海南海药(000566.SZ)：创新药派恩加滨项目于近日完成Ⅱa期临床试验

Core Viewpoint - Hainan Haiyao's innovative drug project, Paengabine, has successfully completed Phase IIa clinical trials, showing promising results for treating refractory epilepsy [1] Group 1: Clinical Trial Results - The Phase IIa clinical trial for Paengabine, developed in collaboration with the Shanghai Institute of Materia Medica, has met both primary and secondary clinical endpoints [1] - The drug, a new generation KCNQ potassium channel agonist, is the first of its kind globally and is intended for the treatment of refractory epilepsy [1] - Initial exploratory efficacy indicators suggest that Paengabine can effectively reduce the frequency of seizures in patients with focal epilepsy after 8 weeks of continuous use [1] Group 2: Regulatory and Development Milestones - Paengabine received approval for clinical trials from the National Medical Products Administration and has completed Phase I trials in healthy subjects [1] - The Phase IIa trial was designed as a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of Paengabine in patients with focal epilepsy [1] - The trial results indicate that Paengabine has good safety and tolerability profiles, with overall risks being manageable [1]