智通财经APP获悉，2月17日，中国国家药监局药品审评中心(CDE)官网公示，辉瑞(PFE.US)(Pfizer)1类新药PF-07934040片获得临床试验默示许可，拟开发治疗携带KRAS突变的晚期实体瘤。根据辉瑞公司公开资料，这是一款在研泛KRAS抑制剂，正在国际范围内开展1期临床。根据公开信息查询，本次是该产品首次在中国获批IND。本次PF-07934040在中国获批临床，意味着该产品即将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。

PF-07934040作用机制示意图(截图来源：辉瑞官网)

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