Methotrexate

As a commonly used antimetabolite folic acid antagonist in clinical practice, methotrexate competitively inhibits dihydrofolate reductase to block the DNA synthesis and replication process of tumor cells, and can also inhibit the release of inflammatory factors through immunomodulatory pathways. Its indications cover a variety of malignant tumors such as acute lymphoblastic leukemia, lymphoma and breast cancer, and it is also a first-line basic medication for autoimmune diseases such as rheumatoid arthritis and psoriasis. The applicable population includes adult and pediatric patients, and the clinical application scenarios span multiple departments such as oncology, rheumatology and immunology, and dermatology.

The global market size of methotrexate has stabilized at around USD 1.2 billion in recent years, with a compound annual growth rate of approximately 3.2%. The growth mainly comes from the expanding demand in the autoimmune disease field. In the domestic market, generic drugs account for more than 95% of the market share. At present, more than 30 enterprises have obtained preparation approval documents, and the winning bid price in centralized procurement has dropped by up to 91% compared with the original research drug, which significantly reduces the medication burden of patients. On the API side, domestic manufacturers supply more than 60% of the global production capacity, and a mature export supply system has been formed.

The original research enterprise of methotrexate is Pfizer, with the original brand name Trexall, and the core compound patent expired in 1982. The main dosage forms currently on the market include tablets (2.5mg, 5mg, 7.5mg, 10mg, 15mg) and injections (5mg/2mL, 50mg/2mL, 1g/10mL). Its original preparation has been included in the FDA Reference Listed Drug Catalog, and is also included in the *China List of Chemical Drugs*. At present, there are more than 20 domestic registration numbers for methotrexate API, among which more than 15 are in A status. The corresponding approved preparation varieties cover all oral and injectable dosage forms, which can fully meet the clinical supply demand. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of methotrexate impurity reference standards. Most products are available from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the use needs of enterprises in different scenarios such as R&D, quality research, and registration and declaration.