Full Press Release Details
Approval of Human Clinical Trial for a Vaccine Candidate Against COVID-19
BEIJING--(BUSINESS WIRE)-- April 14, 2020--
Sinovac Biotech Ltd. (NASDAQ:SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical
products in China, today announced that the Company has obtained approval to conduct a human clinical trial on an inactivated SARS-CoV-2
(commonly referred to as COVID-19) vaccine candidate.
The vaccine development commenced at the end of January 2020.
Sinovac scientists have raced to complete comprehensive preclinical studies in partnership with leading academic research institutes
in China. As part of this work, an animal challenge study has shown that the vaccine candidate protects animals without antibody-dependent
enhancement (or ADE). In addition, the vaccine candidate can neutralize virus strains from different countries, which supports
the potential of using the vaccine to prevent the spread of the disease globally.
Mr. Weidong Yin, Chairman, President, and
CEO of Sinovac, commented, "At present, the whole world is facing an unprecedented public health crisis. It is a matter of
urgency to develop an effective vaccine to control the spread of COVID-19 globally, as quickly as possible. Sinovac has been working
closely with the regulators in China in order to make this happen. Sinovac has always been committed to developing vaccines for
global use when facing pandemics."
Meanwhile, due to measures put in place
to stop the spread of COVID-19, the Company's daily operations have been impacted. Domestic sales have ceased due to the
suspension of vaccinations by the Chinese CDC since February, and exports are disrupted due to cancellations of cargo flights and
inflated freight costs. Any prolonged disruption of Sinovac's clinical trials, suppliers, or contract manufacturers could
delay regulatory approvals or the commercialization of any current or future products. Certain provinces and cities in China are
starting to lift some of the restrictive measures, and delivery of vaccines in China has slowly started to resume. The Company
is closely monitoring the situation in China as well as in the other countries in which it markets its vaccines.
Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization
of vaccines that protect against human infectious diseases. Sinovac's product portfolio includes vaccines against enterovirus71
(EV71), hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella vaccine
and mumps. Healive, the hepatitis A vaccine manufactured by the Company, has passed the assessment under WHO prequalification
procedures in 2017. The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by
EV71, was commercialized in China in 2016. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza
vaccine, which it has supplied to the Chinese Government's vaccination campaign and stockpiling program. The Company is also the
only supplier of the H5N1 pandemic influenza vaccine to the Chinese Government's stockpiling program. The Company is developing
a number of new products including a Sabin-strain inactivated polio vaccine, pneumococcal polysaccharides vaccine, a quadrivalent
influenza vaccine and a SARS-CoV-2 (commonly referred to as COVID-19) vaccine. Sinovac primarily
sells its vaccines in China, while also exploring growth opportunities in international markets. The Company is registering its
products in over 30 countries outside of China. For more information please see the Company's website at www.sinovac.com.
Safe Harbor Statement
release contains "forward-looking statements" within the meaning of the United States federal securities laws. Such
statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity,
performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed
or implied by these forward-looking statements. Factors that might cause such a difference include our inability to compete successfully
in the competitive and rapidly changing marketplace in which we operate, failure to retain key employees, cancellation or delay
of projects, failure to satisfy regulatory and other requirements, disapproval or delay in approval of new products by regulatory
bodies, disruptions to our operations, the results of any pending litigation (including litigation relating to the 2018 annual
general meeting, the validity of our Rights Agreement, and the issuance of the Exchange Shares), Nasdaq's halt in trading
of the Company's securities and any future action taken by Nasdaq regarding the trading of the Company's securities,
the effects of natural disasters, pandemics and outbreaks of contagious diseases and other adverse public health developments,
such as SARS-CoV-2 (commonly referred to as COVID-19), and adverse general economic conditions
in China, the United States and elsewhere. These risks and other factors include those listed under "Risk Factors"
and elsewhere in our Annual Report on Form 20-F as filed with the Securities and Exchange Commission. In some cases, you can identify
forward-looking statements by terminology such as "may," "will," "should," "expects,"
"intends," "plans," "anticipates," "believes," "estimates," "predicts,"
"potential," "continue," or the negative of these terms or other comparable terminology. Although we believe
that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of
activity, performance or achievements. The Company assumes no obligation to update the forward-looking information contained in
Sinovac Biotech Ltd.
Tel: +86-10-8279-9871 or
Fax: +86-10-6296-6910
Email: ir@sinovac.com
U.S.: 1-646-308-1707
Email: william.zima@icrinc.com