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 marks a global first as the only ready-to-use Goserelin extended-release injection to receive clinical approval. By binding with high affinity to pituitary GnRH receptors and inducing receptor downregulation, it suppresses gonadotropin secretion, reducing serum testosterone and estradiol levels to achieve chemical castration.

Leveraging the company's long-acting delivery technology platform, the product utilizes biocompatible excipients that form an in-situ drug depot upon subcutaneous injection, enabling sustained drug release over an extended period. Designed for once-monthly administration, it offers a significant advancement over currently marketed long-acting Goserelin products.

Compared to existing options, this injection employs a finer needle, eliminating the need for specialized implant devices or complex preparation steps, while also reducing injection volume. These features are expected to substantially minimize injection-site trauma and pain, enhancing patient convenience and treatment adherence.

Preclinical studies have demonstrated pronounced prolonged suppression of plasma testosterone. Relative to commercially available microsphere formulations, it exhibits superior efficacy in terms of testosterone castration rates and the duration of castration maintenance, alongside a favorable safety profile.

The approved clinical indication targets solid tumor patients. Additionally, the product holds potential for applications in estrogen-dependent diseases such as endometriosis, indicating broad clinical development prospects.

This clinical trial approval represents another key milestone for the company in the long-acting formulation arena, laying a solid foundation for the expansion of its platform-based product pipeline.