Orpathys wins conditional NMPA approval for MET‑amplified gastric cancer in China | iPharmaCenter
- ipharmaservices
- 1 day ago
- 2 min read
HUTCHMED has secured conditional approval from China’s National Medical Products Administration for savolitinib, marketed as Orpathys, in a new gastric cancer indication.
The decision allows oncologists to use Orpathys in adults with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma whose tumours harbor MET amplification and who have already been through at least two systemic treatment regimens.
Clinical need and patient population
Gastric cancer remains one of the most common malignancies in China and is a leading cause of cancer‑related mortality. Within this broad disease category, MET‑amplified tumours form a smaller but clinically important subset that is associated with aggressive behavior and poor outcomes.
Current estimates suggest that MET amplification occurs in roughly 4 to 6 percent of gastric cancer cases, translating to around 18,000 patients per year in China who may be eligible for a targeted approach once standard therapies have failed.
Phase II data behind the approval
The NMPA’s conditional approval is based on a Phase II registration study conducted in China in patients with MET‑amplified gastric or gastroesophageal junction adenocarcinoma. The trial evaluated savolitinib monotherapy in individuals who had already received at least two prior systemic lines and used independent central review of tumour responses as the primary outcome measure.
By the data cut‑off in October 2025, the study had met its primary endpoint, with an independently assessed objective response rate of 32.3 percent, exceeding the predefined efficacy threshold set for this late‑line population. Secondary measures provided further context: disease control rate was 63.1 percent, median time to response was about 1.4 months, median duration of response reached 9.7 months and median progression‑free survival was approximately 4.0 months. Together, these results support meaningful and durable antitumour activity in a heavily pretreated MET‑driven cohort.
Orpathys and MET biology
Savolitinib is an oral, highly selective inhibitor of the MET receptor tyrosine kinase, a signaling protein that contributes to normal cell development but can also drive cancer growth when aberrantly activated. MET pathway activation can result from exon 14 skipping alterations, other mutations, gene amplification or protein overexpression, all of which can make tumours more dependent on MET signaling.
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