HUTCHMED has announced that the New Drug Application (NDA) for ORPATHYS (savolitinib) has been granted conditional approval by the China National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments.

Gastric cancer remains one of the most common cancers and leading causes of cancer death in China. MET-driven gastric cancer has a very poor prognosis. It is estimated that MET amplification accounts for approximately 4-6 percent of gastric cancer patients. The annual incidence of MET amplification gastric cancer is estimated to be approximately 18,000 in China.

The approval is supported by data from the pivotal phase 2 registration study of ORPATHYS in gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification in China (NCT04923932). The results were recently published in Nature Medicine and highlighted at the American Society of Clinical Oncology (ASCO) Annual Meeting.

Lin Shen, Professor, Peking University Cancer Hospital and leading principal investigator of the registration study, said, “This milestone approval marks a critical leap forward for biomarker-driven precision medicine in gastrointestinal oncology. The clinical data from our pivotal study, recently recognised and published by Nature Medicine, provided compelling evidence that identifying MET amplification through timely molecular testing can directly guide patients to a highly effective, targeted oral option. ORPATHYS’s entry into the MET-amplified gastric cancer clinical setting offers clinicians a powerful, precise new tool to interrupt this aggressive oncogenic driver.”

The study met its primary endpoint of Objective Response Rate (ORR) per RECIST, 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 percent (95 percent CI: 21.2 percent, 45.1 percent), exceeding the pre-specified efficacy threshold. Secondary endpoints included the IRC-assessed Disease Control Rate (DCR) of 63.1 percent, median Time To Response (TTR) of 1.4 months, median Duration of Response (DoR) of 9.7 (95 percent CI: 3.7, 18.5) months, and median Progression-Free Survival (PFS) of 4.0 (95 percent CI: 2.6, 5.0) months, respectively.

Johnny Cheng, Acting Chief Executive Officer (CEO) and Chief Financial Officer (CFO), HUTCHMED, said, “The approval of ORPATHYS for MET-amplified advanced gastric cancer is an important achievement that underscores HUTCHMED’s enduring commitment to bringing in-house discovered innovations to patients. This marks the third approved indication for ORPATHYS in China and further validates our proprietary R&D platform’s ability to address deep unmet medical needs. Together with our partner AstraZeneca, we are proud to expand the clinical application of this highly selective MET inhibitor and look forward to accelerating its commercial availability to transform gastric cancer treatment landscapes in China.”