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Everest Medicines Announces New Drug Application Approval of VELSIPITY® for Adults with Moderately to Severely Active Ulcerative Colitis in Hong Kong
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the Department of Health of the Government of the Hong Kong Special Administrative Region, China, has officially approved the New Drug Application (NDA) for VELSIPITY® (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
About this update from Everest Medicines Ltd.
[{"type":"text","content":"SHANGHAI, April 30, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the Department of Health of the Government of the Hong Kong Special Administrative Region, China, has officially approved the New Drug Application (NDA) for VELSIPITY® (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).","length":566,"tagName":"p"},{"type":"text","content":"Following approvals in the Macau and Singapore, Hong Kong has become the third region within Everest Medicines' licensed territory to approve VELSIPITY®. NMPA of China has also officially accepted the NDA for VELSIPITY® for the treatment of patients with moderately to severely active UC in December 2024.","length":309,"tagName":"p"},{"type":"text","content":"VELSIPITY® is an effective and convenient, once-daily, oral treatment for adult patients with moderately to severely active UC that has already been approved in the U.S., E.U., and other countries by Everest's licensing partner, Pfizer. The approval of the NDA was based on results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12). Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of etrasimod. Etrasimod has been included in the AGA Living Clinical Practice Guideline on the pharmacological management of moderate-to-severe UC as one of the higher-efficacy medications suggested for first line use in advanced therapy-naïve patients.","length":767,"tagName":"p"},{"type":"text","content":""The approval of VELSIPITY® in Hong Kong marks an important milestone in bringing this innovative therapy to UC patients," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "In 2022, there were approximately 600,000 patients with UC in China, and the number is estimated to reach 1 million by 2030, reflecting the significant unmet need for advanced treatment options. VELSIPITY® has already been introduced to hospitals in the Greater Bay Area through the 'Hong Kong and Macau Medicine and Equipment Connect&...