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 field of otolaryngology [1][2]. Group 1: Clinical Trial Results - The Phase II clinical trial involved 148 patients and demonstrated significant efficacy of GPN01360 compared to placebo, with a p-value of 0.0006 for the primary endpoint, the change in HAMD-17 score [2]. - Secondary efficacy indicators, including MADRS and HAMA, also showed significant differences compared to placebo (P<0.05) [2]. - GPN01360 exhibited good safety and tolerability, with no significant adverse effects reported during the trial [2]. Group 2: Product Information - GPN01360 is classified as a Class 1 innovative traditional Chinese medicine, based on the classic formula "Xiaoyao San," and consists of 12 herbal ingredients [2]. - The drug targets liver qi stagnation and spleen deficiency type depression, addressing symptoms such as low mood, cognitive slowing, anxiety, and insomnia [2]. Group 3: Market Context - Depression is a prevalent mental disorder affecting approximately 332 million people globally, with a prevalence rate of about 4.0%, and a higher rate of 6.8% in China [3]. - The clinical cure rate for depression remains below 30%, indicating a significant unmet clinical need for effective treatments [3]. Group 4: Company Strategy - The company is a leading player in the research, production, and sales of otolaryngology drugs, with a diverse product pipeline covering various therapeutic areas [4]. - The company is focusing on traditional Chinese medicine as a key strategic direction, expanding its offerings beyond otolaryngology to include cardiovascular and neurological diseases [4]. - The company emphasizes innovation and advanced technology in product development, aiming to meet unmet clinical needs and enhance its product pipeline [5].
远大医药：中药1类创新药GPN01360在中国开展的II期临床研究成功达到临床终点