Hehuang Pharmaceutical (00013) announced that the phase III phase of the ESLIM-02 Chinese study on solepinib for the treatment of warm-antibody autoimmune hemolytic anemia achieved positive top-line results

Zhitong Finance App News, Hehuang Pharmaceutical (00013) announced that the phase III registration phase of the ESLIM-02 study of the novel spleen tyrosine kinase (Syk) inhibitor zolepinib for the treatment of adult patients with warm-antibody autoimmune hemolytic anemia has reached the main end point of persistent hemoglobin (Hb) response during 5 to 24 weeks of treatment.

The ESLIM-02 study is a randomized, double-blind, placebo-controlled phase II/III clinical trial in adult patients with primary or secondary warm-antibody autoimmune hemolytic anemia who have relapsed or are refractory after receiving at least one standard treatment in the past. The results of phase II of the study were published in “The Lancet Haematology (The Lancet Haematology)” in January 2025. Compared with placebo, solepinib showed encouraging hemoglobin benefits. The overall response rate for the first 8 weeks was 43.8% compared to 0%, and the overall response rate during 24 weeks of solepinib treatment (including patients taking the placebo) was 66.7%, and the safety was good. Additional details of the study can be found on clinicaltrials.gov and search registration number NCT05535933.

Professor Zhang Fengkui of the Hematology Hospital of the Chinese Academy of Medical Sciences, one of the main researchers in the ESLIM-02 study, said, “Warm antibody autoimmune hemolytic anemia is a highly heterogeneous and often chronic recurrent disease. Patients often experience symptoms such as fatigue, which seriously affects the quality of life. If the condition is not effectively controlled, it may even be life-threatening in serious cases. “The positive top-line results of the ESLIM-02 study highlight the potential of solepinib to bring rapid and long-lasting hemoglobin responses to patients with warm-antibody autoimmune hemolytic anemia who have limited treatment options after standard treatment fails, and may mark an important advance in the treatment of this difficult disease.”

Professor Han Bing of Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences and Professor Zhang Liansheng of the Second Hospital of Lanzhou University were also co-lead researchers in the study. The full data from the ESLIM-02 study will be presented at an upcoming academic conference. In the first half of 2026, Hehuang Pharmaceutical plans to submit a marketing application for solepinib as a new drug for the treatment of warm-antibody autoimmune hemolytic anemia to the China National Drug Administration (CFDA).