Everest Medicines Files Velsipity for Ulcerative Colitis in China

Everest Medicines Files Velsipity for Ulcerative Colitis in China

Everest Medicines (HKG: 1952) announced it has submitted a marketing filing in China for Velsipity (etrasimod) to treat adult patients with moderately to severely active ulcerative colitis (UC) who have had inadequate response, loss of response, or intolerance to conventional therapy or biologics. The next‑generation sphingosine‑1‑phosphate (S1P) receptor modulator is already approved in 12 global markets, including the US, EU, Japan, and Hong Kong.

Regulatory Filing & Drug Profile

ItemDetail
CompanyEverest Medicines (1952.HK)
DrugVelsipity (etrasimod)
MechanismNext‑generation S1P receptor modulator (targets S1P1, 4, 5)
IndicationModerately to severely active ulcerative colitis (UC)
Patient PopulationInadequate response/intolerance to conventional therapy or biologics
Filing StatusMarketing application submitted in China
OriginatorArena Pharmaceuticals (acquired by Pfizer 2022)
Everest RightsExclusive development, manufacturing, and commercialization rights in Greater China and South Korea (since 2017)
Global ApprovalsUS, EU, Canada, Japan, Australia, UK, Switzerland, Israel, Turkey, India, Singapore, Hong Kong, Macau

Market Impact & Commercial Outlook

  • China UC Market: Valued at ¥8 billion (~US$1.1 billion) in 2025, growing at 12% CAGR driven by biologics adoption
  • S1P Modulator Competition: Competes with Zeposia (Bristol Myers) and Mayzent (Novartis); etrasimod’s optimized S1P1/4/5 binding profile offers improved safety/tolerability
  • Strategic Value: China filing represents final major market entry for Velsipity; completes Everest’s gastroenterology franchise alongside xeligekimab
  • Revenue Potential: Analysts project ¥1.5–2.5 billion (US$210–350 million) peak annual sales in China by 2028, assuming 15% share of second‑line UC market
  • Next Steps: NMPA review expected 12–18 months; potential approval Q2 2027; commercial launch preparation underway

Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory review timelines, commercial expectations, and revenue projections for Velsipity in China. Actual results may differ due to NMPA review outcomes, competitive dynamics, and market adoption rates.-Fineline Info & Tech