China-based Luye Pharma Group (HKG: 2186) announced that its Phase III clinical study for rotigotine extended-release microspheres for injection (LY03003) in Parkinson’s disease (PD) met all pre-set endpoints. The trial demonstrated the drug’s efficacy and safety in early-stage PD patients.
Study Details
The multi-center, randomized, double-blind, placebo-controlled study enrolled 294 early primary PD patients in China. Results showed significant improvement in the Unified Parkinson’s Disease Rating Scale (UPDRS) II+III scores for LY03003 compared to placebo (P<0.001). Secondary endpoints also showed statistical significance. The drug was safe and well-tolerated, with no serious adverse events linked to the treatment.
Market Context
PD affects over 10 million globally, with China’s patient count projected to rise from 1.99 million in 2005 to nearly 5 million by 2030. LY03003, administered weekly via intramuscular injection, is the world’s first continuous dopamine stimulation drug and a key asset in Luye’s CNS pipeline.
Global Development
LY03003 is under concurrent development in China, the U.S., EU, Japan, and other regions, with filings and launches planned. Luye is also developing a once-monthly version.-Fineline Info & Tech
