CSPC Group (01093): Goserelin Sustained Release Injection (SYH9102 Injection) Approved for Clinical Trials in China

Zhitongcaijing · 3d ago

Zhitong Finance App News, Shiyao Group (01093) announced that the gonadotropin releasing hormone (GnRH) agonist goserelin sustained-release injection (SYH9102 injection) (this product) developed by the Group has been approved by the China Drug Administration and can conduct clinical trials in China.

This product is the world's first clinically approved ready-to-use goserelin sustained-release injection. It can induce receptor downregulation in combination with pituitary GnRH receptors, inhibit gonadotropin secretion, reduce serum testosterone and estradiol levels, and achieve drug castration. Using the Group's long-term delivery technology platform, the product is based on excipients with good biocompatibility to form an in-situ drug storage after subcutaneous injection to achieve long-term drug release.

This product is administered once a month. Compared with marketed goserelin long-term products, this product is injected with a finer needle, does not require special implants or complicated preparation, and has a smaller injection volume. It is expected to significantly reduce injury and pain at the injection site and improve patients' ease of use and treatment compliance. Preclinical studies have shown that this product has obvious long-term plasma testosterone inhibitory effects. Compared with commercially available microsphere preparations, it shows better efficacy in terms of testosterone castration rate and duration of maintenance in the castration state, and is safe.

The approved clinical indication is for patients with solid tumors. In addition, the product can also be used in estrogen-dependent diseases such as endometriosis, and has broad clinical development prospects. The approval of the clinical trial of this product is another important achievement achieved by the company in the field of long-term formulation, laying a solid foundation for the expansion of the platform's product pipeline.