China's First Domestic IL-23p19 Monoclonal Antibody: Innovent's PECONDLE® (Picankibart Injection) Received NMPA Approval

• PECONDLE^® (picankibart injection) has received approval from China's National Medical Products Administration (NMPA) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systematic therapy.
• PECONDLE^® is the world's first IL-23p19 antibody whose registrational Phase 3 clinical trial met its primary endpoint with over 80% of subjects achieving a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at Week 16.
• Among comparable biologics, PECONDLE^® offers the longest dosing interval during the maintenance period (once every 12 weeks). It is poised to provide Chinese patients with moderate-to-severe plaque psoriasis comprehensive benefits, including significant skin clearance, improved quality of life, and enhanced dosing convenience.

SAN FRANCISCO and SUZHOU, China, Nov. 28, 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 China's National Medical Products Administration (NMPA) has approved PECONDLE^® (picankibart injection), a recombinant anti-interleukin-23p19 subunit (IL-23p19) antibody, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systematic therapy.

At present, the number of patients with psoriasis in China exceeds 7 million, among which the number of plaque psoriasis patients is the large, and the disease is characterized by chronicity and recurrence, often accompanied by itching, pain, scaling and changes in appearance, which significantly affect quality of life and mental health. In addition to skin involvement, patients often experience comorbidities such as cardiometabolic risk (hypertension, dyslipidemia, obesity, abnormal glucose and lipid metabolism, etc.) as well as depression and anxiety, all of which contribute to a long-term medical and economic burden to individuals and society.

In recent years, the treatment of moderate-to-severe plaque psoriasis has evolved from traditional systemic therapies to a new era of precision therapy driven by biological agents and small molecule-targeted drugs. The treatment goal has shifted from achieving a PASI improvement of ≥ 75% (PASI 75) to achieving PASI 90/100, along with a marked improvement in quality of life (DLQI 0/1) . At the same time, more attention has been paid to the long-term maintenance and efficacy in special areas (scalp, nail, palmoplantar and perineal). PECONDLE® (picankibart injection) is a next‑generation, domestically developed IL-23p19 monoclonal antibody with an innovatively engineered Fc region that extends its half-life. It has demonstrated superior efficacy in skin lesions clearness and supports longer maintenance dosing intervals than currently available biologics in China^[1,2], delivering a new treatment option for patients with plaque psoriasis.

This approval was based on a pivotal registrational Phase 3 clinical trial, CLEAR-1 (NCT05645627), which evaluated the efficacy and safety of picankibart in Chinese participants with moderate-to-severe plaque psoriasis. The study results showed that:

• At week 16, the proportion of participants achieving PASI 90 (80.3%) and sPGA 0/1 (93.5%) was significantly higher in the picankibart group than in the placebo group (2.0% and 13.1%, p < 0.0001 for both);
• At week 52, the proportions of participants achieving PASI 90 and sPGA 0/1 in the picankibart 100 mg and 200 mg q12w maintenance treatment groups were stable and maintained at a high level;
• The proportion of participants who achieved PASI 75, PASI 100, sPGA 0, and DLQI 0/1 was significantly higher in the picankibart group than in the placebo group (p < 0.0001), and picankibart showed varying degrees of improvement in psoriasis in special areas (scalp, nail, palmoplantar and perineal);
• The overall safety of picankibart was favorable. The most common adverse events (AEs) was upper respiratory tract infection, which was consistent with the safety profile of other IL-23p19 agents. No new safety signals were identified.

Professor Shi Yuling, Principal Investigator of CLEAR-1, Shanghai Skin Disease Hospital, stated, "Psoriasis is a lifelong disease that has a profound impact on patients' physical and mental health and quality of life. Although there is no radical cure, it is crucial to select more effective and individualized treatment options for patients to control the disease, reduce the risk of comorbidities, maintain long-term efficacy, and comprehensively improve quality of life. Current evidences have suggested that antibodies targeting IL-23p19 have significant advantages in long-term efficacy maintenance and treatment convenience. As the first IL-23 p19 monoclonal antibody independently developed by a Chinese enterprise, picankibart has shown significant short-term efficacy and maintained long-term efficacy in CLEAR-1; administration once every 12 weeks during the maintenance period further improves the medication convenience and compliance of patients; while bringing significant clinical benefits and improvement in quality of life, it also shows favorable safety. The investigators of this study and I are very pleased that picankibart's pivotal clinical study results in psoriasis have received approval from national regulatory authorities, leading to its market authorization. This milestone brings a promising new treatment option for patients with psoriasis in China."

Dr. Lei Qian, Chief R&D Officer of General Biomedicine of Innovent Biologics, stated, "We are honored that with the dedication of participants, investigators and regulatory authorities, picankibart^®(picankibart) has been officially approved, and has become the first approved IL-23p19 antibody drug independently developed by Chinese enterprises. The pivotal registration study CLEAR-1 showed that picankibart can rapidly clear skin lesions, significantly improve quality of life, maintain stable efficacy for a long time, and has a favorable safety profile. With its balance of efficacy and safety and convenient long-interval maintenance dosing, picankibart demonstrates strong potential as a best-in-class treatment. As the first and backbone drug of Innovent's innovative pipeline in the field of autoimmunity, picankibart will provide a new treatment option for the majority of psoriasis patients. We are also promoting lifecycle management and building comprehensive clinical evidence by exploring outcomes after randomized withdrawal and switching to picankibart from other biological products, aiming to address unmet clinical needs such as drug resistance and disease recurrence. Innovent will continue to expand its innovative portfolio in ophthalmology, autoimmune diseases, and cardiovascular and metabolic (CVM) conditions, with the aim to help more people achieve healthier lives."

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 and biological agents. Since 2019, biologics have become a central focus in psoriasis treatment in China, with IL-23 inhibitors distinguished by their target precision, rapid onset, robust efficacy, favorable safety profile, and durable effects. These agents offer significant advantages in achieving comprehensive and deep lesion clearance, as well as in prolonging relapse-free periods.

About PECONDLE^® (picankibart injection)

Picankibart (R&D code:IBI112) 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:

• CLEAR-1: A Phase 3 clinical study in patients with moderate-to-severe plaque psoriasis;
• CLEAR-2: A Phase 3 clinical study in patients with moderate-to-severe plaque psoriasis with randomized withdrawal and re-treatment;
• CLEAR-3: A Phase 3 clinical study (CLEAR-3) in patients with moderate to severe plaque psoriasis who were previously treated with biologics;
• A Phase 2 clinical study in patients with moderate to severe plaque psoriasis who were previously treated with biologics;
• A Phase 2 clinical study in patients with moderately to severely 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 Biologics

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 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Sanofi, Incyte, 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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SOURCE Innovent Biologics