HUTCHMED (China) Limited announced that the China National Medical Products Administration (NMPA) has granted conditional approval for ORPATHYS® (savolitinib) for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification. The approval targets patients who have failed at least two prior systemic treatments, addressing a condition with a very poor prognosis. MET amplification accounts for approximately 4-6% of gastric cancer patients, with an estimated annual incidence of 18,000 in China.

The regulatory decision is supported by data from a pivotal Phase II registration study conducted in China. The study met its primary endpoint of objective response rate (ORR) per RECIST 1.1, as assessed by the Independent Review Committee (IRC). As of the data cut-off of October 8, 2025, the IRC-assessed ORR was 32.3% (95%CI: 21.2%, 45.1%), exceeding the pre-specified efficacy threshold.

Secondary endpoints from the study demonstrated further clinical activity. The IRC-assessed disease control rate (DCR) was 63.1%, while the median time to response (TTR) was 1.4 months. The median duration of response (DoR) was 9.7 months (95%CI: 3.7, 18.5), and the median progression-free survival (PFS) was 4.0 months (95%CI: 2.6, 5.0).

Clinical Trial Results

Professor Lin Shen of Peking University Cancer Hospital and leading Principal Investigator of the study stated that the approval marks a critical leap forward for biomarker-driven precision medicine. He noted that the clinical data provided compelling evidence that identifying MET amplification through timely molecular testing can guide patients to a highly effective, targeted oral option.

Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, highlighted that this is the third approved indication for ORPATHYS® in China. He emphasized that the approval validates the company's proprietary R&D platform and its commitment to bringing in-house discovered innovations to patients. HUTCHMED and its partner AstraZeneca plan to accelerate the commercial availability of the drug to transform the gastric cancer treatment landscape in China.

ORPATHYS® is an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI) jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. It blocks atypical activation of the MET receptor tyrosine kinase pathway. The drug is already included in the National Reimbursement Drug List of China (NRDL) since March 2023.

HUTCHMED (China) Limited will announce its interim results for the six months ended June 30, 2026 on Thursday, July 30, 2026. The announcement is scheduled for 7:00 am Eastern Daylight Time (EDT), 12:00 noon British Summer Time (BST), and 7:00 pm Hong Kong Time (HKT). The company operates as an innovative, commercial-stage, biopharmaceutical firm focused on targeted therapies and immunotherapies for cancer and immunological diseases.

Management will conduct two webcast presentations to discuss the interim results, followed by Q&A sessions. The English webcast is set for July 30, 2026, at 8:00 am EDT / 1:00 pm BST / 8:00 pm HKT. The Chinese (Putonghua) webcast will take place at 8:30 am HKT on Friday, July 31, 2026, which corresponds to 1:30 am BST / 8:30 pm EDT on July 30, 2026.

Both webcasts will be accessible live via the company website at www.hutch-med.com/event/ . The presentation materials will be available for download shortly before the webcast begins. A replay of the events will also be hosted on the website shortly after the conclusion of the sessions.

Key Event Details

HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) has focused on bringing drug candidates from in-house discovery to patients globally. Its first three medicines are marketed in China, with the first also approved in the US, Europe, and Japan.