Innovent Announces NMPA Acceptance of NDA for Picankibart (Anti-IL-23p19 Antibody) for Treating Moderate to Severe Plaque Psoriasis

SAN FRANCISCO and SUZHOU, China, Sept. 26, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that the New Drug Application (NDA) for picankibart injection, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of moderate to severe plaque psoriasis. Picankibart is the first IL-23p19 antibody drug to show over 80% of subjects achieving PASI 90 after 16 weeks of treatment in a registrational Phase 3 clinical trial. It also offers the longest maintenance dosing interval (once every 12 weeks) among the same class of biologics. Picankibart is expected to deliver comprehensive benefits, including skin lesion clearance, improved medication convenience and enhanced quality of life for Chinese patients with moderate to severe plaque psoriasis.

This NDA acceptance is based on positive results from the Phase 3 registrational clinical study CLEAR-1 (NCT05645627) in Chinese patients with moderate to severe plaque psoriasis. The study successfully met its primary and all key secondary endpoints in May 2024, showing significantly higher rates of skin lesion clearance (PASI 90, PASI 75, PASI 100, sPGA 0/1, and sPGA 0) and quality of life improvement (DLQI 0/1) in the picankibart group compared to placebo. Picankibart showed a favorable safety profile, with no new safety signals. Detailed data from the CLEAR-1 study will be presented at future academic conferences and published in academic journals.

Professor Yulin Shi, the principal investigator of the clinical study, Shanghai Skin Disease Hospital, stated, "Psoriasis is a chronic, incurable disease that impacts both the physical and mental health, as well as the quality of life, of patients. Selecting effective treatment options is essential for managing the condition, reducing comorbidities, sustaining long-term therapeutic benefits, and improving overall quality of life. Evidence indicates that IL-23p19-targeted antibodies offer advantages in maintaining long-term efficacy and treatment convenience, which Picankibart has clearly demonstrated in clinical trials. Along with fellow investigators in the study, I'm proud of its NDA submission in China, and we are hopeful for the approval of picankibart to benefit Chinese patients with psoriasis."

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated, "We are honored to have received the regulatory acceptance of the NDA for picankibart, thanks to dedication of participants, investigators and regulatory authorities. This marks the first IL-23p19 antibody drug independently developed by a Chinese enterprise to submit an NDA in China. Considering its efficacy, safety, and long-interval maintenance dosing, picankibart demonstrates best-in-class potential. We will maintain active communication with regulatory authorities during the NDA review, aiming to provide a safe and effective treatment option for Chinese patients with moderate to severe psoriasis. Meanwhile, we emphasis on product lifecycle management and will validate more clinical value of picankibart in multiple clinical studies and hope to fulfill unmet needs for patients that have developed drug-resistance or relapse. Innovent continues 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 included 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, 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 Picankibart (IBI112)

Picankibart (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.

Currently, multiple clinical studies of Picankibart are underway, including:

• Phase 3 study conducted in patients with moderate to severe plaque psoriasis (CLEAR-1), which has reached the study endpoints in May 2024;
• Phase 3 study conducted in patients with moderate to severe plaque psoriasis with randomized withdrawal and re-treatment;
• Phase 2 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;

In September 2024, the NMPA accepted the first NDA for picankibart for the treatment of moderate to severe plaque psoriasis.

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 11 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, 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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source: Innovent Biologics