GENFLEET-B (02595.HK): two first-in-class pancreatic cancer combination therapies of GFH375 advance to Phase II studies

NewTimeSpace News: On 20 August 2026, GenFleet Therapeutics (Shanghai) Inc. (stock code: 02595) announced in a voluntary announcement that a three-arm parallel-controlled Phase II clinical study of GFH375 (an oral KRAS G12D ON/OFF inhibitor) has recently been initiated for the treatment of patients with previously treated locally advanced unresectable or metastatic pancreatic cancer with KRAS G12D mutations. The study includes two combination regimens: GFH375 combined with GFS202A, the world's first cachexia bispecific antibody (GDF15/IL-6 bispecific), and GFH375 combined with GFH276, a pan-RAS ON inhibitor. This multi-center, open-label, randomized controlled study will be conducted at dozens of centers in Mainland China, led by Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine.

According to the announcement, in February 2026, GFH375 became the first to obtain breakthrough therapy designation in China for monotherapy of metastatic pancreatic cancer with KRAS G12D mutations, and received fast track designation from the US FDA in 2025. GFH375 has entered the world's first Phase III registration study of an oral KRAS G12D inhibitor; GFS202A, the world's first cachexia bispecific antibody, had its preliminary study data selected for an ASCO 2026 annual meeting poster. KRAS G12D mutations occur in approximately 40% of pancreatic cancer patients, and the cachexia incidence in pancreatic cancer patients ranks first among all tumor types at over 60%.

The announcement states that GenFleet's animal experiments showed synergistic efficacy beyond either monotherapy when GFH375 and GFH276 are combined; compared with molecular glue RAS inhibitor doublet regimens, GenFleet's combination of two RAS-targeting drugs with different mechanisms may optimize the pan-RAS inhibitor dosage to reduce adverse reactions such as rash. GenFleet has entered into license and early collaboration agreements with Verastem Oncology, which obtained the license for GFH375 in January 2025 for development and commercialization outside China, with GenFleet retaining rights within China. Under Rule 18A.05 of the Listing Rules, the Company cannot guarantee successful development or eventual commercialization of the relevant products.

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