HUTCHMED (China) Limited has announced that the new drug application for its product savolitinib, marketed as ORPATHYS®, has received conditional approval from China's National Medical Products Administration. The approval is for the treatment of adult patients with MET-amplified locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have failed at least two prior lines of systemic therapy.
Gastric cancer ranks among the most prevalent cancers in China and is a leading cause of cancer-related mortality. MET-driven gastric cancer is generally associated with a poor prognosis. It is estimated that approximately 4-6% of gastric cancer patients harbor MET amplification, translating to around 18,000 new cases annually in China.
This approval is based on data from a pivotal Phase II registration study conducted in China evaluating savolitinib in patients with MET-amplified gastric or gastroesophageal junction adenocarcinoma. The study met its primary endpoint, which was the objective response rate as assessed by an independent review committee using RECIST 1.1 criteria. As of the data cutoff on October 8, 2025, the IRC-assessed ORR was 32.3%, exceeding the pre-specified efficacy threshold.
Secondary endpoints included an IRC-assessed disease control rate of 63.1%, a median time to response of 1.4 months, a median duration of response of 9.7 months, and a median progression-free survival of 4.0 months. The results from this study have been published in the journal Nature Medicine and were presented at the American Society of Clinical Oncology annual meeting.
The principal investigator of the registration study commented on the significance of the approval, stating it represents a key advancement in biomarker-directed precision medicine for gastrointestinal tumors. The clinical data provides robust evidence that timely molecular testing to identify MET amplification status can directly guide patients to an effective oral targeted therapy, offering clinicians a powerful new tool to address this aggressive cancer driver.
The acting Chief Executive Officer and Chief Financial Officer of HUTCHMED highlighted that this new approval for savolitinib in MET-amplified advanced gastric cancer marks an important milestone, demonstrating the company's commitment to delivering its self-developed innovations to patients. This represents the third approved indication for savolitinib in China and further validates the company's R&D platform in addressing significant unmet medical needs. The company, in close collaboration with its partner AstraZeneca, aims to accelerate commercialization to improve the treatment landscape for gastric cancer in China.
AstraZeneca's oncology business lead in China noted that following success in lung cancer, this gastric cancer approval for savolitinib is another major milestone in the joint development effort and opens a new chapter in precision treatment for MET-amplified gastric cancer. The partnership will continue to advance the development of savolitinib across its lifecycle, exploring its full therapeutic potential to bring innovative treatment options to cancer patients in China and globally.