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PD-1组合赴美上市二度延期,恒瑞回应:确认具体原因后尽快采取措施并重新提交申请

2024年5月,恒瑞第一次收到该上市申请的完整回复信,FDA在回复信中表示,由于生产场地检查缺陷和部分国家的旅行限制导致无法全部完成该项目必需的生物学研究监测计划(BIMO)临床检查,该申请无法在规定审查时间内得到批准 ... 同年10月,恒瑞医药表示已重新向FDA提交卡瑞利珠单抗联合阿帕替尼肝癌一线治疗适应症上市申请并获受理 ... 公司将在确认具体原因后尽快采取措施并重新提交申请,以期能够获得批准。

媒体报道
恒瑞回应PD-1组合出海美国再延迟:确认具体原因后尽快采取措施并重新提交申请 华尔街见闻/格隆汇
PD-1组合赴美上市二度延期,恒瑞回应:确认具体原因后尽快采取措施并重新提交申请 医药魔方

事件追踪
2025-03-21 恒瑞医药「双艾」疗法未获 FDA 批准
2025-01-23 恒瑞医药:舒地胰岛素注射液上市许可申请获受理
2025-01-07 恒瑞正式递表港交所
2025-01-06 恒瑞医药:向香港联交所递交H股发行并上市的申请
2024-05-18 恒瑞医药卡瑞利珠单抗联合疗法在美上市程序延迟
2024-05-17 恒瑞医药PD-1组合疗法在美推迟上市

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PD-1组合赴美上市二度延期,恒瑞回应:确认具体原因后尽快采取措施并重新提交申请

2024年5月,恒瑞第一次收到该上市申请的完整回复信,FDA在回复信中表示,由于生产场地检查缺陷和部分国家的旅行限制导致无法全部完成该项目必需的生物学研究监测计划(BIMO)临床检查,该申请无法在规定审查时间内得到批准 ... 同年10月,恒瑞医药表示已重新向FDA提交卡瑞利珠单抗联合阿帕替尼肝癌一线治疗适应症上市申请并获受理 ... 公司将在确认具体原因后尽快采取措施并重新提交申请,以期能够获得批准。

媒体报道
恒瑞回应PD-1组合出海美国再延迟:确认具体原因后尽快采取措施并重新提交申请 华尔街见闻/格隆汇
PD-1组合赴美上市二度延期,恒瑞回应:确认具体原因后尽快采取措施并重新提交申请 医药魔方

事件追踪
2025-03-21 恒瑞医药「双艾」疗法未获 FDA 批准
2025-01-23 恒瑞医药:舒地胰岛素注射液上市许可申请获受理
2025-01-07 恒瑞正式递表港交所
2025-01-06 恒瑞医药:向香港联交所递交H股发行并上市的申请
2024-05-18 恒瑞医药卡瑞利珠单抗联合疗法在美上市程序延迟
2024-05-17 恒瑞医药PD-1组合疗法在美推迟上市

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