Biopharmaceutical company HUTCHMED (China) Limited (Nasdaq/AIM: HCM) (HKEX: 13) on Wednesday reported positive topline results from the Phase III registration part of the ESLIM-02 trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia in China, meeting the primary endpoint of durable hemoglobin response between weeks five and 24.

ESLIM-02 is a randomised, double-blind, placebo-controlled Phase II/III study in patients with relapsed or refractory wAIHA following at least one prior line of standard therapy. Results from the earlier Phase II portion, published in The Lancet Haematology in January 2025, showed rapid and durable hemoglobin improvements with a favourable safety profile compared with placebo.

HUTCHMED said full Phase III results will be submitted for presentation at a forthcoming scientific conference and plans to file a New Drug Application for sovleplenib in wAIHA with China's National Medical Products Administration in the first half of 2026.

Sovleplenib is an oral, selective spleen tyrosine kinase inhibitor targeting immune mechanisms underlying wAIHA and other autoimmune conditions. HUTCHMED retains worldwide rights to the asset and is also advancing sovleplenib in immune thrombocytopenia, with an NDA resubmission for second-line ITP planned in the first half of 2026.