HutchMed (China) Limited (Nasdaq: HCM) has received conditional NMPA approval for Orpathys (savolitinib) as the first selective MET inhibitor indicated for locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with MET amplification in China — addressing a molecularly defined patient population with limited post-second-line options. The approval, granted for patients who have failed at least two prior systemic treatments, marks the third approved indication for savolitinib in China and extends a precision oncology framework previously established in non-small cell lung cancer into gastrointestinal oncology.
Savolitinib is an oral, highly selective MET tyrosine kinase inhibitor that blocks aberrant activation of the MET receptor pathway driven by gene amplification, exon 14 skipping mutations, or protein overexpression. The drug is jointly developed by HutchMed and AstraZeneca, with AstraZeneca leading commercialization. The conditional approval reflects China’s regulatory pathway for therapies supported by single-arm Phase II data with objective response as the primary endpoint — the same route used for other HutchMed oncology assets progressing through the NMPA.
The approval is supported by a pivotal Phase II registration study (NCT04923932) conducted in MET-amplified gastric or gastroesophageal junction adenocarcinoma patients in China. The study met its primary endpoint of objective response rate as assessed by an Independent Review Committee per RECIST 1.1, reporting an IRC-assessed ORR of 32.3% (95% CI: 21.2%, 45.1%) as of the October 2025 data cutoff — exceeding the pre-specified efficacy threshold. Secondary endpoints included a disease control rate of 63.1%, median duration of response of 9.7 months, and median progression-free survival of 4.0 months. Results were published in Nature Medicine and presented at the ASCO Annual Meeting.