Zhimeng Completes 255-Patient Enrollment in Pivotal ALS Trial
Shanghai – October 31, 2026 -- Shanghai Zhimeng Biopharma has completed enrollment of 255 patients in the pivotal Phase 2/3 trial of CB03-154 for amyotrophic lateral sclerosis (ALS), moving the potassium channel opener toward topline data and a possible new drug application in China.
Trial runs at 15 Chinese centers with a Week 39 primary endpoint
The study is led by Professor Fan Dongsheng of the 3rd Affiliated Hospital of Peking University and spans 15 clinical research centers in Mainland China. Its primary efficacy endpoint is the change from baseline in ALSFRS-R score at Week 39. China's Center for Drug Evaluation (CDE) cleared the Phase 2/3 study in July 2025. The U.S. FDA granted CB03-154 Orphan Drug Designation in October 2023.