Clofarabine

For hematological tumors such as relapsed and refractory acute lymphoblastic leukemia in children, which have extremely limited clinical treatment options, the emergence of nucleoside analog drugs has filled an important treatment gap. As a second-generation purine nucleoside analog, clofarabine inhibits DNA polymerase and ribonucleotide reductase, blocks DNA synthesis and repair, and ultimately induces apoptosis of tumor cells. It is currently one of the few approved drugs specifically for the treatment of refractory acute lymphoblastic leukemia in children, and can also be used as second-line treatment for adult acute myeloid leukemia, providing new survival benefit possibilities for patients who still progress after receiving at least two prior treatment regimens.

The global clofarabine market size is currently in a stable growth stage in the segmented track. Driven by the increased diagnosis rate of childhood hematological tumors and the security policies for rare disease drugs, the compound annual growth rate in the past five years has remained at around 4.2%. Due to the narrow clinically applicable population of this drug and the high difficulty of its synthesis process, the number of manufacturing enterprises worldwide is currently small, and the original research product still occupies the main market share. In China, only a few enterprises have deployed the generic drug R&D of this variety, the market competition is relatively mild, and there is no publicly verifiable specific value of the segmented market size.

The original research enterprise of clofarabine is Bioenvision, which was later acquired by Genzyme. The original research trade name is Clolar. Its core compound patent in the United States expired in 2009, and the compound patent in China expired in 2010. The approved dosage form of the original research product is injection, with a specification of 20mg/20ml (1mg/ml). It has been included in the FDA Reference Listed Drug Catalog, but has not been included in the China Catalog of Reference Preparations for Chemical Drugs. As of now, there is no clofarabine preparation variety approved for marketing in China, and there is no valid registration number of clofarabine in A status or I status that can be publicized on the CDE API Registration Platform. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of clofarabine impurity reference standards, covering various intermediates, by-products and degradation impurities that may be generated during the synthesis process. Most of the products are available from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of pharmaceutical enterprises in the whole process of R&D, quality research and registration declaration.