Everest Medicines Announces China NMPA Approval of VELSIPITY(R) for Adults with Moderately to Severely Active Ulcerative Colitis

HONG KONG, Feb 6, 2026 – (ACN Newswire via SeaPRwire.com) – Everest Medicines today announced that China’s National Medical Products Administration (NMPA) has approved VELSIPITY(R) (etrasimod arginine tablets) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

UC is a chronic, relapsing, non-specific inflammatory bowel disease. In China, the incidence and prevalence of UC are accelerating, with a clear trend toward younger patients. The patient population is projected to increase from approximately 0.98 million in 2025 to 1.50 million by 2031.There remains a critical need for therapies that offer sustained and comprehensive disease control.

As a next-generation selective S1P receptor modulator, VELSIPITY(R) offers the potential for rapid onset of action, and long-lasting clinical remission and mucosal healing through an oral, once-daily regimen for adult patients with moderately to severely active UC.

The approval was based on results from the Asian multicenter Phase 3 ENLIGHT UC study (ES101002) and the global ELEVATE UC Phase 3 program (ELEVATE UC 52 and ELEVATE UC 12). The ENLIGHT UC study is the largest Phase 3 trial of moderately to severely active UC in Asia completed to date, with 340 eligible subjects randomized to treatment with VELSIPITY(R) or placebo. The study results showed that, VELSIPITY(R) demonstrated statistically significant and clinically meaningful improvements across all primary and secondary efficacy endpoints during both the 12-week induction period and the 40-week maintenance period. The safety profile of VELSIPITY(R) was consistent with previous studies, with no new safety signals observed. The study confirms the efficacy and safety of VELSIPITY(R) in this population, with results published in The Lancet Gastroenterology & Hepatology.

From a clinical value perspectiveï¼ŒVELSIPITY(R) is a once-daily oral therapy with rapid onset of action, strong mucosal healing efficacy, and a favorable safety profile. Prof. Chen Minhu, Academic Leader and Chief Expert of the Department of Gastroenterology at The First Affiliated Hospital of Sun Yat-sen University noted that UC is rapidly increasing in China and follows a relapsing course that significantly impairs quality of life and places a substantial burden on both patients and the healthcare system. Achieving mucosal healing is a widely recognized treatment goal in clinical guidelines, as it improves symptom control, reduces relapse risk, and supports long-term disease management.

“UC treatment in China has long faced limited efficacy, high relapse rates, safety concerns, and inconvenient dosing. Despite available biologics and small-molecule therapies, unmet clinical needs persist,” said Prof. Wu Kaichun of the First Affiliated Hospital of AFMU, principal investigator of VELSIPITY(R)’s Asian clinical trial. “Its approval represents an important milestone and validation, providing patients with a novel treatment option and advancing UC management.”

“Autoimmune diseases have long-term impacts on patients worldwide, with significant unmet clinical needs persisting both in China and globally,” said Mr. Yifang Wu, Chairman of the Board of Everest Medicines. “The approval of VELSIPITY(R) underscores the clinical value of innovative therapies for UC and reflects Everest Medicines’ sustained commitment to advancing drug development in line with international R&D standards. We look forward to expanding our global reach and providing patients with broader access to innovative treatment options.”

“Its approval in China addresses a critical unmet medical need and introduces a novel oral therapy promoting deep mucosal healing,” said Mr. Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “We are committed to rapidly commercializing VELSIPITY(R) and working toward its inclusion in the National Reimbursement Drug List to further expand patient access and affordability, benefiting more patients across China.”

The clinical value of VELSIPITY(R) has been recognized in leading international clinical guidelines. Following its inclusion in the American Gastroenterological Association (AGA) Clinical Practice Guideline in December 2024 as a first-line treatment for ulcerative colitis , VELSIPITY(R) was also included in the American College of Gastroenterology (ACG) Clinical Guideline Update in June 2025, with strong recommendations supporting its use for both induction and maintenance of remission in patients with moderately to severely active UC.

In 2024, VELSIPITY(R) was included in the Catalogues of Guangdong Province on Drugs and Medical Devices from Hong Kong and Macao in Urgent Clinical Use in Nine Mainland Municipalities of the Guangdong-Hong Kong-Macao Greater Bay Area, making it available at designated hospitals across the region. The localized production project for VELSIPITY(R) was launched at the Jiashan manufacturing site in March 2025, supporting its future commercialization in China.

The successful approval of VELSIPITY(R) further strengthens Everest Medicines’ product portfolio in the field of autoimmune diseases and also forms a critical part of the 2030 strategy of the Company. This strategy is built on a dual-engine model of business development partnerships and in-house R&D, aiming to generate predictable value through commercialization while building long-term growth momentum through sustained innovation, thereby supporting pipeline continuity and sustainable development.

The Company has established a portfolio of three commercial products and continues to develop a fully integrated commercial platform covering the entire product lifecycle.The Company targets annual revenue exceeding RMB10 billion by 2028, and RMB15 billion by 2030 (including approximately RMB9 billion from the existing pipeline and approximately RMB6 billion from newly in-licensed assets). Revenue is expected to grow at a compound annual growth rate (CAGR) of over 50% from 2025 to 2030 and to remain above 15% thereafte.Over the same period, the number of commercial products is expected to exceed 20, including NEFECON(R), VELSIPITY(R), XERAVA(R), Lerodalcibep and MT1013.

Industry observers widely expect VELSIPITY(R) to become Everest’s next blockbuster product, with analysts projecting peak sales of up to RMB 5 billion. As VELSIPITY(R) realizes its commercial potential, Everest’s revenue mix and growth trajectory are expected to strengthen further. Looking ahead, Everest Medicines will continue to focus on therapeutic areas with significant unmet clinical needs. Leveraging its established commercialization capabilities and in-house R&D, the company aims to accelerate the launch of innovative therapies with global competitiveness, drive sustainable growth, and create greater health value for patients and society.

Published by chee