SHANGHAI, Aug. 14, 2025 -- 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).
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®.
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.
"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."
The clinical part submitted to TFDA is mainly based on results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) and the ENLIGHT study (ES101002). The ELEVATE UC Phase 3 registrational program evaluated the safety and efficacy of etrasimod 2 mg once-daily on clinical remission in UC patients with moderately to severely active UC who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of etrasimod.
The ENLIGHT study (ES101002) conducted by Everest, is a multicenter, randomized, double-blind and placebo-controlled Phase 3 trial of etrasimod in Asian countries, including China Mainland, China Taiwan and South Korea. This is the largest Phase 3 trial of moderately to severely active ulcerative colitis in Asia completed to date, with 340 eligible subjects randomized to treatment with etrasimod or placebo. The results demonstrate that treatment with etrasimod 2 mg resulted in a clinically meaningful and statistically significant improvement in the primary and all secondary endpoints. Notably, a secondary endpoint of mucosal healing as measured by a central read endoscopic subscore≤ 1 (excluding friability) with a Geboes Index score < 2.0, was achieved in 51.9% of the etrasimod treated patients, and mucosal normalization (ES = 0) was achieved in up to 46% of treated patients after 12 months. These findings provide strong evidence supporting the use of etrasimod in adult Asian patients with moderately to severely active ulcerative colitis.
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. Etrasimod has also been included in the ACG Clinical Guideline Update: Ulcerative Colitis in Adults in 2025.
As Everest's third commercialized product, VELSIPITY® has been officially approved by the Guangdong Provincial Medical Products Administration for adult patients with moderately to severely active UC. It is now available at medical institutions designated under the Connect Policy in the Greater Bay Area. Additionally, Everest has launched a factory construction project at its Jiashan site to support local production of VELSIPITY®.
About VELSIPITY® (etrasimod)
VELSIPITY® is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. Regulatory approvals have been granted in US, EU, Canada, Japan, Australia, Singapore, UK, Switzerland, Israel, China Hong Kong SAR and China Macao SAR for VELSIPITY® in ulcerative colitis, as well as additional countries.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.
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