GENFLEET-B (02595) announced that its oral KRAS G12D (ON/OFF) inhibitor, GFH375, has been included in the Breakthrough Therapy Designation (BTD) list by the Center for Drug Evaluation of the National Medical Products Administration. The designation is for the monotherapy treatment of patients with KRAS G12D-mutated metastatic pancreatic cancer who have received at least one prior line of systemic therapy. This marks the first KRAS G12D inhibitor monotherapy regimen in China to receive a BTD for pancreatic cancer. Previously, GFH375 became the first KRAS G12D inhibitor in China to be included in a BTD for non-small cell lung cancer.
Overseas clinical research for GFH375/VS-7375 is being conducted by GENFLEET's partner, Verastem Oncology, which initiated studies in the United States in 2025. VS-7375 has already received Fast Track designation from the U.S. FDA for the treatment of first-line and later-line KRAS G12D-mutated pancreatic ductal adenocarcinoma. GFH375 entered the world's first Phase III registrational study for a KRAS G12D inhibitor monotherapy (GFH375X1301) in 2025. This study is also the first registrational trial globally for an oral KRAS G12D inhibitor and is being conducted across approximately 40 research sites in China.
GFH375 received approval in China to enter Phase I/II clinical trials in June 2024. Data from studies investigating its use as a monotherapy for solid tumors, pancreatic ductal adenocarcinoma, and non-small cell lung cancer were successively selected for breakthrough research abstracts and live oral presentations at the 2025 ASCO, WCLC, and ESMO conferences. Currently, multiple clinical trials for GFH375/VS-7375, involving both monotherapy and combination therapies, are underway in China (led by GENFLEET) and overseas (led by Verastem).
Dr. Wang Yu, Chief Medical Officer of GENFLEET, stated, "We are very pleased that our product has received multiple regulatory designations both domestically and internationally, which confirms the excellent efficacy demonstrated by GFH375 in treating various solid tumors. Throughout the clinical development of GFH375, we have gained a deep understanding of the urgent need for innovative targeted therapies among patients with pancreatic cancer and KRAS G12D mutations. The company looks forward to the smooth progress of all GFH375 trials and to bringing new treatment options to patients as soon as possible. We also plan to present the latest data from GFH375 trials in different indications at academic conferences this year."
Pancreatic cancer is one of the most malignant tumors due to factors such as rapid progression, high heterogeneity, and a complex microenvironment, with a five-year survival rate of less than 10%. RAS mutations occur in up to 90% of pancreatic cancer cases, with the KRAS G12D mutation rate being approximately 40%. Compared to patients with KRAS wild-type and other KRAS mutant subtypes, patients with the KRAS G12D mutation have significantly shorter overall survival and relapse-free survival periods.
Various selective and pan-RAS inhibitors, as well as a bispecific antibody therapy for cancer cachexia, within GENFLEET's pipeline hold the potential to provide a new matrix of targeted therapy options for pancreatic cancer treatment. A project titled "Research on the Pathogenesis of Pancreatic Cancer and a New Paradigm for Clinical Precision Diagnosis and Treatment," in which the company participated, successfully received recognition as a National Major Science and Technology Project in 2025.
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