By Fineline Cube 
China-based Everest Medicines (HKG: 1952) announced that the New Drug Application (NDA) for its Velsipity (etrasimod, trade name in Taiwan: 維長寧) has been accepted for review by Taiwan Food and Drug Administration (TFDA). This marks another step in the global regulatory journey for etrasimod, which treats moderate to severe active ulcerative colitis (UC). Previously, the NDA was approved in Macau SAR, Singapore, and Hong Kong SAR, and is under review in South Korea. China’s National Medical Products Administration (NMPA) also accepted the NDA for etrasimod in December 2024, with approval anticipated by the end of the year or early next year.
About Etrasimod
Etrasimod is a once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator. It effectively promotes intestinal mucosal healing, offers convenient administration, and has a favorable safety profile. The NDA submission is based on the ELEVATE UC Phase III registration studies (ELEVATE UC 52 and ELEVATE UC 12) and the ENLIGHT study (ES101002). These studies showed etrasimod achieved significant and sustained clinical remission and deep endoscopic mucosal healing at weeks 12 and 52. Importantly, all clinical remissions achieved were steroid-free, and the safety profile remained consistent with previous studies.-Fineline Info & Tech