CSPC PHARMA Wins NMPA Approval to Start Clinical Trial for First Long-Acting Subcutaneous Rotigotine Injection

Bulletin Express
Yesterday

CSPC PHARMA announced that China’s National Medical Products Administration has cleared the dopamine-receptor agonist rotigotine long-acting injection (SYH9087) for clinical trials targeting Parkinson’s disease.

The product is the first long-acting subcutaneous rotigotine formulation to reach the clinical stage in China. Developed with CSPC PHARMA’s in-house long-acting delivery platform, the injection forms an in situ depot after administration, enabling once-weekly dosing.

Key design advantages over the marketed intramuscular rotigotine microsphere product include: • Subcutaneous rather than intramuscular delivery, eliminating the reconstitution step. • Use of a finer needle and reduced injection volume, which is expected to lessen site pain and improve patient adherence.

Preclinical studies indicated superior efficacy for Parkinson’s disease and a favourable safety profile versus the commercial microsphere comparator.

Management highlighted that the trial approval strengthens the company’s psychiatric and neurological pipeline and marks another milestone for its long-acting formulation program. The group reiterated its commitment to advancing clinically valuable therapies and expanding treatment options for patients.

The voluntary announcement was issued in Hong Kong on 9 September 2026.

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