— Delivers rapid, durable responses in wAIHA, the more common form of this potentially life-threatening disease — 

HUTCHMED (China) Limited (“HUTCHMED”) announces that the Phase III registration part of the ESLIM-02 clinical trial of sovleplenib, a novel spleen tyrosine kinase (“Syk”) inhibitor, in adult patients with warm antibody autoimmune hemolytic anemia (“wAIHA”) in China has met its primary endpoint of durable hemoglobin (Hb) response rate within weeks 5 to 24 of treatment.

Autoimmune hemolytic anemia (“AIHA”) is an autoimmune disorder characterized by the destruction of red blood cells (“RBCs”) due to the production of antibodies against RBC. The incidence of AIHA is estimated to be 0.8-3.0/100,000 adults per year with an estimated prevalence of 17 per 100,000 adults and a death rate of 8-11%. wAIHA is the most common form of AIHA,³ accounting for about 75-80% of all adult AIHA cases.

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. Results from the Phase II part of the study published in The Lancet Haematology in January 2025 demonstrated encouraging hemoglobin benefit compared with placebo, with overall response rate of 43.8% vs 0% in the first 8 weeks, and overall response rate of 66.7% during the 24 weeks of sovleplenib treatment (including patients that crossed over from placebo) with a favorable safety profile.⁵ Additional details may be found at clinicaltrials.gov, using identifier NCT05535933.

Professor Fengkui Zhang of the Chinese Academy of Medical Sciences Blood Diseases Hospital, and one of the leading principal investigators of the ESLIM-02 study, said: “Warm antibody autoimmune hemolytic anemia is a highly heterogeneous and often chronically relapsing disease. Patients often experience symptoms like fatigue significantly impacting patients’ quality of life. In severe cases, the disease can become life-threatening if not managed effectively. The positive topline results from ESLIM-02 highlight sovleplenib's potential to deliver rapid and durable hemoglobin responses in wAIHA patients who have limited options after failing standard therapies. This could represent a meaningful advancement for managing this challenging condition.”

Professor Bin Han of Peking Union Medical College Hospital and Professor Lianshan Zhang of The Second Hospital of Lanzhou University were also co-leading Principal Investigators of the study. Full results of the ESLIM-02 study will be submitted for presentation at an upcoming scientific conference. HUTCHMED plans to submit the New Drug Application (“NDA”) for sovleplenib for wAIHA to the China National Medical Products Administration (NMPA) in the first half of 2026.