Full Press Release Details
Sinovac Announces Preliminary Results
of Phase III Trial on sIPV
BEIJING, April 19, 2018 -- Sinovac Biotech Ltd.
(NASDAQ: SVA) ("Sinovac " or the "Company"), a leading provider of biopharmaceutical products in China, today
announced preliminary results of a phase III clinical study on Sabin inactivated polio vaccine ("sIPV") developed by
Sinovac Biotech Co., Ltd. ("Sinovac Beijing") on the unblinding conference held on April 19, 2018.
results of the trial after unblinding show the seroconversion rate of poliovirus type
II is superior to the control vaccine and seroconversion rates of the other two types
of poliovirus are non-inferior to the control vaccine. And geometric mean titer ("GMT") of three poliovirus types
are all higher than the control vaccine. The Company will prepare the production license application after the clinical report
The phase III trial is a randomized, double-blind,
controlled clinical trial to evaluate the immunogenicity and safety of sIPV in 2-month-old infants. The trial commenced in August
2017 with twelve hundred healthy volunteer subjects enrolled in the study. The primary vaccination schedule sets three doses with
a one month interval between doses and the trial was carried out in Jiangsu province, China.
Mr. Weidong Yin, Chairman, President and CEO
of Sinovac, commented, "The promising results from the phase III clinical trial are an important milestone we achieved towards
providing vaccines to eliminate human disease related to polio. The Company will commercialize this vaccine in the China market
as well as the markets in which the United Nations ("UN") operates under the WHO's Polio Eradication & Endgame
Strategic Plan. The vaccine will also contribute to the diversification of our pipeline product portfolio by providing us with
the opportunity to develop a sIPV related combo vaccine in the future."
As previously announced, Sinovac has entered
into a license agreement with Intravacc (Institute for Translational Vaccinology) from Netherlands to develop and commercialize
sIPV for distribution to China and other countries. According to the agreement, Sinovac has committed to commercializing the vaccine
in China, inclusive of conducting clinical trials, obtaining regulatory approval, and launching the sIPV. The Company obtained
the clinical license of sIPV in December 2015. The phase I and phase II trials were completed in 2017.
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, or EV71, hepatitis A and
B, seasonal influenza, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), 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, pneumococcal polysaccharides vaccine, pneumococcal conjugate vaccine and varicella vaccine. Sinovac primarily sells
its vaccines in China, while also exploring growth opportunities in international markets. The Company has exported select vaccines
to over 10 countries in Asia and South America. For more information, please visit 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.
Sinovac Biotech Ltd.
Tel: +86-10-8279-9871
Fax: +86-10-6296-6910
Bill Zima U.S: 1-203--682-8233
Email: william.zima@icrinc.com