LUYE PHARMA (02186) announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for a new indication of the group's Class 1 innovative drug, Ruoxinlin® (Toludesvenlafaxine Hydrochloride Extended-Release Tablets), intended for the treatment of Generalized Anxiety Disorder (GAD). This marks another significant milestone for the product following its initial approval in November 2022 for the treatment of major depressive disorder. With the commencement of the review for this new indication, Ruoxinlin® is poised to become China's first serotonin-norepinephrine-dopamine reuptake inhibitor (SNDRI) for GAD, potentially benefiting a broader patient population.
The application for the new indication is based on an 8-week, multicenter, randomized, double-blind, placebo-controlled Phase III clinical study. This trial enrolled 555 patients and used the change from baseline in the total score of the Hamilton Anxiety Scale (HAM-A) as the primary endpoint to evaluate the efficacy and safety of Ruoxinlin® in treating GAD. Results demonstrated that Ruoxinlin® provides rapid and comprehensive improvement of anxiety symptoms, with an efficacy rate exceeding 80% and a remission rate of approximately 50%. The drug exhibited a favorable overall safety and tolerability profile, showing no significant impact on body weight or glucose and lipid metabolism, alongside low incidences of adverse reactions such as somnolence, insomnia, fatigue, and sexual dysfunction. The vast majority of adverse reactions were mild to moderate in severity, and most resolved or improved.
Anxiety disorders represent the most common mental disorders in China. Data from the 2023 Global Burden of Disease (GBD) study indicates that approximately 58.67 million people in China suffer from these conditions. Generalized Anxiety Disorder is a prevalent subtype, with an estimated adult lifetime prevalence ranging from 4.1% to 6.6%. However, its recognition and treatment rates remain low, and it frequently co-occurs with other diseases, imposing a substantial economic burden on patients, families, and society. In clinical practice, Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) are widely used for treating anxiety spectrum disorders and are currently first-line treatments for GAD. Nevertheless, the efficacy of these two drug classes has limitations. Meta-analyses show that the overall efficacy rate for SSRIs/SNRIs is 67.7%, with a remission rate of only 39.7%. Furthermore, these medications are often associated with adverse effects like lipid metabolism disorders, weight gain, somnolence, and sexual dysfunction, which can compromise patient adherence, reduce treatment benefits, and are common reasons for therapy discontinuation.
Despite the significant disease burden, the supply of innovative drugs in China's anti-anxiety treatment landscape is extremely limited. IQVIA data reveals that the market size for SSRIs and SNRIs in 2024 was 4.83 billion yuan, with no new Class 1 innovative drugs approved in this area for nearly two decades. As China's first independently developed and proprietary Class 1 chemical innovative drug for depression, Ruoxinlin® has served nearly 190,000 patients in the over three years since its approval, gaining widespread recognition for its efficacy and safety and becoming one of the fastest-growing new antidepressants in China in recent years. In late 2024, Ruoxinlin® was included in China's National Reimbursement Drug List (NRDL) for the first time. In September 2025, the drug received a Grade 1A recommendation as a first-line treatment in the "Chinese Guidelines for the Prevention and Treatment of Depressive Disorders" under the new SNDRI mechanism category. The ongoing review for this new GAD indication is expected to further enhance the drug's accessibility.
The central nervous system (CNS) therapeutic area, encompassing conditions like depression and anxiety disorders, is one of the group's core strategic focuses for long-term development. The group has established a portfolio of products with differentiated advantages in this field, covering various diseases including schizophrenia, bipolar disorder, and Alzheimer's disease. Beyond Ruoxinlin®, the product portfolio includes Erzofri® (paliperidone palmitate extended-release suspension for injection) and Rykindo® (risperidone extended-release microsphere injection), both approved in the US, as well as the rivastigmine transdermal patch (twice-weekly) approved in several European countries, Japan, and China. Concurrently, the group is actively advancing the development of next-generation innovative drugs, with several other Class 1 candidates in clinical stages, including the VMAT2/Sigma-1R dual-target drug LY03015, the 5-HT2A R/5-HT2C R dual-target drug LY03017, the TAAR1/5-HT2C R dual-target drug LY03020, and the NET/DAT/GABAA R triple-target drug LY03021.
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