RegulatoryJul 2, 2026, 06:11 AM
HUTCHMED NMPA Approves ORPATHYS® for MET-Amplified Gastric Cancer
AI Summary
HUTCHMED (China) Limited announced that the China National Medical Products Administration (NMPA) has granted conditional approval for ORPATHYS® (savolitinib). This approval is for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments. This marks the first selective MET inhibitor approved for this indication in China and the third approved indication for ORPATHYS® in the country, underscoring HUTCHMED's commitment to addressing unmet medical needs.
Key Highlights
- NMPA approved ORPATHYS® (savolitinib) for MET-amplified gastric cancer.
- Indication: locally advanced or metastatic GC/GEJ adenocarcinoma patients.
- First selective MET inhibitor approved for this indication in China.
- Pivotal Phase II study showed ORR of 32.3% (95%CI: 21.2%, 45.1%).
- Study also showed DCR of 63.1% and median PFS of 4.0 months.
- This marks the third approved indication for ORPATHYS® in China.
- ORPATHYS® is jointly developed by AstraZeneca and HUTCHMED.
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