GENFLEET-B(02595): GFH375/VS-7375 has achieved positive progress in multiple domestic and overseas clinical studies, demonstrating excellent efficacy in various RAS-mutant solid tumors.

GENFLEET-B(02595) announced that GFH375/VS-7375 (an oral KRAS G12D inhibitor) has achieved positive progress in multiple domestic and overseas clinical studies, with the latest data from the relevant studies released. To date, GFH375 has received three Breakthrough Therapy Designations (BTD) in China for the treatment of KRAS G12D-mutant pancreatic cancer, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC), and has entered two registrational Phase III studies as monotherapy for pancreatic cancer and NSCLC. GenFleet's overseas partner Verastem Oncology (Verastem) is expected to initiate a registrational Phase III study by the end of this year evaluating multiple combination regimens of VS-7375 (combined with anti-EGFR therapy or chemotherapy) as first-line treatment for PDAC, with progression-free survival (PFS) and objective response rate (ORR) as dual primary endpoints and overall survival (OS) as a secondary endpoint. A consensus on the study protocol has been reached with the U.S. Food and Drug Administration (FDA). Dr. Wang Yu, Chief Medical Officer of GenFleet, stated: "We are pleased to see the preliminary efficacy of GFH375 in combination with cetuximab for the treatment of colorectal cancer in domestic studies, as well as the superior data demonstrated by GFH375/VS-7375 across multiple overseas trials. GFH375 is the world's first oral KRAS G12D inhibitor to enter Phase III studies for NSCLC and pancreatic cancer; the product is also expected to enter the world's first Phase III first-line study of a KRAS G12D inhibitor combined with anti-EGFR therapy overseas by the end of this year as a first-line chemotherapy-free treatment regimen. We look forward to more innovative monotherapy and combination therapies of GFH375/VS-7375 bringing hope to patients worldwide."