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GenFleet Reports KRAS G12C Inhibitor is Under Review in China for NSCLC Approval

publication date: Nov 30, 2023

Shanghai GenFleet Therapeutics reported China’s CDE has accepted for review the company’s NDA for a KRAS G12C inhibitor. It was also granted Priority Review. GenFleet said GFH925 is its first NDA-stage product and China's first KRAS G12C inhibitor to start a NDA review. Based on Phase II results, GFH925 (IBI351) is seeking China approval as a second-line treatment for advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation. One year ago, GenFleet out-licensed greater China rights for GFH925 to Suzhou’s Innovent in a $312 million agreement that could expand to global rights for the candidate. More details...

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