三生国健626启动Ib/II期临床 适应症为系统性红斑狼疮

Group 1 - The core point of the news is that Sangamo Therapeutics has initiated a Phase Ib/II clinical trial for SSGJ-626, a humanized monoclonal antibody injection targeting BDCA2, aimed at evaluating its safety, efficacy, pharmacokinetics, and immunogenicity in systemic lupus erythematosus (SLE) patients [1][2] - The clinical trial is registered under CTR20253492, with the first public information date set for September 1, 2025 [1] - The drug is administered via subcutaneous injection at dosages ranging from 100 mg to 400 mg, with a treatment duration of either 16 or 20 weeks [1] Group 2 - The primary endpoints for the trial include safety assessments during the Ib phase over 32 weeks and the proportion of SLE responders based on the SLE Response Index - 4 (SRI-4) during the II phase over 24 weeks [2] - Secondary endpoints involve various SRI metrics, disease activity changes from baseline, pharmacokinetic endpoints, and immunogenicity assessments, evaluated at multiple time points throughout the study [2] - The trial is currently ongoing, with a target enrollment of 198 participants in China [2]