZERVAYTM?IZERVAY (avacincaptad pegol intravitreal solution) is a prescription eye injection, used to treat geographic atrophy (GA), the advanced form of dry age-related macular degeneration (AMD).What is the most important information I should know about IZERVAY?Do NOT receive IZERVAY if you:Have an infection in or around your eyeHave active swelling in or around your eye that may include pain and rednessIZERVAY can cause serious side effects:Eye injections like the one for IZERVAY can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment).Call your healthcare provider right away if you have redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small specks floating in your vision, flashes of light, or increased sensitivity to light.There is a risk of developing wet AMD with IZERVAY. You should report any symptoms (visual distortions such as straight lines seeming bent, deterioration in vision, dark spots, loss of central vision) to your healthcare provider to monitor.IZERVAY may cause a temporary increase in eye pressure after the injection. Your healthcare provider will monitor this after each injection.Before receiving IZERVAY tell your healthcare provider about all of your medical conditions including if you:Have a history of seeing flashes of light or small specks floating in your vision and if you have a sudden increase of size and number of these specks.Have high pressure in the eye or if you have glaucoma.Are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.Are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider about any medicine you take.What should I avoid while receiving IZERVAY?Your vision may be impaired after receiving an eye injection or after an eye exam. Do not drive or use machinery until your vision has recovered sufficiently.What are the most common side effects of IZERVAY?Blood in the white of the eyeIncrease in eye pressureBlurred visionWet age-related macular degenerationThese are not all the possible side effects of IZERVAY. Tell your healthcare provider about any side effect that bothers you or that does not go away.Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.Please see full Prescribing Information for more information.About Geographic AtrophyAge-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, associated with AMD, leads to further irreversible loss of vision in these patients.About the GATHER Clinical TrialsIZERVAY met its primary endpoint in the GATHER1 (NCT02686658) clinical trial and the GATHER2 (NCT04435366) clinical trial, both of which were randomized, double-masked, sham-controlled, multicenter Phase 3 clinical trials. These trials evaluated the safety and efficacy of monthly 2 mg intravitreal administration of IZERVAY in patients with GA secondary to AMD. For the first 12 months in both trials, patients were randomized to receive either IZERVAY 2 mg or sham monthly. There were 286 participants enrolled in GATHER1 and 448 participants enrolled in GATHER2. The primary efficacy endpoints in both pivotal studies were based on GA area measured by fundus autofluorescence at three time points: baseline, month 6, and month 12. Safety was evaluated in over 700 patients with GA across the two trials.In year 2 of the GATHER2 study, patients treated with IZERVAY in year 1 were re-randomized to receive either IZERVAY dosed monthly (EM, n=96) or every other month (EOM, n=93); patients who received sham in year 1 continued to receive sham in year 2 (n=203). IZERVAY is continuing to be evaluated in an open-label extension study.About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release 

Notice Regarding Change in fair value of contingent conside… 2025年04月25日 15時30分

TOKYO, April 25, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it booked Change in fair value of contingent consideration as other income in the fourth quarter of fiscal year ended March 31,2025 and that there are differences between the financial forecasts (Full basis), which were reported on January 24, 2025, and the actual results for the fiscal year 2024.1. Booking and details of change in fair value of contingent considerationDue to updates to the clinical development plan for zolbetuximab for pancreatic adenocarcinoma, Astellas booked ¥8.0 billion in changes in the fair value of the contingent consideration as other income. Due to the discontinuation of programs related to Xyphos Biosciences, Inc., Astellas booked ¥7.6 billion in changes in the fair value of the contingent consideration as other income.2. The Differences Between Financial Forecasts (announced on January 24, 2025) and Actual results for the Fiscal Year Ended March 31, 2025 (Full basis)Operating profit and other line items (Full basis) were higher than the forecasts due to such matters as Change in fair value of contingent consideration as discussed above.＜Full basis＞(Millions of yen) RevenueOperating profitProfit before taxProfit for the yearProfit attributable to owners of the parentPreviousforecast (A)1,900,00011,0001,00014,00014,000Actual results (B)1,912,32341,03931,23750,74750,747Change (B-A)12,32330,03930,23736,74736,747Change (%)0.6273.1-262.5262.5(Ref.)Actual fiscal year 20231,603,67225,51824,96917,04517,045 The above is reflected in the financial results of Astellas for FY2024 which were announced today. About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.Cautionary NotesIn this press release, statements made concerning current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs considering the information currently available to it and involve known and unknown risks and uncertainties. Several factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development) included in this press release is not intended to constitute an advertisement or medical advice. Click below for a copy of the full press release 

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