HUTCHMED China Ltd

HUTCHMED and AstraZeneca announced positive high-level results from the global Phase III SAFFRON trial showing that ORPATHYS plus TAGRISSO significantly improved progression-free survival and overall survival versus platinum-based chemotherapy in patients with EGFR-mutated non-small cell lung cancer with high MET overexpression or amplification who had progressed on TAGRISSO. The trial enrolled 338 patients across 230 centers in 29 countries, and the safety profile was consistent with the known profiles of each medicine with no new safety findings. The companies plan to present the data at a forthcoming medical meeting and share it with global regulatory authorities. The combination is already approved in China based on the SACHI Phase III trial, and this is the first global Phase III trial to show significant progression-free and overall survival benefits in this setting.

HUTCHMED reported first-half 2026 oncology revenue of $162 million, a 23% increase year over year, and maintained its full-year oncology revenue guidance of $330 million to $415 million. The company posted net income of $16 million and ended the period with $1.4 billion in cash. China sales of ELUNATE and SULANDA each grew more than 40%, while global in-market sales of FRUZAQLA rose 40%, with sales outside the U.S. up 70%. Management noted that FRUZAQLA's international growth runway remains significant as reimbursement coverage is about 50%. The company also highlighted upcoming savolitinib data readouts, positive Phase III results for sovleplenib in warm autoimmune hemolytic anemia, and the initiation of a Phase III trial for HMPL-760 in diffuse large B-cell lymphoma, and said it is in active discussions with multinational companies about potential collaborations for its ATTC programs.

HUTCHMED announced that China's NMPA has granted conditional approval for ORPATHYS® (savolitinib) to treat locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments. The approval is supported by a pivotal Phase II study where the IRC-assessed objective response rate was 32.3%, with a disease control rate of 63.1% and median duration of response of 9.7 months. MET amplification accounts for approximately 4-6% of gastric cancer patients, with an estimated annual incidence of about 18,000 in China. This marks the third approved indication for ORPATHYS® in China, which is jointly developed with AstraZeneca and marketed by AstraZeneca.

HUTCHMED announced that the pivotal Phase 2 registrational study of fanregratinib met its primary endpoint in intrahepatic cholangiocarcinoma, a type of bile duct cancer. The trial reported an objective response rate of 42.5% as assessed by an independent review committee. Key secondary endpoints included a median response time of 1.4 months, median duration of response of 6.9 months, disease control rate of 83.9%, median progression-free survival of 6.9 months, and median overall survival of 16.6 months. The company's New Drug Application for fanregratinib in previously treated advanced FGFR2 fusion/rearrangement-positive intrahepatic cholangiocarcinoma was accepted for review and granted priority review by the Chinese National Medical Products Administration in December 2025. Fanregratinib is an investigational selective inhibitor of fibroblast growth factor receptors 1, 2, and 3.