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Drugs. 2021 Dec;81(18):2133-2137. doi: 10.1007/s40265-021-01626-7.
Regdanvimab (Regkirona™) is a recombinant human monoclonal antibody targeted against the severe acute respiratory syndrome coronavirus 2. It is being developed by Celltrion Inc. for the treatment of coronavirus disease 2019 (COVID-19). In September 2021, regdanvimab received full approval in South Korea for the treatment of COVID-19 in elderly patients aged > 50 years with at least one underlying medical condition (obesity, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, chronic liver disease, and patients on immunosuppressive agents) and mild symptoms of COVID-19 and in adult patients with moderate symptoms of COVID-19. This article summarizes the milestones in the development of regdanvimab leading to this first approval for COVID-19.
雷姆昔韦单抗（Regkirona™）是一种针对严重急性呼吸综合征冠状病毒 2 的重组人源单克隆抗体。它由赛尔群公司开发，用于治疗 2019 冠状病毒病（COVID-19）。2021 年 9 月，雷姆昔韦单抗在韩国获得全面批准，用于治疗 50 岁以上至少有一种基础疾病（肥胖、心血管疾病、慢性肺病、糖尿病、慢性肾病、慢性肝病和接受免疫抑制剂治疗的患者）和 COVID-19 轻症的老年患者，以及 COVID-19 中度症状的成年患者。本文总结了雷姆昔韦单抗开发过程中的重要里程碑，最终使其获得 COVID-19 的首次批准。
