By Fineline Cube 
Innovent Biologics, Inc. (HKG: 1801) announced that PECONDLE (picankibart injection, IBI112), its self‑developed anti‑IL‑23p19 monoclonal antibody, achieved both primary and key secondary endpoints in the Phase 3 CLEAR‑2 study, a randomized withdrawal and retreatment trial in Chinese patients with moderate‑to‑severe plaque psoriasis.
CLEAR‑2 Study Design
| Parameter | Details |
|---|---|
| Trial ID | NCT06049810 |
| Design | Prospective, multicenter, randomized, double‑blind, placebo‑controlled Phase 3 with withdrawal/retreatment |
| Population | Chinese participants with moderate‑to‑severe plaque psoriasis; N = 566 |
| Treatment Phase | All participants received picankibart through Week 32 |
| Randomization | Responders achieving PASI 90 at Week 32 were re‑randomized at Week 32 to: • Maintenance: picankibart 100 mg or 200 mg • Withdrawal: placebo |
| Primary Endpoint | Proportion maintaining PASI 90 at Week 56 |
| Key Secondary Endpoints | PASI 75, PASI 100, sPGA 0/1, sPGA 0, DLQI 0/1 at Week 56 |
Efficacy Results at Week 56
| Endpoint | Picankibart 100 mg Maintenance | Picankibart 200 mg Maintenance | Corresponding Withdrawal Group | P‑value |
|---|---|---|---|---|
| PASI 90 (Primary) | 89.3% | 90.1% | 37.7% (100 mg cohort) 51.7% (200 mg cohort) | < 0.0001 (both) |
| PASI 75 | 94.1% | 95.3% | 48.2% / 62.1% | < 0.0001 |
| PASI 100 | 65.7% | 68.4% | 12.3% / 18.9% | < 0.0001 |
| sPGA 0/1 | 91.2% | 92.5% | 42.1% / 55.8% | < 0.0001 |
| sPGA 0 | 58.9% | 61.2% | 9.8% / 14.5% | < 0.0001 |
| DLQI 0/1 | 71.3% | 73.6% | 22.4% / 31.2% | < 0.0001 |
Robust data demonstrate that quarterly dosing of PECONDLE provides sustained and reliable superior efficacy compared to treatment withdrawal.
Market Opportunity & Competitive Landscape
| Metric | Value | Implication |
|---|---|---|
| China Psoriasis Prevalence | ~ 6.5 million moderate‑to‑severe patients (2024) | Growing diagnosis rate; < 15% receive biologics |
| China IL‑23/IL‑17 Market Size | ¥4.2 billion (≈ US$585 M) | Dominated by Skyrizi (AbbVie) and Tremfya (J&J) |
| PECONDLE Differentiation | Quarterly dosing (vs. Skyrizi q8w, Tremfya q8w); local manufacturing cost advantage | |
| Peak Sales Forecast (2030) | ¥1.8‑2.2 billion (≈ US$250‑305 M) | 12‑15% share of IL‑23 class, driven by dosing convenience |
| Regulatory Status | NMPA approved Nov 2025 for moderate‑to‑severe plaque psoriasis; NRDL negotiation slated for 2026 |
Strategic Implications
- For Innovent: CLEAR‑2 data support long‑term maintenance strategy and differentiate PECONDLE in a crowded IL‑23 market; validates clinical retreatment paradigm for patients requiring drug holidays.
- For Physicians: Quarterly dosing reduces treatment burden and aligns with patient preference for fewer clinic visits; withdrawal design provides evidence‑based guidance for personalized therapy cycles.
- For Payers: Robust maintenance vs. withdrawal data strengthen value‑based pricing arguments for NRDL inclusion, potentially securing 30‑40% discount to imported IL‑23 agents.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding PECONDLE’s commercial rollout, NRDL negotiations, and competitive positioning. Actual results may differ due to pricing pressures, market access delays, or competitive responses.-Fineline Info & Tech