Recently, Hohhot Pharmaceuticals announced that it is currently researching another national Class 1 innovative drug, Soropinib, for the ESLIM-01 Phase III study in adult patients with primary immune thrombocytopenia (ITP). The results of the study were published in The Lancet Hematology. At the same time, the research report was presented in the form of an oral presentation and two posters at the 2024 annual meeting of the European Blood Association on June 14th. Sorepinib is a novel, highly selective oral inhibitor of splenic tyrosine kinase (Syk) 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. Immunothrombocytopenia is a complex autoimmune hemorrhagic disease that leads to a decrease in platelet levels in the patient's peripheral blood. Immune thrombocytopenia may also have an impact on the quality of life of patients due to fatigue, activity restriction, and anxiety. The results of the ESLIM-01 study published in The Lancet Hematology showed that the persistent response rate of treatment was 48.4%, while the placebo was 0%. The subgroup analysis reported at the annual meeting of the European Hematology Association showed consistent clinical benefits regardless of the number of previous treatment lines or previous TPO/TPO-RA treatment status. The study validated the sustained beneficial efficacy and good safety of the SYK inhibitor, soropinib, in primary ITP patients in China, indicating that soropinib has the potential to become a treatment choice for immunothrombocytopenia patients who have received at least one treatment in the past. At present, the first-line treatment of warm antibody type autoimmune hemolytic anemia (wAIHA) in clinical practice mainly relies on glucocorticoids or glucocorticoids combined with rituximab, and splenectomy is also a treatment method. However, due to factors such as efficacy, treatment-related adverse events, and patient acceptance, the patient population still faces unmet medical needs. Therefore, the urgency and importance of new drug development are increasingly prominent, aiming to provide patients with more treatment options, in order to further improve the treatment pattern of wAIHA and enhance the quality of life of patients. In January 2024, the new drug application for the treatment of adult primary immune thrombocytopenia patients with soropinib has been accepted and given priority approval by the National Medical Products Administration of China. Soropinib is expected to be launched within this year to benefit patients with primary immune thrombocytopenia. It is reported that a dose exploration study of the innovative drug is being planned in the United States. In March 2024, Hehuang Pharmaceuticals initiated the registration phase of the Phase II/III study on the use of soropinib for the treatment of warm resistant autoimmune hemolytic anemia (wAIHA) in adult patients in China. Hehuang Pharmaceuticals currently retains all rights of Sorepinib globally. (Lai Xin She)
Edit：Xiong Dafei Responsible editor：Li Xiang
Source：WHB
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