HUTCHMED (China) Limited (HCM) reported that China's NMPA has accepted its NDA for Savolitinib in patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma harboring MET amplification who have failed at least two prior systemic therapies. The NDA has been granted priority review status.
Gastric cancer remains one of the most common malignancies and a leading cause of cancer death in China. MET-driven gastric cancer carries a poor prognosis, with MET amplification estimated to occur in 4-6% of patients, representing an annual incidence of about 18,000 cases in China. Current treatment options for this subgroup are limited, underscoring a significant unmet need.
Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor jointly developed by AstraZeneca and HUTCHMED. It blocks abnormal activation of the MET pathway caused by mutations, gene amplification, or protein overexpression. The drug is already approved in China under the brand name ORPATHYS for non-small cell lung cancer with MET exon 14 skipping alterations and has been included in the National Reimbursement Drug List since March 2023.
The NDA submission is supported by data from a Phase II registration study, which met its primary endpoint of objective response rate as assessed by an independent review committee. The trial enrolled Chinese patients with MET-amplified gastric cancer who had exhausted prior systemic therapies. The NMPA has previously granted Savolitinib Breakthrough Therapy Designation for this indication in 2023.
Savolitinib is also under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, both as monotherapy and in combination with other agents. If approved, it would become the first selective MET inhibitor in China for MET-amplified gastric cancer.
HUTCHMED emphasized that priority review reflects the potential of Savolitinib to address a serious condition with substantial advantages over existing therapies. The company noted that it remains committed to advancing targeted therapies and immunotherapies discovered in-house for patients worldwide.
ORPATHYS generated $9.0 million in the first half of 2025, compared to $13.1 million in the year-ago period.
HCM has traded between $11.51 and $19.50 over the past year. The stock closed yesterday's trading at $13.40, down 2.62%.
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