GENFLEET-B (02595) announced that its oral KRAS G12D (ON/OFF) inhibitor, GFH375, has been included in the Breakthrough Therapy Designation (BTD) list by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. The designation is for the treatment of patients with KRAS G12D-mutant non-small cell lung cancer (NSCLC) who have received at least one prior line of systemic therapy. This recognition is based on treatment outcomes from the GFH375X1101 study in NSCLC patients. Phase I/II trial data demonstrated best-in-class efficacy for GFH375 as a monotherapy in treating KRAS G12D-mutant NSCLC, along with a manageable overall safety and tolerability profile.
Preliminary research data for GFH375 in treating KRAS G12D-mutant solid tumors and NSCLC were previously presented as a Late-Breaking Abstract (LBA) and an on-site oral report at the 2025 American Society of Clinical Oncology Annual Meeting and the World Conference on Lung Cancer. Updated research results for GFH375 in NSCLC patients are expected to be released at an international academic conference later this year.
Professor Lu Shun from Shanghai Chest Hospital commented, "GENFLEET already has successful experience with the research, development, and launch of its product fuzerecept (a KRAS G12C inhibitor). Currently, there are no approved KRAS G12D-targeted therapies globally, and there is a high unmet clinical need across several major cancer types with G12D mutations. Among the KRAS G12D inhibitors currently in clinical development, GFH375's development program for NSCLC is leading globally and has shown excellent efficacy and a favorable safety profile. Based on its monotherapy druggability and efficacy, both GFH375 monotherapy and various potential combination regimens have promising clinical development prospects."
Dr. Wang Yu, Chief Medical Officer of GENFLEET, stated, "During the clinical research process, we have fully recognized the strong demand for innovative targeted therapies among patients with KRAS G12D mutations. We are very pleased with the excellent efficacy GFH375 has demonstrated in clinical trials. We hope this Breakthrough Therapy Designation from the CDE will accelerate the clinical development of this product and lead to its早日上市 for the benefit of patients. Concurrently, multiple monotherapy and combination therapy studies involving GFH375/VS-7375 are progressing smoothly both domestically, led by GENFLEET, and overseas, led by our partner Verastem Oncology, highlighting the product's therapeutic potential across multiple major cancer types. We also plan to disclose the latest research data for GFH375 in treating different indications at international academic conferences this year."
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