Core Viewpoint - The successful completion of the Phase II clinical trial for GPN01360, an innovative traditional Chinese medicine for treating depression, marks a significant milestone for the company in the otolaryngology sector [1][2]. Group 1: Clinical Trial Details - The Phase II clinical trial was a randomized, double-blind, placebo-controlled, multi-center study involving 148 patients with depression, focusing on the efficacy and safety of GPN01360 over an 8-week oral administration period [1]. - The primary endpoint was the change in the Hamilton Depression Rating Scale (HAMD-17) score from baseline, with secondary endpoints including the Montgomery-Åsberg Depression Rating Scale (MADRS), HAMD-17 remission and response rates, Pittsburgh Sleep Quality Index (PSQI), Clinical Global Impression-Severity (CGI-S), and Clinical Global Impression-Improvement (CGI-I) scores [1]. Group 2: Efficacy and Safety Results - Results indicated a significant difference in the primary efficacy endpoint (HAMD-17) compared to placebo (P=0.0006 < 0.05), with secondary efficacy endpoints also showing significant differences (P < 0.05) [2]. - GPN01360 demonstrated good safety and tolerability, with no significant adverse effects reported during the trial, suggesting its potential for treating depression, anxiety, and insomnia symptoms [2]. Group 3: Product Background - GPN01360 is classified as a Class 1 innovative traditional Chinese medicine, derived from the classical formula "Xiaoyao San," optimized through modern pharmacology and clinical research, consisting of 12 herbal ingredients [2]. - The medicine targets liver qi stagnation and spleen deficiency type depression, with typical symptoms including low mood, slow thinking, reduced willpower, anxiety, insomnia, poor appetite, and fatigue [2].
远大医药(00512.HK)：中药创新药“GPN01360”在中国开展的II期临床研究成功达到临床终点