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® for the treatment of generalized anxiety disorder, marking a significant milestone since its approval for depression treatment in November 2022 [1] Group 1: Product Development and Clinical Research - Ruoxinlin® is expected to be the first SNDRI 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 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 reactions such as drowsiness and sexual dysfunction, and no significant impact on weight or glucose-lipid metabolism [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 the lifetime prevalence of generalized anxiety disorder in adults is estimated at 4.1%-6.6% [2] - Current first-line treatments, SSRIs and SNRIs, have limited efficacy, with overall effectiveness rates of 67.7% and remission rates of only 39.7%, alongside common adverse 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 - The central nervous system treatment area, including depression and anxiety, is a core strategic focus for the company, which has developed a differentiated product portfolio addressing various mental health conditions [4] - In addition to Ruoxinlin®, the company’s portfolio includes other approved products such as Erzofri® and Rykindo®, and it is actively developing next-generation innovative drugs targeting multiple mechanisms [4] - Ruoxinlin® has served nearly 190,000 patients since its launch, gaining recognition for its efficacy and safety, and is expected to further enhance accessibility with its new indication [3]