HUTCHMED (00013) announced that the New Drug Application for sovleplenib has been accepted by the National Medical Products Administration of China. The application is for the treatment of adult patients with warm antibody-type autoimmune hemolytic anemia who have had an inadequate response to at least one prior corticosteroid therapy. The NMPA has granted the application priority review status.
Sovleplenib is a novel, highly selective oral inhibitor of spleen tyrosine kinase, developed for treating autoimmune diseases and hematologic malignancies. Autoimmune hemolytic anemia is a condition where the immune system produces antibodies that destroy red blood cells. The estimated incidence of AIHA is 0.8 to 3.0 cases per 100,000 adults annually, with a prevalence of approximately 17 per 100,000 adults and a mortality rate between 8% and 11%. The warm antibody type is the most common form, accounting for 75-80% of all adult AIHA cases.
This NDA is supported by data from the ESLIM-02 study, a randomized, double-blind, placebo-controlled Phase II/III clinical trial conducted in China. The trial enrolled adult patients with relapsed or refractory primary or secondary wAIHA who had received at least one prior standard therapy. In January 2026, the Phase III portion of the study met its primary endpoint, demonstrating a durable hemoglobin response from week 5 to week 24 of treatment. The full Phase III data is scheduled for presentation at the upcoming 2026 European Hematology Association Annual Congress. Results from the Phase II segment were published in The Lancet Haematology in January 2025, showing that sovleplenib provided encouraging hemoglobin benefits compared to placebo, with an overall response rate of 43.8% versus 0% in the first 8 weeks. The overall response rate at 24 weeks, including patients who crossed over from the placebo group, was 66.7%. The treatment also demonstrated a favorable safety profile.
Mr. Zheng Zefeng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, stated, "We are pleased to have submitted the NDA for sovleplenib for wAIHA and that it has been accepted for priority review and designated as a breakthrough therapy. This is the second marketing application submitted for sovleplenib, further highlighting its broad potential as an innovative oral Syk inhibitor. We look forward to providing this much-needed treatment option for wAIHA patients who have limited choices, while also strengthening our hematology portfolio through this important new indication."
Sovleplenib was granted Breakthrough Therapy Designation by the NMPA for wAIHA in March 2026. This designation is awarded to innovative drugs for serious conditions with no effective treatments available, or which demonstrate significant clinical advantages over existing therapies.
Comments