信达生物信迪利单抗癌症联合疗法申报上市,科济药业CAR-T细胞疗法拟纳入突破性治疗品种

医药经济报
22 Feb

信达生物信迪利单抗癌症联合疗法申报上市今日,中国国家药监局药品审评中心(CDE)官网最新公示,信达生物申报的伊匹木单抗注射液和信迪利单抗注射液的上市申请获得受理。公开资料显示,这是信达生物在研的抗CTLA-4单抗IBI310与抗PD-1单抗信迪利单抗联合疗法。这款联合疗法已经被CDE纳入突破性治疗品种,且于几日前(2月5日)被CDE正式纳入优先审评,适应症为伊匹木单抗注射液联合信迪利单抗用于可切除...

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