Why is Etrasimod-Velsipity not sold in mainland China?

Etrasimod(Etrasimod) is a new oral small molecule drug that has attracted widespread attention overseas in recent years. It belongs to the class of selective sphingosine-1-phosphate (S1P) receptor modulators and is mainly used to treat moderate to severe ulcerative colitis. The US FDA has approved the drug for marketing in 2023, providing a new treatment option for patients with ulcerative colitis (UC). However, in mainland China, itrimod has not yet been reviewed and approved by the National Medical Products Administration, so it is currently unavailable through regular domestic pharmacies and hospital channels.

The reasons why drugs are not sold in the country usually involve multiple links. First of all, drug marketing requires the completion of a series of registered clinical trials. This process not only examines efficacy and safety, but also conforms to the standards of local regulatory authorities for drug development and approval. There is currently no public information indicating that Itramod has completed key clinical studies in China, so it cannot enter the review and approval stage. Secondly, new drugs entering the Chinese market usually need to go through processes such as submission of registration application by the company, evaluation by the review center, and approval by the drug regulatory authorities. This cycle may take several years. In addition, even if a drug has been approved overseas, the progress of its introduction in China will be affected by multiple factors such as corporate strategy, market size, medical insurance payment ability, and intellectual property rights.

For patients with ulcerative colitis, currently available treatments in China mainly include traditional aminosalicylic acid drugs, glucocorticoids, immunomodulators, and some commercially available biological agents. The advantage of Itramod is that it is an oral small molecule drug that is easy to take and has a novel mechanism, so it has attracted the attention of the international academic community. With the acceleration of global new drug research and development, it may be introduced into China in the future, but the specific launch time is still uncertain.

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