CSPC PHARMA (01093.HK): SYH9087, China's First Subcutaneous Rotigotine Long-acting Product, Cleared for Clinical Trials

On 9 September 2026, CSPC Pharmaceutical Group Limited (01093.HK) announced in a voluntary announcement that its rotigotine long-acting injection (SYH9087), a dopamine receptor agonist, had received NMPA approval for clinical trials in China, becoming the first subcutaneous rotigotine long-acting product cleared for clinical studies in China; the product is dosed once weekly without preparation, and the approved indication is Parkinson's disease.

NewTimeSpace News: On 9 September 2026, CSPC Pharmaceutical Group Limited (stock code: 01093) issued a voluntary announcement stating that its rotigotine long-acting injection (SYH9087), a dopamine receptor agonist developed by the group, had been approved by the National Medical Products Administration for clinical trials in China.

According to the announcement, the product is the first subcutaneous rotigotine long-acting product approved for clinical trials in China. Developed on the group's long-acting delivery technology platform using biocompatible excipients, it forms an in-situ drug depot after subcutaneous injection for long-acting drug delivery, with a once-weekly dosing regimen. Compared with marketed rotigotine microsphere products, the product switches the route of administration from intramuscular to subcutaneous injection and requires no complex preparation before clinical use.

The announcement noted that the product uses a finer needle with a smaller injection volume, expected to effectively reduce injection site pain and improve clinical convenience and patient adherence. Preclinical results showed more significant anti-Parkinson's efficacy advantages and a good safety profile versus marketed microsphere injections. The approved indication is Parkinson's disease. The company said the approval will further enrich the group's pipeline in the psychiatric and neurological fields and represents another key R&D achievement in long-acting formulations.

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