君实生物:PD-1收到FDA完整回复函,要求进行一项质控流程变更
5月2日,君实生物发布公告,PD-1抗体特瑞普利单抗的上市申请收到FDA的完整回复函(CRL),要求进行一项质控流程变更。君实生物认为该变更较容易完整。君实生物计划在2022年仲夏之前重新递交上市申请。完整回复函中还提到,现场核查因为新冠疫情受阻,具体核查时间另行通知。
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