Core Viewpoint - Green Leaf Pharmaceutical has received formal acceptance from the National Medical Products Administration for the new indication application of its innovative drug Ruoxinlin, aimed at treating generalized anxiety disorder, marking a significant milestone since its approval for depression treatment in November 2022 [1] Group 1: Drug Development and Clinical Research - Ruoxinlin is expected to be the first SNDRI (serotonin, norepinephrine, and dopamine reuptake inhibitor) for generalized anxiety disorder in China, potentially benefiting a larger patient population [1] - The new indication application is based on a Phase III clinical study involving 555 patients, demonstrating an efficacy rate exceeding 80% and a remission rate of approximately 50% [1] - The safety profile of Ruoxinlin is favorable, with low incidences of adverse effects such as drowsiness, insomnia, fatigue, and sexual dysfunction, most of which are mild to moderate and tend to improve over time [1] Group 2: Market Context and Demand - Anxiety disorders are the most common mental disorders in China, with approximately 58.67 million affected individuals, and generalized anxiety disorder has a lifetime prevalence of about 4.1%-6.6% among adults [2] - Current first-line treatments for generalized anxiety disorder, SSRIs and SNRIs, show limited efficacy with overall effectiveness rates of 67.7% and remission rates of only 39.7%, alongside significant side effects that affect patient compliance [2] - The market for SSRIs and SNRIs is projected to reach 4.83 billion yuan in 2024, with no new innovative drugs approved in the last 20 years, highlighting a significant gap in the treatment landscape [2] Group 3: Company Strategy and Product Portfolio - Green Leaf Pharmaceutical has established a long-term strategic focus on the central nervous system treatment field, with a diverse product portfolio addressing various conditions including schizophrenia, bipolar disorder, and Alzheimer's disease [4] - The company’s product lineup includes Ruoxinlin, which has served nearly 190,000 patients since its launch, and has been recognized as one of the fastest-growing antidepressants in China [3] - The company is actively developing next-generation innovative drugs, with several candidates in clinical stages targeting multiple mechanisms [4]