科伦博泰生物(06990.HK)核心产品TROP2 ADC芦康沙妥珠单抗(sac-TMT)新增适应症上市申请获国家药监局受理

智通财经

07/30

【科伦博泰生物(06990.HK)核心产品TROP2 ADC芦康沙妥珠单抗(sac-TMT)新增适应症上市申请获国家药监局受理】智通财经APP讯，科伦博泰生物(06990.HK)发布公告，公司靶向人滋养细胞表面抗原2(TROP2)的抗体偶联药物(ADC)芦康沙妥珠单抗(sac-TMT，亦称SKB264/MK-2870)(佳泰莱®)的一项新增适应症上市申请已获中国国家药品监督管理局(NMPA)药品审评中心(CDE)受理，用于程序性细胞死亡配体1(PD-L1)综合阳性评分(CPS)<10或早期阶段接受过程序性细胞死亡蛋白-1(PD-1)╱PD-L1抑制剂的复发或转移性三阴性乳腺癌(TNBC)的一线治疗。这是芦康沙妥珠单抗(sac-TMT)获NMPA受理的第六项适应症上市申请。

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