Group 1 - The core point of the news is that Green Leaf Pharmaceutical (02186.HK) has completed patient enrollment for its Phase III clinical trial of the innovative drug Ruoxinlin® (Toralacitinib) for 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 from baseline at 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, with a long duration and high recurrence rate impacting patients' quality of life [1] - Ruoxinlin® is expected to be the first drug globally approved for treating GAD that acts as a triple reuptake inhibitor of serotonin (5-HT), norepinephrine (NE), and dopamine (DA) [1] - Current first-line treatments for GAD include SSRIs and SNRIs, which have common side effects leading to low patient compliance and treatment discontinuation [2] Group 3 - Ruoxinlin® is the first domestically developed innovative drug for treating depression in China, having been approved for market since 2022, and has shown efficacy and safety in clinical settings [2] - Clinical trials have demonstrated that Ruoxinlin® significantly improves depression symptoms without causing insomnia, sedation, or affecting sexual function, weight, and lipid metabolism [2] - The drug also shows potential anxiolytic effects, improving HAM-A scores and other anxiety-related measures while providing antidepressant benefits [2]
绿叶制药(02186.HK)：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