SHANGHAI, China - May 25, 2026 - 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 Ministry of Food and Drug Safety (MFDS) in South Korea, has officially approved the New Drug Application (NDA) for Etrasimod (VELSIPITY®) for the treatment of adult with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy (corticosteroids or immunosuppressants) or a biologic agent. Following prior approvals in Macao SAR, Singapore, Hong Kong SAR, and Chinese mainland, this achievement marks another milestone in expanding access to this innovative therapy for patients across the region.
Ulcerative colitis is a chronic, relapsing, non-specific inflammatory bowel disease characterized by symptoms such as mucus and blood in the stool, abdominal pain, diarrhea, and rectal tenesmus, which can significantly impact patients' daily lives and long-term health. There remains a critical need for therapies that offer sustained and comprehensive disease control.
VELSIPITY® is a next-generation, highly selective S1P receptor modulator with best-in-disease potential and strong first-line treatment recommendations in leading international guidelines. Early achievement of mucosal healing is recognized as a key treatment goal, as it can significantly reduce rates of disease relapse, hospitalization, surgery, and the risk of progression to colorectal cancer. VELSIPITY® addresses this need by targeting intestinal inflammation at its source and promoting mucosal healing, while offering a favorable profile of efficacy and safety, along with the convenience of an oral, once-daily regimen, supporting sustained disease management and improving patients' quality of life. It has been strongly recommended as a first-line treatment for moderately to severely active UC in both the American Gastroenterological Association (AGA) Clinical Practice Guideline and the American College of Gastroenterology (ACG) Clinical Guideline Update, reflecting strong recognition of its efficacy and safety by leading international academic societies.
"We are pleased that the NDA for VELSIPITY® has been officially approved in South Korea. This represents an important milestone in our expansion in the autoimmune disease field and underscores our commitment to making this innovative therapy widely available in the region,” said Mr. Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “The burden of ulcerative colitis in the region continues to rise. In South Korea, the number of patients has grown at a compound annual growth rate of approximately 6% over the past five years. In 2024, the total patient population was around 64,000, and this is projected to increase to 90,000 by 2030. As a next-generation, highly selective S1P receptor modulator, VELSIPITY® combines efficacy, safety, and convenience, making it a promising treatment option for patients with moderately to severely active UC in South Korea. It offers both greater convenience and long-term disease management. Everest Medicines will continue to bring innovative therapies to patients across Asia in the future.”
The approval of VELSIPITY® in South Korea was supported by results from the global ELEVATE UC Phase 3 program (including the ELEVATE UC 52 and ELEVATE UC 12 studies) and the Asian multicenter Phase 3 registrational ENLIGHT UC study (ES101002).
ELEVATE UC 52 and ELEVATE UC 12 are randomized, double-blind, placebo-controlled clinical studies in the global ELEVATE UC Phase 3 program. Both studies achieved all primary and key secondary efficacy endpoints, demonstrated statistically significant improvements in clinical remission and mucosal healing, along with a favorable safety profile.
The ENLIGHT UC study (ES101002) is a randomized, double-blind, placebo-controlled clinical study of the largest Phase 3 trial of moderately to severely active UC in Asia (including Chinese mainland, Chinese Taiwan, and South Korea) completed to date, with 340 eligible subjects randomized to treatment with Etrasimod or placebo. Results from the ENLIGHT UC study demonstrated that the clinical remission rate at week 40 of the maintenance period reached 48.1%, and the deep mucosal healing rate reached 51.9%, with an endoscopic mucosal normalization rate of 45.5%1. As the first Phase 3 registrational study in Asian patients with moderately to severely active UC, the study confirms the efficacy and safety of VELSIPITY® in this population, with results published in The Lancet Gastroenterology & Hepatology1. Its approval represents an important milestone and validation, providing patients with a novel treatment option and advancing UC management.
Results from the ELEVATE UC open-label extension demonstrate continuous treatment with VELSIPITY® for up to 3 years resulted in 86.8% of patients achieving a clinical response among the observed cases, with both clinical remission and mucosal healing rates maintained at approximately 60%2. Safety data extending up to five years from the global clinical program further confirm that VELSIPITY® is well tolerated and maintains a favorable and stable safety profile3. Global and Asia-Pacific clinical evidence has demonstrated that VELSIPITY® is effective and well-tolerated across patient populations with different disease stages and treatment backgrounds, providing a solid foundation for its standardized use in real-world clinical practice.
VELSIPITY® has been approved in several territories licensed to Everest Medicines, including Chinese mainland, Hong Kong SAR, Macao SAR, and Singapore. In February 2026, the National Medical Products Administration (NMPA) of China granted approval for VELSIPITY®, and the therapy was prescribed within one month. This highlights Everest’s capability to rapidly bring innovative therapies to patients. To ensure long-term supply and support commercialization, Everest launched a localized production project for VELSIPITY® at its Jiashan manufacturing site in March 2025, strengthening its supply capabilities for Greater China and other Asian markets.
References:
1. 1.K. Wu, et al. Lancet Gastroenterol Hepatol. 2025 Sep 30:S2468-1253(25)00198-0.
2. B E Sands, et al. ECCO 2026. Abstract ID: jjaf231.774.
3. D.T. Rubin, et al. ECCO 2026. Abstract ID: jjaf231.1256.
About VELSIPITY® (Etrasimod)
VELSIPITY® is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds to S1P receptor subtypes 1, 4, and 5. Regulatory approvals have been granted in US, EU, Canada, Japan, Australia, Singapore, UK, Switzerland, Israel, Turkey, India, Hong Kong SAR, Macao SAR and Chinese Mainland for VELSIPITY® in ulcerative colitis, as well as in additional countries.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative pharmaceutical products that address critical unmet medical needs for patients in global markets. The management team of Everest Medicines has deep expertise and an extensive track record both in China and with leading global pharmaceutical companies.
The Company’s therapeutic areas of focus include autoimmune, ophthalmology, critical care, and CKM (cardiovascular, kidney, and metabolic) diseases. Everest Medicines has developed a fully integrated commercialization platform that combines omnichannel commercial capabilities with end-to-end product lifecycle management. Leveraging its proprietary mRNA platform, the Company is advancing its existing pipeline, including mRNA in vivo CAR-T and mRNA cancer vaccines, while selectively expanding into additional high-value therapeutic areas with blockbuster potential, and accelerating its global expansion. For more information, please visit the Company's website: www.everestmedicines.com.
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