SINOVAC Reports on the Clinical Trial Progress of its Anti-COVID-19 Antibody SA55 Injection
- Sinovac's SA55 Injection shows preliminary safety profile in phase I trial
- Phase II trial expected to enroll 150 patients to evaluate efficacy and safety
- Preliminary results anticipated by year's end
- None.
Clinical trials will advance treatment of COVID-19 infection.
SINOVAC’s SA55 Injection, which is intended for the treatment of COVID-19 infections, was approved for clinical trial in
The phase II clinical trial is a multicenter, randomized, double-blind, placebo-controlled study. It is expected to enroll 150 patients aged 18 and above with mild to moderate COVID-19 infection from nearly 20 medical institutions in
Mr. Weidong Yin, Chairman, President and CEO of SINOVAC, said: “After providing over 2.9 billion doses of SINOVAC’s COVID-19 vaccines to the world, we still expect to address the fast-developing COVID-19 virus mutations with a cutting-edge technology. The neutralizing antibody with broad-spectrum effectiveness is our new tool in our ongoing battle against the persistent threat to human health posed by the COVID-19 virus.”
“We hope that our SA55 injection can continuously make valuable contributions to COVID-19 prevention and control efforts, not only in
The broad-spectrum neutralizing antibody SA55 was founded by a research team led by Dr. Xiaoliang Xie, academician of the Chinese Academy of Sciences and Dr. Yunlong Cao, researcher at Peking University’s Biomedical Pioneering Innovation Center. SA55 injection is a fully humanized antibody, which is screened from the blood of recovered SARS patients who have received three doses of COVID-19 vaccine, and then recombinantly expressed, according to Dr. Xie.
Their studies underscore the SA55’s efficacy in neutralizing the omicron variant and its sublineages, including BA.5, BF.7, BQ.1.1, XBB.1.5, BA.2.86 and the currently dominant strain, EG.5. Xie noted that SA55 is reportedly the only clinical antibody that SARS-CoV-2 hasn’t escaped.
Monoclonal neutralizing antibodies for COVID-19 serve as both treatment and prevention. As a treatment option, their good safety profile and fewer contraindications cater to a broader population than small-molecule drugs for COVID-19.
As a prevention option, they have the advantage of rapidly increasing antibody levels post-administration and enjoy a longer half-life, making them suitable for immunocompromised individuals and those who would otherwise be ineligible for vaccination. China’s National Medical Products Administration has approved SINOVAC’s SA55 Nasal Spray for clinical trial in the prevention of COVID-19 infections, in April 2023.
About SINOVAC
Sinovac Biotech Ltd. (SINOVAC) is a
SINOVAC’s product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected hand-foot-mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, mumps, etc.
The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine under "Category 1 Preventative Biological Products" and commercialized in
SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.
SINOVAC continually dedicates itself to pipeline development including but not limited to new technology, new vaccines as well as other biomedical products. We will constantly explore global opportunities of strategic expansion.
For more information, please visit the Company’s website at www.sinovac.com.
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Sinovac Biotech Ltd.
Helen Yang
Tel: +86-10-8279 9720
Email: ir@sinovac.com
Source: Sinovac Biotech Ltd.
