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加科思-B(01167.HK):KRAS G12C抑制剂新药临床实验申请(IND)在美国获批
格隆汇 05-03 08:14

格隆汇 5 月 3日丨加科思-B(01167.HK)发布公告,公司JAB-21822项目KRAS G12C抑制剂的新药临床试验申请(“IND”)已经获得美国食品药品监督管理局(“FDA”)批准。

JAB-21822是公司自主研发的创新变构抑制剂,旨在针对KRAS G12C突变。它将用于治疗KRAS G12C斜体突变的晚期实体瘤,包括但不限于非小细胞肺癌 (NSCLC),结直肠癌(CRC)等晚期实体瘤。

KRAS为人类癌症中突变频率最高的致癌基因,迄今为止,全球尚无获批准及已上市的KRAS G12C抑制剂。在约11.0%的NSCLC患者及较小百分比的其他几种难治癌症患者中发现了KRAS G12C突变。于2019年,NSCLC、卵巢癌、CRC及胰腺癌患者中KRAS G12C突变的全球发病人数达到约29.5万人。

在公司的内部头对头临床前动物研究中,JAB-21822表现出优于同类型药物的药代动力学(PK)特性和良好的耐受性,以及具备杰出的剂量特性潜力。科学研究表明,基于KRAS抑制剂和SHP2抑制剂的互补作用机制,其组合可增强抗肿瘤活性。SHP2抑制剂(RAS上游)有望成为KRAS抑制剂克服适应性耐药的最佳组合搭档。公司是全球极为少数同时拥有SHP2抑制剂和KRAS G12C抑制剂的少数制药公司之一,未来公司计划探索内部的联合用药。、

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