SAN FRANCISCO and SUZHOU, China, Dec. 9, 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.
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.
The primary endpoint was met, demonstrating that quarterly dosing of picankibart sustained long-term efficacy superiority
At Week 56, the proportions of participants maintaining PASI 90 response were 89.3% in the 100 mg group and 90.1% in the 200 mg group for picankibart maintenance treatment, both significantly higher than the corresponding withdrawal groups (37.7% and 51.7%, respectively; P < 0.0001 for both). These robust data demonstrate that quarterly dosing of picankibart provides sustained and reliable superior efficacy compared to treatment withdrawal.
All key secondary endpoints were met, with picankibart delivering comprehensive improvements in both skin clearance and quality of life
All secondary efficacy endpoints were successfully met, with significantly higher proportions of participants in the 100 mg and 200 mg picankibart maintenance groups versus the corresponding withdrawal groups achieving PASI 75, PASI 100 (complete skin clearance), sPGA score of 0 or 1, sPGA score of 0 (clear skin), and DLQI score 0/1 (dermatology life quality index) at Week 56 (P < 0.0001 for all comparisons). These results demonstrate that quarterly dosing of picankibart provides comprehensive and durable clinical benefits.
Picankibart demonstrates durable efficacy post-withdrawal and significantly reduces relapse risk with maintenance treatment
At Week 56, PASI 90 response was maintained in both 100 mg and 200 mg maintenance groups, whereas the corresponding withdrawal groups exhibited median efficacy durability of 20.4 weeks and 24.6 weeks (32.4 weeks and 36.6 weeks post-last dose of picankibart), respectively. Maintenance treatment with picankibart 100 mg and 200 mg significantly reduced the risk of losing PASI 90 response compared with the corresponding withdrawal groups (P < 0.0001). As indicated by the primary endpoint, nearly half of the participants in withdrawal groups still maintained skin clearance (PASI 90) even after 24 weeks of treatment discontinuation, confirming picankibart's disease-modifying effect in achieving deep skin clearance for moderate-to-severe psoriasis.
Picankibart demonstrated a favorable safety profile with no new safety signals identified
Throughout the study, picankibart maintained a consistent safety profile, with no new safety signals observed compared to previous clinical trials.
Professor Shi Yuling, the Principal Investigator of the Clinical Study, Shanghai Skin Disease Hospital, stated, "Existing evidence confirms that IL-23p19 antibodies offer sustained long-term efficacy and superior treatment convenience in psoriasis management. The CLEAR-2 study—China's first randomized withdrawal and retreatment trial of a domestically developed IL-23p19 inhibitor (picankibart)—provides critical insight into the necessity of maintenance therapy, the durability of post-withdrawal, and effective retreatment strategies. We're are greatly encouraged by its success in achieving both primary and secondary endpoints, which underscores picankibart's exceptional long-term stability during maintenance therapy and its outstanding sustained response following treatment discontinuation. These results offer crucial assurance for chronic patients with chronic disease while empowering clinicians with evidence-based guidance to optimize long-term management."
Dr. Lei Qian, the Chief R&D Officer of General Biomedicine from Innovent Biologics, stated, "PECONDLE®'s successful Phase 3 CLEAR-2 results validate its core advantages as a next-generation IL-23p19 inhibitor: achieving deep, durable remission through quarterly dosing, coupled with favorable safety and significant quality-of-life improvements. As China's first self-developed IL-23p19 biologic, these breakthrough findings enable us to deliver convenient, patient-friendly treatment options with verified efficacy for moderate-to-severe cases. We'll continue exploring indication expansion through comprehensive lifecycle management, maximizing clinical value while addressing unmet needs such as treatment resistance."
About Psoriasis
Psoriasis is a chronic, recurrent, inflammatory and systemic disease induced by genetic and environmental factors, affecting individuals of all ages and genders. It typically presents as scaly erythema or plaques, with non-infections, localized or widespread distribution. As a life-long noninfectious condition, psoriasis is notoriously difficult to treat. The disease can be categorized into psoriasis vulgaris (including guttate psoriasis and plaque psoriasis), pustular psoriasis, erythrodermic psoriasis and arthropathic psoriasis. Approximately 80%~90% of patients have plaque psoriasis, with nearly 30% of the cases being moderate-to-severe. Global psoriasis prevalence varies significantly, with over 7 million patients in China alone. Current systemic treatments in China include methotrexate (MTX), cyclosporine A, retinoic acids, small molecule target agents and biological agents. Since 2019, biologics have become a central focus in psoriasis treatment, with IL-23 inhibitors standing out due to their rapid onset, robust efficacy, good safety, and long-lasting effects, which are more advantageous in comprehensive and deep lesion clearance and prolonging relapse-free periods.
About PECONDLE® (Picankibart Injection)
PECONDLE® (picankibart injection) is a monoclonal antibody independently developed by Innovent with proprietary intellectual property rights. This product specifically targets the IL-23p19 subunit, preventing IL-23 from binding to cell surface receptors. Picankibart has the potential to offer a more effective treatment option for patients with psoriasis, ulcerative colitis or other autoimmune diseases.
PECONDLE® (picankibart injection) is approved by the NMPA of China for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Currently, multiple clinical studies of picankibart are underway, including:
- Phase 3 study conducted in patients with moderate-to-severe plaque psoriasis (CLEAR-1);
- Phase 3 study conducted in patients with moderate-to-severe plaque psoriasis with randomized withdrawal;
- Phase 3 study in patients with moderate-to-severe plaque psoriasis who were previously treated with biologics;
- Phase 2 study in patients with moderate-to-severe active ulcerative colitis;
Except for the ongoing CLEAR-3 study, all other studies have met their primary endpoints.
In addition, new clinical studies of picankibart in the treatment of adolescent psoriasis and adult psoriatic arthritis are initiated.
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 17 products in the market. It has 1 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Takeda, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Statement:Innovent does not recommend the use of any unapproved drug (s)/indication (s).
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