HUTCHMED (China) Limited (HCM), a commercial-stage biopharmaceutical company, announced on Wednesday that the National Medical Product Administration (NMPA) of China has accepted the new drug application for Sovleplinib in treating warm autoimmune hemolytic anemia (wAIHA).
Autoimmune hemolytic anemia (AIHA) is a rare autoimmune disease characterized by the immune system lysing the body's own red blood cells (RBCs) through the production of antibodies. In cases of wAIHA, RBC destruction occurs at body temperature, and this is the most common form of AIHA.
Sovleplinib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (Sty), developed by HUTCHMED for the treatment of immunological diseases and haematological malignancies.
The NDA application for sovleplinib was supported by results from the randomized, double-blind, placebo-controlled Phase 2/3 ESLIM-02 trial. Previously published Phase 2 results from 2025 show an overall response rate (ORR) of 66.70% over 24 weeks for patients treated with the drug.
In January 2026, the company reported that Phase 3 had achieved the primary endpoint of a durable haemoglobin response rate within 5-24 weeks. Sovleplinib also exhibited a favorable safety profile.
Alongside the NDA acceptance, Sovleplinib has also been granted a priority review and breakthrough therapy designation for the treatment of wAIHA.
HCM closed Tuesday at $13.59, up 1.04%.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.