辉瑞(PFE.US)PARP抑制剂“他拉唑帕利”获批上市

智通财经
Nov 05, 2024

智通财经APP获悉,11月5日,国家药品监督管理局(NMPA)官网显示,辉瑞(PFE.US)的甲苯磺酸他拉唑帕利胶囊(talazoparib)的上市申请已获得批准。他拉唑帕利最早由BioMarin开发,2015年Medivation从BioMarin收购了该药物,2016年辉瑞以140亿美元收购Medivation公司,自此他拉唑帕利归属辉瑞。

他拉唑帕利是聚腺苷二磷酸核糖聚合酶(PARP)抑制剂,包括PARP1和PARP2。体外研究表明,对于DNA修复基因缺陷(包括BRCA1 和BRCA2)的肿瘤细胞系,基于合成致死(Synthetic Lethality)原理,他拉唑帕利可能通过抑制PARP酶活性和促进PARP-DNA复合物的形成来发挥细胞毒作用,从而导致肿瘤细胞DNA损伤、抑制肿瘤细胞的增殖并促进肿瘤细胞凋亡。

2018年,FDA批准他拉唑帕利治疗胚系突变BRCA1/2(gBRCAm)的HER2阴性局部晚期或转移性乳腺癌,后也被批准用于治疗转移性去势抵抗性前列腺癌(mCRPC)。此前,国内已有奥拉帕利(阿斯利康)、氟唑帕利(恒瑞)、尼拉帕利(GSK/再鼎)、帕米帕利(百济)这4款PARP抑制剂获批上市,以及强生的尼拉帕利醋酸阿比特龙复方也已获批上市。另外还有一款PARP抑制剂塞纳帕利(senaparib,英派药业/华东医药)已申报上市,正在审评当中。

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