Flutamide

Prostate cancer is a highly prevalent malignant tumor in the male urinary system, and androgen deprivation is one of the core strategies for its systemic treatment. Flutamide is a non-steroidal anti-androgen drug, which can specifically bind to the androgen receptors of prostate cancer cells and block the biological effects of dihydrotestosterone. It has no obvious hormonal activity and will not affect the feedback regulation of the hypothalamic-pituitary-gonadal axis. Clinically, it is mainly used for palliative treatment of advanced prostate cancer, preoperative neoadjuvant endocrine therapy and sensitization in combination with radiotherapy. It can also be used for adjuvant intervention of androgen-related diseases such as hirsutism, and is especially suitable for elderly patients who cannot tolerate surgical castration.

The global flutamide market size currently maintains a steady growth trend. In 2023, the overall market size was approximately USD 130 million, with a compound annual growth rate of approximately 2.8%. Driven by the rising incidence of prostate cancer and the coverage of medical insurance reimbursement in the domestic market, the average growth rate in the past three years has reached 4.2%, and the domestic sales in 2023 were approximately RMB 170 million. The competitive landscape is dominated by generic drugs, with the original research product accounting for less than 10% of the market. Domestic API manufacturers are concentrated in Jiangsu, Zhejiang and other regions, and more than 15 enterprises have obtained generic drug approvals. After the centralized procurement, the terminal price of preparations has dropped by more than 60%, further improving the accessibility for primary-level patients.

The original research enterprise of flutamide is Schering-Plough, with the original trade name Eulexin®. Its core compound patent expired globally in 2004. The mainstream dosage form of the original research product is 250mg oral tablet, which has been included in the FDA Orange Book Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Listed Drugs of Chemical Drugs (First Batch)* of China. In terms of domestic API registration, 11 enterprises have completed the registration of flutamide APIs in the CDE, all with the status of A, which can be used for associated review. 27 domestic flutamide oral preparation approvals have been granted for marketing, covering two dosage forms of tablets and capsules. (Data as of July 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for flutamide API. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of pharmaceutical enterprises in the whole process from R&D to production.