HUTCHMED Secures Third Approved Indication in China for ORPATHYS

HUTCHMED has secured conditional approval from China’s National Medical Products Administration for ORPATHYS® (savolitinib) to treat adults with locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma harboring MET amplification who have progressed after at least two prior systemic therapies.

The approval marks the third approved indication for the selective MET inhibitor in China and expands precision medicine options for a patient population with historically poor outcomes.

Targeting an Aggressive Molecular Subtype

Gastric cancer remains one of China’s leading causes of cancer-related mortality. Although MET amplification occurs in only about 4% to 6% of patients, it represents a biologically aggressive disease subtype associated with poor prognosis and limited therapeutic options. HUTCHMED estimates that approximately 18,000 patients in China develop MET-amplified gastric cancer each year, highlighting a significant unmet clinical need for biomarker-driven treatment strategies.

ORPATHYS is an oral, highly selective MET tyrosine kinase inhibitor (TKI) that blocks abnormal activation of the MET signaling pathway caused by gene amplification, MET exon 14 skipping alterations, and other activating mutations. The therapy is jointly developed by HUTCHMED and AstraZeneca and is commercialized in China by AstraZeneca.

Phase 2 Study Demonstrated Clinically Meaningful Responses

The approval is supported by the pivotal Phase 2 registration study (NCT04923932) evaluating savolitinib in Chinese patients with MET-amplified advanced gastric cancer or gastroesophageal junction adenocarcinoma.

The study met its primary endpoint, with an independent review committee (IRC)-assessed objective response rate (ORR) of 32.3% (95% CI, 21.2%–45.1%), exceeding the predefined efficacy threshold. Secondary endpoints also showed encouraging clinical activity, including a disease control rate of 63.1%, a median time to response of 1.4 months, a median duration of response of 9.7 months (95% CI, 3.7–18.5), and a median progression-free survival of 4.0 months (95% CI, 2.6–5.0).

The findings were recently published in Nature Medicine and presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, further supporting the clinical value of molecularly targeted treatment in MET-driven gastric cancer.

Molecular Testing Expands Precision Treatment Opportunities

Lead investigator Professor Lin Shen of Peking University Cancer Hospital said the approval reinforces the importance of routine molecular profiling in advanced gastric cancer. He noted that identifying MET amplification through timely genomic testing enables clinicians to direct eligible patients toward an effective targeted oral therapy, bringing precision medicine further into gastrointestinal oncology practice.

HUTCHMED Acting Chief Executive Officer and Chief Financial Officer Johnny Cheng said the approval reflects the company’s strategy of advancing internally discovered therapies for diseases with high unmet need. AstraZeneca China Oncology General Manager Mary Guan added that the expanded indication strengthens the long-standing collaboration between the two companies and supports broader application of precision oncology in China.

Expanding the Clinical Development of Savolitinib

ORPATHYS was the first selective MET inhibitor approved in China and has been included in the country’s National Reimbursement Drug List since 2023. Beyond gastric cancer, the therapy is approved for MET-driven lung cancer indications and continues to undergo clinical evaluation across multiple solid tumors as both monotherapy and combination therapy. The latest approval further broadens the clinical role of MET inhibition and strengthens the growing use of biomarker-guided treatment strategies in gastrointestinal malignancies.

Reference

HUTCHMED – HUTCHMED Announces NMPA Approval for ORPATHYS^® for the treatment of Gastric Cancer Patients with MET Amplification