Amubarvimab/Romlusevimab: First Approval

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. S. M. Hoy is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here. 

Abstract

Amubarvimab 安巴韦单抗注射液/romlusevimab 罗米司韦单抗注射液 is a combination of two neutralizing recombinant human IgG1 monoclonal antibodies (amubarvimab and romlusevimab) against the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19). Jointly developed by Brii Biosciences, Tsinghua University and the Third People’s Hospital of Shenzhen, it has been approved (in December 2021) by the National Medical Products Administration of China for the treatment of mild COVID-19 in patients aged ≥ 18 years, and those aged 12–17 years with a bodyweight of ≥ 40 kg (conditional approval) who are at high risk of progressing to severe disease, including hospitalization or death. An Emergency Use Authorization application for amubarvimab/romlusevimab is currently under review in the USA. This article summarizes the milestones in the development of amubarvimab/romlusevimab leading to this first approval for the treatment of COVID-19. 

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