Full Press Release Details
Sinovac Announces Product License for
23-Valent Pneumococcal Polysaccharide Vaccine
BEIJING, December 9, 2020--(BUSINESS WIRE)--Sinovac
Biotech Ltd. (NASDAQ:SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products
in China, today announced that the China National Medical Products Administration (NMPA) has approved and issued a product license
for the Company's 23-Valent Pneumococcal Polysaccharide ("PPV") Vaccine to prevent the infection by streptococcus
pneumonia in adults and children ages 2 years old and above.
Mr. Weidong Yin, Chairman, President and
CEO of Sinovac, commented, "The approval of our pneumococcal vaccine allows us to provide another high-quality product to
address unmet medical needs for the Chinese population. This is our first bacterial vaccine product approved so far, broadening
the potential of the company's product portfolio."
Sinovac started research and development
of the 23-valent pneumococcal polysaccharide vaccine in 2009, completed pre-clinical studies in 2011 and was approved to conduct
human clinical trials in May 2014. A phase III non-inferiority study conducted in 2015 demonstrated a good
safety and immunogenicity profile and non-inferiority of immunogenicity of all 23 serotypes were observed, which was published
in the Human Vaccines and Immunotherapeutics medical journal.
About Streptococcus Pneumonia
Streptococcus Pneumonia, a highly bacterial
pathogen, contains more than 90 serotypes. The pathogen is directly spread mainly through respiratory droplets and can cause many
diseases including Pneumonia, meningitis, bacteremia, and otitis media, among others. Streptococcus Pneumonia usually affects children
and elderly people and results in hundreds of thousands of deaths worldwide each year.
Sinovac Biotech 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, 23-Valent
Pneumococcal Polysaccharide ("PPV"), 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 government stockpiling program. The Company is developing a number of new products including
a Sabin-strain inactivated polio vaccine and combined vaccines. The COVID-19 vaccine, CoronaVac, developed by the Company is being
tested in phase III trial in several countries outside of China. Sinovac primarily sells its vaccines in China, while also exploring
growth opportunities in international markets. The Company is seeking market authorization of 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
This announcement may include certain statements that are not
descriptions of historical facts, but are forward-looking statements. These statements are made under the "safe harbor"
provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by
terminology such as "will," "expects," "anticipates," "future," "intends,"
"plans," "believes," "estimates" and similar statements. Forward-looking statements involve
risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements.
In particular, the outcome of any litigation is uncertain, and the Company cannot predict the potential results of the litigation
it filed or filed against it by others. Additionally, the triggering of a shareholder rights plan is nearly unprecedented, and
the Company cannot predict the impact on the Company or its stock price as a result of the trigger of the rights plan.
This announcement contains forward-looking
information about the Company's efforts to develop a potential COVID-19 vaccine that involves substantial risks and uncertainties
that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties
include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated
clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval
dates and/or launch dates, as well as risks associated with clinical data (including the Phase III trial data); the ability to
produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed
to date, in additional analyses of the Phase III trials or in larger, more diverse populations upon commercialization; the risk
that clinical trial data are subject to differing interpretations and assessments, and by regulatory authorities; the risk that
we may not be able to create or scale up manufacturing capacity on a timely basis or have access to logistics or supply channels
commensurate with global demand for any potential approved vaccine, which would negatively impact our ability to supply the estimated
numbers of doses of our vaccine candidate; uncertainties regarding the ability to obtain recommendations public health authorities;
uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.
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