HONG KONG, Oct 9, 2025 - (ACN Newswire) - Everest Medicines today announced that the results of its Asian multicenter Phase III ENLIGHT UC study (ES101002) of etrasimod (VELSIPITY(R)) for the treatment of subjects with moderately to severely active ulcerative colitis (UC) have been published in the prestigious international journal The Lancet Gastroenterology & Hepatology, marking the global recognition of this next-generation selective S1P receptor modulator’s efficacy in Asian patients.
The published results are from the ENLIGHT UC study (ES101002), a multicenter, randomized, double-blind, placebo-controlled Phase III trial of etrasimod conducted across Asia. ENLIGHT is the largest completed Phase III trial to date in Asian patients with moderately to severely active UC, enrolling 340 eligible subjects who were randomized to receive once-daily etrasimod or placebo for 12 weeks of induction treatment. All patients had an inadequate response or intolerance to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy.
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. The safety profile of etrasimod was consistent with previous studies, with no new safety signals observed.
Prof. Wu Kaichun at the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod’s Asia clinical trial said: “As the largest Phase III trial of UC in Asia, the results fill the gap in clinical data on active UC in Asia. The results confirm that etrasimod shows good efficacy and safety in Asian patients including Chinese patients, with positive effects on improving clinical symptoms and promoting endoscopic improvement.”
“Publication of the ENLIGHT UC study in The Lancet Gastroenterology & Hepatology underscores etrasimod’s strong clinical value in the treatment of moderately to severely active UC and providing stronger clinical evidence to support patients across Asia.” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines.“The company initiated local production of etrasimod in March and remains committed to accelerating the regulatory approval process in Mainland China and other Asian markets, helping more patients achieve higher-quality, longer-lasting disease remission.”
VELSIPITY(R) has been approved in Singapore, Macao SAR, and Hong Kong SAR. Its NDA has also been accepted in South Korea and Taiwan, China. In December 2024, China’s National Medical Products Administration (NMPA) officially accepted the NDA for VELSIPITY(R), with approval expected in the first half of 2026. As Everest’s third commercialized product, VELSIPITY(R) has been approved by the Guangdong Provincial Medical Products Administration for adult patients with moderately to severely active UC, and is now available at medical institutions designated under the Connect Policy in the Greater Bay Area. The localized production project for VELSIPITY(R) was officially launched at the Jiashan manufacturing site in March 2025, providing strong support for its future commercialization.
As a core product of Everest Medicines, etrasimod is an innovative and advanced therapy that provides rapid onset of action, clinical remission and endoscopic improvement through an oral, once-daily regimen. Following its inclusion in the American Gastroenterological Association (AGA) Clinical Practice Guideline as a first-line treatment for ulcerative colitis in December 2024, etrasimod was included in the American College of Gastroenterology (ACG) Clinical Guideline Update in June 2025, strongly recommended for both induction and maintenance of remission in patients with moderately to severely active UC.
From the market perspective, the number of UC patients in Asia is rising rapidly, while treatment options remain relatively limited. In China alone, the UC patient population was estimated at approximately 800,000 in 2024 and is projected to reach 1.5 million by 2031. With its proven efficacy and safety, VELSIPITY(R) is expected to quickly enter and reshape the market landscape. To ensure accessibility and supply stability, Everest has launched a localized production project at its Jiashan manufacturing site, with an expected annual production capacity of up to 50 million tablets to enhance supply stability and cost efficiency.
Notably, in late August Everest launched a proactive build-up of its commercial team for etrasimod, with the team expected to expand significantly around the time of approval. This deployment will not only ensure the efficient commercialization of VELSIPITY(R) upon launch, but also lay a solid foundation for future inclusion in the National Reimbursement Drug List (NRDL) and large-scale uptake.
Industry observers widely expect VELSIPITY(R) to become Everest’s next blockbuster product, with analysts projecting peak sales of up to RMB 5 billion. As VELSIPITY(R) realizes its commercial potential, Everest’s revenue mix and growth trajectory are expected to strengthen further, providing greater visibility and confidence for long-term investors.