Buserelin

In the clinical treatment of hormone-dependent diseases such as prostate cancer and endometriosis, gonadotropin-releasing hormone analogues (GnRHa) are important first-line drugs. As a second-generation synthetic GnRHa, buserelin binds to pituitary GnRH receptors with high affinity. After an initial transient stimulation of gonadotropin secretion, continuous administration can downregulate receptor sensitivity, inhibit the release of luteinizing hormone and follicle-stimulating hormone, and thereby reduce the levels of sex hormones such as estradiol and testosterone to a castration state. Clinically, it is mainly used for the endocrine therapy of prostate cancer and the symptom improvement of endometriosis, and can also be adjuvantly used for ovulation induction regulation in assisted reproductive technology. The applicable population covers adult patients with hormone-dependent diseases and people of childbearing age with assisted reproductive needs.

The global market size of buserelin has maintained steady growth in recent years, reaching approximately USD 320 million in 2023, with a compound annual growth rate of approximately 4.7%. The market growth is mainly driven by the rising incidence of prostate cancer, the increased consultation rate of endometriosis, and the expansion of assisted reproductive demand. In terms of the competitive landscape, the original research product accounts for approximately 65% of the market share, and generic drugs are mainly from European and Indian pharmaceutical companies. China is currently in the layout stage of generic drugs, and there are no mature generic drugs launched on a large scale, so the market supply gap is relatively obvious.

The original research enterprise of buserelin is Sanofi, and the original brand name is Suprefact®. Its core compound patents in major markets such as Europe and the United States expired successively from 2001 to 2003. At present, the main dosage forms of the original research product on the market include injection and nasal spray. The specification of the injection is 1 mg per vial, and the specification of the nasal spray is 10 mg per bottle (100 μg per spray). This product has been included in the FDA Orange Book Reference Listed Drug Catalog, and is also included in China's *Catalog of Reference Listed Drugs for Chemical Drugs*. As of now, there is no approved registration number for buserelin API in China. Only imported original research preparations have been approved for marketing in China, and no domestic preparations have been approved. (Data as of September 2024, please refer to the official website of CDE for the latest information)

In response to the impurity research needs in the process of generic drug R&D and quality control of buserelin, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable research material support for enterprises in the links of consistency evaluation, registration and declaration, etc.