中国抗体-B(03681)：SM17新药研究申请获国家药品监督管理局药品审评中心受理

Core Viewpoint - China Antibody-B (03681) has submitted an Investigational New Drug (IND) application for SM17 targeting inflammatory bowel disease (IBD) to the National Medical Products Administration (NMPA), which has been accepted [1] Group 1: Drug Development and Clinical Trials - The IND approval allows the use of data from completed or ongoing Phase 1 clinical trials in healthy volunteers to support the advancement of IBD indications to Phase 2 clinical development [1] - SM17 is currently undergoing a formulation conversion bridging clinical trial, expected to complete by the end of February next year, with plans to enter Phase 2 clinical trials for atopic dermatitis (AD) by mid-2026 [4] Group 2: Mechanism of Action - SM17 is a novel humanized IgG4-k monoclonal antibody that targets the IL-25 receptor to modulate type II inflammatory responses, blocking the signaling cascade induced by IL-25, which is associated with inflammatory bowel diseases [2] - The drug has dual potential benefits in Crohn's disease (CD) by regulating Th17-driven inflammation and exhibiting anti-fibrotic effects, which may help improve complications such as bowel strictures and fistulas [2] Group 3: Market Opportunity and Unmet Medical Needs - IBD, including CD and ulcerative colitis (UC), presents significant unmet medical needs, with existing therapies failing to meet the needs of 20% to 50% of patients due to primary non-response or secondary loss of response [3] - The global annual cost for managing IBD is estimated to exceed $34 billion, highlighting the substantial market opportunity for effective treatments [3] - The expansion of SM17's indications from AD to IBD represents a significant clinical and commercial opportunity to address unmet medical needs in this area [4]