The approval follows the clearance from China’s National Medical Products Administration in April 2023 for the clinical trial of the SA55 nasal spray in the prevention of Covid-19 infections
Sinovac Biotech will begin clinical trial of the neutralising antibody SA55 nasal spray and injection. (Credit: Viktor Forgacs on Unsplash)
Sinovac Biotech has announced that its anti-Covid-19 antibody SA55 for injection, designed to treat Covid-19 infections, has been approved for clinical trial in China.
The approval follows the clearance from China’s National Medical Products Administration in April 2023 for the clinical trial of the SA55 nasal spray in the prevention of Covid-19 infections.
Sinovac Biotech is engaged in the production of various broad-spectrum neutralising antibody products like anti-Covid-19 antibody SA55 for injection and SA55 nasal spray.
According to the Chinese biopharmaceutical company, the products are designed to fight the mutating strains of the novel coronavirus.
With these approvals, Sinovac Biotech will begin the clinical evaluation of the neutralising antibody SA55 nasal spray and injection.
The neutralising antibody SA55 was discovered by a research team headed by Dr Yunlong Cao, a researcher at Peking University’s Biomedical Pioneering Innovation Centre.
The scientists suggested that broadly neutralising antibody therapies should target non-immunodominant epitopes inside the receptor-binding region to avoid escape mutations brought on by herd immunity.
Sinovac Biotech said that a wide variety of broad-spectrum sarbecovirus neutralising antibodies were detected including SA55 in people who had recovered from SARS and received the SARS-CoV-21 vaccine subsequently.
Additional research highlight SA55’s effectiveness in neutralising the omicron variant and its sublineages, including XBB, XBB.1, and XBB.1.5, said the biopharmaceutical products provider.
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.”
According to Cao, the injection is helpful in the treatment and prevention of severe cases, particularly in elderly and immunocompromised people, or those who are not eligible for vaccination or with poor immune responses.
Furthermore, the company is said to be capable of large-scale production of the broad-spectrum neutralising antibody products in compliance with Good Manufacturing Practice standards.
In July 2021, Sinovac Biotech signed an advance purchase agreement (APA) with COVAX Facility to supply up to 380 million doses of inactivated Covid-19 vaccine CoronaVac.