Luye Pharma Group (HKG: 2186) has announced that the National Medical Products Administration (NMPA) has accepted a market filing for its once-weekly rotigotine extended-release microspheres for injection (LY03003), indicated for the treatment of Parkinson’s disease (PD), with a priority review status.
LY03003: A Breakthrough in Dopamine Stimulation
Hailed as the world’s first continuous dopamine stimulation drug, LY03003 is one of Luye’s leading central nervous system therapy pipeline candidates. Administered once per week via intramuscular injection, the drug allows for stable release in the body, continuously mitigated symptoms, and reduced complication incidence. The stable release of LY03003 in the human body can improve both motor and non-motor symptoms of early and advanced Parkinson’s disease patients, reduce the “on/off” phenomenon in Parkinson’s disease patients, and prevent the occurrence of motor complications. Long-term use is expected to delay the onset of motor complications.
Global Marketing Plans and Pipeline Development
Luye plans to file for marketing approval for LY03003 in China, the US, Europe, and other regions while developing once-monthly rotigotine microsphere injection (LY03009). This strategic move underscores Luye’s commitment to expanding access to innovative treatments for Parkinson’s disease globally.
Recent Approvals and Contributions to Healthcare
In addition to the development of LY03003, Luye’s injectable goserelin acetate in microsphere form was approved in China in June this year for the treatment of prostate cancer requiring androgen castration treatment. In January this year, Rykindo (risperidone) extended-release injectable suspension received approval in the US for the treatment of schizophrenia in adults and as a monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.-Fineline Info & Tech
