中国生物制药(01177):TQB3205(pan-KRAS 抑制剂)临床试验获NMPA批准

智通财经
Mar 11

智通财经APP讯,中国生物制药(01177)发布公告,本集团附属公司正大天晴药业集团股份有限公司(正大天晴)自主研发的国家1类创新药TQB3205(pan-KRAS 抑制剂)已获得中国国家药品监督管理局(NMPA)的临床试验批准,拟用于治疗晚期恶性肿瘤。

TQB3205是一款口服的pan-KRAS抑制剂。其核心作用机制是与多种KRAS突变蛋白高亲和力结合,通过抑制SOS1介导的KRAS核苷酸交换,阻断RAS激活,抑制下游ERK磷酸化,从而有效抑制多种 KRAS突变肿瘤细胞的增殖。

KRAS基因是RAS家族中突变频率最高的基因。全球约30%的癌症病例与RAS基因突变相关,其中由 KRAS突变导致的癌症占所有RAS突变的85%,在胰腺癌(90%)、结直肠癌(30%-50%)、非小细胞肺癌( 15%-20%)等多种癌症中普遍存在。然而,不同肿瘤类型的KRAS突变亚型差异显着,常见类型包括G12C、G12V、G12D、G13D等。目前全球已获批上市的5款KRAS抑制剂均仅针对G12C单一突变亚型。

本集团联合开发的KRAS G12C抑制剂格索雷塞(商品名:安方宁)已于2024年11月获得NMPA的上市批准。尽管如此,KRAS领域的临床需求远未得到满足,亟需能覆盖更广泛突变亚型的pan-KRAS抑制剂。本集团将加速推动TQB3205的临床开发,致力于突破现有治疗局限,为更广泛的KRAS突变晚期恶性肿瘤患者带来新的治疗选择。

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