CSPC Wins NMPA Clinical Trial Approvals for Two Long‑Acting Injections – Weekly Rotigotine (SYH9087) for Parkinson’s Disease and World’s First Ready‑to‑Use Monthly Goserelin (SYH9102) for Solid Tumours

CSPC Pharmaceutical Group Limited (HKG: 1093) announced that two long‑acting injection products have obtained approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials: rotigotine long‑acting injection (SYH9087 injection) for the treatment of Parkinson’s disease, and goserelin sustained‑release injection (SYH9102 injection) for the treatment of solid tumours. Both products leverage the Group’s proprietary long‑acting delivery technology platform, which — based on excipients with excellent biocompatibility — forms an in situ drug depot following subcutaneous injection to achieve sustained drug delivery.

Regulatory Milestone

Platform Technology – In Situ Depot Long‑Acting Delivery

• Core Technology: Both candidates are built on CSPC’s long‑acting delivery technology platform.
• Mechanism of Delivery: Using excipients with excellent biocompatibility, each product forms an in situ drug depot after subcutaneous injection, enabling sustained release over weeks without implants or microspheres requiring reconstitution.
• Patient‑Centric Design: Compared with marketed long‑acting formulations, both products utilise a finer injection needle and a smaller administration volume, expected to alleviate injection‑site pain and enhance convenience and compliance.

Drug Profile – SYH9087 Rotigotine Long‑Acting Injection

• Positioning: The first long‑acting subcutaneous rotigotine product approved for clinical trials in China, administered once weekly.
• Target & Class: Rotigotine, a dopamine agonist delivered transdermally or by injection for Parkinson’s disease; SYH9087 converts it into a weekly subcutaneous depot formulation.
• Advantages vs. Marketed Microsphere Product: Administered subcutaneously rather than intramuscularly; no complex reconstitution required prior to clinical use; finer needle and smaller volume.
• Preclinical Evidence: Compared with the commercially available microsphere injection, SYH9087 exhibited superior efficacy in Parkinson’s disease models with a favourable safety profile. Quantitative endpoints: Not disclosed.

Drug Profile – SYH9102 Goserelin Sustained‑Release Injection

• Positioning: The world’s first ready‑to‑use goserelin sustained‑release injection approved for clinical trials, administered once monthly.
• Mechanism of Action: Binds pituitary GnRH receptors with high affinity and induces receptor downregulation, inhibiting gonadotropin secretion and reducing serum testosterone and oestradiol levels — achieving medical castration for hormone‑dependent solid tumours.
• Advantages vs. Marketed Long‑Acting Goserelin: No specialised implantation needle, no complex preparation procedures, finer needle and smaller injection volume — expected to significantly reduce local tissue injury and injection‑site pain and improve medication compliance.
• Preclinical Evidence: Demonstrated significant and prolonged suppression of plasma testosterone; versus the commercially available microsphere formulation, SYH9102 showed superior pharmacological efficacy in testosterone castration rate and duration of castration, with a favourable safety profile. Quantitative endpoints: Not disclosed.

Market Impact & Outlook

• Parkinson’s Disease Burden: China carries the world’s largest Parkinson’s disease population, and dopaminergic therapy adherence is challenged by daily dosing and motor fluctuations — a once‑weekly subcutaneous rotigotine addresses a real convenience and compliance gap. Patient‑number estimates: Not disclosed in the announcement.
• GnRH Agonist Franchise: Monthly goserelin is a cornerstone of hormone‑driven oncology care; a ready‑to‑use formulation removes clinic workflow burdens (implantation needles, reconstitution), a differentiator for hospital adoption and patient experience.
• Dual First‑in‑Class‑Style Positioning: First in China (SYH9087) and world’s first ready‑to‑use (SYH9102) statuses strengthen CSPC’s claim to leadership in next‑generation long‑acting injectables.
• Platform Validation: Two simultaneous IND clearances from a single delivery platform validate CSPC’s (HKG: 1093) long‑acting technology as a pipeline engine capable of upgrading existing marketed molecules into differentiated sustained‑release assets.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development, trial outcomes, regulatory timelines, and commercial expectations for SYH9087 and SYH9102. Actual results may differ materially due to risks including clinical safety and efficacy findings, further NMPA requirements, competitive dynamics, and manufacturing scale‑up. Clinical trial approval does not guarantee eventual marketing authorization.-Fineline Info & Tech