Core Viewpoint - Green Leaf Pharmaceutical has officially submitted a new indication application for its innovative drug Ruxinlin® to treat generalized anxiety disorder, marking a significant milestone following its approval for depression treatment in November 2022 [1][3]. Group 1: Company Developments - Ruxinlin® is expected to be the first domestic drug to treat generalized anxiety disorder as a serotonin, norepinephrine, and dopamine reuptake inhibitor (SNDRI) [1]. - The new indication application is based on a Phase III clinical study involving 555 patients, demonstrating an efficacy rate exceeding 80% and a response rate of approximately 50% [1]. - Ruxinlin® has served nearly 190,000 patients since its launch, gaining recognition for its efficacy and safety, and is one of the fastest-growing antidepressants in China [3]. Group 2: Industry Context - 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% [2]. - Current first-line treatments for anxiety disorders, including SSRIs and SNRIs, show limited efficacy, with overall effectiveness rates of 67.7% and response rates of only 39.7% [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 supply of innovative anxiety treatments [2].
绿叶制药(02186.HK)：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