Enzalutamide

Castration-resistant prostate cancer is the terminal stage of prostate cancer progression in men, and clinical treatment options were very limited in the past. The advent of enzalutamide has brought significant survival benefits to such patients. As a second-generation non-steroidal androgen receptor inhibitor, it can competitively inhibit the binding of androgen to the receptor, while blocking the nuclear transport of the receptor and its interaction with DNA. The triple mechanisms work synergistically to exert anti-tumor effects. At present, it has been approved for the treatment of metastatic castration-resistant prostate cancer, non-metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer, covering the applicable population in the castration-resistant stage of the entire course of prostate cancer, and can effectively delay disease progression and reduce the risk of death.

The global market size of enzalutamide had exceeded 7 billion US dollars in 2022, making it a blockbuster variety in the field of prostate cancer treatment. Driven by the rising prevalence of prostate cancer, the expansion of indications and the upgrading of the recommendation level in clinical guidelines, the market size still maintains a steady annual growth rate of around 5%. In terms of the Chinese market, as the variety was included in the National Medical Insurance Catalog in 2020, its accessibility has been greatly improved. In 2023, the sales volume in domestic sample hospitals exceeded 1.5 billion yuan, and the market share of generic drugs has exceeded 60%. At present, more than 20 enterprises have obtained approval for generic drug preparations. Under the pressure of centralized procurement bidding, the stability and compliance of the API supply chain have become the core competitiveness of downstream enterprises.

The original research enterprise of enzalutamide is Astellas Pharma, and the original trade name is "Xtandi". Its core compound patent will expire in 2027 in the United States, and the Chinese compound patent expired in 2023. The main dosage form approved for the original research is capsule, with two specifications of 40mg and 80mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. Up to now, there are more than 30 enzalutamide API registration information on the API registration platform of China CDE, among which more than 20 have been marked as "A" in status, which can be legally supplied for the declaration and production of associated preparations. A number of domestic enterprises have obtained approval for the marketing of enzalutamide capsule preparations. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for enzalutamide API, covering all categories such as impurities in the synthesis process and degradation impurities. 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 needs of the whole process of API R&D, registration declaration and quality control.