CSPC PHARMA (01093.HK): SYH9102, World's First Ready-to-use Goserelin Extended-release Injection, Cleared for Clinical Trials in China

NewTimeSpace News: On 9 September 2026, CSPC Pharmaceutical Group Limited (stock code: 01093) issued a voluntary announcement stating that its goserelin extended-release injection (SYH9102), a gonadotropin-releasing hormone (GnRH) receptor agonist developed by the group, had been approved by the National Medical Products Administration for clinical trials in China.

According to the announcement, the product is the world's first ready-to-use goserelin extended-release injection approved for clinical trials. It binds with high affinity to GnRH receptors in the pituitary and induces receptor down-regulation, inhibiting gonadotropin secretion and lowering serum testosterone and oestradiol levels to achieve medical castration. Developed on the group's long-acting delivery technology platform using biocompatible excipients, the product forms an in-situ drug depot after subcutaneous injection for long-acting drug release, with a once-monthly dosing regimen.

The announcement noted that, compared with marketed goserelin long-acting products, the product uses a finer needle without the need for a dedicated implantation needle or complex preparation, and has a smaller injection volume, expected to significantly reduce injection site damage and pain while improving patient convenience and treatment adherence. Preclinical studies showed prolonged suppression of plasma testosterone, with superior castration rates and longer maintenance of the castrated state versus marketed microsphere formulations, together with a good safety profile. The approved clinical indication covers patients with solid tumours, and the product may also be applied to oestrogen-dependent diseases such as endometriosis. The company said the clinical trial approval represents another important achievement of the group in long-acting formulations.

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