On February 13, 2026, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration announced that GFH375 tablets have been included in the Breakthrough Therapy Designation for the treatment of patients with KRAS G12D-mutant non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy.
Cracking the Code of the “Undruggable” Target
KRAS mutations were once regarded by the medical community as an “undruggable” target. However, with the progression of scientific research, this challenge is gradually being overcome. KRAS G12D is one of the most common subtypes of KRAS mutations, frequently observed in pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and colorectal cancer.
Encouraging Clinical Data: GFH375 Demonstrates Potent Anti-tumor Activity
Clinical data from the Phase I trial of GFH375 in patients with advanced KRAS G12D-mutant solid tumors, presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, provided encouraging results. The data demonstrated good oral bioavailability and highly selective tumor inhibition activity of GFH375. As of the data cutoff date, 62 patients with previously treated advanced KRAS G12D-mutant solid tumors had been enrolled in the Phase I trial of GFH375 monotherapy.
Target Dose Cohorts: Particularly Notable Efficacy
Among 49 patients receiving oral daily doses of 400mg or 600mg, the efficacy data were particularly impressive:
Overall Objective Response Rate (ORR): In 43 evaluable patients, the ORR reached 42%, and the Disease Control Rate (DCR) was as high as 91%.
Pancreatic Ductal Adenocarcinoma (PDAC) Patients: Among 23 evaluable PDAC patients, the ORR was 52%, and the DCR reached 100%.
Non-Small Cell Lung Cancer (NSCLC) Patients: Among 12 evaluable NSCLC patients, the ORR was 42%, and the DCR was 83%.
All Dose Cohorts: Broad and Significant Activity
In 52 patients who completed at least one post-treatment tumor assessment, the ORR across all dose cohorts was 38%, with a DCR of 90%. Notably, 38 patients experienced a reduction in their target lesions, and 20 patients achieved a partial response. These preliminary data indicate that GFH375 demonstrates significant tumor inhibitory activity in patients with solid tumors such as PDAC and NSCLC, including those who have progressed after multiple lines of therapy.
Facing such cutting-edge medical breakthroughs, choosing a medical institution capable of providing advanced treatment options and comprehensive services is crucial. The International Department at Beijing South Region Oncology Hospital is dedicated to offering cutting-edge cancer diagnosis and treatment services to both domestic and international patients. We stay abreast of the latest developments in international oncology research and are committed to bringing breakthrough therapies like GFH375 to patients in need as quickly as possible.
Our advantages include:
Cutting-Edge Medical Solutions: We keep pace with international standards, focusing on and introducing advanced treatment methods including GFH375, offering potential therapeutic opportunities for patients with KRAS G12D mutations.
Multidisciplinary Expert Team: We bring together top domestic oncology experts who collaborate in multidisciplinary consultations to develop personalized and precise comprehensive treatment plans for every patient.
International Service Standards: From consultation, appointment scheduling, translation services to the entire treatment process, we provide seamless communication and attentive service, ensuring a comfortable and reassuring medical experience for international patients and their families.
Comprehensive Patient Support: We strive for excellence not only in treatment but also focus on patients’ psychological well-being and quality of life, providing全方位的 support and care.
Contact Us Now to Explore New Hope for Treatment
If you or a family member has been diagnosed with KRAS G12D-mutant non-small cell lung cancer or other solid tumors and has had an inadequate response to existing treatment options, please contact the International Department at Beijing South Region Oncology Hospital. Our professional team will provide you with the latest medical information and personalized diagnosis and treatment recommendations.
Please reach out to us through the following methods:
Phone: 400-880-3716
WeChat: 17801183037
Email: 100085_010@163.com 或 myimmnet@163.com
Do not let distance or language barriers become obstacles in your search for advanced treatment. The International Department at Beijing South Region Oncology Hospital is here to stand with you in the fight against cancer.
Post time: Feb-25-2026