Hutchmed announces NDA acceptance in China for sovleplenib

Hutchmed 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. In August 2023, HUTCHMED announced that the trial had met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in durable response rate in patients treated with sovleplenib as compared to patients treated with placebo. 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.