CSPC PHARMA (01093): The long-acting injection of Rotigotine (SYH 9087 injection) has received clinical trial approval in China.

CSPC PHARMA (01093) announced that its developed dopamine receptor agonist, long-acting injection of rotigotine (SYH 9087 injection), has been approved by the National Medical Products Administration of the People's Republic of China to conduct clinical trials in China. This product is the first subcutaneous long-acting rotigotine product approved for clinical trials in the country. It utilizes the group's long-acting delivery technology platform, based on excipients with good biocompatibility, to form an in-situ drug reservoir after subcutaneous injection, thus enabling prolonged drug delivery. The product is administered once a week and, compared to the approved rotigotine microsphere product, has changed the administration route from intramuscular injection to subcutaneous injection, without requiring complex preparation before clinical use. Additionally, the injection needle is finer and the administration volume is smaller, which is expected to effectively reduce patient pain at the injection site, enhance clinical usability, and improve patient adherence to medication. Preclinical research results show that, compared to commercially available microsphere injections, this product exhibits more significant efficacy advantages against Parkinson's disease and good safety. The approved indication is Parkinson's disease. This approval for clinical trials will further enrich the group's product line in the field of psychoneurology and represents another important research and development achievement for the group in the area of long-acting formulations. The group will continue to strive to develop more drugs with high clinical value to provide better treatment options for a wide range of patients.