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Hutchmed China Ltd on Friday said phase III trial results for its investigational drug sovleplenib showed significant efficacy and a favourable safety profile in patients with warm antibody autoimmune hemolytic anaemia, or wAIHA. The Hong Kong-based biopharmaceutical firm said data from the ESLIM-02 phase III study were presented at the European Hematology Association Congress in Stockholm. The study evaluated sovleplenib in adult patients with primary or secondary wAIHA who had relapsed or were refractory to at least one prior standard treatment. The condition is a rare autoimmune disorder in which the immune system destroys red blood cells. Hutchmed said the trial met its primary endpoint, with 66% of patients receiving sovleplenib achieving a durable response during weeks five to 24, compared with 15% in the placebo group. The overall response rate was 70% for sovleplenib versus 22% for placebo. Use of rescue therapy was reduced from 54% to 16%, and fewer patients required red blood cell transfusions, from 43% to 11%. Median time to response was 3.1 weeks for sovleplenib, versus 6.3 weeks for placebo. Among responders, the median duration of response was 16.1 weeks compared with 6.1 weeks. The company said efficacy was consistent across all patient subgroups, including those previously treated with rituximab, where durable response rates were 69% for sovleplenib and 16% for placebo. Sovleplenib also demonstrated a favourable safety profile. Grade 3 or higher treatment-emergent adverse events occurred in 43% of patients receiving sovleplenib, compared with 59% in the placebo arm. No treatment-related deaths or treatment discontinuations were reported in the sovleplenib group. Hutchmed noted that a new drug application for sovleplenib in adult patients with wAIHA who have had an insufficient response to at least one glucocorticoid treatment was accepted for review and granted priority review by China’s National Medical Products Administration in April. The drug also received Breakthrough Therapy Designation in March. Shares in Hutchmed were 1.9% lower at 166.00 pence in London on Friday afternoon. Copyright 2026 Alliance News Ltd. All Rights Reserved.
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