RegulatoryJul 2, 2026, 04:31 AM
HUTCHMED ORPATHYS® Approved in China for MET-Amplified Gastric Cancer
AI Summary
HUTCHMED (China) Limited announced that its New Drug Application (NDA) for ORPATHYS® (savolitinib) has received conditional approval from the China National Medical Products Administration (NMPA). The approval is 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. This milestone, supported by positive Phase II study data published in Nature Medicine, marks the third approved indication for ORPATHYS® in China, further validating HUTCHMED's R&D platform and expanding its partnership with AstraZeneca.
Key Highlights
- ORPATHYS® (savolitinib) received conditional approval from China NMPA.
- Approved for locally advanced or metastatic gastric cancer/GEJ adenocarcinoma with MET amplification.
- Patients must have failed at least two prior systemic treatments.
- Pivotal Phase II study showed an Objective Response Rate (ORR) of 32.3%.
- Disease Control Rate (DCR) was 63.1%, and median DoR was 9.7 months.
- This marks the third approved indication for ORPATHYS® in China.
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