明星肿瘤疗法出海美国第三次遇阻，恒瑞称未涉及有效性等问题

澎湃新闻07-10

恒瑞医药PD-1肿瘤药想要在美国获批的计划再次遇阻。　　7月10日，恒瑞医药（600276.SH，1276.HK）公告称，收到美国食品药品监督管理局（FDA）关于卡瑞利珠单抗（中文商品名：艾瑞卡）联合合作伙伴Elevar Therapeutics的药物Rivoceranib（国内上市产品名称为阿帕替尼，商品名：艾坦）（“双艾”组合）用于不可切除或转移性肝细胞癌患者一线治疗的生物制品许可申请（BLA...

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CGMP监督检查，公司已针对监管机构提出的反馈意见进行详细评估，并着手制定相应的改进措施。本次申报涉及的相关场地在2025年通过了欧盟的检查。　　按照恒瑞医药公布的研究数据，CARES-310研究最终分析结果显示，“双艾”组合治疗组的中位总生存期达到23.8个月，在获批的不可切除或转移性肝细胞癌治疗方案中，成为迄今为止获得最长中位OS研究数据的治疗方案。恒瑞医药强调，此次CRL未涉及对产品临床研究数据、安全性及有效性方面的问题，“基于坚实的临床研究数据，我们仍对该组合方案在肝癌治疗领域的长期潜力保持充分信心”。　　早在2023年10月，恒瑞医药与美国 ElevarTherapeutics 公司达成协议，将卡瑞利珠单抗项目有偿许可给Elevar，Elevar将获得在除大中华区和韩国以外的全球范围内开发和商业化卡瑞利珠单抗联用治疗肝细胞癌的独家权利。恒瑞医药称，公司将积极与FDA及合作伙伴Elevar Therapeutics进行密切沟通，以明确后续的申报计划。稳步推进国际化是公司的长期发展战略，公司多项创新药的海外研发进程均按计划持续推进中。　　7月10日，恒瑞医药A股收涨0.25%，报55.75元/股，市值3700.2亿元；H股收涨1.28%，报59.25港元/股，市值3932.5亿港元。（文章来源：澎湃新闻）","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"-1","news_tag":"policyRegulatory","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; 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