Cytarabine

For the clinical treatment of malignant hematological diseases such as acute myeloid leukemia, antimetabolite chemotherapeutic drugs have always been the core component of first-line regimens, and cytarabine is one of the varieties with the longest application history and the most sufficient evidence-based evidence among them. As a pyrimidine antimetabolite, it inhibits the activity of DNA polymerase by embedding into the DNA strand of cells, and blocks the proliferation process of S-phase cells. Clinically, it is mainly used for induction of remission and consolidation therapy of acute myeloid leukemia and acute lymphoblastic leukemia in adults and children. High-dose regimens can also be used for the prevention and treatment of central nervous system leukemia, and it is an indispensable basic drug in the diagnosis and treatment system of hematological malignancies.

At present, the global market size of cytarabine is approximately US$480 million, with a compound annual growth rate of 3.2% in the past five years. The growth momentum mainly comes from the improvement of the diagnosis and treatment rate of hematological malignancies in developing countries and the popularization of high-dose regimens. For the domestic market, the sales volume in sample hospitals in 2023 was approximately RMB 720 million, of which generic drugs accounted for more than 90%, and the top 3 enterprises occupied nearly 75% of the market share. After the implementation of centralized drug procurement, the terminal price dropped by 68%, which significantly improved the accessibility of drugs for patients, but there is still a market gap for high-end generic drugs and characteristic dosage forms.

The original research enterprise of cytarabine is Pfizer, and the original brand name is Cytosar. The core compound patent expired globally in 1988, and the market is now fully open to generic production. The core dosage form of the original product is injection, with conventional specifications including 100mg, 500mg and 1g, which has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA reference preparation catalogue. In terms of domestic API registration, 12 enterprises have obtained A-status registration numbers for cytarabine APIs after passing the evaluation of CDE, and there are a total of 37 varieties of cytarabine for injection approved in China, which can fully meet the needs of clinical use and industrial production. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of cytarabine impurity reference standards, covering all categories of research needs such as process impurities and degradation impurities. Most of the products are in stock, and spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for the quality research work of API manufacturers and preparation R&D institutions.