China NMPA Approves VELSIPITY for Moderately to Severely Active Ulcerative Colitis
核心洞察
China's National Medical Products Administration has approved VELSIPITY (etrasimod arginine tablets) for adults with moderately to severely active ulcerative colitis who have inadequate response to conventional or biologic therapies.
The approval was based on the largest Phase 3 trial of UC in Asia to date, involving 340 patients, which demonstrated statistically significant improvements in clinical remission and mucosal healing endpoints.
VELSIPITY offers a once-daily oral S1P receptor modulator with rapid onset of action, addressing critical unmet medical needs in China's growing UC patient population projected to reach 1.50 million by 2031.
Everest Medicines (搜索) announced that China's National Medical Products Administration (NMPA) has approved VELSIPITY® (etrasimod arginine tablets) for treating adult patients with moderately to severely active ulcerative colitis (UC) who have had inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
As a next-generation selective S1P receptor modulator, VELSIPITY® 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.
Pivotal Clinical Trial Results
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 represents 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® or placebo.
The study demonstrated that VELSIPITY® achieved 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. A significantly greater proportion of patients treated with etrasimod than those treated with placebo achieved clinical remission at induction Week 12 (57 [25.0%] of 228 patients vs 6 [5.4%] of 112 patients; adjusted difference 20.4%, 95% CI 13.4–27.4, p<0.0001) and at maintenance Week 40 (37 [48.1%] of 77 patients vs 10 [12.5%] of 80 patients; adjusted difference 35.9%, 95% CI 22.5–49.2, p<0.0001).
At maintenance Week 40, the clinical remission rate reached 48.1%, and the deep mucosal healing rate reached 51.9%, with an endoscopic mucosal normalization rate of 45.5%. The safety profile of VELSIPITY® was consistent with previous studies, with no new safety signals observed.
Addressing Growing Medical Need in China
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. Symptoms include mucous and bloody stools, abdominal pain, diarrhea and rectal tenesmus, all of which significantly impact patients' long-term quality of life.
"Ulcerative colitis 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," said Prof. Chen Minhu, Academic Leader and Chief Expert of the Department of Gastroenterology at The First Affiliated Hospital of Sun Yat-sen University. "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."
Clinical Expert Perspectives
Prof. Wu Kaichun of the First Affiliated Hospital of AFMU, principal investigator of VELSIPITY®'s Asian clinical trial, noted that "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." He emphasized that the approval "represents an important milestone and validation, providing patients with a novel treatment option and advancing UC management."
International Recognition and Commercial Strategy
The clinical value of VELSIPITY® 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® 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® 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® was launched at the Jiashan manufacturing site in March 2025, supporting its future commercialization in China.
"In China, a large population of patients with moderately to severely active UC continues to face substantial unmet medical needs," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines (搜索). "VELSIPITY® provides patients with moderately to severely active ulcerative colitis a once-daily oral therapy with the potential to achieve steroid-free remission and a favorable benefit–risk profile. We are committed to rapidly commercializing VELSIPITY® and working toward its inclusion in the National Reimbursement Drug List to further expand patient access and affordability."
About VELSIPITY®
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 Mainland China for VELSIPITY® in ulcerative colitis, as well as in additional countries.