Sinovac Biotech, a provider of biopharmaceutical products, has secured approval to undertake clinical trial in the country for its anti-Covid-19 antibody SA55 Injection.
It received the approval on 24 May and it comes following the approval from the National Medical Products Administration (NMPA) in April this year for the clinical trial of SA55 Nasal Spray in preventing Covid-19 infections.
Sinovac, based in Beijing, China, has been developing many wide-spectrum neutralising antibody products, including the Anti-COVID-19 Antibody SA55 for Injection and SA55 Nasal Spray, in an effort to combat the mutating strains of the coronavirus.
The neutralising antibody SA55 was developed by a research team led by Dr Yunlong Cao, a researcher at Peking University’s Biomedical Pioneering Innovation Center.
SA55 was discovered within a large list of wide-spectrum sarbecovirus neutralising antibodies found in those individuals who had recovered from SARS and were later vaccinated against SARS-CoV-21.
Further studies underline the efficacy of SA55 in neutralizing the omicron variant and its sublineages, such as XBB, XBB.1, and XBB.1.52.
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In a recent interview with Science and Technology Daily, Dr. Yunlong Cao said: “SA55 is almost absent in the current population immunity and is currently the only antibody in clinical development that is effective against all known circulating strains of the novel coronavirus.”
Cao added that the injection can be useful in treating and preventing severe cases, especially the elderly and immunocompromised individuals, or those who are not eligible for getting vaccination or suffering with poor immune responses.
Following the latest approvals, Sinovac will commence clinical trials for the injection and nasal spray forms of the SA55 neutralising antibody.
Sinovac stated that it is equipped for large-scale manufacturing of the wide-spectrum neutralising antibody products in compliance with Good Manufacturing Practice standards.
So far, over 2.9 billion doses of CoronaVac, Sinovac’s Covid-19 vaccine, have been shipped across the world.
In July last year, Sinovac Biotech signed a partnership agreement with researchers at the University of Hong Kong Clinical Trials Centre and Gleneagles Hospital Hong Kong to begin a clinical trial of an Omicron-specific Covid-19 inactivated vaccine for usage as a booster.