[One Picture, One Medicine] From Sotrovimab to see the new coronavirus neutralizing antibody and its competitive landscape

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Sotrovimab is a new coronavirus neutralizing antibody, a recombinant human immunoglobulin, which is highly conserved on the receptor binding domain (RBD) of the new coronavirus spike protein (S) Position binding, using Xencor'sXtend™ Fc technology to increase lung bioavailability, developed by VirBiotechnology in cooperation with GlaxoSmithKline [1]
.

On August 26, 2021, it was temporarily approved by the Therapeutic Goods Administration (TGA) of Australia for adults and adolescents (12 years and older, weighing at least 40Kg) COVID-19 patients [2]
.

On a global scale, emergency use authorization was obtained in the United States on May 26, 2021[3], and positive opinions from the European Commission for Human Medical Products (CHMP) were obtained, and in Canada, Egypt, Italy, South Korea, Brazil, Kuwait, Qatar, Singapore And the United Arab Emirates obtained temporary authorization
.

As of September 9, 2021, the new crown epidemic has caused the cumulative number of confirmed diagnoses worldwide to exceed 200 million, and the cumulative death toll has exceeded 4 million
.

The entry of SARS-CoV-2 virus into host cells is mediated by the transmembrane spike (S) glycoprotein.
The S protein is a homotrimeric structure and contains two functional subunits S1 and S2.
Human hACE2 binds, and the S2 subunit mediates the fusion of viral and cell membranes
.

In 2003, when analyzing the memory B cells of a recovered patient infected with SARS-CoV-1, a neutralizing antibody called S309 was discovered.
S309 is the predecessor of sotrovimab
.

The approval of Sotrovimab is based on a review of the interim analysis of the data from the COMET-ICE clinical trial (NCT04545060) Phase 1/2/3.
This is a randomized, double-blind, placebo-controlled clinical trial with more than hospitalizations for all causes on day 29.
The relative mortality at 24 hours or for any reason (adjusted) was significantly lower than placebo by 79% [95% CI (50%-91%)], reaching the primary endpoint of the trial [2]
.

In March 2021, Vir and GSK jointly announced that based on the positive interim analysis results, the Independent Data Monitoring Committee (IDMC) recommended early termination of Phase III clinical trials
.

The continuous evaluation of Sotrovimab shows that it retains the activity against the currently circulating SARS-CoV-2 virus and various variants (including: Alpha (B.
1.
1.
7), Beta (B.
1.
351), Delta (B.
1.
617.
2), Epsilon (B.
1.
427/B.
1.
429), Gamma (P.
1), Iota (B.
1.
526), ​​Kappa (B.
1.
617.
1) and Lambda (C.
37), and from Bristol (B.
1.
1.
7+E484K) and Cameroon (B.
1.
619) new variants)
.

For details of Sotrovimab (XEVUDY) and the competitive landscape of new coronavirus neutralizing antibodies, see the picture below: (click to enlarge) You can also click the link below to get the corresponding PDF HD version: https://data.
pharmacodia.
com/v3/insight/# /ListPdf?tag=2 Reference materials 1.
Yaodu data https://data.
pharmacodia.
com.
2.
Australian Public Assessment Report for Sotrovimab: https:// -sotrovimab-210820.
pdf 3.
FDA issuean Emergency Use Authorization (EUA) for the emergency use of sotrovimab: https://