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Innovent Announces PECONDLE® (Picankibart Injection) Phase 3 Study (CLEAR-2) Meets Endpoints, Delivering Superior Long-Term Management Solution for Moderate-to-Severe Psoriasis
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that that PECONDLE® (picankibart injection, R&D code: IBI112), its self-developed recombinant anti-interleukin-23p19 subunit monoclonal antibody, achieved both primary and key secondary efficacy endpoints in the
About this update from Innovent Biologics, Inc.
[{"type":"text","content":"SAN FRANCISCO and SUZHOU, China, Dec. 8, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that that PECONDLE® (picankibart injection, R&D code: IBI112), its self-developed recombinant anti-interleukin-23p19 subunit monoclonal antibody, achieved both primary and key secondary efficacy endpoints in the Phase 3 CLEAR-2 study – a randomized withdrawal and retreatment clinical trial in Chinese participants with moderate-to-severe plaque psoriasis. As the first China-developed IL-23p19 monoclonal antibody, PECONDLE® received market approval from the National Medical Products Administration (NMPA) in November 2025 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.","length":1006,"tagName":"p"},{"type":"text","content":"This study (NCT06049810) is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial using a randomized withdrawal and retreatment design. It aims to evaluate the efficacy of subcutaneous picankibart in participants with moderate-to-severe plaque psoriasis during maintenance treatment and after withdrawal, following achievement of treatment targets. A total of 566 participants were enrolled and all received picankibart treatment through Week 32. Those who achieved ≥90% improvement in Psoriasis Area Severity Index (PASI 90) at Week 32 were re-randomized either to a maintenance group receiving picankibart 100 mg or 200 mg, or to a withdrawal group receiving placebo. The primary endpoint was the proportion of participants who maintained a PASI 90 response at Week 56. This endpoint objectively quantifies sustained high-level lesion clearance during long-term therapy, establishing a validated measure for efficacy durability and maintenance regimen superiority.","length":1024,"tagName":"p"},{"type":"text","content":"The primary endpoint was met, demonstrating that quarterly dosing of picankibart sustained long-term efficacy superiority","length":126,"tagName":"p"},{"type":"text","content":"At Week 56, the proportions of participants ...