HUTCHMED (NASDAQ:HCM) announced on Tuesday that Chinese regulators have accepted its New Drug Application (NDA) for savolitinib and granted it priority review, clearing a path for the drug to become the first selective MET inhibitor approved for gastric cancer in the region.
The application, submitted to the National Medical Products Administration (NMPA), targets patients with locally advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma harboring MET amplification.
These patients typically face a poor prognosis and have failed at least two prior lines of systemic therapy.
The filing is backed by data from a Chinese Phase II registration study, which met its primary endpoint of objective response rate (ORR).
Savolitinib, which is being jointly developed with AstraZeneca (NASDAQ:AZN), previously received Breakthrough Therapy designation for this indication in 2023.
MET amplification occurs in approximately 4% to 6% of gastric cancer cases.
In China alone, this translates to an estimated 18,000 new patients annually, representing a significant niche market for the oncology-focused firm.
Savolitinib is already marketed in China under the brand name Orpathys for certain types of lung cancer.
If approved for gastric cancer, it would mark the drug's second major indication in its home market.
Under the terms of their 2011 agreement, AstraZeneca handles commercialization in China while sharing development costs with HUTCHMED.
The priority review status generally shortens the regulatory timeline, potentially positioning HUTCHMED for a commercial launch in this new indication by mid-2026.