HUTCHMED Highlights Sovleplenib ESLIM-02 Phase III Data in Warm Antibody Autoimmune Hemolytic Anemia Presented at EHA 2026 Congress

— Sovleplenib demonstrated rapid and durable hemoglobin response with favorable safety profile —

—The ESLIM-02 study underscores sovleplenib’s potential to address critical unmet needs in a treatment landscape currently devoid of approved targeted therapies  —

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 12, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces results from the Phase III part of the ESLIM-02 study of sovleplenib in patients with warm antibody autoimmune hemolytic anemia (“wAIHA”) in China  were presented on Thursday, June 11, 2026 during the European Hematology Association (“EHA”) Congress in Stockholm, Sweden.

Supported by data from the ESLIM-02 study, a New Drug Application (“NDA”) for sovleplenib for the treatment of adult patients with wAIHA who have had an insufficient response to at least one previous glucocorticoid treatment has been accepted for review and granted priority review by the China National Medical Products Administration (“NMPA”) in April 2026. The NMPA granted Breakthrough Therapy Designation to sovleplenib for the treatment of wAIHA in March 2026. The ESLIM-02 presentation was selected for the official EHA Press Program.

Professor Bing Han of Peking Union Medical College Hospital, and co-leading Principal Investigator of the ESLIM-02 study, said: “The wAIHA treatment paradigm has remained stagnant for decades, with patients often trapped in a cycle of high-dose steroids and frequent relapses. The ESLIM-02 data are transformative as they demonstrate that targeting the Syk pathway can achieve both rapid and durable control of hemolysis. We are particularly encouraged by the robust data across all patient subgroups, regardless of their prior treatments. Sovleplenib’s ability to significantly reduce the need for rescue therapies and blood transfusions represents a major step forward in restoring the quality of life for these patients.”

ESLIM-02 is a randomized, double blind, placebo-controlled China Phase II/III study in adult patients with primary or secondary wAIHA who had relapsed or were refractory to at least one prior line of standard treatment (NCT05535933). Results from the Phase II part of the study were published in The Lancet Haematology in January 2025. In Phase III part of the study, 90 patients were randomized 1:1 to receive either sovleplenib (n=44) or placebo (n=46) at a dose of 300 mg once daily for 24 weeks.

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