CSPC Group (01093): Rotigotin Long-acting Injection (SYH 9087 Injection) Approved for Clinical Trials in China

Zhitong Finance App News, Shiyao Group (01093) announced that the dopamine receptor agonist rotigotin long-term injection (SYH 9087 injection) developed by the Group has been approved by the State Drug Administration of the People's Republic of China and can conduct clinical trials in China.

This product is the first subcutaneous rotigotin long-term product approved for clinical trials in China. Using the Group's long-term delivery technology platform, an in-situ drug storage is formed after subcutaneous injection using the Group's long-term delivery technology platform, and an in-situ drug storage is formed after subcutaneous injection, so that long-term drug delivery can be achieved. This product is administered once a week. Compared with rotigotin microsphere products that have been approved for marketing, the route of administration was changed from intramuscular injection to subcutaneous injection, and no complicated preparation is required before clinical use. Furthermore, the product has a finer injection needle and a smaller dosage volume, which is expected to effectively reduce pain at the injection site of patients and improve the convenience of clinical use and patients' adherence to medication. Preclinical study results showed that compared to commercially available microsphere injections, the product showed more significant anti-Parkinson's disease efficacy advantages and better safety.

The approved indication is Parkinson's disease. The approval of this clinical trial will further enrich the Group's product line in the field of neuropsychiatry, and is also another important research achievement achieved by the Group in the field of long-term formulation. The Group will continue to work to develop more drugs with high clinical value to provide patients with better treatment options.