Mycophenolic Acid

Addressing the clinical challenge of immune rejection after organ transplantation, which has long restricted the survival rate of transplant patients, mycophenolic acid, as a selective inhibitor of inosine monophosphate dehydrogenase (IMPDH) and an immunosuppressant, significantly reduces the risk of rejection by highly selectively inhibiting the proliferation of T and B lymphocytes. It is clinically often used in the form of its ester prodrug, mainly for the prevention of rejection in solid organ transplants such as kidney, liver and heart transplants, and can also be used for the treatment of autoimmune diseases such as systemic lupus erythematosus and rheumatoid arthritis. It is one of the core drugs in immunosuppressive regimens in the field of organ transplantation.

The global market size of mycophenolic acid drugs has long been stable at more than US$2 billion, and the compound annual growth rate of the Chinese market has remained at around 4%, with the annual sales of hospital preparations exceeding RMB 2.5 billion. At present, the proportion of generic drugs in the domestic market has exceeded 85%. With the implementation of the centralized procurement policy, the price of preparations has dropped by more than 70%, which has driven the continuous increase in demand for upstream APIs. The proportion of domestic API supply has been increasing year by year, and China has become the world's major supplier of mycophenolic acid APIs.

The original developer of mycophenolic acid is Roche, and the original product is mycophenolate mofetil, with the trade name CellCept. Its core compound patent expired in the European and American markets in 2014, and the compound patent in China also expired in 2014. The main dosage forms approved for the original product include tablets, capsules, dry suspensions and injections. The commonly used oral specifications are 250mg and 500mg, and the injection specification is 500mg per vial. It has been included in the *Catalogue of Chemical Reference Preparations* of China and the FDA Reference Preparation Catalogue. As of now, there are more than 30 mycophenolic acid API registration numbers on the CDE API Registration Platform, of which nearly 20 are in status A, and more than 40 domestic enterprises have obtained approval for the marketing of mycophenolate mofetil preparations. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of mycophenolic acid impurity reference standards. Relevant products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most impurities are in sufficient stock. Orders placed before 16:00 can be shipped on the same day, which can fully meet the demand for impurity reference standards in the process of API R&D, quality research and production, and help R&D and production enterprises efficiently advance project progress.