--- title: "Everest Medicines' Velsipity (R) Approved for Marketing by China's National Medical Products Administration" description: "Everest Medicines' Velsipity (R) Approved for Marketing by China's National Medical Products Administration, Offering a New Treatment Option for Moderate to Severe Ulcerative Colitis Everest Medicines" type: "topic" locale: "en" url: "https://longbridge.com/en/topics/38591516.md" published_at: "2026-02-08T15:09:36.000Z" author: "[亚太商讯那些事儿](https://longbridge.com/en/profiles/18018177)" --- # Everest Medicines' Velsipity (R) Approved for Marketing by China's National Medical Products Administration Everest Medicines' Velsipity (R) Approved for Marketing by China's National Medical Products Administration, Offering New Treatment Option for Moderate to Severe Ulcerative Colitis Everest Medicines announced today that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for Velsipity (R) (Arginine Etrasimod Tablets, VELSIPITY(R)) for the treatment of adult patients with moderate to severe active ulcerative colitis who have had an inadequate response, loss of response, or intolerance to conventional therapy or biologics. Ulcerative colitis is a chronic inflammatory bowel disease with an unclear etiology and a tendency to relapse. In recent years, the incidence of ulcerative colitis in China has continued to rise, showing a trend towards affecting younger populations. The number of patients is expected to grow from approximately 980,000 in 2025 to about 1.5 million in 2031. The disease imposes a long-term burden on patients' quality of life, creating an urgent clinical need for more stable and durable disease control. As a new-generation, highly selective S1P receptor modulator, Velsipity (R) is an oral, once-daily medication that enables rapid onset of action and potent, deep mucosal healing, with a favorable safety profile. It has the potential to be a best-in-disease therapy, providing a new first-line treatment option for adult patients with ulcerative colitis. It is reported that this approval of Velsipity (R) is based on results from the Asia-Pacific multicenter Phase III registration clinical study ENLIGHT UC (ES101002) and the global Phase III registration studies ELEVATE UC (including ELEVATE UC 52 and ELEVATE UC 12). The ENLIGHT UC study is the largest Phase III registration clinical study completed to date involving Asian patients with moderate to severe active ulcerative colitis, enrolling a total of 340 patients. Results showed that the Velsipity (R) treatment group achieved statistical significance and clinical relevance across all primary and secondary efficacy endpoints, with a favorable safety profile. The study results have been published in the international top-tier academic journal The Lancet Gastroenterology & Hepatology. From a clinical value perspective, with its once-daily oral dosing regimen, Velsipity (R) can achieve rapid onset of action and clinical remission, while also demonstrating significant efficacy in mucosal healing and histological improvement, alongside a favorable safety profile. In this regard, Professor Chen Minhu, former Chairman of the Chinese Society of Gastroenterology, Head of the Inflammatory Bowel Disease Group, Academic Leader of Gastroenterology at the First Affiliated Hospital of Sun Yat-sen University, and Chief Expert, pointed out that China is currently in a phase of rapidly rising incidence and prevalence of ulcerative colitis. The disease often recurs, severely impacting patients' quality of life and imposing a heavy burden on individuals, families, and healthcare resources. Achieving mucosal healing helps control symptoms more effectively, reduces the risk of relapse, and improves patients' quality of life. Mucosal healing is recognized as a treatment goal for ulcerative colitis in both domestic and international clinical guidelines, which is not only related to long-term symptom relief but also closely linked to improving patients' quality of life. Professor Wu Kaichun, Lead Investigator of the Velsipity (R) Asia-Pacific clinical trials, Executive Committee Member and Treasurer of the World Gastroenterology Organisation, Vice Chairman of the Asia-Pacific Association of Gastroenterology, Vice Chairman of the 10th and 11th Chinese Society of Gastroenterology, and from Xijing Hospital of Digestive Diseases, Air Force Medical University, pointed out that for a long time, the treatment of ulcerative colitis in China has faced many limitations, including limited efficacy of conventional therapies, poor convenience of administration, and numerous adverse reactions. Approved biologics and small molecule therapies also face issues such as an "efficacy ceiling" and "loss of response." Velsipity (R) controls intestinal inflammation at its source and promotes mucosal healing by regulating lymphocyte migration. In multiple clinical studies, Velsipity (R) has demonstrated significant efficacy, showing clear clinical advantages particularly in rapid onset of action, achieving steroid-free remission, and deep mucosal healing. This approval marks the complete validation of Velsipity (R) from clinical research to market, providing patients with an innovative treatment option and advancing the management of moderate to severe ulcerative colitis into a new stage. Wu Yifang, Chairman of the Board of Everest Medicines, stated: "Autoimmune diseases have long-term and profound impacts on patients globally. There remains a significant unmet clinical need both in China and worldwide. The approval of Velsipity (R) not only reflects the clinical value of innovative therapies in treating ulcerative colitis but also demonstrates the company's long-term strategy of adhering to international R&D standards to advance the development of innovative drugs. We look forward to benefiting more patients with high-quality, breakthrough treatment options through continued expansion of our global footprint." Luo Yongqing, Chief Executive Officer of Everest Medicines, stated: "This approval of Velsipity (R) in China fills an important gap in the treatment of moderate to severe ulcerative colitis and provides a new option for innovative oral therapy aimed at deep mucosal healing. The company will accelerate the commercialization process of Velsipity (R) and actively promote its inclusion in the National Reimbursement Drug List, continuously improving the accessibility and affordability of innovative therapies in China, so that more patients can benefit." It is worth mentioning that the clinical value of Velsipity (R) has been fully recognized by several international authoritative guidelines. It has been successively included in the 2024 American Gastroenterological Association (AGA) Clinical Practice Guidelines and the 2025 American College of Gastroenterology (ACG) Clinical Guidelines, receiving strong recommendations. Previously, the drug was listed in the 2024 and 2025 Catalog of Clinically Urgently Needed Drugs and Medical Devices Imported from Hong Kong and Macao for the Nine Mainland Cities in the Guangdong-Hong Kong-Macao Greater Bay Area (listed as "Etrasimod" in the document). Currently, Velsipity (R) has received new drug marketing approvals in multiple countries and regions including the United States, the European Union, Mainland China, Hong Kong China, Macao China, and Singapore. In March 2025, Everest Medicines initiated the Velsipity (R) Jiashan Factory construction project, providing strong support for localized production and long-term accessibility. The successful approval of Velsipity (R) further solidifies Everest Medicines' product portfolio in the autoimmune disease field and is an important component of the company's 2030 development strategy. This strategy centers on a dual-engine drive of "BD collaboration + independent R&D," aiming to achieve definitive value through commercialization while building long-term growth momentum through continuous innovative R&D, promoting pipeline continuity and sustainable development. In terms of commercialization platform development, Everest Medicines has already commercialized three products and is focused on establishing a full-channel commercialization system and end-to-end product lifecycle commercialization capabilities. The plan is to achieve revenue exceeding RMB 10 billion by 2028 and exceeding RMB 15 billion by 2030 (with existing pipeline sales revenue of approximately RMB 9 billion and newly introduced pipeline sales revenue of approximately RMB 6 billion). The compound annual growth rate of revenue is expected to exceed 50% from 2025 to 2030 and remain above 15% after 2030. Simultaneously, the number of commercialized products will increase to over 20, including Nefecon (R), Velsipity (R), Eiger (R), Lirebop (R) (Ledasibep), and MT1013, among others. The industry widely believes that Velsipity (R) has the potential to become another blockbuster product for Everest Medicines, with its peak sales expected to reach RMB 5 billion. As the commercialization of Velsipity (R) continues to advance, the company's overall revenue structure and growth trajectory are expected to be further optimized. In the future, Everest Medicines will continue to focus on major unmet clinical needs, continuously strengthen its differentiated innovative pipeline, accelerate the implementation of internationally competitive innovative therapies, support the company's sustainable growth, and create greater health value for patients and society. ### Related Stocks - [01952.HK - EVEREST MED](https://longbridge.com/en/quote/01952.HK.md) --- > **Disclaimer**: This article is for reference only and does not constitute any investment advice.