Group 1 - The core point of the news is that China Antibody-B (03681.HK) has submitted a new drug research application (IND) for SM17 targeting inflammatory bowel disease (IBD) to the National Medical Products Administration (NMPA) of China, which has been accepted [1] - The approval of the IND application allows the data from the completed or ongoing Phase 1 clinical trials in healthy volunteers to be used to support the advancement of IBD indications to Phase 2 clinical development [1] - This IND application marks a significant milestone for SM17, expanding its treatment range from atopic dermatitis (AD) to IBD, which includes chronic and debilitating diseases such as Crohn's disease (CD) and ulcerative colitis (UC), addressing significant unmet medical needs [1] Group 2 - SM17 is a novel, globally first humanized IgG4-k monoclonal antibody designed to target the type II immune core "alarmin" molecule interleukin-25 (IL-25) receptor, regulating type II inflammatory responses [2] - By binding to the IL-25 receptor on the surface of type II innate lymphoid cells (ILC2s) and Th2 cells, SM17 can block the signaling cascade induced by IL-25, thereby inhibiting downstream cytokines IL-4, IL-5, and IL-13 [2] - This mechanism positions SM17 as a promising candidate for treating UC, where IL-25 plays a pro-inflammatory role, and it also offers dual potential benefits in CD by regulating Th17-driven inflammation and exerting anti-fibrotic effects, which may help improve complications such as intestinal strictures and fistulas [2]
中国抗体-B(03681.HK)：SM17新药研究申请获药监局药品审评中心受理