Core Viewpoint - Innovent Biologics has received approval from China's National Medical Products Administration (NMPA) for PECONDLE (picankibart injection), a novel treatment for moderate-to-severe plaque psoriasis, marking a significant advancement in the management of this chronic condition in China [1][5]. Company Overview - Innovent Biologics is a leading biopharmaceutical company founded in 2011, focusing on developing high-quality medicines for various diseases, including oncologic, autoimmune, cardiovascular, and metabolic conditions [11]. - The company has launched 17 products and has multiple assets in clinical trials, indicating a robust pipeline and commitment to innovation [11]. Product Details - PECONDLE (picankibart injection) is the first IL-23p19 monoclonal antibody independently developed by a Chinese enterprise, targeting the IL-23p19 subunit to treat moderate-to-severe plaque psoriasis [9][10]. - The product has shown superior efficacy in clinical trials, with over 80% of subjects achieving a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at Week 16 [5][6]. - The dosing interval for PECONDLE is once every 12 weeks during the maintenance period, which is the longest among comparable biologics, enhancing patient convenience [5][6]. Clinical Trial Insights - The approval was based on the CLEAR-1 Phase 3 clinical trial, which demonstrated significant efficacy and safety in Chinese participants with moderate-to-severe plaque psoriasis [4][6]. - At Week 16, the picankibart group showed a PASI 90 achievement rate of 80.3% and a sPGA 0/1 rate of 93.5%, significantly higher than the placebo group [6]. - The overall safety profile of picankibart was favorable, with upper respiratory tract infections being the most common adverse event, consistent with other IL-23p19 agents [6]. Market Context - The prevalence of psoriasis in China exceeds 7 million, with plaque psoriasis being the most common form, affecting quality of life and mental health [2][8]. - The treatment landscape for moderate-to-severe plaque psoriasis has shifted towards precision therapies, with a focus on long-term maintenance and improved quality of life [3][4].