智通财经APP讯,加科思-B(01167)公布,公司自主研发的Pan-KRAS抑制剂AB-23E73的新药临床试验申请(IND)已经获得国家药品监督管理局(NMPA) 药品审评中心(CDE)批准。此前,美国的IND申请也已经获得美国食品药品监督管理局(FDA)批准,将在中国和美国同步开展I/IIa期晚期实体瘤临床试验。
KRAS广泛存在于多种肿瘤突变,约23%-25%的癌症患者带有KRAS突变,全球每年新增约270万带有KRAS相关突变的肿瘤患者有望从Pan-KRAS抑制剂中获益。
JAB-23E73可同时抑制KRAS的活性及非活性状态的KRAS,并对HRAS、NRAS 无明显抑制。作为口服KRAS抑制剂,JAB-23E73的临床前资料展现了良好的药代动力学特性。
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