Written By: Pharmacally Medical News Desk
Innovent Biologics’ PECONDLE® (picankibart injection) marks China’s first domestically developed IL-23p19 monoclonal antibody approved by the National Medical Products Administration (NMPA) for moderate-to-severe plaque psoriasis in adults eligible for systemic therapy.
The approval is based on the pivotal Phase 3 CLEAR-1 trial (NCT05645627) in Chinese patients with moderate-to-severe plaque psoriasis. At week 16, 80.3% of picankibart-treated patients achieved PASI 90 (90% improvement in Psoriasis Area and Severity Index), compared to 2.0% on placebo, while 93.5% reached sPGA 0/1 (clear or almost clear skin) versus 13.1% on placebo. Efficacy remained stable through week 52 with every-12-week maintenance dosing at 100 mg or 200 mg, outperforming placebo in PASI 75, PASI 100, DLQI 0/1 (quality of life), and special areas like scalp, nails, palmoplantar, and perineal psoriasis.
Picankibart (IBI112) selectively targets the IL-23p19 subunit to block receptor binding, featuring an engineered Fc region for extended half-life. This enables the longest maintenance interval among comparable biologics once every 12 weeks enhancing patient convenience and compliance over existing options in China. Safety aligns with other IL-23p19 agents, with upper respiratory tract infection as the most common adverse event and no new signals identified.
Picankibart advances in trials for ulcerative colitis (Phase 2 met endpoint), biologic-failed psoriasis (CLEAR-2/3), adolescent psoriasis, and psoriatic arthritis. Innovent, a leader in biologics with 17 marketed products, positions PECONDLE as a best-in-class option for autoimmune diseases, addressing over 7 million Chinese psoriasis patients.
Professor Shi Yuling, Principal Investigator of CLEAR-1 at Shanghai Skin Disease Hospital, Tongji University School of Medicine, said, “Psoriasis profoundly impacts patients’ physical, mental health, and quality of life, requiring effective treatments to control disease, reduce comorbidities, and ensure long-term efficacy.” She added that picankibart demonstrates superior short- and long-term efficacy in CLEAR-1, with every-12-week dosing enhancing compliance, safety, and quality-of-life benefits as China’s first domestically developed IL-23p19 antibody.
Dr. Lei Qian, Chief R&D Officer of General Biomedicine at Innovent Biologics, said, “Picankibart is honored as China’s first domestically approved IL-23p19 antibody, showing rapid skin clearance, quality-of-life improvements, stable long-term efficacy, and favorable safety in CLEAR-1.” He noted its best-in-class potential with convenient dosing, serving as Innovent’s autoimmune backbone while advancing lifecycle management for unmet needs like drug resistance.
References
China’s First Domestic IL-23p19 Monoclonal Antibody: Innovent’s PECONDLE® (Picankibart Injection) Received NMPA Approval, 28 November 2025, Innovent, https://en.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=565