Core Viewpoint - Green Leaf Pharmaceutical's innovative drug, Ruoxinlin® (Toluoxetine Hydrochloride Sustained-Release Tablets), has received approval from the Macau Drug Regulatory Authority for the treatment of depression, marking it as China's first independently developed chemical innovative drug for this condition [1][2]. Group 1: Product Development and Approval - Ruoxinlin® is recognized as the first innovative drug for depression in China with independent intellectual property rights [1]. - The drug exhibits reuptake inhibition effects on serotonin (5-HT), norepinephrine (NE), and dopamine (DA), supported by PET/CT studies showing its binding to DA transporters in the brain [1]. - Phase III clinical trials have demonstrated Ruoxinlin®'s ability to comprehensively and stably treat depression, improving anxiety, fatigue, anhedonia, and cognitive function while promoting social functioning recovery [1]. Group 2: Market Impact and Clinical Recognition - Since its approval in mainland China in November 2022, Ruoxinlin® has rapidly gained clinical recognition, becoming one of the fastest-growing new antidepressants, serving over 30,000 patients [2]. - The drug is expected to be included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List by the end of 2024, enhancing accessibility and benefiting more patients [2]. - Ongoing Phase III clinical trials are also being conducted for Ruoxinlin® in the treatment of generalized anxiety disorder [2].
绿叶制药(02186)：抗抑郁1类创新药若欣林®在中国澳门获批上市