
Pharmaceutical R&D Developer
Intelligent Finance APP learned on December 5 that the clinical trial application for Pfizer's (PFE.US) Class 1 new drug PF-07934040 tablets has been accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration. Public information shows that this is a research drug developed by Pfizer.Pan-KRAS Inhibitor, is currently conducting Phase 1 clinical trials internationally. This is the first time the product has been submitted for an IND application in China. The submission of PF-07934040 for clinical trials in China indicates that the product may soon begin clinical research in the country.

Screenshot source: CDE official website
According to the introduction on Pfizer's official website, PF-07934040 is aPan-KRAS "ON/OFF" inhibitor, active against wild-type (wt) KRAS and major mutant subtypes, with no activity against NRAS or HRAS.PF-07934040 shows binding to both the OFF (GDP-bound) and ON (GTP-loaded) states of KRAS wt, with very low binding affinity to mutants. Its selectivity for binding to KRAS is 5,000 times higher than that for HRAS/NRAS.
Studies show that PF-07934040 blocks the binding of RAF-RBD to GTPgS-loaded KRAS mutants, suggesting its mechanism of action may include binding to the active state of KRAS and inhibiting RAF binding, modulating downstream signaling.
According to the ClinicalTrials website, Pfizer is conducting a Phase 1 clinical study to evaluate the optimal dose, efficacy, and safety of PF-07934040 as a single agent or in combination with other targeted therapies for patients with advanced solid tumors harboring KRAS gene mutations.The study plans to enroll patients with non-small cell lung cancer, colorectal cancer, pancreatic ductal adenocarcinoma, etc., and aims to recruit 330 participants internationally.