Group 1 - The core point of the news is that Green Leaf Pharmaceutical has completed patient enrollment for the Phase III clinical trial of its innovative drug, Ruoxinlin, aimed at treating generalized anxiety disorder (GAD) [1] - The Phase III trial is a multi-center, randomized, double-blind, placebo-controlled study involving 555 patients, with the primary endpoint being the change in Hamilton Anxiety Scale (HAM-A) scores at the end of week 8 [1] - The company expects to complete the clinical trial by the end of this year and submit a marketing application for this indication [1] Group 2 - Generalized anxiety disorder is the most common mental disorder in China, affecting approximately 53.1 million people as of 2021 [1] - There have been no innovative drugs approved for the treatment of anxiety disorders globally in the past 15 years, making Ruoxinlin a potential first-in-class serotonin, norepinephrine, and dopamine reuptake inhibitor (SNDRI) for GAD [1] Group 3 - Ruoxinlin is the first independently developed innovative drug in China for treating depression, having been approved in 2022, and has shown significant clinical efficacy and safety [3] - The drug has been recognized for its ability to improve depressive symptoms without causing insomnia, sedation, or affecting sexual function, weight, and lipid metabolism [3] - Ruoxinlin has served over 80,000 patients since its launch and is the fastest-growing antidepressant in China [3] Group 4 - The demand for treatments in the central nervous system field, including depression and anxiety, is substantial, but new drug development has been relatively slow [4] - The company has received approvals for a series of competitive innovative drugs in various markets, including the US, Europe, and Japan [4] - The company is actively developing next-generation innovative drugs, with several first-class innovative drugs in clinical stages targeting multiple receptors [4]
绿叶制药(02186)：若欣林®治疗广泛性焦虑障碍的中国Ⅲ期临床试验完成所有患者入组