Luye Pharma (02186) announced that its Class 1 innovative drug Ruoxinlin (toludesvenlafaxine hydrochloride sustained-release tablets) has successfully been renewed on the National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug List (2026 edition), indicated for the treatment of depression.

Ruoxinlin was approved for marketing in China in November 2022 and was first included in the national medical insurance drug list in November 2024. The product is China's first independently developed Class 1 chemical innovative drug for treating depression with independent intellectual property rights, achieving a breakthrough for domestically developed innovative drugs in this therapeutic area.

As a serotonin (5-HT), norepinephrine (NE), and dopamine (DA) reuptake inhibitor (SNDRI), Ruoxinlin can comprehensively and steadily treat depression, significantly improving patients' anxiety states, retardation/fatigue symptoms, anhedonia, and cognitive function, promoting the recovery of social functioning, while demonstrating good safety and tolerability without causing drowsiness or affecting sexual function, body weight, or lipid metabolism.

With its clearly defined clinical value, Ruoxinlin, as the only SNDRI-class antidepressant currently available, has been listed as a first-line recommended medication in the Guidelines for the Prevention and Treatment of Depressive Disorders in China (2025 edition) and the Guidelines for Community-Based Prevention and Treatment of Depression in China.

Additionally, the marketing application for Ruoxinlin in treating generalized anxiety disorder was accepted by the Center for Drug Evaluation of the National Medical Products Administration in January 2026.

The Group believes that the successful renewal of Ruoxinlin on the national medical insurance drug list will help continuously reduce patients' medication burden, further expand the product's market coverage, and broaden space for its long-term growth.

The central nervous system (CNS) is a therapeutic area in which the Group has long been deeply engaged. The Group will continue to advance innovative research and development around unmet clinical needs, promoting the global development and commercialization of CNS innovative drugs.