HCM · Hutchison China Ltd.

HUTCHMED (China) Limited announced a significant regulatory milestone with the acceptance of its New Drug Application (NDA) for sovleplenib by the China National Medical Products Administration (NMPA) for the treatment of warm antibody autoimmune hemolytic anemia (wAIHA). The application secured both Priority Review status and Breakthrough Therapy Designation, the latter granted in March 2026 for serious conditions lacking effective treatment options. This marks the second indication for sovleplenib, reinforcing its potential as a novel oral Syk inhibitor. The filing is supported by data from the ESLIM-02 Phase II/III study, where the Phase III portion met its primary endpoint of durable hemoglobin response in January 2026. Phase II results published in The Lancet Haematology demonstrated an overall response rate of 66.7% over 24 weeks. Additionally, the company noted that the NDA for sovleplenib in immune thrombocytopenia (ITP) was accepted for review with priority status in February 2026. HUTCHMED retains all worldwide rights to the drug.