Ozanimod

Multiple sclerosis is a chronic disabling demyelinating disease of the central nervous system, and there has been a long-term clinical lack of long-term maintenance regimens that are both safe and convenient. Ozanimod is a second-generation sphingosine-1-phosphate (S1P) receptor modulator. It binds to S1P1 and S1P5 receptors with high selectivity, reduces the infiltration of lymphocytes in the peripheral circulation into the central nervous system, and also has a neuroprotective effect. Compared with first-generation S1P modulators, it significantly reduces the risk of cardiac adverse reactions. At present, this drug has been approved for adult patients with relapsing multiple sclerosis, including clinically isolated syndrome, relapsing-remitting multiple sclerosis and active secondary progressive multiple sclerosis. It can also be used for adult patients with moderate to severe active ulcerative colitis, providing patients with an oral medication option that does not require first-dose cardiac monitoring.

The global ozanimod market size exceeded US$2 billion in 2023, with a compound growth rate of more than 40% in the past three years, making it one of the fastest growing small molecule drugs in the autoimmune field at present. In terms of the competitive landscape, the original research product still accounts for more than 90% of the global market share, and the Chinese market is still in the introduction period. As of 2024, more than 10 domestic pharmaceutical companies have deployed the research and development of generic ozanimod, among which 3 companies have submitted applications for bioequivalence trials. It is expected that with the launch of generic drugs after the patent expires, the accessibility of domestic medication will be greatly improved.

The original research enterprise of ozanimod is Bristol-Myers Squibb, and the original research trade name is "Zeposia". The expiration time of its core compound patent in the United States is 2029, and the expiration time of the Chinese compound patent is 2031. At present, the dosage form of the original research approved globally is oral capsule, with specifications including 0.23mg, 0.46mg and 0.92mg. This dosage form has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by the NMPA, and is also included in the FDA Reference Preparation Catalogue. In terms of the domestic market, the original research ozanimod capsules were approved for import in 2021. As of October 2024, 7 enterprises have submitted registration applications for ozanimod APIs on the CDE API registration platform, among which 2 have been approved through the associated review with preparations. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of ozanimod impurity reference standards. 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 compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the various testing needs of pharmaceutical companies in the stages of API research and development, quality research and declaration.