Why is Etrasimod-Velsipity banned?

The currently circulating statement that"Etrasimod(Etrasimod) Velsipity" is banned is not true. Itramod is not banned from sale, but has not yet been approved for marketing in mainland China. The foreign original drug is produced by Pfizer and has been approved by the US FDA and the EU EMA in 2023. It is used to treat moderate to severe ulcerative colitis (UC) in adults. It is an oral S1P receptor modulator with immunomodulatory properties.

The main reason for the misunderstanding is the difference in drug registration and sales areas. Currently, Itramod is only available for sale in some European and American countries. Mainland China has not yet introduced registration documents for the drug, so it cannot be legally purchased in domestic pharmacies or e-commerce platforms. Some consumers obtain European and American versions of drugs through overseas drug purchase platforms, so some people mistakenly believe that domestic sales are "banned". In fact, it is not imported and not banned.

From a pharmacological perspective, itridimod has a good safety profile, and its main adverse reactions are related to immune system adjustments, such as slight heart rate changes, fluctuations in liver function indicators, or temporary leukopenia. Since these physiological reactions are within the controllable range of immune drugs, they do not constitute a reason for a ban on sales. Neither FDA nor EMA has issued any recalls or warning announcements, indicating that the drug is still legally circulated overseas.

It should be pointed out that the price of Itramod is relatively expensive overseas, and the European and American versions (such as the American version and the European version) may cost thousands of dollars per box. High prices and limited channels make patient acquisition costs high.

If the drug enters the Chinese market in the future, it is expected that Pfizer China or its authorized partners will submit a registration application and undergo review by the National Medical Products Administration (NMPA). With the expansion of the domestic immune disease treatment market, itridimod is expected to become an important member of the oral S1P targeted drugs in the future.

Reference materials:https://www.drugs.com/mtm/etrasimod.html