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Everest Medicines Announces Acceptance of the New Drug Application for VELSIPITY® by the Taiwan Food and Drug Administration for the Treatment of Moderately to Severely Active Ulcerative Colitis
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 Taiwan Food and Drug Administration (TFDA) has officially accepted the New Drug Application (NDA) for VELSIPITY® (etrasimod) for the treatment of patients with moderately to severely active ulcerative colitis (UC).
About this update from Everest Medicines Ltd.
[{"type":"text","content":"SHANGHAI, Aug. 14, 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 Taiwan Food and Drug Administration (TFDA) has officially accepted the New Drug Application (NDA) for VELSIPITY® (etrasimod) for the treatment of patients with moderately to severely active ulcerative colitis (UC).","length":512,"tagName":"p"},{"type":"text","content":"Building on prior approvals in Singapore, Hong Kong SAR, and Macao SAR, as well as NDA acceptance in South Korea, this marks significant progress in the commercialization of VELSIPITY® across Asia. In December 2024, China's National Medical Products Administration (NMPA) officially accepted the NDA for VELSIPITY®.","length":319,"tagName":"p"},{"type":"text","content":"As a next-generation selective S1P receptor modulator, once-daily oral etrasimod demonstrates robust efficacy across multiple endpoints, including clinical remission, mucosal healing, endoscopic normalization and histological remission. Its clinical value has been robustly demonstrated in multiple global Phase III studies, including ELEVATE UC 52, ELEVATE UC 12 and ENLIGHT (ES101002) studies.","length":400,"tagName":"p"},{"type":"text","content":""The NDA acceptance for VELSIPITY® in Taiwan, China marks another key progress in our commercialization pathway across Asia. As the number of UC patients in Asia continues to rise, there remains a significant unmet medical need. In China alone, there were approximately 800,000 patients with UC in 2024, and the number is estimated to reach 1 million by 2030. UC patients face the dual challenges of long-term treatment and maintaining quality of life." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "This NDA acceptance underscores the clinical value of VELSIPITY®. We remain committed to accelerating access to this innovative therapy in Mainland China and other Asian markets, supporting long-term disease management while enhancing patients' quality of life."","length":818,"tagName":"p"},{"type":"text","content":"The clinical part submitted to TFDA is mainly based on results from the ELEVATE UC Phase 3 r...