洛利昔珠单抗 T39057

Product Introduction
Bioactivity


英文名: Rozanolixizumab

描述: Rozanolixizumab（RYSTIGGO）是一种针对人类新生儿 Fc 受体（FcRn）的高亲和力人源化免疫球蛋白 G4 单克隆抗体，用于研究自身免疫和同种免疫疾病中致病性 IgG 。

体外活性: Demonstrating similar affinity at both pH 6.0 (Kd 23 pM and 25 pM for human and cynomolgus monkey, respectively) and pH 7.4 (34 pM and 53 pM for human and cynomolgus monkey, respectively), Rozanolixizumab binds to human FcRn and cynomolgus monkey FcRn[1].In a dose-dependent manner, Rozanolixizumab is observed to inhibit the recycling of human IgG by human FcRn-transfected MDCK cells, with an IC50 of 0.41 nM. The recycling of IgG is similarly inhibited in cynomolgus monkey FcRn-transfected MDCK cells (IC50 0.98 nM)[1].Additionally, Rozanolixizumab causes an increase in intracellular IgG AF647[1].

体内活性: Demonstrating non-linear pharmacokinetics indicative of target-mediated drug disposition, intravenous (IV) dosing of rozanolixizumab in cynomolgus monkeys showed that single IV doses (30 mg/kg) reduced plasma IgG concentration by 69% by Day 7 post-administration. Throughout the treatment period of 42 days, daily IV administration of rozanolixizumab (initial 30 mg/kg loading dose; 5 mg/kg daily thereafter) consistently reduced plasma IgG concentrations in all cynomolgus monkeys, maintaining low concentrations[1].

存储条件: store at low temperaturestore at -20°C

关键字: UCB 7665 | UCB-7665 | Rozanolixizumab

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注：该产品未在中华人民共和国食品药品监督管理部门申请医疗器械注册和备案，不可用于临床诊断或治疗等相关用途