HUTCHMED(00013.HK): Sostarlimab Phase III study successful; plans to submit new drug application to NMPA in the first half of 2026
NewTimeSpace News: On January 7, 2026,HUTCHMED (China) Limited announced that the Phase III registration stage of the ESLIM-02 study on its novel spleen tyrosine kinase (Syk) inhibitor, sostarlimab, for the treatment of adult patients with warm antibody autoimmune hemolytic anemia has met the primary endpoint. The announcement stated that the primary endpoint was "sustained hemoglobin (Hb) response during the treatment period from Week 5 to Week 24".
Autoimmune hemolytic anemia (AIHA) is an autoimmune disease characterized by the destruction of red blood cells due to the production of antibodies against one's own red blood cells. According to data cited in the announcement, the incidence of the disease is estimated to be 0.8-3.0 cases per 100,000 people per year, the prevalence is estimated to be 17 cases per 100,000 people, and the mortality rate is 8-11%. The warm antibody type is the most common, accounting for 75-80% of all adult cases of autoimmune hemolytic anemia.
The ESLIM-02 study is a randomized, double-blind, placebo-controlled Phase II/III clinical trial conducted in China, involving adult patients with primary or secondary warm antibody autoimmune hemolytic anemia who relapsed or were refractory after receiving at least one standard treatment. The results of the Phase II stage of the study were published in *The Lancet Haematology* in January 2025. Compared with placebo, sostarlimab showed encouraging hemoglobin benefits, with an overall response rate of 43.8% versus 0% in the first 8 weeks, and an overall response rate of 66.7% during the 24-week sostarlimab treatment period (including patients who crossed over from placebo), with a good safety profile.
HUTCHMED stated in the announcement that the full data of the ESLIM-02 study will be submitted for publication at an upcoming academic conference, and the company plans to submit a new drug application for sostarlimab for the treatment of warm antibody autoimmune hemolytic anemia to the National Medical Products Administration in the first half of 2026.
In addition to warm antibody autoimmune hemolytic anemia, studies on sostarlimab for the treatment of primary immune thrombocytopenia are also underway. Positive results from the ESLIM-01 Chinese Phase III study of sostarlimab for the treatment of primary immune thrombocytopenia have been published in *The Lancet Haematology*.HUTCHMED also plans to resubmit a new drug application for sostarlimab for the second-line treatment of immune thrombocytopenia in the first half of 2026. Currently,HUTCHMED retains all global rights to sostarlimab.
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