Luye Pharma Group (HKG: 2186) has announced that it has received marketing approval from the National Medical Products Administration for its once-weekly rotigotine extended-release microspheres for injection (LY03003), indicated for the treatment of Parkinson’s disease (PD).
Parkinson’s disease is a prevalent neurodegenerative condition among middle-aged and elderly individuals, characterized by motor symptoms such as tremors and non-motor symptoms like autonomic dysfunction, severely impacting patients’ quality of life. LY03003 is recognized as the world’s first continuous dopamine stimulation drug and is one of Luye’s leading pipeline candidates for central nervous system therapy. Administered once weekly via intramuscular injection, the drug provides stable release, continuous symptom mitigation, and reduced complication rates.
A multi-center, randomized, double-blinded, placebo-controlled Phase III study has demonstrated that LY03003 can comprehensively and continuously improve the motor symptoms of Parkinson’s disease patients, significantly enhance their treatment response, and improve their quality of life, with a favorable safety and tolerability profile.- Flcube.com
