Core Viewpoint - China Antibody-B (03681) has received approval from the National Medical Products Administration (NMPA) for the clinical trial application (IND) of its first-in-class (FIC) therapeutic product SM17 for treating inflammatory bowel disease (IBD) patients, marking a significant milestone in expanding its treatment scope from atopic dermatitis (AD) to IBD, which includes Crohn's disease (CD) and ulcerative colitis (UC) [1][2] Group 1 - SM17 is a novel, FIC 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] - The mechanism of SM17 involves binding to the IL-25 receptor on the surface of type II innate lymphoid cells (ILC2s) and Th2 cells, inhibiting IL-25 mediated signaling, and downregulating downstream inflammatory cytokines such as interleukin-4, interleukin-5, and interleukin-13 [2] - SM17's multi-mechanism characteristics differentiate it from existing single-pathway therapies, providing a new treatment option for refractory or complex phenotype patients [2][3] Group 2 - The company has completed follow-up for the Phase I bridging study of the subcutaneous formulation of SM17 in healthy volunteers, with data supporting the advancement of IBD indications into Phase II clinical development [1] - The company expects to complete the bridging study from intravenous to subcutaneous administration by the first quarter of this year and plans to initiate Phase II clinical trials for AD by the second quarter [2] - The expansion of SM17's indications from AD to IBD is viewed as a significant opportunity to address unmet medical needs in a clinically and commercially valuable area [2][3]
中国抗体-B：SM17用于治疗IBD的IND获NMPA批准