By Fineline Cube 
China Medical System Holdings (CMS; HKG: 0867) announced that the National Medical Products Administration (NMPA) has approved a market filing for Opzelura (ruxolitinib) cream, allowing its use as a local treatment for non‑segmental vitiligo with facial involvement in patients aged 12 years and older.
Product & Regulatory Details
| Item | Detail |
|---|---|
| Company | China Medical System Holdings (CMS; HKEX: 0867) |
| Product | Opzelura (ruxolitinib cream) |
| Mechanism | Topical JAK inhibitor |
| New Indication | Non‑segmental vitiligo with facial involvement (patients ≥12 years) |
| NMPA Approval Date | January 2026 |
| Previous Approval | Hong Kong (November 2024) |
| US Approval | September 2021 (atopic dermatitis) |
| EU Approval | Registered for vitiligo (adults and adolescents ≥12 years) |
Licensing & Geographic Rights
| Item | Detail |
|---|---|
| Licensor | Incyte Pharmaceuticals Inc. (NASDAQ: INCY) |
| License Date | December 2022 |
| Territory | Greater China (Mainland, HK, Macau, Taiwan) + 11 Southeast Asian countries |
| Southeast Asia Markets | Indonesia, Philippines, Vietnam, Thailand, Myanmar, Malaysia, Cambodia, Laos, Singapore, Timor‑Leste, Brunei |
Market Impact & Strategic Context
- Vitiligo Burden: Affects ~10 million patients in Greater China; facial involvement significantly impacts quality of life
- Unmet Need: No approved topical JAK inhibitors for vitiligo in mainland China; Opzelura offers first‑in‑class targeted therapy
- Commercial Leverage: CMS can leverage existing dermatology sales infrastructure from atopic dermatitis launch
- Revenue Potential: Analysts project ¥800 million–1.2 billion (US$110–170 million) peak annual sales in China vitiligo indication by 2029
- Next Steps: Commercial launch expected Q2 2026; reimbursement discussions with National Healthcare Security Administration underway
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial launch timelines, revenue projections, and market adoption for Opzelura. Actual results may differ due to reimbursement negotiations, competitive dynamics, and market conditions.-Fineline Info & Tech