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百济神州(06160.HK)胰腺癌进口药上市申请获受理
阿思达克 06-04 07:26

百济神州(06160.HK)公布,国家药监局已受理ABRAXANE注射用紫杉醇(纳米蛋白颗粒结合型)联合吉西他滨,用於治疗一线转移性胰腺癌患者的进口药品新适应症上市申请。

ABRAXANE於2008年在内地首次获批用於治疗转移性乳腺癌患者。公司获得新基公司授予的ABRAXANE独家经销,可在内地独家销售该药品。

此外,国家药监局也已受理了一项在研抗PD-1抗体替雷利珠单抗用於治疗先前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。

替雷利珠单抗是第一款由百济神州的免疫肿瘤生物平台研发的候选药物,目前正作为单药疗法及联合疗法开发针对一系列实体瘤和血液肿瘤治疗适应症。

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