HUTCHMED Announces NDA Acceptance in China for Sovleplenib for the Treatment of Primary Immune Thrombocytopenia with Priority Review Status

— NDA accepted and granted Priority Review following its Breakthrough Therapy designation granted in January 2022 —

— NDA is supported by data from successful Phase III ESLIM-01 trial in patients with adult primary immune thrombocytopenia who have received at least one previous therapy —

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 10, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the New Drug Application (“NDA”) for sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (“ITP”) has been accepted for review and granted priority review by the China National Medical Products Administration (“NMPA”). Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (“Syk”), 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.

The NMPA granted Breakthrough Therapy designation (“BTD”) to sovleplenib for the indication studied in ESLIM-01 in January 2022. The NMPA granted this 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.

“We are pleased to have initiated the rolling submission of an NDA for sovleplenib in China as we look to bring this novel treatment to ITP patients,” said Dr. Weiguo Su, Executive Director, Chief Executive Officer and Chief Scientific Officer of HUTCHMED. “Our submission includes data from the successful Phase III ESLIM-01 trial in China which demonstrated a durable response rate of sovleplenib for patients. There is a significant need for new therapies in adult primary ITP which can significantly impair the quality of life for patients.”