Shares of HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) rose 6.5% on Thursday after the company announced that China’s National Medical Products Administration (NMPA) granted conditional approval for ORPATHYS® (savolitinib) to treat patients with MET‑amplified advanced gastric cancer or gastroesophageal junction adenocarcinoma.
The NMPA authorization covers locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients whose tumors display MET amplification and who have previously received at least two systemic treatment regimens. ORPATHYS® is the first selective MET inhibitor to receive approval in China for this specific patient population.
The regulatory decision was based on results from a pivotal Phase II registration study conducted in China. With a data cut‑off of October 8, 2025, the Independent Review Committee (IRC) assessed an objective response rate (ORR) of 32.3%, which exceeded the study’s pre‑specified efficacy threshold. Key secondary outcomes reported in the analysis included a disease control rate (DCR) of 63.1%, a median time to response of 1.4 months, a median duration of response of 9.7 months, and a median progression‑free survival (PFS) of 4.0 months.
Approximately 4-6% of gastric cancer patients have MET amplification, translating to an estimated annual incidence of about 18,000 cases in China, according to the figures cited with the approval. The statement reiterated that gastric cancer remains among the most prevalent cancers and a leading cause of cancer mortality in China.
This approval is the third indication for ORPATHYS® in China. The oral MET tyrosine kinase inhibitor, designed to block atypical activation of the MET receptor pathway caused by mutations, gene amplification, or protein overexpression, is being jointly developed by AstraZeneca and HUTCHMED and will be commercialized by AstraZeneca. ORPATHYS® has been included on China’s National Reimbursement Drug List since March 2023.
Market reaction - a 6.5% intraday increase in HUTCHMED shares - followed the announcement. The approval reinforces ORPATHYS®’s positioning in a narrowly defined molecular subgroup of gastric cancers and adds another label to the drug’s approved uses in China.
Investors and healthcare stakeholders will likely watch how commercialization by AstraZeneca and reimbursement status translate into patient access for the estimated eligible population.