Everest Medicines announced that Taiwan's Food and Drug Administration (TFDA) has officially accepted the New Drug Application for VELSIPITY (etrasimod) for treating patients with moderately to severely active ulcerative colitis. This regulatory milestone represents another step forward in the company's Asian commercialization strategy for the once-daily oral S1P receptor modulator.
Expanding Asian Market Access
The Taiwan acceptance follows prior approvals in Singapore, Hong Kong SAR, and Macao SAR, as well as NDA acceptance in South Korea. China's National Medical Products Administration (NMPA) officially accepted the NDA for VELSIPITY in December 2024, demonstrating the drug's regulatory momentum across the region.
"The NDA acceptance for VELSIPITY in Taiwan, China marks another key progress in our commercialization pathway across Asia," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "As the number of UC patients in Asia continues to rise, there remains a significant unmet medical need."
Growing Patient Population Drives Need
The company highlighted the substantial patient burden in the region, with approximately 800,000 patients with UC in China alone in 2024. This number is estimated to reach 1 million by 2030, according to Everest's projections. Luo emphasized that "UC patients face the dual challenges of long-term treatment and maintaining quality of life."
Clinical Evidence Supporting Application
The clinical submission to TFDA draws primarily from the ELEVATE UC Phase 3 registrational program, including ELEVATE UC 52 and ELEVATE UC 12 studies, along with the ENLIGHT study (ES101002). The ELEVATE UC program evaluated etrasimod 2 mg once-daily in UC patients with moderately to severely active disease who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy.
Both ELEVATE UC studies achieved all primary and key secondary efficacy endpoints, demonstrating a favorable safety profile consistent with previous etrasimod studies.
Asian-Specific Trial Data
The ENLIGHT study, conducted by Everest, represents the largest Phase 3 trial of moderately to severely active ulcerative colitis completed in Asia to date. This multicenter, randomized, double-blind, placebo-controlled trial enrolled 340 eligible subjects across China Mainland, China Taiwan, and South Korea.
Treatment with etrasimod 2 mg resulted in clinically meaningful and statistically significant improvement in the primary and all secondary endpoints. 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 etrasimod-treated patients. Mucosal normalization (ES = 0) was achieved in up to 46% of treated patients after 12 months.
Mechanism and Clinical Profile
VELSIPITY is a next-generation selective S1P receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. The once-daily oral medication demonstrates robust efficacy across multiple endpoints, including clinical remission, mucosal healing, endoscopic normalization, and histological remission.
The drug has gained recognition in clinical guidelines, being included in the AGA Living Clinical Practice Guideline on the pharmacological management of moderate-to-severe UC as one of the higher-efficacy medications suggested for first-line use in advanced therapy-naïve patients. Etrasimod has also been included in the ACG Clinical Guideline Update: Ulcerative Colitis in Adults in 2025.
Commercial Progress in Greater China
As Everest's third commercialized product, VELSIPITY has been officially approved by the Guangdong Provincial Medical Products Administration for adult patients with moderately to severely active UC. The drug is now available at medical institutions designated under the Connect Policy in the Greater Bay Area.
To support local production, Everest has launched a factory construction project at its Jiashan site for VELSIPITY manufacturing.
Global Regulatory Status
Regulatory approvals for VELSIPITY in ulcerative colitis have been granted in multiple markets including the US, EU, Canada, Japan, Australia, Singapore, UK, Switzerland, Israel, China Hong Kong SAR, and China Macao SAR, with additional countries also providing approval.
