智通财经APP获悉，12月5日，中国国家药监局药品审评中心(CDE)官网公示，辉瑞(PFE.US)1类新药PF-07934040片临床试验申请获得受理。公开资料显示，这是辉瑞公司在研的一款泛KRAS抑制剂，正在国际范围内开展1期临床。本次是该产品首次在中国申报IND，PF-07934040在中国申报临床，意味着该产品有望在不久后在中国开展临床研究。

截图来源：CDE官网

据辉瑞官网介绍，PF-07934040是一种泛KRAS“ON/OFF”抑制剂，具有抗野生型(wt)KRAS和主要突变亚型的活性，对NRAS或HRAS无活性。PF-07934040显示与KRAS wt的OFF(GDP-bound)和ON (GTP-loaded)状态均有结合，并且与突变体的结合亲和力非常低，结合KRAS的选择性比HRAS/NRAS高5000倍。

研究表明，PF-07934040阻断了RAF-RBD与装载GTPgS的KRAS突变体的结合，表明其作用机制可能包括与KRAS on状态的结合和抑制RAF结合，调节下游信号传导。

根据ClinicalTrials官网，辉瑞正在开展一项1期临床研究，评估PF-07934040作为单一药物或与其他靶向药物联合用于KRAS基因突变晚期实体肿瘤患者的最佳剂量、疗效和安全性，研究拟纳入非小细胞肺癌、结直肠癌、胰腺导管腺癌等患者，拟在国际范围内入组330名受试者。

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