The Center for Drug Evaluation (CDE) website indicates that China-based Innovent Biologics’ (HKG: 1801) Category 1 chemical drug GFH925 has been awarded a breakthrough therapy designation (BTD) for the treatment of KRASG12C mutant advanced colorectal cancer (CRC). This designation highlights the potential of GFH925 in addressing a significant unmet medical need.
GFH925: A Promising KRAS G12C Inhibitor with Best-in-Class Potential
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 numerous tumor cell lines carrying the KRAS G12C mutation, positioning it as a promising candidate for the treatment of advanced CRC.
Innovent Biologics’ Strategic Acquisition and Development Rights
Innovent Biologics struck a significant USD 312 million deal with GenFleet in September 2021, securing exclusive development and commercialization rights to GFH925 in Greater China, including mainland China, Hong Kong, Macau, and Taiwan. The drug had previously obtained BTD status for treating KRASG12C mutant advanced non-small cell lung cancer in patients who had received at least one systemic therapy, as recognized by the NMPA in China in December of the previous year.
Phase I Study Results and Market Potential
A Phase I study assessing the safety and efficacy of GFH925 in advanced malignant tumors with KRAS G12C mutations that have failed or were intolerant to standard treatment showed positive results. Out of 5 patients with advanced CRC who received GFH925 treatment, 3 patients achieved partial remission, with both objective response rate (ORR) and disease control rate (DCR) at 60%. This data supports the drug’s potential in the market, especially considering that there are no KRAS inhibitors like Amgen’s Lumakras and Mirati Therapeutics, Inc.’s Adagras approved for marketing in China.-Fineline Info & Tech
