By Fineline Cube 
China-based GenFleet Therapeutics announced on July 25, 2025, that its oral KRAS G12D inhibitor, GFH375/VS-7375, has been granted Fast Track designation by the U.S. FDA. This designation applies to the first-line and later-line treatment of patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) harboring KRAS G12D mutations. GFH375 received clinical approval in China in June 2024 and is currently in Phase II development there. The Phase I/IIa study of GFH375/VS-7375 in the U.S. was initiated by GenFleet’s partner, Verastem Oncology (NASDAQ: VSTM), earlier this year.
Drug Mechanism and Clinical Progress
GFH375 is a highly potent, highly selective, non-covalent small molecule inhibitor targeting the KRAS G12D mutation. It inhibits tumor cell proliferation by blocking the sustained activation of KRAS and its downstream pathways. Phase I data presented at ASCO 2024 demonstrated an Overall Response Rate (ORR) of 52% and a Disease Control Rate (DCR) of 100% in PDAC patients. In NSCLC patients, the ORR was 42% and the DCR was 83%, indicating promising preliminary efficacy and oral bioavailability.
Collaboration with Verastem Oncology
In August 2023, GenFleet Therapeutics entered into a licensing and early-stage co-development agreement with Verastem for three products developed by GenFleet. In January 2025, Verastem exercised its option for GFH375/VS-7375, securing the development and commercialization rights for GFH375 outside of Greater China. This strategic partnership underscores the potential of GFH375 and accelerates its global development.-Fineline Info & Tech