HUTCHMED has secured conditional approval from China’s National Medical Products Administration (NMPA) for ORPATHYS (savolitinib), marking a major regulatory milestone in precision oncology for gastric cancer patients with MET amplification.
The drug is now approved for adults with locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma who have MET amplification and have already failed at least two prior systemic treatments.
Gastric cancer remains a major health burden in China, where MET-driven disease is associated with particularly poor outcomes. An estimated 4–6% of gastric cancer patients carry MET amplification, translating to roughly 18,000 cases annually.
“This milestone approval marks a critical leap forward for biomarker-driven precision medicine in gastrointestinal oncology,” said Professor Lin Shen of Peking University Cancer Hospital and leading Principal Investigator of the registration study.
“The clinical data from our pivotal study, recently recognized 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 approval is backed by a Phase II registration study in China that demonstrated clinically meaningful activity in this hard-to-treat population. The trial met its primary endpoint, with an independent review committee reporting an objective response rate (ORR) surpassing the prespecified efficacy threshold.
Secondary endpoints showed a disease control rate of 63.1%, median time to response of 1.4 months, median duration of response of 9.7 months, and median progression-free survival of 4.0 months.
"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,” said Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED.
AstraZeneca echoed the significance of the approval, with Mary Guan, General Manager of AstraZeneca China Oncology Business, stating: “Following its success in lung cancer, the approval of ORPATHYS in gastric cancer marks another pivotal chapter in our joint development journey with HUTCHMED.
