By Fineline Cube 
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that the National Medical Products Administration (NMPA) has accepted its clinical filing for firsekibart, a Category 1 drug, for the treatment of non‑infectious uveitis using an IL‑1β monoclonal antibody (mAb) mechanism. If approved, firsekibart would be the first IL‑1β mAb globally approved for this indication.
Drug Profile & Regulatory Status
| Item | Detail |
|---|---|
| Company | Changchun High & New Technology Industries (SHE: 000661) |
| Drug | Firsekibart (IL‑1β monoclonal antibody) |
| Indication | Non‑infectious uveitis |
| Filing Status | NMPA clinical filing accepted for review |
| Mechanism | Blocks IL‑1β binding to IL‑1R, inhibiting downstream signaling pathways |
| Innovation | First IL‑1β mAb for non‑infectious uveitis globally |
| Category | Category 1 drug (China) |
| Pipeline | Also in development for endometriosis, CTD‑ILD, sJIA; approved for acute gouty arthritis (2025) |
Clinical Rationale & Market Opportunity
- Unmet Need: Current standard of care for non‑infectious uveitis relies on anti‑TNFα agents, but a significant portion of patients experience inadequate response or intolerance
- Clinical Evidence: Anti‑IL‑1β mAbs have demonstrated favorable outcomes in refractory non‑infectious uveitis patients in existing research
- Mechanism Advantage: IL‑1β inhibition offers a novel pathway distinct from TNFα blockade, potentially addressing treatment‑resistant cases
- Patient Population: Non‑infectious uveitis affects an estimated 100,000–150,000 patients in China, with limited therapeutic options
Market Impact & Commercial Outlook
- China Ophthalmology Market: Valued at ¥15 billion : (~US$2.1 billion) in 2025, growing at 10% CAGR driven by biologic adoption
- First‑Mover Advantage: Firsekibart would be the first‑in‑class IL‑1β inhibitor for uveitis, commanding premium pricing and market share
- Pipeline Synergy: Success in uveitis could accelerate approvals in endometriosis, CTD‑ILD, and sJIA, creating a multi‑indication franchise
- Revenue Potential: Analysts project ¥800 million–1.2 billion (US$110–170 million) peak annual sales for uveitis indication alone by 2030
- Regulatory Pathway: Category 1 status enables priority review; NMPA approval could come as early as 2027
- Next Steps: Phase I trial initiation planned for Q2 2026; global partnership opportunities under evaluation
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and revenue projections for firsekibart. Actual results may differ due to clinical trial outcomes, competitive dynamics, and NMPA review processes.-Fineline Info & Tech