Mizoribine

As a new generation of immunosuppressant drugs, mizoribine specifically inhibits the activities of inosine monophosphate dehydrogenase and guanosine monophosphate synthetase during lymphocyte proliferation, blocks the de novo synthesis pathway of guanine nucleotides, and thus selectively inhibits the activation and proliferation of T and B lymphocytes. Compared with traditional immunosuppressants, it has lower hepatorenal toxicity and lower risk of myelosuppression. It is mainly used clinically to prevent and treat rejection after organ transplantation, and can also be applied in the treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis, providing a safer medication option for patients requiring long-term immunosuppression.

At present, the global mizoribine market size is growing steadily, among which the demand from the organ transplantation field accounts for more than 65%. In terms of the domestic market, with the annual increase in the number of organ transplantation surgeries and the improvement in the diagnosis rate of autoimmune diseases, the compound annual growth rate of the mizoribine preparation market in the past three years has reached 8.2%, and the domestic market size exceeded 320 million yuan in 2023. In terms of the competitive landscape, the original research product still accounts for about 45% of the market share. Three domestic enterprises have obtained the approval documents for generic preparation. After being included in the centralized procurement, the terminal price has dropped by about 42%, further promoting the improvement of clinical accessibility.

The original research enterprise of mizoribine is Asahi Kasei Pharma Corporation of Japan, and the original brand name is "Bredinin". Its core compound patent expired in Japan and major European and American markets in 2019, and the compound patent in China expired in 2021. The marketed dosage form of the original research product is tablet, with specifications of 25mg and 50mg. This product has been included in the *Catalogue of Reference Preparations for Chemical Drugs (29th Batch)* of China, and is also listed as an FDA reference preparation. As of now, there are 6 mizoribine API registration entries on China's CDE API Registration Platform, among which 3 are in Status A. Multiple tablet varieties including the original research product and generics have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information.)

CATO provides a full set of mizoribine impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for API R&D, quality research and generic drug consistency evaluation.