Fingolimod

Multiple sclerosis is a chronic disabling demyelinating disease of the central nervous system, which mostly occurs in young adults aged 20 to 40, and immunomodulation is the core direction of its long-term treatment. Fingolimod is an innovative drug belonging to the sphingosine-1-phosphate receptor modulator class. By binding to the S1P receptors on the surface of lymphocytes, it prevents lymphocytes from entering the central nervous system and reduces the attack of inflammatory factors on the nerve myelin sheath. It is the world's first oral disease-modifying therapy approved for relapsing multiple sclerosis, which can significantly reduce the annual relapse rate and the risk of disability progression of patients, and provides a more convenient treatment option for multiple sclerosis patients who require long-term injection therapy.

The peak size of the global fingolimod market once exceeded 3 billion US dollars. With the expiration of patents and the launch of generic drugs, the current market size is about 1.2 billion US dollars, with a compound annual growth rate maintained at around 4%. For the domestic market, as multiple sclerosis has been included in the rare disease catalogue, the market growth rate has remained above 25% in the past three years. Currently, 7 generic drug preparations have been approved in China, and the market share of the original research drug has dropped to less than 30%. After the implementation of centralized procurement, the price has dropped by more than 70%, which further improves the accessibility of drugs for patients, and the demand for upstream API has also continued to expand accordingly.

The original research enterprise of fingolimod is Novartis, with the trade name Gilenya (Jielingya). Its core compound patent in the United States expired in 2019, and its compound patent in China also expired in 2019. The main dosage form approved for the original research drug is capsules, with specifications of 0.5mg and 0.25mg, which have been included in the Chinese *Catalogue of Chemical Reference Preparations* and the FDA Reference Preparation Catalogue. In terms of domestic API registration, more than 15 enterprises have obtained A-status registration numbers for their fingolimod APIs after passing the approval of the CDE, and the original research drug and multiple generic drug preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for fingolimod, and can customize impurity reference standards to match the synthesis process routes of different enterprises. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and fully meet the full-process testing needs of API enterprises for registration and declaration, quality research and batch release.