On May 26, the US Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) to GlaxoSmithKline (GSK) and Vir Biotechnology's sotrovimab (VIR-7831) to treat mild-to-moderate COVID-19 for adult and paediatric COVID-19 patients aged 12 years or above, who are at increased risk for progressing to severe disease, including hospitalisation or death.
At present, the global novel coronavirus epidemic is still severe. Sotrovimab became the fourth novel coronavirus antibody drug approved for emergency use in the United States after Eli Lilly and Regeneron's antibody drug.
In addition to emergency use authorization, currently, there's just one antiviral approved by the FDA to treat COVID-19, which is Remdesivir by Gilead Sciences.
However, in the face of the novel coronavirus, which is still raging and new variants are constantly appearing, current treatment drugs may be even more ineffective. Sotrovimab may provide another effective treatment for novel coronavirus.
Monoclonal antibodies are proteins made in laboratories that mimic the immune system's ability to resist viruses and other harmful antigens. As a monoclonal antibody, Sotrovimab specifically targets the spike protein of SARS-CoV-2, which has the potential to block the virus from entering healthy cells and eliminate infected cells.
Sotrovimab targets a conserved epitope of the spike protein, which is unlikely to mutate over time. It is also designed to achieve high concentrations in the lungs to ensure optimal penetration into the airway tissues affected by SARS-CoV-2 and to extend the half-life. According to relevant data, among high-risk, newly diagnosed COVID-19 patients, Sotrovimab can reduce hospitalization or mortality by 85% compared with placebo. The information submitted for EUA also includes published in vitro research data, which show that Sotrovimab is effective against all known virus variants, including those from Brazil (P.1), California (B.1.427/B.1.429), India (B.1.617), New York (B.1.526), South Africa (B.1.351) and the United Kingdom (B.1.1.7).
In addition to the above-mentioned authorized drugs, the most promising drugs for the treatment of COVID-19 are Molnupiravir jointly developed by Merck and Ridgeback and PF-07321332 developed by Pfizer. Different from the previous injectable drugs, these two drugs can be taken orally at home.
In April, Merck announced they were beginning a Phase 3 clinical trial of molnupiravir for people who have COVID-19 but aren't in the hospital. The companies scrapped plans to use the antiviral candidate in hospitalized COVID-19 patients after deciding that the population is probably too sick to see any benefit from the antiviral. Merck also plans to start a trial in the second half of this year to study whether molnupiravir can prevent infections in people who have been exposed to SARS-CoV-2.
The oral clinical candidate PF-07321332 was identified in July 2020 and began Phase 1 clinical trials in February. During an earnings report earlier in May, Pfizer announced plans to begin a Phase 2/3 trial of PF-07321332 later this year and to apply for an emergency use authorization for the compound before the end of 2021 if those results are positive.
Now, more and more drugs are being developed to treat COVID-19, and more and more vaccines are also in use. We will finally defeat COVID-19. Huateng Pharma has always insisted on making its own contributions to overcome the COVID-19 epidemic. We are focusing on the research and development of intermediates for COVID-19 treatment drug Remdesivir, and we are currently able to provide some of the main intermediates of Remdesivir. At the same time, we can also provide COVID-19 vaccine excipients for your research, such as mPEG-N,N-Ditetradecylacetamide (ALC-0159), mPEG-DMG.
 GSK and Vir Biotechnology Announce Sotrovimab (VIR-7831) Receives Emergency Use Authorization from the US FDA for Treatment of Mild-to-Moderate COVID-19 in High-Risk Adults and Pediatric Patients. Retrieved May 27, 2021, from https://investors.vir.bio/news-releases/news-release-details/gsk-and-vir-biotechnology-announce-sotrovimab-vir-7831-receives
 Corti et al. (2021). Tackling COVID-19 with neutralizing monoclonal antibodies. Cell, https://doi.org/10.1016/j.cell.2021.05.005
 Sotrovimab (VIR-7831), an Investigational Antibody Utilizing Xencor's Xtend™ Technology, Receives U.S. FDA Emergency Use Authorization for the Treatment of COVID-19. Retrieved May 27, 2021, from https://www.businesswire.com/news/home/20210526006159/en