By Fineline Cube Livzon Pharmaceutical (HKG: 1513) announced that lecankitug, jointly developed with Beijing Kanova Biopharma, has been approved for marketing by the National Medical Products Administration (NMPA) for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. As China’s first domestically developed innovative biologic targeting both IL-17A and IL-17F, the approval strengthens the domestic alternatives in one of immunology’s most competitive therapeutic classes.
Regulatory Milestone
| Element | Detail |
|---|---|
| Agency | National Medical Products Administration (NMPA), China |
| Approval Type | Marketing approval |
| Product | Lecankitug, recombinant humanized anti-IL-17A/F monoclonal antibody |
| Indication | Adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy |
| Date | 28 Aug 2026 |
| Development Partners | Livzon Pharmaceutical and Beijing Kanova Biopharma |
Drug Profile & Mechanism of Action
- Molecule: Lecankitug, a recombinant humanized anti-human IL-17A/F monoclonal antibody
- Target: Dual blockade of the pro-inflammatory cytokines IL-17A and IL-17F
- Innovation: First domestically developed innovative biologic in China targeting both IL-17A and IL-17F
- Mechanism: Simultaneously blocking both cytokines provides broader suppression of the IL-17 inflammatory axis than IL-17A-only inhibitors
- Development Model: Joint development between Livzon Pharmaceutical and Beijing Kanova Biopharma
Clinical Evidence – Phase III vs. Secukinumab
| Endpoint | Lecankitug | Control (Secukinumab) | Result |
|---|---|---|---|
| Onset of Action | Faster | Benchmark | Superior to control |
| Skin Lesion Clearance Rate | Higher | Benchmark | Superior to control |
| Long-Term Efficacy | Sustained | Benchmark | Superior to control |
| Safety Profile | Comparable to control | Benchmark | No significant safety signal |
Lecankitug completed a Phase III clinical trial in moderate-to-severe plaque psoriasis with secukinumab as the positive control. Data demonstrated that lecankitug was superior to the control group in terms of onset of action, skin lesion clearance rate, and long-term efficacy, with a safety profile comparable to that of the control group — a head-to-head result that provides a direct evidence base for switching or initiating on the dual IL-17A/F mechanism.
Market Impact & Outlook
- First-Mover Domestic Position: As China’s first homegrown dual IL-17A/F biologic, lecankitug holds a differentiation edge over imported IL-17A inhibitors and competing domestic biosimilar strategies
- Head-to-Head Evidence: Superiority versus secukinumab, an established global standard, gives prescribers a clear efficacy rationale in a crowded psoriasis market
- Franchise Expansion: The approval broadens Livzon Pharmaceutical’s (HKG: 1513) innovative biologic portfolio beyond its traditional small-molecule and diagnostic strengths
- Partnership Model: The joint development with Beijing Kanova Biopharma illustrates the China biopharma trend of co-development partnerships sharing risk across discovery and commercialization
Forward‑Looking Statements – This brief contains forward-looking statements regarding commercial adoption, market competition, and portfolio outlook. Actual results may differ materially due to pricing, reimbursement, and competitive dynamics. Not investment advice.-Fineline Info & Tech