LUYE PHARMA (02186) announced that its independently developed Class 1 innovative drug Ruoxinlin® (Toludesvenlafaxine Hydrochloride Extended-Release Tablets) has completed patient enrollment for its Phase III clinical trial in treating generalized anxiety disorder.
This Phase III clinical trial is designed as a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Ruoxinlin® in treating generalized anxiety disorder. The trial enrolled a total of 555 patients, with the primary endpoint being the change in Hamilton Anxiety Rating Scale (HAM-A) total score from baseline at the end of week 8 of treatment. The company expects to complete this clinical trial and submit the marketing application for this indication by the end of this year.
Anxiety disorders represent the most prevalent mental health conditions in China, characterized by prolonged duration and high recurrence rates, significantly impacting patients' daily quality of life. Generalized anxiety disorder is a common subtype of anxiety disorders. As of 2021, approximately 53.1 million people in China suffered from anxiety disorders. Over the past 15 years, no innovative drugs for anxiety treatment have received global approval for market launch.
Ruoxinlin® is positioned to potentially become the world's first serotonin (5-HT), norepinephrine (NE), and dopamine (DA) triple reuptake inhibitor (SNDRI) for treating 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 of SSRI and SNRI medications include sexual dysfunction, drowsiness, weight gain, and lipid metabolism disorders, leading to poor patient compliance and subsequently affecting treatment outcomes, which are also common reasons for treatment discontinuation.
Ruoxinlin® is China's first independently developed Class 1 innovative chemical drug with proprietary intellectual property rights for treating depression. Since receiving approval for market launch in China in 2022, its efficacy and safety in treating depression have gained continuous clinical recognition. Previous clinical trials of Ruoxinlin® for depression treatment have demonstrated the drug's comprehensive improvement of depressive symptoms, particularly notable improvements in anhedonia, retardation, and cognitive impairment, overcoming deficiencies of existing medications while not causing insomnia or drowsiness, and not affecting sexual function, weight, or lipid metabolism.
Additionally, Ruoxinlin® showed significant improvements in HAM-A total score, HAM-A psychic anxiety factor and somatic anxiety factor scores, and 17-item Hamilton Depression Rating Scale (HAM-D17) anxiety/somatization factor scores for depression patients, indicating that while exerting antidepressant effects, the drug also possesses potential anti-anxiety properties.
In less than three years since its 2022 launch, Ruoxinlin® has served over 80,000 patients, becoming the fastest-growing new antidepressant drug in terms of domestic sales in recent years. At the end of 2024, Ruoxinlin® was included in the National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance Drug Catalog (2024) for the first time, enhancing innovation accessibility. With the smooth progress of the drug's Phase III clinical trial for treating generalized anxiety disorder and related marketing applications, Ruoxinlin® is expected to benefit more patients.
The central nervous system treatment field, including depression and anxiety disorders, has enormous patient demand, but new drug development progress has been relatively slow. In this field, the company has obtained approval for a series of internationally competitive innovative drugs and formulations in markets including China, the United States, Europe, and Japan, including: Erzofri® (Paliperidone Palmitate Extended-Release Injectable Suspension) and Rykindo® (Risperidone Extended-Release Microsphere Injection) approved for market launch in the United States, rivastigmine transdermal patches (2x/week) approved in multiple European countries, Japan, and China, Ruoxinlin® (Toludesvenlafaxine Hydrochloride Extended-Release Tablets) and Jinyouping® (Rotigotine Microsphere for Injection) approved in China.
Meanwhile, the company is actively developing next-generation innovative drugs, with multiple Class 1 innovative drugs in clinical stages, including TAAR1/5-HT2C R dual-target new drug LY03020, VMAT2/Sigma-1 dual-target new drug LY03015, and 5-HT2A R/5-HT2C R dual-target new drug LY03017.