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

智通财经
Jul 10
【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】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关于卡瑞利珠单抗联合合作伙伴Elevar Therapeutics的药物Rivoceranib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。这意味着,该联合疗法再次被FDA延迟批准上市。对此,恒瑞医药方面回应称,此次FDA审批反馈主要与阿帕替尼相关生产场地的CGMP检查观察项有关,该场地于2026年4月接受了FDA 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。恒瑞医药方面亦表示,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。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。

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