Innovent Biologics, Inc. announced a phase I/II clinical study of KRAS G12C inhibitor IBI351 in Chinese patients with solid tumors (ClinicalTrials.gov, NCT05005234) completed dosing of the first subject. This study is an open-label, multi-center Phase I/II clinical study in Chinese patients with advanced solid tumors (non-small cell lung cancer (NSCLC) and gastrointestinal cancer) harboring KRAS G12C mutation, with the primary objective to assess the safety/tolerability, pharmacokinetics and efficacy of IBI351. IBI351 (GenFleet's R&D code: GFH925) is a highly effective oral new molecular, independently developed by GenFleet Therapeutics Inc. and has complete intellectual property rights. By covalently and irreversibly modifying the cysteine residue of KRAS G12C mutant, it effectively inhibits the protein-mediated GTP/GDP exchange and thus down-regulates the KRAS protein activation level. Preclinical cysteine selectivity test also shows the highly selective inhibitory potency of IBI351 on this mutation point. In addition, inhibition of KRAS protein by IBI351 inhibited downstream signaling pathways, profoundly induced tumor cell apoptosis and cell cycle arrest, and achieved anti-tumor effect. In September 2021,Innovent and GenFleet Therapeutics (Shanghai) Inc. ("GenFleet"), entered into an exclusive license agreement in which Innovent will be responsible for clinical development and commercialization of IBI351 in China including mainland China, Hong Kong, Macau and Taiwan with additional option-in rights for global development and commercialization.