HUTCHMED (00013) announced that the New Drug Application (NDA) for savolitinib has been accepted by the China National Medical Products Administration (NMPA) and granted priority review. The application is for the treatment of adult patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma harboring MET gene amplification who have failed at least two prior lines of therapy. This NDA is supported by data from a single-arm, multicenter, open-label Phase II registration study conducted in China, which evaluated savolitinib in gastric cancer patients with MET amplification. The study met its primary endpoint of Objective Response Rate (ORR) as assessed by RECIST 1.1 criteria. Further details of this study can be found on clinicaltrials.gov under the identifier NCT04923932. Savolitinib was previously designated as a Breakthrough Therapy by the NMPA for this potential indication in 2023. This Breakthrough Therapy designation from the NMPA acknowledges savolitinib as an innovative treatment for a serious condition, with clinical evidence demonstrating significant advantages over existing therapeutic options.