Why is Etrasimod not sold in mainland China?

Etrasimod has been approved for marketing in Europe, the United States and other regions, and its main indication is moderately to severely active ulcerative colitis (Ulcerative Colitis, UC). This disease is one of the chronic autoimmune inflammatory bowel diseases. Patients usually present with persistent diarrhea, bloody stools, mucus stools, abdominal pain and mucosal ulcers, which seriously affects the quality of life. Itramod can effectively prevent pathogenic T cells from migrating to intestinal inflammation areas by regulating S1P receptors, thereby inhibiting the intestinal mucosal immune response. Studies have shown that itrimod can quickly induce clinical remission and maintain efficacy, with a low incidence of adverse reactions, and has high safety and compliance advantages in the field of immunomodulatory treatment.

Although itrimod has original drug versions such as the US version (approved by the US FDA) and the European version (approved by the EMA European Medicines Agency) abroad, it has not yet been launched in mainland China. This is mainly determined by several factors. First of all, China's National Medical Products Administration (NMPA) has not received or is still reviewing its marketing application; secondly, domestic treatments for ulcerative colitis are still dominated by traditional 5-ASA preparations and biological preparations, and the acceptance and promotion of new S1P modulators are still in the early stages. In addition, the drug has not yet passed the evaluation standards of the Chinese Medical Insurance Drug List. The main reason is that clinical data need to be established in the Chinese population. At the same time, price evaluation, cost-effectiveness and medical insurance payment ability need to be comprehensively considered. Since China's new drug registration system adopts a parallel strategy of internationally synchronized clinical data requirements and localized research, the market entry speed of this type of new drugs has been delayed to a certain extent.

Currently, some patients choose to obtain the European or American version of the original drug Itrimod through overseas drug purchase platforms in Hong Kong, Europe and the United States, but most of these channels are imported at their own expense.

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