China-based Luye Pharma Group (HKG: 2186) has officially launched its Category 1 chemical drug toludesvenlafaxine (LY03005) in China. The extended-release treatment for depression has received its first prescriptions and is being launched through a multi-channel strategy that includes hospitals, pharmacies, and online platforms.
Drug Profile and Mechanism
Toludesvenlafaxine is a new molecular entity with a novel mechanism of action, described as a serotonin (5-HT), norepinephrine (NE), and dopamine (DA) triple reuptake inhibitor (SNDRI/TRI). Clinical studies have confirmed that it can act as a comprehensive treatment for depression, significantly improving patients’ emotional symptoms and cognitive abilities, and promoting the recovery of social functions. Additionally, it has demonstrated good safety and tolerability, without causing drowsiness or affecting sexual function, weight, or lipid metabolism.
Regulatory and Development Status
The drug is currently awaiting regulatory decisions in the US and has completed a Phase I study in depression in Japan. A Phase III study in generalized anxiety disorder (GAD) is also underway in China, highlighting Luye Pharma’s commitment to expanding the drug’s indications and global reach.-Fineline Info & Tech
