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
| Item | Detail |
|---|---|
| Company | Everest Medicines (1952.HK) |
| Drug | Velsipity (etrasimod) |
| Mechanism | Next‑generation S1P receptor modulator (targets S1P1, 4, 5) |
| Indication | Moderately to severely active ulcerative colitis (UC) |
| Patient Population | Inadequate response/intolerance to conventional therapy or biologics |
| Filing Status | Marketing application submitted in China |
| Originator | Arena Pharmaceuticals (acquired by Pfizer 2022) |
| Everest Rights | Exclusive development, manufacturing, and commercialization rights in Greater China and South Korea (since 2017) |
| Global Approvals | US, 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
