Full Press Release Details
Receives Clinical Trial Approval for Varicella Vaccine Candidate
BEIJING, Oct. 26, 2015 /PRNewswire/ --
Sinovac Biotech Ltd. (NASDAQ:SVA), a leading provider of biopharmaceutical products in China, today announced that one of its subsidiaries,
Sinovac Dalian, has received approval to begin human clinical trials on its varicella vaccine candidate. The clinical trial application
for the varicella vaccine was officially accepted by the China Food and Drug Administration (CFDA) in January 2013.
In preparation to begin human clinical
trials, Sinovac Dalian is currently finalizing the trial protocol, confirming the site, training staff and preparing for volunteer
screening. The Company expects to complete the trial in 2017. Simultaneously, Sinovac Dalian is renovating of an existing building
on its Dalian campus, which will serve as the commercial production plant for the varicella vaccine. The plant will have a designed
annual capacity of 5 million doses.
The Company's varicella vaccine candidate
is a live attenuated vaccine derived from a human cell line. Development of the vaccine began in 2010 and the clinical trial application
was officially accepted by the CFDA in January 2013, after the preclinical study was completed. The Company expects to be able
to commercialize its varicella vaccine by the end of 2019. Ultimately, Sinovac plans to develop a measles-mumps-rubella-varicella
(MMRV) combination vaccine. The Company has licensed a mumps vaccine for sale in China, has clinical trial approval for its internally-developed
rubella vaccine and plans to begin development of a measles vaccine.
Currently, the varicella vaccine is sold
exclusively in the private-pay market in China by four domestic producers. In some regions, the varicella vaccine is included in
the emergency immunization programs of several provinces for free vaccination due to outbreaks. According to the China CDC, the
varicella vaccine is recommended to children over 12 months with different immunization schedules implemented in different provinces
and it's specified in the product specification. Generally, a one-dose scheme is recommended for children from 12 months to 12
years old and two doses for those 13 years and older. Recently, one booster shot has been recommended for children 4 to 12 years
old by some local CDCs. This is expected to become standard protocol throughout the country in the coming years, which would increase
market demand. In the past five years, approximately 15-16 million doses were released to China market annually.
Mr. Weidong Yin, Chairman, President
and CEO of Sinovac, commented, "Obtaining the clinical trial approval marks a significant step in the R&D process for
our varicella vaccine candidate. Once commercialized, this vaccine will be supplied to the existing market demand and support Sinovac
Dalian for its asset utilization, cash flow and profitability in the near future, and position us to capture share with the potential
market expansion in the coming years. Meanwhile, there is a meaningful opportunity for an MMRV vaccine in the private-pay market
in the future. This represents another milestone as we further develop our vaccine product portfolio to fulfill China's unmet medical
Varicella, also commonly referred to as
"chickenpox," is an acute and highly contagious disease. It is caused by primary infection with the varicella-zoster
virus (VZV). Varicella occurs worldwide and in the absence of a vaccination program, affects nearly every person by mid-adulthood.
The epidemiology of the disease differs between temperate and tropical climates. The reasons for the differences are poorly understood
and may relate to properties of VZV (known to be sensitive to heat), climate, population density and risk of exposure (e.g., attendance
at childcare facility or school or the number of siblings in the household).
VZV is highly transmissible via respiratory
droplets or direct contact with characteristic skin lesions of the infected person. The first symptoms of clinical varicella generally
appear after a 10-21 day incubation period and include fever, malaise and the characteristic itchy rash. Varicella is generally
self-limited and vesicles gradually develop crusts, which disappear over a period of 7-10 days. Individuals remain contagious until
all lesions have crusted over. The disease is typically mild, but severe complications may arise, including bacterial infections
(e.g. cellulitis, pneumonia) and neurological complications (e.g. encephalitis), and these can be fatal. The disease is associated
with higher morbidity and mortality in infants and in individuals with an impaired immune system.
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 hepatitis A and B, seasonal influenza,
H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), mumps and canine rabies. 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. Sinovac has filed a new drug application with the China Food & Drug Administration for its proprietary enterovirus
71 vaccine, having been proven effective in preventing hand, foot and mouth disease in infants and children during its Phase III
clinical trial. The Company is currently 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 Mexico,
Mongolia, Nepal, and the Philippines, and was recently granted a license to commercialize its hepatitis A vaccine in Chile. For
more information, please visit the Company's website at www.Sinovac.com.
Sinovac Biotech Ltd.
Tel: +86-10-8279-9871
Fax: +86-10-6296-6910
Email: ir@sinovac.com
U.S: +1 (646) 308-1707
Email: william.zima@icrinc.com
Phone: +1 (646) 277-1276
Email: katherine.knight@icrinc.com