HUTCHMED(00013.HK): ORPATHYS® (Savolitinib) Receives Conditional NMPA Approval for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma with MET Amplification
NewTimeSpace News: HUTCHMED (China) Limited (00013.HK) issued a voluntary announcement stating that ORPATHYS® (savolitinib), its proprietary oral MET inhibitor, has obtained conditional marketing approval from the National Medical Products Administration (NMPA) of China for adult patients with locally advanced or metastatic gastric or gastroesophageal junction (GC/GEJ) adenocarcinoma harbouring MET gene amplification, who have failed at least two lines of prior systemic therapy. This marks the third approved indication of savolitinib in China.
NewTimeSpace News: HUTCHMED (China) Limited (00013.HK) released a voluntary announcement dated 2 July 2026, disclosing that the New Drug Application (NDA) for ORPATHYS® (savolitinib) has been granted conditional approval by NMPA. The approved indication covers adult patients with locally advanced or metastatic GC/GEJ adenocarcinoma with MET amplification, after progression on at least two lines of systemic treatment.
Savolitinib is the first selective MET inhibitor approved in China for MET-amplified advanced gastric or gastroesophageal junction adenocarcinoma, and this new indication becomes its third approved therapeutic use nationwide.
The approval is supported by pivotal Phase II registration study (NCT04923932) conducted in China, whose full data has been published inNature Medicineand presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. The trial met its primary efficacy endpoint. As of the data cut-off date of 8 October 2025, per Independent Review Committee (IRC) assessment:Objective Response Rate (ORR): 32.3% (95%CI: 21.2%, 45.1%)Disease Control Rate (DCR): 63.1%Median Duration of Response (DoR): 9.7 monthsMedian Progression-Free Survival (PFS): 4.0 months
Savolitinib is a potent, highly selective oral MET tyrosine kinase inhibitor co-developed by HUTCHMED and AstraZeneca. It has been included in China’s National Reimbursement Drug List (NRDL), with AstraZeneca undertaking its commercialisation in China.
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