HUTCHMED (00013): Sovleplenib, a Chinese new drug used to treat warm antibody type autoimmune hemolytic anemia patients, has received acceptance for market application and has been included in priority review and breakthrough therapy varieties.

HUTCHMED (00013) announced that the new drug application for solvecplenib for the treatment of warm antibody type autoimmune hemolytic anemia (wAIHA) in adult patients who have had an inadequate response to corticosteroid treatment has been accepted by the National Medical Products Administration (NMPA) of China, and has been granted priority review. Solvecplenib is a novel, highly selective oral spleen tyrosine kinase (Syk) inhibitor developed for the treatment of autoimmune diseases and hematologic malignancies. Autoimmune hemolytic anemia (AIHA) is an autoimmune disease characterized by the production of antibodies against self-red blood cells, leading to the destruction of red blood cells. The incidence of AIHA is estimated to be 0.8-3.0 cases per 100,000 adults per year, with a prevalence of 17 cases per 100,000 adults, and a mortality rate of 8-11%. Warm antibody type AIHA is the most common type, accounting for 75-80% of all cases of adult AIHA. The data from the ESLIM-02 study supported this new drug application. The ESLIM-02 study is a randomized, double-blind, placebo-controlled Phase II/III clinical trial conducted in adult patients with relapsed or refractory primary or secondary warm antibody type AIHA who have received at least one standard treatment in the past. In January 2026, the Phase III stage of the study reached the primary endpoint of sustained hemoglobin (Hb) response during weeks 5 to 24 of treatment. The Phase III data of the study will be presented at the upcoming 2026 European Hematology Association (EHA) annual meeting. The results of the Phase II stage of the study were published in January 2025 in The Lancet Haematology, showing encouraging hemoglobin benefits with solvecplenib compared to placebo, with an overall response rate of 43.8% in the first 8 weeks compared to 0% for placebo, and an overall response rate of 66.7% during the 24-week solvecplenib treatment period (including patients crossed over from placebo), with good safety. Mr. Christian Hogg, CEO and CFO of HUTCHMED, said, "We are pleased to have submitted the new drug application for solvecplenib for the treatment of warm antibody type AIHA and to have qualified for priority review from the NMPA, as well as breakthrough therapy designation. This is the second indication for solvecplenib submission, further demonstrating its broad potential as an innovative oral Syk inhibitor. We look forward to bringing this much-needed treatment option to patients with limited treatment choices for warm antibody type AIHA, and to further enhance our hematology product portfolio through this important new indication." Solvecplenib was granted breakthrough therapy designation by the NMPA in March 2026 for the treatment of warm antibody type autoimmune hemolytic anemia. The NMPA included solvecplenib in the breakthrough therapy designation as an innovative drug for the treatment of a serious disease without effective treatment options and with clear clinical advantages compared to existing treatment options.