HUTCHMED (China) Limited announced that the New Drug Application for Sovleplenib for the treatment of adult patients with primary immune thrombocytopenia has been accepted for review and granted priority review by the China National Medical Products Administration. Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase, being developed for the treatment of hematological malignancies and immune diseases. The NDA is supported by data from ESLIM-01, a randomized, double-blinded, placebo-controlled Phase III trial in China of sovleplenib in 188 adult patients with primary ITP who have received at least one prior line of standard therapy.

Secondary endpoints including response rate and safety were also met. Full results will be published in due course. Results from the proof of concept study that led to the ESLIM-01 study were published in The Lancet Haematology.

The NMPA granted Breakthrough Therapy designation to sovleplenib as a new drug that could treat a serious condition for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies.