绿叶制药(02186)：1类创新药若欣林®用于治疗广泛性焦虑障碍的新适应症中国上市申请获得受理

Group 1 - The core point of the news is that Green Leaf Pharmaceutical has received formal acceptance from the National Medical Products Administration of China for the new indication application of its innovative drug, Ruoxinlin®, for the treatment of generalized anxiety disorder, marking a significant milestone since its approval for depression treatment in November 2022 [1] - Ruoxinlin® is expected to be the first SNDRI (serotonin, norepinephrine, and dopamine reuptake inhibitor) in China for treating generalized anxiety disorder, potentially benefiting a larger patient population [1] - The new indication application is based on a Phase III clinical study involving 555 patients, demonstrating that Ruoxinlin® can rapidly and comprehensively improve anxiety symptoms, with an efficacy rate exceeding 80% and a relief rate of approximately 50% [1] Group 2 - Anxiety disorders are the most common mental disorders in China, with approximately 58.67 million people affected, and generalized anxiety disorder has a lifetime prevalence rate of about 4.1%-6.6% among adults [2] - Current first-line treatments for generalized anxiety disorder, SSRIs and SNRIs, have limited efficacy, with a meta-analysis showing an overall efficacy rate of 67.7% and a relief rate of only 39.7% [2] - The market size for SSRIs and SNRIs is projected to be 4.83 billion yuan in 2024, with no innovative drugs approved in the last 20 years, highlighting a significant gap in the supply of innovative anti-anxiety treatments in China [2] Group 3 - Ruoxinlin® has served nearly 190,000 patients since its approval, gaining widespread recognition for its efficacy and safety, and is one of the fastest-growing antidepressants in China [3] - The drug is expected to be included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog by the end of 2024, further enhancing its accessibility [3] - The company has a long-term strategic focus on the central nervous system treatment field, with a diverse product portfolio that includes treatments for schizophrenia, bipolar disorder, and Alzheimer's disease, alongside ongoing development of next-generation innovative drugs [4]