Everest Medicines Announces China NMPA Approval of VELSIPITY(R) for Adults

Everest Medicines 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 randomised 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 perspective，VELSIPITY(R) is a once-daily oral therapy with rapid onset of action, strong mucosal healing efficacy, and a favourable 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 recognised 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 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.”