HUTCHMED wins NMPA approval for Orpathys in MET-amplified gastric cancer

HUTCHMED announced on July 2, 2026 that China's National Medical Products Administration granted conditional approval of ORPATHYS (savolitinib) for locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments.¹

The company said gastric cancer remains one of the most common cancers and leading causes of cancer death in China, and MET-driven gastric cancer carries a very poor prognosis, with MET amplification estimated to account for roughly 4-6% of gastric cancer cases and about 18,000 new MET-amplified cases annually in China.¹

The approval rests on a registration trial identified as NCT04923932, testing savolitinib in this patient population. The results were recently published in Nature Medicine and highlighted at the American Society of Clinical Oncology (ASCO) Annual Meeting.¹ The study met its primary endpoint of objective response rate under RECIST 1.1 as assessed by an Independent Review Committee, with an IRC-assessed ORR of 32.3% (95% CI: 21.2%, 45.1%) as of the October 8, 2025 data cutoff, exceeding the pre-specified efficacy threshold.¹ Secondary endpoints included an IRC-assessed disease control rate of 63.1%, a median time to response of 1.4 months, a median duration of response of 9.7 months (95% CI: 3.7, 18.5), and a median progression-free survival of 4.0 months (95% CI: 2.6, 5.0).¹

HUTCHMED said this marks the third approved indication for ORPATHYS in China¹, and the drug is developed jointly with AstraZeneca. ORPATHYS is an oral, potent, and highly selective MET tyrosine kinase inhibitor jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.¹ It is the first selective MET inhibitor approved in China and has been included on the National Reimbursement Drug List since March 2023.¹