Everest Medicines received approval from China’s National Medical Products Administration for VELSIPITY® (etrasimod arginine tablets). Consequently, the oral therapy targets adults with moderately to severely active ulcerative colitis. This decision introduces a once-daily treatment for patients who failed conventional or biologic therapies.
The approval follows evidence from the Asian ENLIGHT UC Phase III and global ELEVATE UC trials. Moreover, both studies showed clear improvements in induction and maintenance of remission compared with placebo. VELSIPITY®, through its 12-week induction and 40-week maintenance phases, attained a significant improvement in both the primary and secondary endpoints. This, in turn, provided improved long-term control of ulcerative colitis symptoms and also contributed positively to disease management.
Ulcerative colitis is a chronic inflammatory bowel disease. Its prevalence in China is rising, particularly among younger adults. In addition, patients experience abdominal pain, diarrhea, rectal bleeding, and mucus discharge, which significantly reduce quality of life. Furthermore, the disease imposes ongoing burdens on healthcare systems.
Clinicians aim for deep mucosal healing in UC management. Achieving it reduces relapse risk and improves long-term outcomes. Therefore, VELSIPITY®, a selective S1P receptor modulator, promotes rapid mucosal recovery and remission.
Mr. Yifang Wu, Chairman of Everest Medicines, emphasized that the approval demonstrates the company’s commitment to delivering innovative therapies for autoimmune diseases. He also added that VELSIPITY® reflects Everest’s focus on international drug standards and expanded patient access to advanced treatments.
Existing ulcerative colitis therapies in China face high relapse rates, complex dosing, and safety concerns. However, VELSIPITY® provides a convenient oral option, which may improve adherence and patient satisfaction.
Professor Chen Minhu, an expert in gastroenterology, commented that VELSIPITY is a viable long-term option for treating patients with IBD. Clinical data show it also aids in healing the mucosa and reducing disease activity. Dr. Chen noted that since VELSIPITY is taken once a day, it makes compliance with treatment more straightforward for patients.
Similarly, Prof. Wu Kaichun, principal investigator of the Asian Phase III trial, highlighted the ENLIGHT UC study’s clinical relevance. Deep mucosal healing reached nearly 52 percent at week 40, therefore showing potential benefits for disease progression and quality of life.
Mr. Rogers Yongqing Luo, CEO of Everest Medicines, explained that the company plans to rapidly commercialize VELSIPITY® in China. They also aim to include it in the National Reimbursement Drug List, which would consequently expand access and affordability.
VELSIPITY® has already obtained approval in multiple markets, including the United States, European Union, Canada, Japan, Australia, Singapore, the United Kingdom, Switzerland, Israel, Turkey, and India. Furthermore, this demonstrates its global therapeutic potential.
Leading clinical guidelines have recognized VELSIPITY®’s value. In 2024, the American Gastroenterological Association included it in the treatment protocol for UC. Furthermore, the American College of Gastroenterology recommended that it be used as an induction and maintenance therapy for remission from UC.
Going forward, Everest Medicines intends to introduce VELSIPITY® as a component of the UC treatment schemes in countries across Asia. In addition, the Jiashan facility, operational as of March 2025, will produce VELSIPITY® in local markets, thereby enhancing the availability of this innovative therapy.
