Globenewswire·2026-01-07 00:00Core Insights - HUTCHMED announced that the Phase III registration part of the ESLIM-02 clinical trial for sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) has met its primary endpoint of durable hemoglobin response rate within weeks 5 to 24 of treatment [1][3] Group 1: Clinical Trial Results - The ESLIM-02 study is a randomized, double-blind, placebo-controlled trial focusing on adult patients with primary or secondary wAIHA who have relapsed or are refractory to at least one prior line of standard treatment [2] - Results from the Phase II part of the study showed an overall response rate of 43.8% compared to 0% in the first 8 weeks, and 66.7% during the 24 weeks of treatment with sovleplenib, indicating a significant hemoglobin benefit [2][3] - The positive topline results suggest that sovleplenib could provide rapid and durable hemoglobin responses for patients with limited treatment options [3] Group 2: Drug Information - Sovleplenib is a novel, investigational selective small molecule inhibitor targeting spleen tyrosine kinase (Syk), which plays a crucial role in B-cell receptor and Fc receptor signaling [4] - The mechanism of action involves the inhibition of phagocytosis and reduction of antibody production, which may be beneficial in treating wAIHA [5] - In addition to wAIHA, sovleplenib is also being studied for immune thrombocytopenia (ITP), with positive results from a Phase III trial in China [6] Group 3: Future Plans - HUTCHMED plans to submit a New Drug Application (NDA) for sovleplenib for wAIHA to the China National Medical Products Administration (NMPA) in the first half of 2026 [3] - Full results of the ESLIM-02 study will be presented at an upcoming scientific conference, indicating ongoing commitment to transparency and scientific communication [3]