智翔金泰GR1803注射液启动一期临床 适应症为系统性红斑狼疮

Group 1 - The core point of the article is the initiation of a clinical trial for GR1803 injection, aimed at evaluating its safety, tolerability, and preliminary efficacy in patients with systemic lupus erythematosus [1] - The clinical trial is an open-label, multi-center Phase Ib/IIa study, with a target enrollment of 44 participants [2] - The drug is a biological product specifically indicated for systemic lupus erythematosus, which is an autoimmune disease affecting multiple systems in the body [1] Group 2 - The trial's primary endpoint includes the assessment of adverse events, while secondary endpoints focus on pharmacokinetic characteristics, immunogenicity, pharmacodynamic indicators, and changes in clinical scores [1] - The drug is administered intravenously with a dosage range of 3 µg/kg to 180 µg/kg over a treatment cycle of 4 weeks [1] - The clinical trial registration number is CTR20254402, with the first public information date set for November 14, 2025 [1]