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).
"Over the past eight years, we've built a powerful pipeline that includes the first China-developed KRAS inhibitor. Anchored by a leading-edge RAS-targeted matrix, the pipeline tackles critical unmet needs globally in cancers such as pancreatic, lung, and colorectal cancer. Riding the waves of innovation, we've kept moving forward and delivered novel therapeutics and solid out-licensing milestones, for the benefit of patients and the value creation of shareholders."
The conference will take place in Barcelona, Spain from Sept. 6-9, with a mini oral presentation scheduled for Sept. 7 to highlight the efficacy and safety data of GFH375 in patients with advanced non-small cell lung cancer (NSCLC).
