Jiangxi Jemincare’s KRAS Inhibitor Earns Breakthrough Designation from China’s CDE for NSCLC

The China Center for Drug Evaluation (CDE) website has indicated that Jiangxi Jemincare Group’s proprietary small-molecule KRAS inhibitor, JMKX001899, has been granted breakthrough therapy designation (BTD) status for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation in patients who have previously received at least one systemic therapy.

Preclinical data on JMKX001899 suggests that the drug exhibits strong brain permeability and carries no risk of cardiac toxicity or drug interactions compared to other products targeting the same molecule. The drug’s clinical trial application was filed in China in October 2021, and preparations are underway for a clinical filing in the US. Jemincare, in collaboration with HuyaBio International, plans to explore the potential of combining a KRAS inhibitor with an SHP inhibitor in multiple solid tumor types.- Flcube.com

Fineline Info & Tech