排名前五的靶点	数量

CLDN18.2(Claudin 18.2蛋白)	3
Troponin tropomyosin complex(肌钙蛋白-原肌球蛋白复合体)	2
PBPs(细菌青霉素结合蛋白家族)	2
KRAS G12D(KRAS G12D突变)	2
RP4(视紫红质)	2

关联

153

项与 Astellas Pharma, Inc. 相关的药物

Zolbetuximab

佐妥昔单抗

靶点

CLDN18.2

作用机制

CLDN18.2抑制剂 [+2]

在研机构

Astellas Pharma Global Development, Inc. [+7]

原研机构

Ganymed Pharmaceuticals AG

在研适应症

晚期胃食管交界处腺癌 [+11]

非在研适应症

腺癌 [+3]

最高研发阶段批准上市

首次获批国家/地区

日本

首次获批日期2024-03-26

Avacincaptad pegol

靶点

作用机制

C5抑制剂

在研机构

Astellas Pharma Global Development, Inc. [+3]

原研机构

Ocular Therapeutix, Inc.

在研适应症

年龄相关性黄斑变性 [+2]

非在研适应症

干性年龄相关性黄斑病变 [+2]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2023-08-04

Fezolinetant

非唑奈坦

靶点

NK3

作用机制

NK3拮抗剂

在研机构

Astellas Pharma Global Development, Inc. [+4]

原研机构

Ogeda SA [+1]

在研适应症

潮热 [+7]

非在研适应症

肝损伤

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2023-05-12

1,410

项与 Astellas Pharma, Inc. 相关的临床试验

NCT07425808

/ Not yet recruiting临床2/3期IIT

Gilteritinib in Combination With Azacitidine and Venetoclax Compared to Induction Chemotherapy "7+3" in Combination With a FLT3-inhibitor in Fit, Newly Diagnosed, FLT3-ITD Mutated Adult AML Patients: a Randomized Trial of the EORTC Leukemia Group and GIMEMA.

This international, multicenter, randomized (1:1), open-label phase II/III trial will evaluate the efficacy and safety of gilteritinib combined with azacitidine and venetoclax (experimental arm) versus standard "7+3" induction plus a FLT3inhibitor (quizartinib or midostaurin) (control arm) in newly diagnosed FLT3-ITD mutated AML patients eligible for intensive chemotherapy.

开始日期2026-12-01

申办/合作机构

European Organisation for Research & Treatment of Cancer

[+2]

NCT07417137

/ RecruitingN/AIIT

A Longitudinal Natural History Study of Adults and Children With Angelman Syndrome

The goal of this observational study is to learn about the natural progression of Angelman syndrome (AS) in children and adults with a confirmed genetic diagnosis of AS. The main questions it aims to answer are:
* How do developmental skills, such as communication, motor abilities, and adaptive behaviors, change over a 1-year period in people with AS?
* Are there specific patterns in brain activity or sleep that are associated with changes in AS symptoms over time?
Participants will:
* Visit the study site 5 times over 1 year (approximately every 3 months) for assessments.
* Complete tests and questionnaires about development, behaviors, and sleep with the help of their caregivers.
* Undergo electroencephalograms (EEGs) to measure brain activity and wear a sleep-monitoring device at home (to collect actigraphy data).

开始日期2026-06-01

申办/合作机构

The Massachusetts General Hospital

[+1]

NCT07290985

/ Not yet recruiting临床2期

AACR Adaptive Biomarker-Driven Organ Preservation Trial In Gastroesophageal Adenocarcinomas (AACR-ADOPT-GEA)

This study will test a new personalized treatment approach for patients with stomach or esophageal cancer. It will take place in two stages and aims to find the best combination of chemotherapy, immunotherapy, and targeted drugs based on each patient's tumor biomarkers.
Upon enrollment onto the study, patients will consent to tumor biomarker testing and may receive one cycle of standard chemotherapy while awaiting results. Those with a matching biomarker will join the corresponding treatment group that combines chemotherapy, an immune checkpoint inhibitor, and/or a targeted therapy. In Stage I of the study, treatment lasts about four months before surgery, followed by an additional eight months of therapy for a total of one year.
The most effective treatments from Stage I will be studied further in Stage II of the study to see whether some patients can safely avoid surgery. Those patients enrolled during Stage II will receive four months of the same combination treatment (chemotherapy, an immune checkpoint inhibitor, and/or a targeted therapy) but may be eligible to skip surgery if their cancer completely disappears after pre-surgery therapy. All patients will then receive an additional eight months of therapy and those who skipped surgery will be closely monitored with scans and endoscopies.

开始日期2026-05-01

申办/合作机构

American Association for Cancer Research

[+5]

100 项与 Astellas Pharma, Inc. 相关的临床结果

登录后查看更多信息

0 项与 Astellas Pharma, Inc. 相关的专利（医药）

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3,345

项与 Astellas Pharma, Inc. 相关的文献（医药）

2026-05-01·SLAS Technology

Continuous evolving humanoid for advanced cellular models

Article

作者: Hirose, Sho-Ichi ; Sasamata, Miho ; Shimojo, Daisuke ; Namatame, Ichiji ; Qiu, Shimeng ; Sasaki-Iwaoka, Haruna ; Matsukuma, Kenji ; Yamagishi, Yukiko

Drug discovery research faces significant challenges, with around 90 % of candidate drugs failing in clinical trials. Traditional animal models do not always accurately reflect human physiology and pathology, leading to low predictability of clinical outcomes. In vitro human model using induced pluripotent stem cells (iPSCs), offers a potential solution, but long culture periods and variability among experiments have prompted a shift towards automation in human biomimetic research. We optimized the automated cell culture system "Maholo LabDroid" to establish a platform for the long-term culture of undifferentiated iPSCs and for conducting complex cell-based assays. The Maholo LabDroid, a humanoid robotic system with excellent reproducibility, allows for the addition of peripherals and devices to execute new protocols. To enhance the use of iPSCs, we addressed limitations in detecting real-time changes in cells, supplying sufficient high-quality cells and handling 3D cell models that reflect more physiologically relevant conditions. We integrated a robot arm-assisted imaging system for real-time observation, introduced Bluetooth-enabled electronic pipettes for flexible liquid handling, and expanded the types of culture containers used. These improvements enabled us to determine optimal culture conditions, obtain sufficient quantities of cells, and automatically generate organoids with physiological functions. Using the LabDroid Maholo, we built a platform technology for the provision of advanced cellular models. This platform has the potential to enhance drug discovery research and contribute to the development of cell therapy products.

2026-05-01·JOURNAL OF PHARMACEUTICAL SCIENCES

Flow imaging for particle characterization and quantification in biologicals: A perspective from the Japanese Biopharmaceutical Consortium

Review

作者: Kiyoshi, Masato ; Menzen, Tim ; Uchiyama, Susumu ; Kito, Hirokazu ; Ishii-Watabe, Akiko ; Torisu, Tetsuo ; Suetomo, Hiroyuki ; Hayashi, Yu ; Krayukhina, Elena ; Sakurai, Maho ; Inaba, Kazue ; Shibata, Hiroko ; Hawe, Andrea

Protein aggregates and particles in biologicals are considered impurities and critical quality attributes because they could elicit immunogenicity. An appropriate control strategy should be established to monitor and control them following their characterization. As aggregates and particles range in size from nanometer to millimeters, various analytical techniques are required to characterize aggregates and particles depending on their size, the scope of the analysis, and the development stage. To characterize protein aggregates and particles in the micron size range, light obscuration (LO), flow imaging (FI), and membrane microscopy are primarily used in the biopharmaceutical industry. LO is the preferred technique for quantifying subvisible particles as the internationally harmonized pharmacopoeia test. However, there have been several issues associated with LO for more than a decade, and FI has emerged as a promising technique to complement LO. This perspective paper discusses the efforts made by the Japanese Biopharmaceutical Consortium regarding FI to resolve issues related to LO and outlines the newly listed general information chapter of the Japanese Pharmacopoeia. Finally, the use of FI as well as future challenges for the generalization of FI are summarized from an industry perspective.

2026-04-01·JOURNAL OF UROLOGY

Enzalutamide Monotherapy for the Treatment of Prostate Cancer With High-Risk Biochemical Recurrence: EMBARK Secondary End Points

Article

作者: Tutrone, Ronald F. ; Kliment, Ján ; Rosbrook, Brad ; Shore, Neal D. ; Rosales, Matt ; Karsh, Lawrence I. ; Supiot, Stéphane ; Freedland, Stephen J. ; Marx, Gavin ; Zohren, Fabian ; Bailen, James L. ; Tang, Yiyun ; De Giorgi, Ugo ; Haas, Gabriel P. ; Uchio, Edward M. ; Ramirez-Backhaus, Miguel ; Tarazi, Jamal ; Roos, Erik P. M.

PURPOSE:

Primary analysis of the phase 3 EMBARK trial reported efficacy and safety outcomes for enzalutamide monotherapy in patients with high-risk biochemical recurrence. Here, we report secondary end points for enzalutamide monotherapy vs leuprolide alone.

MATERIALS AND METHODS:

Patients were randomized (1:1:1) to enzalutamide plus leuprolide, leuprolide alone, or enzalutamide monotherapy. Overall survival was a key secondary end point; non-key secondary end points were time to: distant metastasis, symptomatic progression, first symptomatic skeletal event, and resumption of any hormonal therapy. Sexual health was assessed using the Quality of Life Questionnaire-Prostate 25. Time-to-event end points were summarized using Kaplan-Meier methods with nominal P values.

RESULTS:

Five-year probability rates (95% CI) for enzalutamide monotherapy vs leuprolide alone were: overall survival, 89.5% (85.6-92.4) vs 87.2% (83.0-90.4); time to remaining free from distant metastasis, 86.8% (82.3-90.2) vs 81.5% (76.3-85.7); symptomatic progression, 66.6% (61.2-71.4) vs 53.3% (47.6-58.6); and first symptomatic skeletal event, 95.8% (92.9-97.6) vs 91.5% (87.8-94.1). After treatment suspension, the 5-year probability rate (95% CI) of remaining free from resumption of any hormonal therapy for leuprolide alone vs enzalutamide monotherapy was 7.8% (4.4-12.3) vs 5.6% (3.3-8.8). Sexual health was better preserved in patients treated with enzalutamide monotherapy than leuprolide alone (HR 0.76; 95% CI: 0.62-0.94; P = .008). After discontinuation, most patients were subsequently treated with hormonal therapies in both groups.

CONCLUSIONS:

Secondary end point results support enzalutamide monotherapy as a potential option to improve efficacy and preserve sexual health vs leuprolide alone for patients with high-risk biochemical recurrence.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT02319837.

3,973

项与 Astellas Pharma, Inc. 相关的新闻（医药）

2026-04-20

·药明康德

产业新闻 | FDA授予Keytruda/ADC组合疗法优先审评资格；潜在“first-in-class”新药积极临床数据公布……

FDA授予Keytruda/ADC组合疗法优先审评资格！默沙东（MSD）今日宣布，美国FDA已受理其两项补充生物制品许可申请（sBLA），并授予优先审评资格。此次申请涉及抗PD-1疗法Keytruda（pembrolizumab）静脉输注制剂，以及Keytruda Qlex（pembrolizumab和berahyaluronidase alfa）皮下注射制剂。上述两种方案均拟联合辉瑞（Pfizer）和安斯泰来（Astellas）共同开发的抗体偶联药物（ADC）Padcev（enfortumab vedotin），用于治疗适合接受顺铂化疗的肌层浸润性膀胱癌（MIBC）患者。FDA已将该申请的PDUFA目标审评日期定为2026年8月17日。根据新闻稿，若获批，该联合疗法有望成为首个适用于所有MIBC患者（无论是否适合顺铂治疗）的围手术期治疗选择，并可能成为新的标准治疗方案。此次申报主要基于3期KEYNOTE-B15研究结果。数据显示，Keytruda联合Padcev方案在研究参与者中实现了具有统计学显著性且具临床意义的无事件生存期（EFS）和总生存期（OS）改善。之前公布的分析显示，在中位随访33.6个月后，Keytruda联合Padcev达到了研究的主要终点。与新辅助化疗联合手术相比，该方案将EFS事件风险降低47%（HR=0.53，95% CI：0.41–0.70，p<0.0001）。Keytruda联合Padcev组的中位EFS尚未达到，而对照组为48.5个月（95% CI：43.3–NR）。在两年时，约79.4%接受该联合治疗的患者仍存活且未出现疾病进展或复发，而新辅助化疗联合手术组为约66.2%。 Padcev是一种抗体偶联药物，其靶点为Nectin-4，这是一种位于细胞表面并在膀胱癌中高表达的蛋白质。Keytruda则是一种PD-1单克隆抗体，可阻断PD-1与其配体PD-L1和PD-L2之间的相互作用，从而激活T淋巴细胞，以发挥抗肿瘤功效。治疗斑秃，潜在“first-in-class”新药积极临床数据公布 Nektar Therapeutics今日公布其2b期REZOLVE-AA研究中一项盲态16周延长期治疗的新结果。该研究正在评估在研药物rezpegaldesleukin用于治疗重度至极重度斑秃患者。REZOLVE-AA为一项全球研究，共纳入92名重度至极重度斑秃患者，旨在进一步评估该疗法的疗效与安全性。数据显示，在持续每月两次给药的治疗方案下，18 µg/kg和24 µg/kg延长期治疗组分别有29%和31%的患者在第36周至第52周期间新达到斑秃严重度评分工具（SALT）评分≤20（即80%以上的头皮毛发覆盖率），显示出持续治疗带来的进一步获益。与此同时，越来越多患者在多个SALT评估指标上达到具有临床意义的毛发生长标准，且94%的患者完成了延长期治疗。安全性方面，该药物在52周内维持了良好的安全性特征，与此前公布结果一致。上述数据支持rezpegaldesleukin推进至斑秃适应症后期临床开发阶段。 Rezpegaldesleukin是一种潜在“first-in-class”、针对调节性T细胞（Treg）的生物制品，旨在解决患者免疫系统的失衡。它通过作用于体内白细胞介素-2受体复合物，刺激具强效免疫抑制性的调节性T细胞的增殖。通过激活这些细胞，rezpegaldesleukin有望帮助免疫系统恢复平衡。 70亿美元！礼来收购基因疗法新锐礼来（Eli Lilly and Company）与Kelonia Therapeutics今日宣布，双方已达成最终协议，礼来将收购Kelonia。根据协议，Kelonia最高可获得70亿美元款项，其中包括32.5亿美元预付款，以及在达到特定临床、监管和商业里程碑后支付的后续款项。此次交易将进一步拓展礼来在遗传医学领域的布局，并获得一项具有广泛应用潜力的新型体内基因递送与整合技术平台。 Kelonia开发了专有体内基因植入系统iGPS，该平台利用特殊工程化慢病毒颗粒，可在体内高效且选择性地进入T细胞，使患者自身在体内生成嵌合抗原受体T细胞（CAR-T）疗法，以治疗相关疾病。公司核心项目KLN-1010是一款潜在“first-in-class”的静脉注射一次性基因疗法，可在体内生成靶向BCMA蛋白的CAR-T细胞，用于治疗复发/难治性多发性骨髓瘤，目前处于1期临床开发阶段。该项目近期临床数据显示初步临床验证及令人鼓舞的耐受性表现。若后续开发顺利，KLN-1010有望通过免除传统体外个体化细胞制备流程及给药前化疗步骤，为多发性骨髓瘤治疗带来显著进展。参考资料： [1] FDA Grants Priority Review for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev® (enfortumab vedotin-ejfv), for Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer. Retrieved April 20, 2026 from https://www.businesswire.com/news/home/20260420766130/en/FDA-Grants-Priority-Review-for-KEYTRUDA-pembrolizumab-and-KEYTRUDA-QLEX-pembrolizumab-and-berahyaluronidase-alfa-pmph-Each-with-Padcev-enfortumab-vedotin-ejfv-for-Cisplatin-Eligible-Patients-with-Muscle-Invasive-Bladder-Cancer [2] 52-Week Topline Results from 16-Week Blinded Treatment Extension of REZOLVE-AA Demonstrate Deepening of Responses in Severe-to-Very-Severe Alopecia Areata with Rezpegaldesleukin. Retrieved April 20, 2026 from https://ir.nektar.com/news-releases/news-release-details/52-week-topline-results-16-week-blinded-treatment-extension [3] Lilly to acquire Kelonia Therapeutics to advance in vivo CAR-T cell therapies. Retrieved April 20, 2026 from https://investor.lilly.com/news-releases/news-release-details/lilly-acquire-kelonia-therapeutics-advance-vivo-car-t-cell 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

2026-04-20

·药事纵横

FDA授予默沙东和辉瑞/安斯泰来的膀胱癌疗法优先审评资格

2026年4月20日—— 安斯泰来制药与辉瑞公司，以及默沙东公司分别宣布，FDA授予了他们的膀胱癌疗法优先审评资格。该申请旨在批准PADCEV™与KEYTRUDA®的联合方案，用于顺铂适合的肌层浸润性膀胱癌患者的围手术期治疗。此次申请基于III期EV-304/KEYNOTE-B15临床试验的积极数据。若获批准，该方案将成为首个且唯一一个不限顺铂 eligibility的MIBC围手术期治疗方案，有望树立新的治疗标准。FDA根据《处方药使用者费用法案》设定的目标审评日期为2026年8月17日。关于EV-304/KEYNOTE-B15临床试验 EV-304试验是一项在顺铂适合的MIBC患者中开展的开放标签、随机、对照的III期研究，评估了围手术期PADCEV联合KEYTRUDA对比新辅助化疗的疗效与安全性。疗效数据：试验结果显示，与标准新辅助化疗相比，PADCEV联合KEYTRUDA的围手术期治疗方案显著改善了患者的生存结局——总生存期与标准新辅助化疗相比，PADCEV + KEYTRUDA 治疗方案将患者的死亡风险降低了35%；与标准新辅助化疗（吉西他滨+顺铂）相比，PADCEV + KEYTRUDA 的围手术期治疗方案将患者的无事件生存风险降低了47%。安全性数据：在EV-304试验中观察到的PADCEV联合KEYTRUDA的安全性特征与两者联合用药的既往经验一致，未发现新的安全性信号。关于PADCEV与KEYTRUDA PADCEV是一种由安斯泰来与西雅图遗传学共同发现和开发、并由辉瑞与安斯泰来在全球共同商业化的靶向Nectin-4的抗体偶联药物。它通过与癌细胞表面的Nectin-4蛋白结合，内化后释放细胞毒载荷MMAE，从而诱导癌细胞死亡。 KEYTRUDA是默沙东研发的抗PD-1单克隆抗体。它通过阻断PD-1与其配体PD-L1和PD-L2的相互作用，激活T淋巴细胞，增强机体免疫系统侦测与抗击肿瘤细胞的能力。当前批准状态与意义 PADCEV联合KEYTRUDA已于2025年11月获得FDA批准，用于顺铂不适合的MIBC患者的围手术期治疗。本次申请旨在将该适应症扩展至所有MIBC患者，无论其顺铂适合与否。安斯泰来肿瘤开发负责人Moitreyee Chatterjee-Kishore博士表示：“EV-304试验的数据让我们向为所有MIBC患者提供围手术期治疗方案的目标更近一步。尽管接受了以治愈为目的的手术，仍有超过50%的患者面临复发风险，这凸显了改善治疗策略的持续需求。” 辉瑞首席肿瘤官Jeff Legos博士称：“对于MIBC患者，手术往往只是一段漫长而充满不确定性的旅程的开始。如果获批，PADCEV联合KEYTRUDA的围手术期方案将有望改变这一现状，帮助患者降低复发风险、延长生命。” 默沙东实验室全球临床开发高级副总裁兼肿瘤学负责人Marjorie Green博士指出：“KEYNOTE-B15的结果挑战了长期以来对MIBC患者的预期。即使在根治性手术和化疗后，患者仍面临疾病进展或生存期有限的问题。这些数据进一步证明，PADCEV与KEYTRUDA的联合方案有潜力重塑我们治疗这类患者的方式并改善其结局。” 此次申请是安斯泰来/辉瑞与默沙东临床合作的一部分，两家公司计划与全球其他卫生监管部门分享这些数据，以寻求未来的注册申请。立即扫码加入药事纵横交流群

2026-04-20

·医药代表

一知名药企副总被留置调查！

月初刚补缴税款近四百万，现在浙江震元的副总又被查了。 4 月 18 日，浙江震元股份有限公司于深交所发布《关于公司董事、副总经理被留置调查的公告》，披露公司于 2026 年 4 月 16 日收到监察机关《留置通知书》和《立案通知书》，公司董事、副总经理魏民被立案调查并实施留置措施。浙江震元表示，截至本公告披露日，公司对魏民负责的相关工作已进行了妥善安排，董事及其他高级管理人员均正常履职，公司生产经营情况正常，没有受到影响。另外，截至本公告披露日，公司尚未知悉调查的进展及结论。浙江震元的前身可追溯至两百多年前的震元堂药店，始创于清乾隆十七年（公元 1752 年），至今已有 272 年历史，是我国首批“中华老字号”。 1993 年，震元堂的主管单位绍兴医药采购供应站实行规范化股份制改造，新公司以“震元”两字冠名，改名为浙江震元股份有限公司。 1997年，浙江震元在深交所挂牌上市，据浙江震元介绍，这是国家中医药管理局推荐的第一家上市企业。2022年，震元股份、震元连锁分列全国药品流通行业批发、零售企业百强榜单第 38、36 位；震元连锁入围中国连锁药店综合实力百强榜位列 55 位，全国百强单店占 7 家。浙江震元现有九个职能部室，五大事业部（医药工业事业部、医药商业事业部、供应链事业部、中药事业部和医养康事业部），员工 2000 余人。 ▌ 补缴税款近四百万这家药企的闹心事儿还不止这个，本月 9 日，浙江震元于深交所发布《关于公司补缴税款的公告》，披露其全资子公司浙江震元制药有限公司近期依据国家税收法律法规的要求，对涉税事项开展自查。内容显示，经自查，浙江震元全资子公司震元制药需补缴税款及滞纳金合计 389.51 万元，截至公告披露日，上述税款及滞纳金已全部缴纳完毕，本次补缴税款事项不涉及行政处罚，也不会影响公司的正常经营。浙江震元表示，根据相关规定，上述补缴税款及滞纳金事项不属于前期会计差错，不涉及前期财务数据追溯调整。上述税款和滞纳金将计入 2026 年当期损益，对公司 2026 年度归属于上市公司股东的净利润的具体影响，最终以 2026 年度经审计的财务报表为准。近日热点阅读：盘点！B司中国合作周看点超800亿！印度药王要买下这一跨国药企销售涉贿被开！威高发布致歉声明从副总转岗专员？同仁堂人事变动引关注已更新！2026重点监控药品名单国家医保局：这35种情况可举报不只做仿制药！印度医药产业要换打法？毕井泉被逮捕，已提起公诉！第四批中成药国采正式开始突发！这家跨国药企出清OTC业务拜耳赫新诺®中国获批国药控股原董事长，获刑12年诺华CEO，入局AI大厂国家中医药管理局原局长被逮捕、起诉宗忱就任和铂医药总裁总裁离任，普药裁员，9成MR用AI 又有16家药企进入案源线索名单一周两连发，药物发现大模型竞争打响重磅！速福达®儿童剂型扩龄至1岁+ 6.5亿美元出手！优时比押注这一新疗法赛诺菲疫苗全国热招中安斯泰来泌尿团队全国热招拜耳最新全国热招职位一览最新药企内部招聘（4月18日更新） #跨国药企在进博会医药代表伴您成长！

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