By Fineline Cube AbbVie Inc. (NYSE: ABBV) announced that China’s National Medical Products Administration (NMPA) has approved Risankizumab (SKYRIZI) for adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to conventional or biologic therapies. This marks the second major indication for risankizumab in China, following its approval for Crohn’s disease last year.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | AbbVie Inc. (NYSE: ABBV) |
| Drug | Risankizumab (SKYRIZI) |
| Mechanism | Interleukin‑23 (IL‑23) inhibitor |
| Approval | NMPA (China) for ulcerative colitis |
| Patient Population | Adults with moderately to severely active UC, refractory to conventional/biologic therapies |
| Significance | Second indication in China; first IL‑23 inhibitor approved for UC globally |
| Previous Approval | Crohn’s disease (China, 2025) |
Clinical Profile & Guideline Support
- Mechanism: Selective IL‑23p19 inhibitor that blocks a key inflammatory pathway in ulcerative colitis
- Global Innovation: World’s first IL‑23 inhibitor approved for UC treatment
- Guideline Endorsement:
- 2024 AGA guidelines: Recommended for induction and maintenance therapy in moderate‑to‑severe UC
- 2025 ACG guidelines: Included for induction and maintenance treatment
- AGA advanced‑therapy‑naive: Suggested for UC patients naive to advanced therapies
- Clinical Differentiation: Offers an alternative mechanism for patients failing TNF inhibitors or vedolizumab
Market Impact & Commercial Outlook
- China UC Market: Estimated 400,000–500,000 patients with moderate‑to‑severe ulcerative colitis, with diagnosis rates rising
- Competitive Landscape: Competes with TNF inhibitors (adalimumab, infliximab) and vedolizumab; IL‑23 class represents a novel option
- Revenue Forecast: Analysts project ¥1.5–2.0 billion (US$210–280 million) peak annual sales for risankizumab in China’s UC indication by 2029
- Strategic Benefit: Strengthens AbbVie’s inflammatory bowel disease franchise in China, leveraging existing Crohn’s disease infrastructure
- Pricing & Access: Likely premium pricing; awaiting 2026 NRDL update discussions for reimbursement potential
- Launch Timeline: Commercial availability expected Q2 2026
Forward‑Looking Statements
This brief includes forward‑looking statements regarding commercial expectations, market penetration, and revenue projections for risankizumab in China. Actual results may differ due to competitive dynamics, pricing negotiations, and market adoption rates.-Fineline Info & Tech