HUTCHMED Announces NDA Acceptance for Sovleplenib in China

HUTCHMED (China) Limited has announced that its New Drug Application (NDA) for sovleplenib has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA). The application is for the treatment of adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) who have not responded sufficiently to at least one previous glucocorticoid treatment. Sovleplenib is an oral inhibitor targeting spleen tyrosine kinase (Syk). The NDA is supported by data from a Phase II/III study (ESLIM-02), which met its primary endpoint for durable hemoglobin response rate. The Phase III results will be presented at the upcoming European Hematology Association (EHA) Congress 2026. The NMPA previously granted Breakthrough Therapy Designation to sovleplenib for wAIHA in March 2026. Sovleplenib is also being studied for immune thrombocytopenia (ITP), with a resubmitted NDA for ITP also granted priority review by the NMPA in February 2026. HUTCHMED retains all worldwide rights to sovleplenib.