Gacos-B (01167) announced that Glecir, a KRAS G12C inhibitor independently developed by the company...
Zhitong Finance App News, Gacos-B (01167) announced that the new drug marketing application (NDA) for the KRAS G12C inhibitor Glecirasib (JAB-21822) independently developed by the company has been officially accepted by the China National Drug Administration (NMPA) Drug Evaluation Center (CDE) and included in the priority review process for second-line treatment of advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutations.
The NDA was accepted and included in the priority review based on the results of a phase II registered clinical study (NCT05276726) conducted in China. The study aimed to evaluate the efficacy and safety of Glecirasib as a single agent for non-small cell lung cancer patients with KRAS G12C mutations. According to the regulations of the China Drug Administration, the review time limit for drug marketing license applications included in the priority review process is 130 working days. This will further accelerate the marketing of Glecirasib and meet unmet clinical needs.