JingFang Medicine's GFH375 Receives China's First Breakthrough Therapy Designation for KRAS G12D-Mutated NSCLC
核心洞察
JingFang Medicine (搜索)-B's oral KRAS G12D (搜索) inhibitor GFH375 has been granted China's first Breakthrough Therapy Designation for treating KRAS G12D-mutated non-small cell lung cancer patients who have received at least one systemic treatment.
Phase I/II trial data from the GFH375X1101 study demonstrated best-in-class efficacy for GFH375 monotherapy in KRAS G12D (搜索)-mutated NSCLC with manageable safety and tolerability profiles.
The designation addresses a significant unmet medical need, as no KRAS G12D (搜索)-targeted therapies are currently approved globally across various tumor types with G12D mutations.
JingFang Medicine (搜索)-B has achieved a significant regulatory milestone with its oral KRAS G12D (搜索) inhibitor GFH375 receiving China's first Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration. The designation covers treatment of patients with KRAS G12D-mutated non-small cell lung cancer (NSCLC) who have received at least one systemic treatment.
Clinical Trial Results Drive Regulatory Recognition
The breakthrough designation is based on treatment outcomes from NSCLC patients in the GFH375X1101 study. Phase I/II trial data demonstrated that GFH375 monotherapy achieved best-in-class efficacy in treating KRAS G12D (搜索)-mutated NSCLC, with overall safety and tolerability remaining manageable.
Preliminary research data on GFH375 for treating KRAS G12D (搜索)-mutated solid tumors and NSCLC were featured as a Late-Breaking Abstract (LBA) and presented orally at the 2025 American Society of Clinical Oncology Annual Meeting and the World Conference on Lung Cancer. The latest research results of GFH375 in treating NSCLC patients are expected to be released at international academic conferences this year.
Addressing Critical Unmet Medical Need
Professor Lu Shun from Shanghai Chest Hospital emphasized the significance of this development: "JingFang already has successful experience in developing and launching Fuzelase (搜索) (a KRAS G12C (搜索) inhibitor). Currently, there is no KRAS G12D (搜索)-targeted therapy available globally, and there is a significant unmet clinical need across various large tumor types with G12D mutations."
Among the KRAS G12D (搜索) inhibitors currently in clinical development, GFH375 leads globally in its progress in treating NSCLC and has shown excellent efficacy and good safety. Professor Lu noted that based on its single-agent drug potential and efficacy, GFH375 monotherapy and multiple potential combination therapies present promising prospects for clinical development.
Accelerated Development Timeline
Dr. Wang Yu, Chief Medical Officer of JingFang, expressed optimism about the regulatory milestone: "During the clinical research process, we have fully recognized the urgent demand among patients with KRAS G12D (搜索) mutations for innovative targeted therapies. We are pleased with the outstanding efficacy shown by GFH375 in clinical trials and hope that this CDE Breakthrough Therapy Designation will expedite the clinical development of this product so it can reach the market sooner and benefit patients."
Global Development Strategy
Multiple monotherapy and combination therapies involving GFH375/VS-7375 are proceeding smoothly both domestically, led by JingFang, and overseas, led by Verastem Oncology. This dual-track approach showcases the therapeutic potential of this product across several major tumor types.
The company plans to disclose the latest research data of GFH375 in treating different indications at this year's international academic conferences, providing further insights into the drug's clinical potential across various cancer types with KRAS G12D (搜索) mutations.