China-based Everest Medicines (HKG: 1952) has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its Velsipity (etrasimod), a treatment for moderate to severe active ulcerative colitis (UC).
Velsipity’s Mechanism and Licensing Background
Velsipity is a once-daily, oral medication that functions as a sphingosine 1-phosphate (S1P) receptor modulator, selectively binding to S1P receptor subtypes 1, 4, and 5. In 2017, Everest Medicines entered into a licensing agreement with Pfizer’s subsidiary Arena Pharmaceuticals, securing development rights for Velsipity in Greater China and South Korea.
Global Approvals and GBA Inclusion
The drug has already received approval in the US for the treatment of moderate-to-severe UC in October of the previous year, followed by marketing authorizations in the European Union, Macau, and Singapore, among other regions. Its recent inclusion in the list of clinically urgent drugs and medical devices for the Guangdong-Hong Kong-Marco Greater Bay Area (GBA) will facilitate rapid access to Velsipity in 45 medical institutions designated under the “Hong Kong-Macau Drug and Device Access” policy, which is part of the Greater Bay Area initiative allowing patients to access drugs across Hong Kong, Macau, and various cities in Guangzhou.-Fineline Info & Tech
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