Mycophenolate Mofetil

Rejection after organ transplantation is a core risk affecting the long-term survival of patients, and the optimization of immunosuppressive regimens has always been a research focus in the field of transplantation. Mycophenolate mofetil is an immunosuppressant belonging to the purine synthesis inhibitor class. It highly selectively inhibits the activity of hypoxanthine mononucleotide dehydrogenase in lymphocytes, blocks the de novo synthesis pathway of guanine nucleotides, and then inhibits the proliferation of T and B lymphocytes and antibody production. Compared with traditional immunosuppressants, it has lower hepatorenal toxicity. At present, it has become a first-line drug for anti-rejection after solid organ transplantation such as kidney, heart and liver transplantation. It can also be used for the treatment of autoimmune diseases such as lupus nephritis and systemic lupus erythematosus, and the applicable population covers adult transplant patients and some child patients who meet the indications.

The global market size of mycophenolate mofetil has exceeded 2 billion US dollars. In recent years, with the steady growth of global organ transplantation surgery volume and the expansion of autoimmune disease indications, the compound annual growth rate has remained at around 3.2%. China is a major producer and exporter of this type of active pharmaceutical ingredient (API), and the domestic generic preparation market accounts for more than 85%; with the advancement of national medical insurance coverage and provincial centralized drug procurement, the terminal sales of domestic preparations have stabilized at around 4 billion yuan in the past three years, the price decline has tended to be stable, and the demand for upstream APIs has significant rigid characteristics.

The original research enterprise of mycophenolate mofetil is Roche, and the original research trade name is CellCept. Its core compound patents in major markets such as the United States and Europe expired in 2014, and the Chinese compound patent also expired in the same period. The main dosage forms approved for the original research include tablets, capsules, dry suspensions and injections, with common specifications of 250mg and 500mg, which have been included in the Chinese *Catalogue of Chemical Reference Preparations* and the FDA Reference Preparation Catalogue. Up to now, there are more than 30 mycophenolate mofetil registration numbers on the API registration platform of the Center for Drug Evaluation of China, most of which are in A status, and nearly 20 domestic enterprises have obtained approval for the marketing of their preparation products. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for mycophenolate mofetil, which can fully cover the reference substance needs of the whole process of R&D, registration and quality control of APIs and preparations. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and provide stable support for the R&D and production links of relevant enterprises.