强生(JNJ.US)first-in-class新药在国内申报上市 CDE将其纳入拟优先审评

Core Viewpoint - Johnson & Johnson's (JNJ) first-in-class drug Icotrokinra has been submitted for market approval in China, targeting moderate to severe plaque psoriasis in adults and children aged 12 and older, marking a significant step in its commercialization process in the country [1][4]. Group 1: Drug Development and Approval - Icotrokinra, an oral peptide drug developed by Johnson & Johnson with an investment of nearly $1 billion from Protagonist, is the first IL-23R antagonist to seek market approval globally [2]. - The drug has already been submitted for approval in the United States and Europe earlier this year, with expectations of peak annual sales exceeding $5 billion [2]. - The Chinese submission has been prioritized for review by the CDE, based on its demonstrated efficacy and safety in multiple international clinical trials [4]. Group 2: Clinical Trial Results - The ICONIC-ADVANCE1 and 2 trials, which are randomized controlled Phase III studies, evaluated the efficacy and safety of Icotrokinra compared to placebo and the first approved TYK-2 inhibitor, deucravacitinib, in moderate to severe plaque psoriasis patients [3]. - Icotrokinra achieved significant primary endpoints at week 16, showing superior skin clearance rates compared to both placebo and deucravacitinib, with a similar incidence of adverse events [3]. - Long-term data from the ICONIC-LEAD study indicated sustained skin clearance and good safety profiles for Icotrokinra at week 52 [4]. Group 3: Future Research and Comparisons - Johnson & Johnson has initiated the Phase III ICONIC-ASCEND study, which aims to demonstrate the superiority of Icotrokinra over the injectable biologic drug ustekinumab in a head-to-head comparison [4].