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

Core Viewpoint - Innovent Biologics has received acceptance for the New Drug Application (NDA) of picankibart injection, an IL-23p19 antibody, for treating moderate to severe plaque psoriasis in China, marking a significant milestone for the company and the treatment landscape in the region [1][2][3]. Company Overview - Innovent Biologics is a leading biopharmaceutical company founded in 2011, focusing on developing high-quality medicines for various diseases, including oncology, autoimmune, cardiovascular, and metabolic conditions [7]. - The company has launched 11 products and has multiple assets in various stages of clinical trials, including 3 new drug applications under regulatory review [7]. Product Details - Picankibart (IBI112) is a monoclonal antibody that targets the IL-23p19 subunit, showing over 80% of subjects achieving PASI 90 after 16 weeks in a Phase 3 clinical trial [1][6]. - The drug offers the longest maintenance dosing interval in its class, administered once every 12 weeks, which enhances patient convenience and quality of life [1][2]. Clinical Study Insights - The NDA acceptance is based on positive results from the CLEAR-1 Phase 3 clinical study, which met all primary and key secondary endpoints, demonstrating significant skin lesion clearance and quality of life improvement compared to placebo [2][3]. - The safety profile of picankibart was favorable, with no new safety signals reported during the trial [2]. Market Context - Psoriasis is a chronic, recurrent inflammatory disease affecting a significant portion of the population, with approximately 80% to 90% of patients having plaque psoriasis, and nearly 30% of these cases classified as moderate to severe [4]. - The global prevalence of psoriasis is notable, with over 7 million patients in China alone, highlighting the potential market for effective treatments like picankibart [4]. Future Directions - Innovent plans to continue its communication with regulatory authorities during the NDA review process and aims to validate more clinical value of picankibart through additional studies [3][6]. - The company is also expanding its innovative portfolio in other therapeutic areas, including ophthalmology and cardiovascular diseases, to address unmet medical needs [3][7].