Hong Kong, Shanghai & Florham Park, N.J., July 2, 2026
HUTCHMED has achieved a major regulatory milestone after the China National Medical Products Administration (NMPA) granted conditional approval for ORPATHYS® (savolitinib) to treat patients with locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma with MET amplification who have failed at least two prior systemic therapies. The approval makes ORPATHYS the first selective MET inhibitor approved in China for MET-amplified advanced gastric cancer, representing a significant advance in precision oncology for a patient population with limited treatment options and poor prognosis. The approval is based on positive results from a pivotal Phase II registration study, recently published in Nature Medicine and presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting the growing importance of biomarker-driven targeted therapies in gastrointestinal cancers. Jointly developed by HUTCHMED and AstraZeneca, ORPATHYS further expands the clinical application of precision medicine in China while reinforcing HUTCHMED’s innovation-driven oncology pipeline.
Phase II Study Demonstrates Strong Clinical Benefit
The approval was supported by data from the pivotal Phase II registration trial (NCT04923932) evaluating ORPATHYS in Chinese patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinoma. The study successfully met its primary endpoint, achieving an Independent Review Committee-assessed Objective Response Rate (ORR) of 32.3%, exceeding the predefined efficacy threshold. Additional clinical outcomes further reinforced the therapy’s effectiveness, including a Disease Control Rate (DCR) of 63.1%, a median Time to Response (TTR) of 1.4 months, a median Duration of Response (DoR) of 9.7 months, and a median Progression-Free Survival (PFS) of 4.0 months.
Investigators emphasized that timely molecular testing for MET amplification enables physicians to identify patients who are most likely to benefit from this targeted oral therapy, providing an important new treatment option for an aggressive disease that affects approximately 18,000 patients annually in China.
Precision Medicine Expands Options for MET-Driven Cancers
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ORPATHYS (savolitinib) is an oral, highly selective MET tyrosine kinase inhibitor (TKI) designed to inhibit abnormal activation of the MET signaling pathway, which plays a critical role in tumor growth, proliferation, and metastasis. By selectively targeting tumors driven by MET amplification, the therapy interrupts oncogenic signaling while offering a more personalized treatment strategy compared with conventional chemotherapy. MET amplification is found in approximately 4% to 6% of gastric cancer patients, a subgroup associated with particularly poor clinical outcomes and limited targeted treatment options.
Company leaders and clinical investigators described the approval as a milestone for biomarker-guided oncology, demonstrating how genomic testing can help match patients with therapies specifically designed for the molecular characteristics of their disease. The approval also represents the third approved indication for ORPATHYS in China, following its earlier success in lung cancer, further expanding its therapeutic reach across multiple MET-driven malignancies.
HUTCHMED and AstraZeneca Strengthen Oncology Innovation
The latest approval reinforces the long-standing collaboration between HUTCHMED and AstraZeneca, combining HUTCHMED’s innovative drug discovery platform with AstraZeneca’s extensive global development and commercialization expertise. ORPATHYS is already included in China’s National Reimbursement Drug List (NRDL) and continues to be evaluated across multiple tumor types as both a standalone treatment and in combination with other anticancer therapies. HUTCHMED’s expanding oncology portfolio includes targeted therapies and immunotherapies developed to address significant unmet medical needs worldwide.
The approval underscores the company’s commitment to transforming cancer care through precision medicine, enabling physicians to use molecular diagnostics to guide treatment decisions while delivering innovative therapies that improve outcomes for patients with difficult-to-treat cancers. As additional clinical programs continue to advance, HUTCHMED and AstraZeneca aim to broaden the global impact of ORPATHYS across a growing range of MET-driven solid tumors.
Source: HUTCHMED press release
