China-based Luye Pharma Group (HKG: 2186) has announced that its Category 1 chemical drug LY03005 has been approved by the National Medical Products Administration (NMPA) for the treatment of depression. This marks a significant milestone in the company’s efforts to address the growing need for effective depression treatments.
LY03005 Profile
LY03005 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). This innovative drug aims to provide comprehensive treatment for depression by targeting multiple neurotransmitter systems. The drug is currently awaiting regulatory decisions in the US and has completed a Phase I study in depression in Japan. Additionally, a Phase III study in generalized anxiety disorder (GAD) is well underway in China.
Future Development
The approval from the NMPA underscores Luye Pharma’s commitment to advancing innovative treatments for mental health conditions. By targeting multiple neurotransmitter systems, LY03005 aims to offer a more effective and comprehensive treatment option for patients with depression. The ongoing clinical studies in the US and Japan, along with the Phase III study in China, highlight the company’s global approach to developing and commercializing this novel therapy.-Fineline Info & Tech
