SHANGHAI, March 9, 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 the commercial launch of VELSIPITY® (etrasimod arginine tablets) in Mainland China, highlighted by the issuance of the first prescription at The First Affiliated Hospital of Sun Yat-sen University, marking a milestone in patient access in the region. As a once-daily oral therapy with sustained efficacy, a favorable safety profile, and the ability to achieve deep mucosal healing, VELSIPITY® offers a novel treatment option for patients with moderately to severely active ulcerative colitis (UC), supporting long-term disease control and improved outcomes.
VELSIPITY® is a next-generation, highly selective S1P receptor modulator with best-in-disease potential and strong first-line treatment recommendations in leading international guidelines. China's National Medical Products Administration (NMPA) has approved VELSIPITY® on February 2, 2026, 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.
"With the first prescription now issued, VELSIPITY® is being incorporated into routine clinical practice, providing physicians with an innovative treatment option for patients living with UC who continue to face ongoing disease challenges, " said Prof. Chen Minhu, Academic Leader of the Department of Gastroenterology at The First Affiliated Hospital of Sun Yat-sen University. "Results from multiple global clinical studies have demonstrated that VELSIPITY® delivers meaningful clinical benefits, including rapid onset of action, long-lasting clinical remission, steroid-free remission, and deep mucosal healing, with a favorable safety profile. In the ENLIGHT UC study, the largest Asian multicenter Phase 3 clinical study, 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]. These findings demonstrate VELSIPITY®'s potential to improve long-term disease outcomes and reduce the risk of relapse and disease progression.
Results from the ELEVATE UC open-label extension demonstrate continuous treatment with VELSIPITY® for up to 3 years resulted in 86.8% of patients achieving a clinical response among the observed cases, with both clinical remission and mucosal healing rates maintained at approximately 60%[2]. Safety data extending up to five years from the global clinical program further confirm that VELSIPITY® is well tolerated and maintains a favorable and stable safety profile[3].
Under the 'Hong Kong and Macao Drug and Medical Devices Transit' policy, VELSIPITY® has been introduced into clinical use in the Greater Bay Area, where real-world outcomes have demonstrated efficacy and safety consistent with those observed in clinical trials. We expect VELSIPITY® to play an important role in optimizing UC management and advancing treatment toward the goal of mucosal healing, benefiting more patients."
Ulcerative colitis is a chronic, relapsing, non-specific inflammatory bowel disease characterized by symptoms such as mucus and blood in the stool, abdominal pain, diarrhea, and rectal tenesmus, which can significantly impact patients' daily lives and long-term health. In China, both the incidence and prevalence of UC are increasing, with a clear trend toward younger patients. There remains a critical need for therapies that offer sustained and comprehensive disease control.
"We are pleased to see that VELSIPITY® achieved its first prescription in Mainland China just one month after approval, making this potentially best-in-disease therapy clinically available to a broader population of patients living with UC. This milestone underscores our ability to efficiently translate cutting-edge global therapies into clinical practice," said Mr. Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "UC is an incurable disease, and the patient population is projected to grow from approximately 0.98 million in 2025 to 1.50 million by 2031 in China[4],[5]. Patients require long-term management to maintain disease control.
Early achievement of mucosal healing is recognized as a key treatment goal, as it can significantly reduce rates of disease relapse, hospitalization, surgery, and the risk of progression to colorectal cancer. VELSIPITY® addresses this need by targeting intestinal inflammation at its source and promoting mucosal healing, while offering a favorable profile of efficacy and safety, along with the convenience of an oral, once-daily regimen, supporting sustained disease management and improving patients' quality of life.
Everest has built a proven platform for the commercialization of innovative medicines, integrating scientific and commercial insights with coordinated access, medical, marketing, and sales (A2MS). We are confident in accelerating the rollout of VELSIPITY® through multi-channel access, diversified patient support programs, and innovative reimbursement solutions. And we will work to secure inclusion of VELSIPITY® in the National Reimbursement Drug List, further enhancing patient access and affordability."
In 2024 and 2025, 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. To support long-term supply and commercialization, Everest launched the localized production project for VELSIPITY® at its Jiashan manufacturing site in March 2025, strengthening its supply capabilities for Greater China and other Asian markets.
VELSIPITY® has been strongly recommended as a first-line treatment for moderately to severely active ulcerative colitis in both the American Gastroenterological Association (AGA) Clinical Practice Guideline and the American College of Gastroenterology (ACG) Clinical Guideline Update, reflecting strong recognition of its efficacy and safety by leading international academic societies.
The approval of VELSIPITY® in China was supported by 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)6, which demonstrated statistically significant improvements in clinical remission and mucosal healing, along with a favorable safety profile. 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®.
References:
- K. Wu, et al. Lancet Gastroenterol Hepatol. 2025 Sep 30:S2468-1253(25)00198-0.
- B E Sands, et al. ECCO 2026. Abstract ID: jjaf231.774.
- D.T. Rubin, et al. ECCO 2026. Abstract ID: jjaf231.1256.
- Shao B, et al. Front Public Health. 2022 Oct 25;10:1032679.
- Kaplan GG. Nat Rev Gastroenterol Hepatol. 2015;12(12):720-727.
- Sandborn WJ, et al. Lancet. 2023 Apr 8;401(10383):1159-1171.
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 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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