Hutchmed (China) announced today that the results of the ESLIM-01 Phase III study of Soplepinib (sovleplenib, HMPL-523) for adults with primary immune thrombocytopenia have been published in The Lancet Haematology. Additional details of the study and subgroup results have also been presented in the form of an oral report and two posters at the European Hematology Association (EHA) 2024 annual meeting on June 14.

Soplepinib is a new, highly selective oral spleen tyrosine kinase (Syk) inhibitor used for the treatment of hematological malignancies and immune disorders. Syk is an important component of the Fc receptor and B cell receptor signaling pathways. Immune thrombocytopenia is a complex autoimmune bleeding disorder that leads to a decrease in platelet levels in the peripheral blood of patients. Immune thrombocytopenia may also affect the quality of life of patients due to fatigue, activity limitations, and anxiety. The results of the ESLIM-01 study published in The Lancet Haematology indicate that Soplepinib has the potential to become a treatment choice for immune thrombocytopenia patients who have received at least one previous treatment.

The China National Medical Products Administration (NMPA) has included the use of Soplepinib for this indication in the breakthrough therapy category and accepted its new drug application for priority review in January 2024. A dose-exploration study being conducted in the United States is planned (NCT06291415). Hutchmed (China) has also launched the registration stage of the II/III study of Soplepinib for the treatment of warm-type autoimmune hemolytic anemia (wAIHA) in adult patients in China in March 2024 (NCT05535933). Hutchmed (China) currently retains all rights to Soplepinib globally.