百济神州(06160.HK)替雷利珠单抗相关上市申请获纳入优先审评
百济神州(06160.HK)今日(8日)宣布,国家药监局已将其具有独特Fc的在研抗PD-1抗体替雷利珠单抗用於治疗既往接受过治疗的局部晚期,或转移性尿路上皮癌患者的新适应症上市申请(sNDA)纳入优先审评。
优先审评是为加强药品注册管理,加快具有临床价值的新药的研发上市;料审批时限将被缩短。尿路上皮癌(UC),又称移行细胞癌(TCC),是目前最常见的一种膀胱癌。2018年,中国预计共有82,270新增膀胱癌案例,占全世界膀胱癌新增案例的15%。尽管UC最常见於膀胱中,但在可发生在泌尿系统的其他部分中。
替雷利珠单抗用於治疗既往接受过治疗的局部晚期或转移性尿路上皮癌患者的新适应症上市申请,於2019年5月被国家药监局受理。
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