EVEREST MED (01952) obtains approval for listing in Korea, deeply cultivating the Asian market and unlocking commercial value.

On May 25, Hong Kong-listed innovative drug company EVEREST MED (01952) announced that the South Korean Ministry of Food and Drug Safety (MFDS) had officially approved the new drug application (NDA) for VELSIPITY (Chinese mainland name: ), also known as amiselimod, for the treatment of moderate to severe active ulcerative colitis in adults who have had an inadequate response or are intolerant to conventional therapies (such as corticosteroids or immunosuppressants) or biologics. VELSIPITY is a once-daily oral therapy, a next-generation highly selective S1P receptor modulator, with the potential to be best-in-disease and targeting mucosal healing as a first-line therapy for innovative oral treatment. This approval represents another significant breakthrough for VELSIPITY in the Asian market. Data shows that in recent years, the incidence and prevalence of ulcerative colitis in the Asian region have been increasing, with a significant rise in the number of patients in Korea. The number of patients has grown at a Compound Annual Growth Rate (CAGR) of approximately 6% in the past five years, with an estimated total of 64,000 patients by 2024, projected to increase to 90,000 by 2030, highlighting a significant unmet clinical need in treatment. The approval of amiselimod in Korea will significantly improve the accessibility of this advanced therapy in the Asia-Pacific region and further demonstrates the successful internationalization of EVEREST MED's innovative product portfolio. With its rapid onset of action and deep mucosal healing, VELSIPITY brings proven benefits to patients. Ulcerative colitis, known as the "green cancer" due to its chronic and difficult-to-cure nature, is characterized by symptoms such as bloody diarrhea, abdominal pain, urgency, and incontinence, severely impacting the long-term quality of life and increasing the risk of colorectal cancer by 13.91% after 30 years of the disease, 1.7 times higher than the general population. In recent years, the number of ulcerative colitis patients in Korea has been steadily increasing, creating a clinical need for innovative therapies that can achieve stable and long-term disease control. "As a new generation highly selective S1P receptor modulator, amiselimod offers triple advantages of efficacy, safety, and oral convenience, providing a more convenient and long-term management option for moderate to severe ulcerative colitis patients in Korea. In the future, EVEREST MED will continue to accelerate the registration and commercialization process of innovative products in the Asian market to benefit more patients," said Reggie Yung, CEO of EVEREST MED. The approval of amiselimod in Korea is based on the results of the global Phase III ELEVATE UC registration study (including ELEVATE UC 52 and ELEVATE UC 12) and the results of the Asian multicenter Phase III ENLIGHT UC registration clinical study (ES101002). ELEVATE UC 52 and ELEVATE UC 12 are two randomized, double-blind, placebo-controlled clinical studies that have met all primary and key secondary endpoints, demonstrating superior and sustained clinical remission and deep mucosal healing at weeks 12 and 52, with 100% of clinical remission being steroid-free. The safety profile is good and consistent with previous studies. Mucosal healing is a recognized core goal in current UC treatment, closely related to recurrence rates, hospitalization rates, and long-term cancer risk. VELSIPITY achieves mucosal healing by regulating lymphocyte migration, controlling intestinal inflammation at the source, and promoting mucosal healing. The results of the ENLIGHT UC study (ES101002) show that the clinical remission rate after 12 weeks of induction therapy and 52 weeks of maintenance therapy was 48.1%, the mucosal healing rate was 51.9%, and the endoscopic normalization rate was 45.5%, with good safety and tolerability. This study is the largest Asian multicenter, randomized, double-blind, placebo-controlled Phase III study of moderate to severe ulcerative colitis conducted by EVEREST MED in the Asian region (including mainland China, Taiwan, and Korea). The study data fully demonstrate the significant efficacy and good safety of amiselimod in Asian patients, with the study results published in the top international journal The Lancet Gastroenterology & Hepatology, receiving global academic recognition. Long-term data validates efficacy, accelerating the commercial value release of VELSIPITY In terms of long-term efficacy and stability, open-label extension study data from the global Phase III ELEVATE study confirms that continuous treatment with VELSIPITY for 3 years resulted in a clinical response rate of 86.8% in observed cases, with clinical remission and mucosal healing rates maintained at about 60%. Five-year follow-up data from global clinical trials further demonstrate its stable and good safety characteristics, with overall good tolerability. Global and Asia-Pacific clinical evidence not only validates the stable efficacy and good safety of VELSIPITY in long-term treatment but also fully demonstrates the general applicability and reliable efficacy of amiselimod in different treatment contexts and populations with different disease severity, providing a solid basis for its standardized application in real clinical practice. From a regional perspective, the approval of VELSIPITY in Korea further strengthens its commercial footprint in the Asian market and aligns with the rapid growth trend of the ulcerative colitis track in the Asia-Pacific region. Prior to this, the drug had already received marketing approval in authorized territories of EVEREST MED such as mainland China, Hong Kong, Macau, and Singapore, forming a layout network covering core markets in East Asia and Southeast Asia. Benefiting from EVEREST MED's proven commercial operation capability, the company has established an outstanding Innovative Drug Commercialization Platform (A2MS), providing solid support for the rapid launch of products. In February 2026, VELSIPITY received marketing approval from the National Medical Products Administration of China and achieved the first rapid prescription landing in mainland China within a month of approval, demonstrating EVEREST MED's excellent strength in promoting the rapid accessibility of innovative drugs to patients. The approval in Korea, an important pharmaceutical market in Asia, will accelerate the penetration of VELSIPITY in the Asia-Pacific market and help the company fully capitalize on the growth opportunities in the UC track in the Asia-Pacific region. With an expected peak sales value of 5 billion, the product's enormous commercial potential highlights its role as a core driver of sustained growth in EVEREST MED's autoimmune disease portfolio.