Dimethyl Fumarate

Multiple sclerosis, as a chronic progressive autoimmune disease of the central nervous system, is prone to cause irreversible nerve injuries such as dyskinesia and visual impairment in patients, and there has been a long-term lack of oral treatment regimens that take both safety and compliance into account in clinical practice. Dimethyl fumarate belongs to the immunomodulator class of neurological drugs. It can reduce oxidative stress injury by activating the nuclear factor erythroid 2-related factor 2 (Nrf2) pathway, while inhibiting the release of pro-inflammatory factors and regulating the differentiation of T cell subsets. It is a first-line treatment drug for relapsing multiple sclerosis recommended by global guidelines, suitable for adult patients with relapsing-remitting multiple sclerosis, and can significantly reduce the annual relapse rate and delay the progression of disability.

The global market size of dimethyl fumarate reached a peak of USD 4.32 billion in 2021. Affected by patent expiration and the entry of generic drugs, the market size has declined, but it still remained above USD 2.1 billion in 2023. Among them, the growth rate of the Chinese market in recent years is significantly higher than the global average, with a compound annual growth rate of more than 28% from 2019 to 2023. At present, the original research product still dominates the domestic market, and 3 domestic enterprises have been approved for generic drug preparations. In the 9th batch of nationally organized drug centralized procurement in 2024, this variety was successfully awarded, and the winning price was about 74% lower than the original research price, which is expected to further improve clinical accessibility and drive the expansion of upstream API demand.

The original research enterprise of dimethyl fumarate is Biogen, and the original research trade name is Tecfidera. Its core compound patent in the United States expired in 2020, and the crystal form patent in China will expire in 2028. The main dosage form approved for the original research product is enteric-coated capsules, with two specifications of 120mg and 240mg, which have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs (5th Batch)*. Up to now, there are 19 dimethyl fumarate registration numbers on the API registration platform of China Center for Drug Evaluation (CDE), of which 11 have been activated with A status, and 7 generic drug preparation products have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the R&D, production and quality control needs of dimethyl fumarate, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable support for enterprises' impurity research, quality standard establishment and registration and declaration work.