Shanghai, April 7, 2025 - Luye Pharma Group today announced that Ruoxinlin® (Toludesvenlafaxine Hydrochloride Extended-Release Tablets), its innovative drug for treating Major Depressive Disorder (MDD), has been approved for marketing in Macao by the Pharmaceutical Administration Bureau of the Macao SAR Government.

Ruoxinlin is China’s first locally developed proprietary antidepressant approved for marketing through the pathway for Class 1 chemical drugs. Preclinical studies have shown that it acts as a serotonin (5-HT)-norepinephrine (NE)-dopamine (DA) reuptake inhibitor (SNDRI). In addition, a PET/CT study has shown that the drug can bind to the DA transporters in the brains of both rats and healthy human subjects, another piece of strong evidence proving that it is an SNDRI¹.

A Phase 3 clinical trial has demonstrated that Ruoxinlin is able to treat MDD in a comprehensive and stable manner. Specifically, it significantly reduces anxiety, retardation, fatigue, and anhedonia, improves cognitive abilities, and promotes the recovery of social functions, in addition to being safe and well-tolerated, without causing somnolence or negatively affecting sexual functioning, body weight, and lipid metabolism.

Patients with MDD are known to experience high recurrence, suicide and disability rates. They can generally benefit from existing antidepressants, but still have major unmet needs. Even after taking medications, most patients would still experience residual symptoms, including anxiety, cognitive impairment, fatigue, and anhedonia. Those symptoms severely impair their social functions and precipitate relapses.^2-5 In addition, current treatments often cause adverse reactions, such as sexual dysfunction, weight gain, emotional retardation, and somnolence, resulting in poor medication compliance, an important reason for poor prognosis.^6,7

Since its approval and launch in the Chinese Mainland in November 2022, Ruoxinlin has gained growing recognition for its efficacy and safety among doctors and patients alike, becoming one of the fastest-growing new antidepressants in the Chinese Mainland in recent years. More than 30,000 patients have benefited from the drug to date. At the end of 2024, following successful negotiations, Ruoxinlin was able to get covered by China’s National Reimbursement Drug List (NRDL) for the first time in the 2024 edition of the list. This helps to improve the drug’s accessibility and availability, allowing it to benefit more patients. In addition, a Phase 3 clinical trial of the drug for treating Generalized Anxiety Disorder (GAD) is currently underway. 

About Luye Pharma Group

Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 20 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has achieved multiple innovations in new chemical entities and antibodies, and is also actively making strategic developments in the fields of cell therapies and gene therapies.

Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets -- China, the U.S., Europe and Japan, as well as in fast growing emerging markets.

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