安巴韦单抗注射液（BRII-196）及罗米司韦单抗注射液（BRII-198）——中国首个自主知识产权新冠病毒中和抗体联合治疗药物

摘要/Abstract

摘要： 2019年年底爆发的新型冠状病毒肺炎（COVID-19，以下简称“新冠肺炎”）疫情仍在全球肆虐，对中国及全球的公共卫生健康乃至经济发展造成严重影响，亟需高效的药物和疫苗用于新冠肺炎的治疗和预防。清华大学、深圳市第三人民医院以及腾盛博药于2020年年初合作，从上百株针对新型冠状病毒（SARS-CoV-2）的人源单克隆抗体中筛选出一对活性较高、具有互补作用的候选中和抗体，通过改造获得了半衰期更长的安巴韦单抗注射液（BRII-196）及罗米司韦单抗注射液（BRII-198）。该抗体组合对目前已有的SARS-CoV-2突变株包括德尔塔突变株、奥密克戎突变株等均显示出较好的中和活性；且全球多款中和抗体参与的国际临床试验ACTIV-2研究的Ⅲ期分析数据显示，该抗体在临床试验研究中显示能够在疾病进展高风险的新冠肺炎门诊患者中，使住院及死亡的复合终点风险降低80%。国家药品监督管理局于2021年12月8日应急批准安巴韦单抗注射液（BRII-196）及罗米司韦单抗注射液（BRII-198）注册申请，该药物将可能满足我国新冠肺炎患者的临床需求以及作为预防SARS-CoV-2感染的候选药物，使我国更从容地应对复杂多变的新冠肺炎疫情。

关键词: font-size:medium, ">新冠肺炎；安巴韦单抗注射液（BRII-196）及罗米司韦单抗注射液（BRII-198）；中和抗体联合治疗药物

Abstract: Corona virus disease 2019 (COVID-19) is still raging around the world and has been threatening the global public health and economy. Efficient drugs and vaccines are urgently needed for COVID-19 prophylactic and protective treatment. Tsinghua University， Shenzhen Third People′s Hospital and Brii Biosciences cooperated in early 2020 and selected a pair of potent and synergistic neutralizing antibodies candidates from hundreds of human monoclonal antibodies against severe acute respiratory syndrome coronavirus 2 （SARS-CoV-2）. The antibody candidates have been modified to BRII-196 (amubarvimab) and BRII-198 (romlusevimab) with longer half-life. The antibody combination showed broadly neutralizing activity against currently existing SARS-CoV-2 variants including Delta and Omicron. BRII-196/BRII-198 combination demonstrated a statistically significant 80% reduction of hospitalization and death and improved safety over placebo in non-hospitalized COVID-19 patients at high risk of clinical progression to severe disease. On December 8,2021, the amubarvimab/romlusevimab(BRII-196/BRII-198) combination was approved the registration application by the National Medical Products Administration (NMPA) of China for the treatment, which it may satisfy the clinical needs of patients with pneumonia and as a candidate drug for the prevention of SARS-CoV-2 infection, to make us more comfortable to deal with the complex and changing COVID-19 situation.

Key words: font-size:medium, ">SARS-CoV-2； COVID-19； Amubarvimab (BRII-196) and romlusevimab (BRII-198)； Neutralizing antibodies combination therapy

中图分类号:

单思思, 王若珂, 张绮, 张林琦. 安巴韦单抗注射液（BRII-196）及罗米司韦单抗注射液（BRII-198）——中国首个自主知识产权新冠病毒中和抗体联合治疗药物[J]. 中国医药导刊, 2022, 24(1): 2-8.

SHAN Sisi, WANG Ruoke, ZHANG Qi, ZHANG Linqi. China′s First Approved Novel Neutralizing Antibody Combination Therapy Against SARS-Cov-2——BRII-196/BRII-198[J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2022, 24(1): 2-8.

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