科伦药业(002422.SZ)：TROP2 ADC芦康沙妥珠单抗(sac-TMT)新增适应症上市申请获受理

智通财经07-30 19:31

智通财经APP讯，科伦药业(002422.SZ)发布公告，科伦博泰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。

此前，芦康沙妥珠单抗(sac-TMT)用于一线治疗不可手术切除的局部晚期、复发或转移性PD-L1阴性TNBC已获NMPA授予突破性疗法认定(BTD)。本次新增适应症上市申请亦已纳入优先审评审批程序，成为芦康沙妥珠单抗(sac-TMT)纳入该程序的第六项上市申请。纳入优先审评审批程序有望进一步加快审评及上市进程，使这一创新治疗方案更早惠及患者。

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