By Fineline Cube 
China-based Luye Pharma Group (HKG: 2186) announced that its extended-release depression treatment, toludesvenlafaxine (LY03005), has received marketing approval in Macau. This marks another milestone in the drug’s journey following its approval in China in November 2022 and subsequent inclusion in the National Reimbursement Drug List (NRDL) in 2024.
Drug Profile
Toludesvenlafaxine is the first home-grown Category 1 chemical drug for depression developed in China. It has demonstrated comprehensive and stable efficacy in treating depression, with significant improvements in symptoms such as anxiety, fatigue, loss of pleasure, and cognitive impairment. The drug also supports social function recovery without causing drowsiness or affecting sexual function, weight, or lipid metabolism.
Clinical Trial Results
Phase III trials showed that toludesvenlafaxine effectively alleviates various symptoms of depression while maintaining good safety and tolerability. These results highlight its potential as a valuable addition to the treatment landscape for depression.
Market Approval
The approval in Macau further expands the drug’s reach and reinforces Luye Pharma’s position in the mental health treatment sector. This development is expected to benefit patients in Macau by providing a new, effective treatment option for depression.-Fineline Info & Tech