Biopharmaceutical company HUTCHMED (China) Limited (Nasdaq:HCM) (AIM:HCM) (HKEX:13) announced on Wednesday that the New Drug Application for sovleplenib has been accepted for review and granted priority status by the China National Medical Products Administration for the treatment of adult patients with warm antibody autoimmune hemolytic anaemia who have failed at least one prior glucocorticoid therapy.

Sovleplenib, an oral spleen tyrosine kinase inhibitor, has also received Breakthrough Therapy Designation in March 2026, reflecting its potential to address a serious condition with limited treatment options. The submission is supported by data from the ESLIM-02 Phase II/III study, with the Phase III portion meeting its primary endpoint of durable haemoglobin response between weeks 5 and 24.

Earlier Phase II results demonstrated improved response rates versus placebo alongside a favourable safety profile, with findings published in The Lancet Haematology in January 2025. Full Phase III data are scheduled for presentation at the European Hematology Association Congress 2026.

Sovleplenib is also under development for immune thrombocytopenia, with a separate New Drug Application already accepted for review with priority status in February 2026. HUTCHMED retains global rights to the therapy, which targets immune and haematological disorders through inhibition of spleen tyrosine kinase.