HUTCHMED Announces NDA Acceptance in China with Priority Review Status for Savolitinib for the treatment of Gastric Cancer Patients with MET Amplification
Globenewswire·2025-12-30 10:00

Core Insights - The New Drug Application (NDA) for savolitinib has been accepted and granted priority review by the China National Medical Products Administration (NMPA) for treating gastric cancer patients with MET amplification who have failed at least two prior systemic treatments [1][2] - Savolitinib is positioned to be the first selective MET inhibitor in China for MET-amplified gastric cancer, which has a poor prognosis [1][3] - The NDA is supported by positive Phase II registration study data demonstrating a significant objective response rate [2][4] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on the discovery and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [7] - Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and it is already approved in China under the brand name ORPATHYS [6][5] - The drug has been included in the National Reimbursement Drug List of China since March 2023, indicating its significance in the market [6] Industry Context - Gastric cancer is one of the most common cancers and a leading cause of cancer death in China, with MET amplification occurring in approximately 4-6% of gastric cancer patients [3] - The annual incidence of MET amplification gastric cancer in China is estimated to be around 18,000 cases [3] - The NMPA granted Breakthrough Therapy Designation to savolitinib in 2023, highlighting its potential advantages over existing therapies [4]