LUYE PHARMA: The Phase III clinical trial of Ruoxinlin® for the treatment of generalized anxiety disorder in China has completed the enrollment of all patients

According to the Zhitong Finance APP, LUYE PHARMA (02186) announced that the Phase III clinical trial of its independently developed Class 1 innovative drug Ruoxinlin® (Venlafaxine Hydrochloride Extended-Release Tablets) for the treatment of Generalized Anxiety Disorder has completed the enrollment of all patients. This Phase III clinical trial is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of Ruoxinlin® in treating Generalized Anxiety Disorder. A total of 555 patients were included in the trial, with the primary endpoint being the change in the Hamilton Anxiety Scale (HAM-A) total score from baseline at the end of week 8 of treatment. The group expects to complete this clinical trial by the end of this year and submit a marketing application for this indication. Anxiety disorders are the most common mental disorders in China, characterized by long duration and high recurrence rates, significantly impacting the quality of daily life for patients. Generalized Anxiety Disorder is a common type of anxiety disorder. As of 2021, approximately 53.1 million people in China suffer from anxiety disorders. In the past 15 years, no innovative drugs for the treatment of anxiety disorders have been approved globally. Ruoxinlin® is expected to become the world's first serotonin (5-HT), norepinephrine (NE), and dopamine (DA) triple reuptake inhibitor (SNDRI) for the treatment of Generalized Anxiety Disorder. Currently, first-line treatment medications for Generalized Anxiety Disorder include selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). However, common adverse reactions associated with SSRIs and SNRIs include sexual dysfunction, drowsiness, weight gain, and lipid metabolism disorders, leading to low patient compliance and affecting treatment outcomes, which are also common reasons for discontinuation of these medications. Ruoxinlin® is China's first independently developed chemical Class 1 innovative drug for the treatment of depression, with independent intellectual property rights. Since its approval for marketing in China in 2022, its efficacy and safety in treating depression have been continuously recognized in clinical settings. Previous clinical trials of Ruoxinlin® for the treatment of depression have confirmed that the drug can comprehensively improve depressive symptoms, particularly in alleviating anhedonia, psychomotor retardation, and cognitive impairment, overcoming the shortcomings of existing medications, and does not cause insomnia or drowsiness, nor does it affect sexual function, weight, or lipid metabolism. Additionally, Ruoxinlin® has shown significant improvements in the HAM-A total score, HAM-A psychic anxiety factor, and somatic anxiety factor scores, as well as the 17-item Hamilton Depression Scale (HAM-D17) anxiety/somatization factor scores in patients with depression, indicating that the drug has potential anxiolytic effects while exerting antidepressant effects. In less than three years since its launch in 2022, Ruoxinlin® has served over 80,000 patients, becoming the fastest-growing new antidepressant in domestic sales in recent years. By the end of 2024, Ruoxinlin® will be included in the "National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2024)," enhancing innovative accessibility. With the smooth progress of the Phase III clinical trial and related marketing application for the treatment of Generalized Anxiety Disorder, Ruoxinlin® is expected to benefit more patients. The demand for patients in the field of central nervous system treatments, including depression and anxiety disorders, is enormous, but the progress of new drug development is relatively slow. In this field, the group has obtained approval for a series of internationally competitive innovative drugs and formulations in markets such as China, the United States, Europe, and Japan, including Erzofri® (Paliperidone Palmitate Extended-Release Injection) Rykindo® (Risperidone Extended-Release Microsphere Injection) has been approved for marketing in the United States, and Lisdexamfetamine Transdermal Patch (2 times/W) has been approved for marketing in multiple countries in Europe, Japan, and China. Ruxindong® (Venlafaxine Hydrochloride Extended-Release Tablets) and Jinyouping® (Rocuronium Bromide Microspheres for Injection) have been approved for marketing in China, among others. At the same time, the group is actively laying out the research and development of the next generation of innovative drugs, with several Class 1 innovative drugs in clinical stages, including the dual-target new drug LY03020 (TAAR1/5-HT2C R), the dual-target new drug LY03015 (VMAT2/Sigma-1), and the dual-target new drug LY03017 (5-HT2A R/5-HT2C R)