恒瑞医药回应PD-1联合疗法在美延迟批准：未涉及产品临床研究数据问题

第一财经07-10

恒瑞医药（600276.SH；01276.HK）的国产PD-1联合疗法在美上市一事再度出现波折。　　7月10日中午，恒瑞医药发布公告称，公司收到美国食品药品监督管理局（FDA）关于卡瑞利珠单抗联合合作伙伴Elevar Therapeutics的药物Rivoceranib（国内上市产品名称为阿帕替尼）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的完整回复信（下称“CRL”）。　　这...

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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。　　CARES-310研究最终分析结果显示，该PD-1联合疗法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（总生存期）研究数据的治疗方案。　　恒瑞医药表示，基于坚实的临床研究数据，该公司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。（文章来源：第一财经）","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"0","news_tag":"","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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