Goserelin

The long-term management of hormone-dependent diseases such as prostate cancer and endometriosis always requires clinical solutions that take both therapeutic efficacy and medication convenience into account. Goserelin belongs to gonadotropin-releasing hormone (GnRH) agonist drugs. Through continuous stimulation of pituitary GnRH receptors, it ultimately downregulates gonadal hormone secretion to achieve the effect of "medical castration". Clinically, it is mainly used for endocrine therapy of prostate cancer and hormone therapy of premenopausal and perimenopausal breast cancer. Meanwhile, it can relieve the pain symptoms of endometriosis and reduce the volume of fibroids. It is one of the basic medications in the relevant disease fields, covering the applicable population of all age groups in adults.

As one of the sustained-release polypeptide drugs with the highest global sales, the global market size of goserelin has remained stable at more than USD 3 billion in recent years, with an annual growth rate of around 15% in the Chinese market. In 2023, the sales of goserelin in domestic sample hospitals exceeded RMB 1.8 billion. Currently, the original research product still dominates the market. As the core patent expired in 2022, generic preparations from 3 domestic enterprises have been approved for marketing, and have been included in the seventh batch of national centralized drug procurement. The winning price has dropped by more than 70% compared with the original research product. The rapid expansion of downstream preparation production capacity directly drives the continuous rise in the demand for upstream API.

The original research enterprise of goserelin is AstraZeneca, and the original brand name is "Zoladex". Its core compound patent expired in China in 2022. The main dosage form is sustained-release implant, and the existing specifications include 3.6mg (1-month dosage form) and 10.8mg (3-month dosage form). The original preparation has been included in the China Listed Drug Catalogue as the reference listed drug, and is also included in the FDA Reference Listed Drug Catalogue. Up to now, goserelin APIs from 6 domestic enterprises have completed registration in CDE (status is A), and API applications from more than 10 other enterprises are under review. Corresponding to this, there are a total of 5 goserelin sustained-release implant varieties approved for marketing in China, covering the original research product and 3 domestic generics. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for goserelin API. Most products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API research and development, quality research and registration declaration.