Bicalutamide

In the systemic treatment regimen for prostate cancer, bicalutamide, as a representative of non-steroidal anti-androgen drugs, competitively binds to the androgen receptors on the surface of prostate cells to block the tumor proliferation-promoting effect of dihydrotestosterone, and is one of the core medications for the whole-course management of hormone-sensitive prostate cancer. Compared with traditional steroidal anti-androgen drugs, it has higher selectivity for androgen receptors and lower incidence of cardiovascular adverse reactions. It can be used alone for elderly patients intolerant to castration therapy, or combined with gonadotropin-releasing hormone agonists as first-line treatment for advanced metastatic prostate cancer, covering a wide range of patient populations from locally high-risk to metastatic stages.

Currently, the global prevalence of prostate cancer continues to rise, driving the steady growth of market demand for bicalutamide. In 2023, the global market size of bicalutamide preparations was approximately USD 1.9 billion, and the domestic market size was approximately RMB 1.2 billion, with a compound annual growth rate of 4.8% in the past three years. As the core patents have long expired, generic drugs have become the mainstream in the market. More than 15 domestic preparation manufacturers have passed the consistency evaluation. After the implementation of volume-based procurement, the price of preparations has dropped by more than 90%, and the upstream API supply has also formed a competitive pattern dominated by domestic enterprises, with domestic production capacity accounting for more than 75% of the total global supply.

The original developer of bicalutamide is AstraZeneca, with the original brand name "Casodex". Its core compound patent expired in 2007 in major markets such as the United States and Europe, and the compound patent in China expired in 2004. The originally marketed dosage form is tablet, with main specifications of 50mg and 150mg, which have been included in the Chinese *Catalogue of Chemical Reference Preparations* and the FDA Reference Preparation Catalogue. At present, more than 20 domestic enterprises have completed the registration of bicalutamide APIs with A status in the CDE, and the approved and marketed preparation varieties cover two dosage forms of conventional tablets and capsules, with sufficient supply. (Data as of July 2025, please refer to the official CDE website for the latest information)

To meet the requirements of quality research and impurity control for bicalutamide APIs and preparations, CATO can provide a full set of impurity reference standards for this API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. Meanwhile, the products comply with the regulatory requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully support enterprises to complete research work in different scenarios such as consistency evaluation, registration and declaration, and daily quality control.