SHANGHAI, Feb. 6, 2026 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced that China's National Medical Products Administration (NMPA) has approved VELSIPITY® (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.
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.
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® or placebo. The study results showed that, VELSIPITY® 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® was consistent with previous studies, with no new safety signals observed. ELEVATE UC 52 and ELEVATE UC 12 are randomized, double-blind, placebo-controlled global phase 3 pivotal studies, which further demonstrate the positive benefit-risk profile of VELSIPITY®.
"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® 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."
"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. As a next-generation selective S1P receptor modulator, VELSIPITY® is a once-daily oral therapy with rapid onset of action, strong mucosal healing efficacy, and a favorable safety profile, offering a new long-term treatment option for adults with moderately to severely active UC."
"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®'s Asian clinical trial. "Results from the ENLIGHT UC study demonstrated that the clinical remission rate at week 40 of the maintenance period reached 48.1%, and the deep mucosal healing rate reached 51.9%, with an endoscopic mucosal normalization rate of 45.5%[1]. As the first Phase 3 registrational study in Asian patients with moderately to severely active UC, the study confirms the efficacy and safety of VELSIPITY® in this population, with results published in The Lancet Gastroenterology & Hepatology[1]. Its approval represents an important milestone and validation, providing patients with a novel treatment option and advancing UC management."
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[2],[3]. Symptoms include mucous and bloody stools, abdominal pain, diarrhea and rectal tenesmus, all of which significantly impact patients' long-term quality of life. There remains a critical need for therapies that offer sustained and comprehensive disease control.
"In China, a large population of patients with moderately to severely active UC continues to face substantial unmet medical needs," said Mr. Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "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. Its approval in China addresses a critical unmet medical need and introduces a novel oral therapy promoting deep mucosal healing. 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, benefiting more patients across China."
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.
About VELSIPITY® (etrasimod arginine tablets)
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.
About Phase 3 ENLIGHT UC Registrational study (ES101002)
ENLIGHT is the largest Phase III trial of moderately to severely active ulcerative colitis in Asia completed to date, with 340 eligible subjects randomized to receive etrasimod or placebo. Patients with an inadequate response or intolerance to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy were randomized to receive etrasimod once-daily or placebo for 12 weeks of induction treatment. Patients who completed the 12-week induction period and responded were re-randomized into the 40-week maintenance period to receive once-daily etrasimod or placebo.
The primary efficacy endpoints were the proportion of patients achieving clinical remission at Week 12 (induction) and Week 40 (maintenance). The key secondary endpoints of the study were the proportion of patients achieving endoscopic improvement and clinical response at Week 12 (induction) and at Week 40 (maintenance).
The study results showed that, during both the 12-week induction phase and the 40-week maintenance phase, etrasimod demonstrated statistically significant and clinically meaningful improvements across all primary and secondary efficacy endpoints.
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 induction Week 12, a significantly greater proportion of patients treated with etrasimod than those treated with placebo showed endoscopic improvement (85 [37.3%] of 228 patients treated with etrasimod vs 11 [9.8%] of 112 patients treated with placebo; adjusted difference 28.6%, 95% CI 20.5–36.7, p<0·0001) and clinical response (133 [58.3%] of 228 patients treated with etrasimod vs 31 [27.7%] of 112 patients treated with placebo; adjusted difference 32.0%, 95% CI 21.8–42.2, p<0·0001).
At maintenance Week 40, a significantly greater proportion of patients treated with etrasimod than those treated with placebo showed endoscopic improvement (47 [61.0%] of 77 patients treated with etrasimod vs 12 [15.0%] of 80 patients treated with placebo; adjusted difference 46.6%, 95% CI 33.2–60.1, p<0·0001) and clinical response (61 [79.2%] of 77 patients treated with etrasimod vs 28 [35.0%] of 80 patients treated with placebo; adjusted difference 45.6%, 95% CI 31.9–59.3, p<0·0001). Other secondary endpoints, including mucosal healing, endoscopic normalization, and histological remission, also significantly favored patients treated with etrasimod compared with placebo. Notably, mucosal healing as measured by a central read endoscopic subscore≤ 1 (excluding friability) with a Geboes Index score < 2.0, was achieved in 51.9% of the etrasimod treated patients compared to 8.8% in the placebo group (p<0.0001). The safety profile of etrasimod during the maintenance period was consistent with previous studies, with no new safety findings observed.
About ELEVATE UC Phase 3 Registrational Program (ELEVATE UC 52 and ELEVATE UC 12)
ELEVATE UC 52 and ELEVATE UC 12 are pivotal trials that are part of the ELEVATE UC Phase 3 registrational program[4].
ELEVATE UC 52 is a randomized, double-blind, placebo-controlled trial that utilized a treat-through design comprising a 12-week induction period followed by a 40-week maintenance period. Subjects were randomized to receive etrasimod or placebo and continued on treatment without re-randomization for the entire duration of the study. Beginning at Week 12, all patients could continue their randomized treatment; patients whose disease had not improved or had worsened compared with baseline could discontinue treatment and, if eligible, enroll in an open-label extension study. The primary objective of this trial was to assess the safety and efficacy of etrasimod 2 mg once daily on clinical remission after both 12 and 52 weeks. The primary endpoint was based on the 3-domain, modified Mayo score (MMS). In ELEVATE UC 52, clinical remission was achieved by 27.0% of patients receiving etrasimod compared with 7.0% of patients receiving placebo at Week 12 (19.8% differential, P˂0.0001) and by 32.0% compared with 7.0% at Week 52 (25.4% differential, P˂0.0001). Statistically significant improvements were observed in all key secondary endpoints, including endoscopic improvement and mucosal healing at Weeks 12 and 52, and corticosteroid-free remission and sustained clinical remission at Week 52.
ELEVATE UC 12 is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of etrasimod 2 mg once daily in subjects with moderately to severely active UC. The primary objective of this trial was to assess the safety and efficacy of etrasimod on clinical remission at Week 12, as assessed by the 3-domain MMS. In ELEVATE UC 12, clinical remission was achieved among 25.0% of patients receiving etrasimod compared with 15.0% of patients receiving placebo (9.7% differential, P=0.026). All key secondary endpoints were met at Week 12, including endoscopic improvement and mucosal healing.
In ELEVATE UC 12, a similar proportion of patients experienced treatment-emergent adverse events (AEs) between the etrasimod 2 mg and placebo treatment groups, while in ELEVATE UC 52, the proportion of adverse events was higher in the etrasimod 2 mg group compared with placebo. The proportion of patients experiencing serious AEs was similar between treatment groups in both trials. The most common treatment-emergent AEs occurring in 3% or more of etrasimod-treated patients and at a higher frequency than placebo through Week 52 in either trial were headache, elevated liver tests, worsening of UC, COVID-19 infection, dizziness, pyrexia, arthralgia, abdominal pain and nausea. Data support that initiation of etrasimod treatment does not require a complex up-titration regimen.
Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12, respectively, were naïve to biologic or JAK inhibitor therapy.
References:
[1]. K. Wu, et al. Lancet Gastroenterol Hepatol. 2025 Sep 30:S2468-1253(25)00198-0.
Full results of the ENLIGHT UC study (ES101002) by The Lancet Gastroenterology & Hepatology. |
[2]. Shao B, et al. Front Public Health. 2022 Oct 25;10:1032679. |
[3]. Kaplan GG. Nat Rev Gastroenterol Hepatol. 2015;12(12):720-727. |
[4]. Sandborn WJ, et al. Lancet. 2023 Apr 8;401(10383):1159-1171. |
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative pharmaceutical products that address critical unmet medical needs for patients in global markets. The management team of Everest Medicines has deep expertise and an extensive track record both in China and with leading global pharmaceutical companies.
The Company's therapeutic areas of focus include autoimmune, ophthalmology, critical care, and CKM (cardiovascular, kidney, and metabolic) diseases. Everest Medicines has developed a fully integrated commercialization platform that combines omnichannel commercial capabilities with end-to-end product lifecycle management. Leveraging its proprietary mRNA platform, the Company is advancing its existing pipeline, including mRNA in vivo CAR-T and mRNA cancer vaccines, while selectively expanding into additional high-value therapeutic areas with blockbuster potential, and accelerating its global expansion. For more information, please visit the Company's website: www.everestmedicines.com.
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