GenFleet’s RAS-targeted matrix encompasses multiple selective and Pan RAS inhibitors, as well as targeted therapies for potential co-mutations associated with the RAS pathway. This matrix includes small and large molecules with diversified modalities and mechanisms; preclinical research data of three compounds - GFH276 (non-degrading molecular glue), GFS784 (novel ADC linking functional antibody with synergistic targeted payload) and GFH603 (molecular glue-like covalent allosteric activator) - w
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GenFleet Therapeutics announced that oral KRAS G12D (ON/OFF) inhibitor GFH375 has been granted with the Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), for treatment of KRAS G12D-mutant non-small cell lung cancer (NSCLC) patients who have received at least one prior systemic therapy.
This product was successfully included into the NRDL on its first negotiation attempt, for treatment of advanced non-small cell lung cancer (NSCLC) adult patients harboring KRAS G12C mutation who have received at least one systemic therapy. The updated list will take effect on January 1, 2026.
The trial has been initiated at Peking University Cancer Hospital, building on GFH375’s position as one of the fastest advancing oral KRAS G12D inhibitors in clinical development.
Phase Ib trial will be conducted at approximately 15 investigational sites including Beijing Cancer Hospital. The primary objectives of the overall study are to evaluate the safety/tolerability, efficacy and pharmacokinetic profile of GFH375 in combination with cetuximab or chemotherapy. In the phase II trial, the combination of GFH375 with chemotherapy (albumin-bound paclitaxel and gemcitabine, AG) will be administered to untreated patients with advanced PDAC, while the combination of GFH375 wi
Among 59 heavily pretreated patients with advanced disease (nearly 70% in the third- or later-line setting) who had their first dose at least 4 months prior to data cut-off date and finished at least one post-treatment tumor assessment: the objective response rate was 40.7%; the disease control rate was 96.7%; the median progression-free survival (PFS) was 5.52 months and the 4-month OS rate was 92.2%.
GFH276 is the third candidate in GenFleet’s RAS-targeted matrix to enter clinical research, following successful development of a marketed KRAS G12C inhibitor (fulzerasib) and a phase-II KRAS G12D inhibitor (GFH375).
