China’s Center for Drug Evaluation (CDE) website indicates that China-based Innovent Biologics (HKG: 1801) has received a breakthrough therapy designation (BTD) for its Category 1 chemical drug GFH925. The drug is intended for the treatment of KRASG12C mutant advanced non-small cell lung cancer (NSCLC) in patients who have previously received at least one systemic therapy.
Drug Profile and Development
GFH925, a KRAS G12C inhibitor originated by GenFleet Therapeutics Inc., has demonstrated best-in-class potential in pre-clinical studies. It can effectively inhibit the growth of many tumor cell lines carrying the KRAS G12C mutation and has shown promise as part of combination regimens with other therapies. In September 2021, Innovent Bio struck a USD 312 million deal with GenFleet, securing exclusive development and commercialization rights to the drug in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
Future Prospects and Strategic Implications
The receipt of the BTD from the CDE marks a significant milestone in the development of GFH925. This designation underscores the potential of GFH925 to address significant unmet medical needs in the treatment of KRASG12C mutant advanced NSCLC. Innovent Biologics’ commitment to advancing this innovative therapy positions the company to improve patient outcomes and contribute to the global fight against lung cancer.-Fineline Info & Tech
