GenFleet Therapeutics (02595.HK): GFH375 Enters Phase‑II Study for First‑line NSCLC, Evaluating Monotherapy and Combination Regimens

NewTimeSpace News: On August 26, 2026, GenFleet Therapeutics (02595.HK) announced that GFH375 has entered Phase‑II study for first‑line treatment of advanced KRAS‑G12D‑mutant non‑small‑cell lung cancer, covering three treatment arms: monotherapy, combination with cetuximab, and combination with pemetrexed.

According to the announcement, GFH375 has advanced into the world’s first registrational Phase‑III trial of an oral KRAS G12D inhibitor for NSCLC. Updated Phase‑I/II data for GFH375 monotherapy in NSCLC has been accepted for oral presentation at this year’s WCLC conference. Pre‑clinical studies demonstrate that the combination of GFH375 and cetuximab yields substantially superior tumour‑suppression efficacy compared with monotherapy. GenFleet has entered into a licensing collaboration with Verastem Oncology. Verastem holds development and commercialisation rights outside China, while GenFleet retains rights within China.

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