Innovent's PECONDLE Delivers Durable Efficacy And Safety In Phase 3 Psoriasis Trial

Innovent Biologics’ PECONDLE (picankibart), the first China-developed IL-23p19 monoclonal antibody approved by the NMPA in November 2025, met the primary and key secondary endpoints in the Phase 3 CLEAR-2 randomized withdrawal/retreatment trial in 566 Chinese patients with moderate-to-severe plaque psoriasis. At Week 56, PASI 90 was maintained in 89.3% (100 mg) and 90.1% (200 mg) of maintenance patients versus 37.7% and 51.7% in withdrawal groups (P < 0.0001); all secondary endpoints (PASI 75/100, sPGA 0/1, DLQI 0/1) were also significantly superior and maintenance dosing markedly reduced relapse risk, while median durability off treatment was 20.4–24.6 weeks and nearly half of withdrawal patients remained PASI 90 at 24 weeks, suggesting disease‑modifying potential. The safety profile was consistent with prior trials with no new signals, reinforcing picankibart’s durable quarterly-dosing profile and supporting its commercial positioning in China’s systemic psoriasis market.

Analysis

Innovent Biologics reported that PECONDLE (picankibart), its China‑developed IL‑23p19 monoclonal antibody approved by the NMPA in November 2025, met both the primary and all key secondary endpoints in the Phase 3 CLEAR‑2 randomized withdrawal/retreatment trial in 566 Chinese patients with moderate‑to‑severe plaque psoriasis. The primary endpoint—maintenance of PASI 90 at Week 56—was achieved by 89.3% of the 100 mg maintenance group and 90.1% of the 200 mg group versus 37.7% and 51.7% in the respective withdrawal arms (P < 0.0001), demonstrating a large and statistically robust durability benefit from maintenance dosing.

All key secondary endpoints (PASI 75, PASI 100, sPGA 0/1, sPGA 0, and DLQI 0/1) were significantly superior in maintenance versus withdrawal (P < 0.0001), and median durability off treatment in withdrawal arms was 20.4 and 24.6 weeks with nearly half of withdrawal patients still PASI 90 at 24 weeks, indicating potential disease‑modifying characteristics and support for quarterly dosing.

Safety remained consistent with prior trials with no new signals observed. The clinical profile—durable quarterly efficacy, deep clearance rates, and an NMPA approval—supports a favorable commercial positioning in China, but investor impact will hinge on real‑world uptake, pricing, reimbursement and competitive dynamics; sentiment metrics in the report are strongly positive (0.75) with a moderate market impact score (0.5).

Key Decisions for Investors

• Consider increasing exposure to Innovent Biologics (HKEX:01801) on the strength of statistically robust Phase 3 efficacy and recent NMPA approval, while sizing positions to reflect commercialization and execution risk
• Monitor early commercial metrics closely—launch uptake, list price negotiations and payer/reimbursement decisions in China should be treated as primary catalysts for revenue realization
• Track post‑marketing safety data and real‑world durability; any emerging safety signals or materially different real‑world effectiveness versus trial results should prompt reassessment
• Adopt a phased entry or hedged position ahead of initial sales and payer milestones given a moderately positive market impact and the potential for competitive IL‑23 entrants to influence market share