GENFLEET-B (02595): GFH375 has been identified as a groundbreaking therapy for the treatment of non-small cell lung cancer with the first domestic KRAS G12D inhibitor.

GENFLEET-B(02595) announced that the oral KRAS G12D (ON/OFF) inhibitor GFH375 has been included in the Breakthrough Therapy Designation (BTD) list by China's National Medical Products Administration Drug Evaluation Center (CDE), intended for patients with KRAS G12D mutant non-small cell lung cancer (NSCLC) who have received at least one systemic treatment. This designation is based on the treatment results of NSCLC patients in the GFH375X1101 study. Phase I/II trial data showed that GFH375 monotherapy for KRAS G12D mutant NSCLC has similar best efficacy and manageable overall safety/tolerability. Preliminary study data on GFH375 treatment of KRAS G12D mutant solid tumors and NSCLC were presented at the American Society of Clinical Oncology Annual Meeting and World Lung Cancer Congress in 2025 as a Keynote Abstracts (LBA) and oral presentations. The latest research results on GFH375 treatment for NSCLC patients are expected to be released at international academic conferences this year. Professor Lu Shun from Shanghai Chest Hospital said, "Jinfang has successfully developed and marketed the KRAS G12C inhibitor, sotorasib. There is currently no targeted therapy available for KRAS G12D globally, and there is a high unmet clinical need for many G12D mutant tumors. Among the KRAS G12D inhibitors currently in clinical development, GFH375's progress in treating NSCLC is leading globally and showing excellent efficacy and safety. Based on the single-drug pharmacokinetics and efficacy, GFH375's monotherapy and various potential combination therapy options have promising clinical development prospects." Dr. Wang Yubo, Chief Medical Officer of Jinfang, said, "During the clinical research process, we fully understand the demand of KRAS G12D mutant patients for innovative targeted therapy. We are pleased with the excellent efficacy demonstrated by GFH375 in clinical trials and hope that this CDE breakthrough therapy designation will accelerate the clinical development of the product and bring it to market soon to benefit patients. At the same time, multiple single and combination therapy options of GFH375/VS-7375 are progressing smoothly domestically (led by Jinfang) and overseas (led by Verastem Oncology), demonstrating the treatment prospects of the product for multiple large tumors. We will also unveil the latest research data on GFH375's treatment of different indications at international academic conferences this year."