Floxuridine

As a classic variety of antimetabolite antineoplastic drugs, floxuridine blocks DNA synthesis by inhibiting thymidylate synthase, and can also be embedded into RNA to interfere with its function. The dual mechanism of action can precisely kill tumor cells in the proliferative phase. It is mainly used clinically for the treatment of liver cancer, gastrointestinal cancer and breast cancer, especially suitable for patients who cannot tolerate the systemic toxic and side effects of fluorouracil. Arterial infusion administration can greatly increase the drug concentration in local lesions and reduce the incidence of systemic adverse reactions, which has irreplaceable clinical value in the palliative treatment of advanced solid tumors and perioperative adjuvant therapy.

The global market size of floxuridine is stable at around USD 320 million, with a compound annual growth rate of approximately 2.1%. The growth driver mainly comes from the increase in clinical demand in areas with high incidence of liver cancer. The domestic market is currently dominated by generic drug supply, with an overall size of approximately RMB 470 million. As this drug is included in the Class B catalog of medical insurance, the proportion of its use in primary medical institutions has increased from 18% in 2020 to 31% in 2023. It has not yet been included in the national centralized drug procurement category, the competitive landscape of manufacturers is relatively scattered, and the market share of leading enterprises is less than 20%.

The original research enterprise of floxuridine is Roche, and the original research brand name is FUDR. The compound patent in the US market expired in 1990, and all core patents in China have expired. The main dosage form approved for the original research product is injection, with a specification of 500 mg per vial. It has been included in the FDA Reference Listed Drug Catalog, but is not yet included in China's *Catalog of Reference Preparations for Chemical Drugs*. There are a total of 6 registration entries of floxuridine API on the domestic CDE API registration platform, 3 of which are in status A and can be used for associated preparation declaration. A number of domestic enterprises have obtained marketing approval for floxuridine for injection. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for floxuridine API. Most of the products are in stock. 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 the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises in impurity research, quality control and registration declaration.