HUTCHMED (China) Ltd

HUTCHMED announced positive Phase III results for sovleplenib in warm antibody autoimmune hemolytic anemia (wAIHA) from its ESLIM-02 study, presented at the European Hematology Association Congress. The study met its primary endpoint, demonstrating significantly superior efficacy and a favorable safety profile compared to placebo. China's National Medical Products Administration has accepted the New Drug Application for sovleplenib for priority review and granted it Breakthrough Therapy Designation.

HUTCHMED announced positive Phase III results from its ESLIM-02 study of sovleplenib for warm antibody autoimmune hemolytic anemia (wAIHA) in China. The study met its primary endpoint, showing a significantly higher durable response rate of 66% compared to 15% for placebo. The drug also demonstrated superior efficacy in overall response rate, reduction in rescue therapy, and a favorable safety profile. Following these results, the New Drug Application for sovleplenib for wAIHA has been accepted for priority review by China's NMPA, which previously granted it Breakthrough Therapy Designation. Additionally, a resubmitted NDA for sovleplenib in immune thrombocytopenia (ITP) was also granted priority review in February 2026.

HUTCHMED (China) Limited announced an application to the London Stock Exchange for a block admission of 43,616,756 ordinary shares to be traded on AIM. These shares are intended for issuance through the exercise of share options under the Company's newly adopted 2026 Share Option Scheme. The admission is expected to be effective on June 11, 2026, and the total issued share capital will remain 872,335,120 Ordinary Shares.

HUTCHMED announced that new and updated clinical data from several of its compounds will be presented at the 2026 ASCO Annual Meeting. The pivotal Phase II registration study of savolitinib in gastric cancer met its primary endpoint, showing an objective response rate of 32.3%. These positive results supported the New Drug Application submission to China's NMPA, which was accepted and granted priority review in December 2025. Additionally, further analyses of fruquintinib and surufatinib studies across various tumor indications will be highlighted.

HUTCHMED (China) Limited announced that new and updated data from several studies of its compounds will be presented at the ASCO Annual Meeting from May 29 to June 2, 2026. Key among these are results from the pivotal Phase II registration study of savolitinib in gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification in China. The study met its primary endpoint with an objective response rate (ORR) of 32.3%, supporting the New Drug Application (NDA) submission to the China NMPA, which was accepted and granted priority review. Additionally, further analyses of fruquintinib's FRESCO, FRESCO-2, FRUSICA-1, and FRUSICA-2 studies, as well as investigator-initiated studies of fruquintinib and surufatinib, will be presented.

HUTCHMED (China) Limited and Innovent Biologics, Inc. jointly announced that the China National Medical Products Administration (NMPA) has approved their combination therapy of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection). This approval is for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior VEGFR-TKI therapy. The decision is supported by data from the FRUSICA-2 study, which demonstrated a 63% reduction in the risk of disease progression or death, with a median progression-free survival of 22.2 months.

HUTCHMED (China) Ltd and Innovent Biologics, Inc. jointly announced that the China NMPA has approved the New Drug Application for the combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection). This approval is for the second-line treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior VEGFR-TKI therapy and have not received PD-1 or PD-L1 inhibitor therapy in the first-line setting. The decision is based on compelling data from the FRUSICA-2 study, which demonstrated significant improvements in progression-free survival, objective response rate, and duration of response for the combination therapy.

HUTCHMED (China) Limited announced that all ordinary and special resolutions put to its Annual General Meeting (AGM) held on May 12, 2026, were duly passed by shareholders. Key approvals included the adoption of the 2025 audited financial statements, the re-election of all nine directors, and the re-appointment of PricewaterhouseCoopers as independent auditors. Shareholders also granted mandates for the issuance and repurchase of shares and approved the 2026 Share Option Scheme.

HUTCHMED (China) Ltd announced that its New Drug Application (NDA) for sovleplenib has been accepted in China. The NDA, which seeks approval for the treatment of warm antibody autoimmune hemolytic anemia, has been granted both priority review status and breakthrough designation by China's National Medical Products Administration (NMPA). This accelerates the potential market entry for the drug in China.

HUTCHMED announced that China's NMPA accepted its New Drug Application (NDA) for sovleplenib to treat adult patients with warm antibody autoimmune hemolytic anemia (wAIHA), granting it priority review and Breakthrough Therapy Designation. This NDA is supported by positive data from the ESLIM-02 Phase II/III study, which met its primary endpoint in the Phase III part. Sovleplenib, a novel oral Syk inhibitor, is also under NMPA priority review for immune thrombocytopenia (ITP), marking its second indication.