Teriflunomide

For the long-term disease management of relapsing multiple sclerosis (RMS), teriflunomide is a widely used first-line oral disease-modifying therapy globally, belonging to the immunomodulator category of pyrimidine synthesis inhibitors. Its mechanism of action is to reversibly inhibit dihydroorotate dehydrogenase, reduce the proliferation of activated T lymphocytes without affecting the basal functions of normal immune cells, and combine efficacy with good tolerability. Currently, its clinical indications include relapsing-remitting multiple sclerosis and clinically isolated syndrome, and it is suitable for adult and pediatric patients with relapsing multiple sclerosis aged 10 years and above, which can significantly reduce the annual relapse rate and delay the progression of disability.

At present, the global market size of teriflunomide is stable at around USD 1.2 billion, and the Chinese market has achieved remarkable growth in recent years. In 2023, the sales in sample hospitals exceeded RMB 320 million, with a compound annual growth rate of over 18%. In terms of the competitive landscape, the original research product still accounts for about 60% of the market share. Three domestic enterprises have obtained marketing approval for their generic versions, which have been included in the national centralized drug procurement. The winning bid price is more than 70% lower than that of the original research product, which has greatly improved the accessibility of the drug and driven the continuous release of demand in the primary market. It is expected that the domestic market will maintain an annual growth rate of more than 12% in the next three years.

The original research enterprise of teriflunomide is Sanofi-Aventis, with the trade name Aubagio. The core compound patent of the drug in China expired in August 2023. The main dosage form approved for the original product is tablet, with specifications of 7 mg and 14 mg. It has been included in the Reference Listed Drug Catalog of China Listed Medicines and also included in the FDA Reference Listed Drug Catalog. Up to now, more than 15 domestic enterprises have completed the CDE registration of teriflunomide active pharmaceutical ingredients, among which 8 are in status A, and more than 20 other enterprises have obtained marketing approval for their oral preparations. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of teriflunomide impurity reference standards, covering process impurities, degradation impurities and isotope-labeled substances. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can meet the needs of the whole process of API R&D, quality research and registration declaration.