CSPC PHARMA (01093) has announced that its self-developed gonadotropin-releasing hormone (GnRH) receptor agonist, Goserelin Extended-Release Injection (SYH9102 Injection), has received approval from China's National Medical Products Administration to proceed with clinical trials in the country.

This product stands as the world's first ready-to-use Goserelin extended-release injection to receive clinical trial approval. It works by binding with high affinity to GnRH receptors in the pituitary gland, inducing receptor down-regulation to suppress gonadotropin secretion, thereby reducing serum testosterone and estradiol levels to achieve chemical castration.

Leveraging the company's long-acting delivery technology platform, the injection utilizes biocompatible excipients that form an in-situ drug depot upon subcutaneous administration, enabling sustained drug release over an extended period. The product is designed for once-monthly dosing.

Compared to existing long-acting Goserelin products on the market, this formulation employs a finer needle for injection, eliminating the need for specialized implant needles or complex preparation steps. With a smaller injection volume, it is expected to significantly reduce injection site trauma and pain, enhancing patient convenience and treatment adherence.

Preclinical studies have demonstrated that the product achieves pronounced, sustained testosterone suppression in plasma, outperforming commercially available microsphere formulations in terms of testosterone castration rates and the duration of castration maintenance, while maintaining a favorable safety profile.

The clinical indication approved for this trial targets patients with solid tumors. Additionally, the product holds potential for use in estrogen-dependent diseases such as endometriosis, offering broad prospects for clinical development.

The approval of this clinical trial marks another significant milestone for the company in the long-acting formulation arena, laying a solid foundation for expanding its pipeline within this platform.