Pharma Focus Asia

HUTCHMED's Sovleplenib Receives NDA Approval in China for Primary Immune Thrombocytopenia Treatment with Priority Review Status

Thursday, January 11, 2024

HUTCHMED (China) Limited has made an announcement regarding the acceptance for review and the granting of priority review by the China National Medical Products Administration (NMPA) for the New Drug Application (NDA) of sovleplenib. This novel oral inhibitor targeting spleen tyrosine kinase (Syk) is being developed for the treatment of primary immune thrombocytopenia (ITP) in adult patients.

The NDA submission is supported by data from the ESLIM-01 Phase III trial, a randomized, double-blinded study conducted in China with 188 adult patients who had received at least one prior line of standard therapy for primary ITP. The trial successfully met its primary endpoint by demonstrating a clinically meaningful and statistically significant increase in durable response rate in patients treated with sovleplenib compared to those treated with a placebo. Secondary endpoints, including response rate and safety, were also met.

The NMPA had previously granted Breakthrough Therapy designation to sovleplenib in January 2022, recognizing it as a new drug with the potential to treat a serious condition for which there are currently no effective treatment options.

Dr. Weiguo Su, Executive Director, CEO, and Chief Scientific Officer of HUTCHMED, expressed satisfaction with the initiation of the NDA submission, emphasizing the significant need for new therapies in adult primary ITP.

Sovleplenib, a selective Syk inhibitor, is currently under clinical investigation for the treatment of hematological malignancies and immune diseases. The results from the Phase I/II study in China, published in The Lancet Haematology, demonstrated rapid and durable increases in platelet counts in previously treated ITP patients. The drug is also being studied for warm antibody autoimmune hemolytic anemia and indolent non-Hodgkin’s lymphoma.

ITP is an autoimmune disorder characterized by platelet destruction, leading to an increased risk of bleeding and bruising. The positive outcomes of the Phase III trial and the Breakthrough Therapy designation underscore the potential of sovleplenib as a novel and effective treatment option for adult patients with primary ITP.



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