- Zolbetuximab is currently the first and only therapy approved in the European Union to target claudin 18.2, a biomarker positively expressed by 38% of patients with advanced gastric cancer1,2- Treatment with the claudin 18.2-targeted monoclonal antibody shown to significantly extend both progression-free survival and overall survival in Phase 3 trials1,2TOKYO, Sept. 20, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the European Com ...

文章核心观点 - 阿斯利康推出了一款名为DIGITIVA的数字健康解决方案,旨在帮助心力衰竭患者更好地管理自己的疾病 [1][2][3] - DIGITIVA包括三个组件:Eko Health公司开发的CORE 500数字听诊器、基于Welldoc平台的心力衰竭患者智能手机应用程序,以及专门的临床审查团队 [2][4][5] - DIGITIVA可以监测患者的生物标志物,并在检测到可能需要医生干预的信号时通知患者的医生,旨在改善临床结果,如急性失代偿事件和再次住院 [2][3] - 阿斯利康认为DIGITIVA有助于患者和医生更好地管理心力衰竭,并表示这是阿斯利康在数字健康技术方面的重要里程碑 [3] - 心力衰竭是一个全球性的健康问题,在美国,心力衰竭的患病率预计将从2020年的690万增加到2030年的850万 [3] 公司信息 - 阿斯利康是一家在全球70多个国家开展业务的制药公司,致力于创新科技与专业知识相结合,为患者创造价值 [6][7] - Eko Health是一家领先的数字健康公司,致力于通过其数字听诊器、患者和医生软件以及人工智能分析,提高医疗专业人员检测和监测心肺疾病的能力 [8] - Welldoc是一家数字健康领导者,致力于通过其综合数字健康平台,为患有心血管代谢疾病的个人提供个性化、实时和可操作的洞见,从而改善健康和结果 [9][10] 行业信息 - FDA将医疗器械分为三类,DIGITIVA被归类为I类软件医疗器械,无需经过510(k)预市场审查 [6] - Welldoc已获得11项用于糖尿病功能的510(k)批准,并拥有45项先进人工智能和首创技术的专利 [10] - Welldoc在业内享有很高的声誉,曾多次获得行业奖项,如"最佳数字健康公司"和"医疗人工智能创新奖" [10]

- Eight abstracts, including two oral presentations, feature new clinical data from Astellas' oncology portfolio and two lead pipeline programs across a broad range of cancer types -TOKYO, Sept. 11, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will highlight new data from across its approved and investigational cancer therapies during the 2024 European Society for Medical Oncology (ESMO) Congress being held in Barcelona, Spain on 13-17 September. Eight ...

The new LEED-certified construction is home to the company's first U.S.-based SakuLab™, a shared laboratory space for highly innovative external partners. The new ALSC will also house the company's Engineered Small Molecules (ESM) unit which focuses on advancing research into targeted protein degradation, a novel treatment approach aimed at removing specific proteins from cells to unlock targets that have previously been considered 'undruggable.'Approximately 400 Astellas employees will operate out of the n ...

- Pooled analyses from two SKYLIGHT™ studies highlight impact on sleep disturbance and impairment, relationship between improvements in the frequency or severity of hot flashes and mood- Pooled data from three SKYLIGHT™ studies assess safety and tolerability in Hispanic/Latina women- Responder analysis from DAYLIGHT™study evaluates reduction in VMS frequency in women unwilling or unable to take hormone therapyTOKYO, Sept. 4, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okam ...

- First regimen approved in advanced urothelial cancer to demonstrate superiority to platinum-containing chemotherapy, the standard of care for nearly 40 years1- European Marketing Authorization based on positive overall survival and progression-free survival results from the global Phase 3 EV-302 trial1TOKYO, Aug. 28, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the European Commission has granted Marketing Authorization for PADCEV ...

财务数据和关键指标变化 - 第一季度收入增长26.2%,达到4731亿日元 [14] - 核心营业利润增长20.5%,达到883亿日元 [14] - 剔除汇率影响,收入和利润仍有增长 [14] - 其他费用中计提了55亿日元的或有对价公允价值增加,主要是由于汇率影响 [15] XTANDI和战略品牌的表现 - XTANDI全球销售增长29%,达到2242亿日元,主要受益于美国市场的强劲表现 [16][17][18] - 战略品牌(PADCEV、IZERVAY、VEOZAH、VYLOY、XOSPATA)总销售增长3倍,达到750亿日元 [19] - PADCEV全球销售增长152%,达到384亿日元,美国和欧洲市场表现强劲 [20][26][27][28][29] - IZERVAY在美国销售超预期,第一季度销售127亿日元,增长73% [36][37][38][39][40][41][42][43][44][45] - VEOZAH在美国的销售稳步增长,医保覆盖率从50%提升至60% [31][32][33][34][35] - VYLOY在日本6月成功上市,其他市场也在积极推进审批和准备上市 [23][24][25][58][59] 成本管理和投资 - 销售成本率上升0.9个百分点,主要由于一次性因素 [46] - 销售管理费用(不含XTANDI美国合作费用)增长17.5%,主要是战略品牌的促销费用增加 [47][48][49] - 研发费用增长34.4%,主要是加强主要关注领域和研发职能的投入 [51][52] - 在投资未来增长的同时,也通过关注投资回报率来及时管控费用 [49][50] 新的发展计划 - XTANDI在中国获批新适应症,PADCEV在欧洲和日本获批新适应症 [54][55][56][59] - IZERVAY在欧洲的审评进展中,公司正在与监管机构沟通 [56] - VYLOY正在推进全球上市,并启动了新的临床试验 [58][59][60][61][62] - 主要关注领域的管线进展,如ASP3082和ASP1570的临床数据将在ESMO会议上发表 [63][64][65][66][67][68] 未来展望 - 预计战略品牌总销售将在2025财年达到5000亿日元 [72] - 公司正在密切关注IZERVAY和VEOZAH的表现,并根据进展情况适时调整预测 [43][130][131][132]

业绩总结 - FY2024财报显示，Astellas Pharma Inc.的营收同比增长26.2%，达到473.1亿日元[10] - 公司战略品牌总营收达到75.0亿日元，同比增长3倍[7] - 公司在2024年7月份取得了稳健的业绩，核心运营利润率为15.2%[66] 用户数据 - XTANDI在美国市场表现突出，为公司整体增长做出了贡献[6] - IZERVAY在美国市场表现超出预期，市场份额达到约35%[28] 未来展望 - 公司计划在2025年上半年开始进行zolbetuximab和化疗联合治疗的第三阶段研究[49] - 公司预计2024年和2025年的汇率为145日元和155日元，对美元和欧元的汇率变动对财务结果的影响为45.4亿日元的收入增加和11.6亿日元的核心运营利润增加[79][80] 新产品和新技术研发 - PADCEV和VEOZAH在美国和欧洲市场的销售增长强劲，预计未来将继续贡献销售额[21] - Enfortumab Vedotin (EV)在临床研究中取得了多项重要进展，包括针对不同类型癌症的多项关键研究[137] 市场扩张和并购 - 公司在2024年6月底的资产总额为3735.5亿日元，现金及现金等价物为302.9亿日元，归属于母公司所有者的总权益为1676.4亿日元，资产负债率为44.9%[83] 负面信息 - 食管和食道腺癌患者EV治疗目标为17.5%，实际结果为4.3%[101]

-       If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2-targeted therapy approved in the European Union -       A decision on the EU marketing authorization is expected by October 2024TOKYO, July 26, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that on July 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion rec ...

- If approved, enfortumab vedotin in combination with pembrolizumab will be the first and only treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care for those with unresectable or metastatic urothelial cancer- Positive opinion is based on Phase 3 EV-302 clinical trial results which showed enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival compared to platinum-containing chemotherapy1TOKYO, July 26, 2024 /PRNewswire/ -- As ...