” 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...
Sovleplenib (HMPL-523) provided a statistically significant and clinically meaningful increase in durable response rate over placebo in adult patients with primary immune thrombocytopenia (ITP) in China, meeting the primary end point of the phase 3 ESLIM-01 trial (NCT05029635). The agent also met key secondary end points, such as response rate and safety.1
” Randomized, double-blind, controlled trial met primary endpoint of durable response rate and all secondary endpoints ” ” Overall safety consistent with sovleplenib known profile ” ” Plans for...
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:?HCM, HKEX:?13) today announces that it has completed patient enrollment of ESLIM-01, a pivotal Phase III clinical trial of sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (“ITP”) in China. The last patient was enrolled on December 31, 2022.