HUTCHMED Announces that the Sovleplenib Phase III ESLIM-01 Study Met Its Primary Endpoint in Primary Immune Thrombocytopenia in China
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Aug. 20, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the pivotal Phase III trial ESLIM-01 evaluating the investigational use of sovleplenib met its primary endpoint of durable response rate and all secondary endpoints in adult patients with primary immune thrombocytopenia (“ITP”) in China. HUTCHMED plans to submit the New Drug Application (“NDA”) around the end of 2023.
- The National Medical Products Administration of China (“NMPA”) granted Breakthrough Therapy designation (“BTD”) to sovleplenib for the indication studied in ESLIM-01 in January 2022.
- As such, the sovleplenib NDA may be considered for priority review for its use in ITP.
- ESLIM-01 is 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.
- Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (“Syk”) for the treatment of hematological malignancies and immune diseases.