Jan. 7 at 3:25 PM
HUTCHMED announced that its Phase III ESLIM-02 trial of sovleplenib met its primary endpoint in adults with warm autoimmune hemolytic anemia (wAIHA) in China. The study showed a durable hemoglobin response between weeks 5 and 24 in patients who had relapsed or were refractory to at least one prior standard therapy.
Sovleplenib, a novel spleen tyrosine kinase inhibitor, builds on strong Phase II data that demonstrated significantly higher response rates versus placebo. wAIHA is a rare but serious autoimmune disorder with limited treatment options. Investigators noted the drug’s potential to deliver rapid and sustained hemoglobin improvements.
HUTCHMED plans to submit a New Drug Application for sovleplenib in wAIHA to China’s regulator in the first half of 2026 and is also advancing the drug for immune thrombocytopenia, with another NDA planned in the same timeframe.
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