【恒瑞医药“双艾”组合闯关FDA再受挫 公司称将重新提交申请】金十数据3月21日讯，恒瑞医药二级市场上的股价盘中跌幅超过3%，盘面上，有消息称，恒瑞医药的“双艾”疗法（卡瑞利珠单抗联合阿帕替尼）未能获得美国FDA的批准。记者从恒瑞医药方面获悉，公司与韩国合作伙伴合作开发的“双艾”方案在美上市再次收到FDA发出的完整回复函。回复信中，FDA表示相关生产场地检查需进一步提交答复，但FDA并未在回复信中说明具体原因。恒瑞医药表示，相关生产场地在2025年1月再次接受FDA检查，FDA核实去年发出CRL的检查中发现的问题都已经整改完毕，仅提出了3个新的改进要求，公司在规定时间内已对相关问题进行了积极回复，并一直与FDA保持密切沟通。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。
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