Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its rasagiline (sublingual delivery) to treat primary Parkinson’s disease (PD) as a monotherapy and patients with drug end fluctuation combined with levodopa. This marks a significant step forward in the development of innovative treatments for Parkinson’s disease.
Rasagiline Profile
Rasagiline is a novel monoamine oxidase-B (MAO-B) inhibitor that inhibits MAO-B activity, preventing the decomposition of endogenous and exogenous dopamine in the brain. By increasing dopamine levels in the synaptic space, rasagiline effectively improves various symptoms of Parkinson’s disease. The sublingual delivery method allows the drug to be absorbed through the oral mucosa, avoiding the first pass effect and offering convenient administration, good patient compliance, and accurate dosing.
Market Landscape
Currently, there is no sublingual delivery dosage of rasagiline marketed anywhere in the world, while tablet forms are commercially available. In China, manufacturers of the drug include Changzhou Siyao Pharm, Qilu Pharma, and Teva. The NMPA clearance for Shanghai Pharmaceuticals’ sublingual rasagiline highlights the company’s commitment to advancing innovative delivery methods for existing treatments.
Future Development
The clinical clearance from the NMPA underscores Shanghai Pharmaceuticals’ dedication to improving patient outcomes through innovative drug delivery systems. The sublingual delivery of rasagiline aims to enhance the convenience and efficacy of treatment for patients with Parkinson’s disease, potentially setting a new standard for the administration of MAO-B inhibitors.-Fineline Info & Tech
