Innovent's NDA for Picankibart in Treating Plaque Psoriasis Accepted by NMPA

Innovent Biologics, Inc., a prominent biopharmaceutical company, has announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for picankibart injection. Picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, is proposed for the treatment of moderate to severe plaque psoriasis. Notably, picankibart is the pioneering IL-23p19 antibody drug to achieve over 80% of subjects attaining PASI 90 after 16 weeks of treatment in a Phase 3 clinical trial. Additionally, it offers the longest maintenance dosing interval of once every 12 weeks among similar biologics. This is expected to significantly benefit Chinese patients by providing improved skin lesion clearance, enhanced medication convenience, and a better quality of life.

The NDA submission is underpinned by successful outcomes from the Phase 3 clinical study CLEAR-1 (NCT05645627) involving Chinese patients with moderate to severe plaque psoriasis. The study met its primary and all key secondary endpoints in May 2024, demonstrating notably 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 the placebo group. Picankibart also exhibited a favorable safety profile with no new safety concerns. Detailed data from the CLEAR-1 study will be shared at forthcoming academic conferences and published in scholarly journals.

Professor Yulin Shi, the principal investigator of the clinical study from Shanghai Skin Disease Hospital, emphasized the chronic and incurable nature of psoriasis, which significantly impacts patients' physical and mental health. Effective treatment options are crucial for managing the condition, reducing comorbidities, and improving quality of life. Professor Shi highlighted that IL-23p19-targeted antibodies like picankibart provide advantages in maintaining long-term efficacy and treatment convenience.

Dr. Lei Qian, Vice President of Clinical Development at Innovent, expressed gratitude for the regulatory acceptance of the NDA for picankibart. Dr. Qian noted that picankibart is the first IL-23p19 antibody drug independently developed by a Chinese company to submit an NDA in China. Given its efficacy, safety, and extended maintenance dosing, picankibart represents a best-in-class potential. Innovent aims to maintain active communication with regulatory authorities during the NDA review process to offer a safe and effective treatment option for Chinese patients with moderate to severe psoriasis. The company emphasizes product lifecycle management and plans to validate the clinical value of picankibart through multiple clinical studies, addressing unmet needs for patients with drug resistance or relapse. Innovent continues to expand its innovative portfolio in areas such as ophthalmology, autoimmune diseases, and cardiovascular and metabolic conditions.

Psoriasis is a chronic, recurrent, and inflammatory disease influenced by genetic and environmental factors, affecting individuals of all ages and genders. It is characterized by scaly erythema or plaques, which are noninfectious and may be localized or widespread. Psoriasis can be categorized into various forms, with plaque psoriasis being the most common, affecting 80% to 90% of patients. In China, the prevalence of psoriasis is significant, with over 7 million patients. Since 2019, biological agents, particularly IL-23 inhibitors, have become central to psoriasis treatment due to their rapid onset, robust efficacy, good safety, and long-lasting effects.

Picankibart (IBI112) is a monoclonal antibody developed by Innovent that specifically targets the IL-23p19 subunit, preventing IL-23 from binding to cell surface receptors. It offers a promising treatment option for psoriasis, ulcerative colitis, and other autoimmune diseases. Several clinical studies of picankibart are currently in progress, including Phase 3 and Phase 2 studies for moderate to severe plaque psoriasis and ulcerative colitis. The NMPA accepted the first NDA for picankibart in September 2024 for the treatment of moderate to severe plaque psoriasis.

Innovent, founded in 2011, aims to provide affordable, high-quality biopharmaceuticals globally. The company focuses on innovative medicines that target cancer, cardiovascular and metabolic, autoimmune, and eye diseases. Innovent has launched multiple products and has several drug applications under regulatory review along with numerous assets in clinical trials. The company collaborates with over 30 global healthcare organizations, maintaining a commitment to high industry standards and widespread accessibility to first-rate pharmaceutical drugs.