Full Press Release Details
SINOVAC 6K, PRESS RELEASE, 04.18.05
SINOVAC BIOTECH LTD. ISSUES CORPORATE UPDATE
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BEIJING, April 18, 2005 - Sinovac Biotech Ltd. ("Sinovac") ("the Company")
(AMEX: SVA) today updates on the status of the vaccines comprising its product
Hepatitis A - Healive(TM)
Sinovac continues to experience strong sales growth of its Hepatitis A vaccine,
Healive(TM). 2004 domestic Chinese sales were approximately US $6.5 million for
the year ended 31st December 2004 - more than two times 2003 sales..
Hepatitis A&B Combined - Bilive(TM)
In January 2005, Sinovac received final approval for the marketing and sales of
its combined Hepatitis A & B vaccine, Bilive(TM), by the Chinese FDA. This is
the first combined inactivated Hepatitis A&B vaccine developed by Chinese
scientists. Indeed, the vaccine has only one directly competing combined
Hepatitis A&B vaccine in the world, GlaxoSmithkline's TwinrixTM, which is not
currently available in China and sells for a much higher price than BiliveTM in
countries where it is for sale.
China is a country that has been greatly affected by viral hepatitis for a long
time. The prevention and control of hepatitis is very important for the
country's social development and public health. Currently, Hepatitis B virus
infects about 50-70% of China's 1.3 billion citizens at some point in their
lives. Sinovac's launch of its combined hepatitis A & B Vaccines, Bilive(TM)
will target this domestic issue and eventually the international marketplace.
The domestic sales proceeds of BiliveTM that Sinovac grosses will be
approximately 65 RmB per dose, which is between US $7 to US $8. The standard
primary vaccination course consists of 3 of these doses. Sinovac has already
built a successful sales team of over 40 people that has been selling
Healive(TM) to each of the individual local Centers of Disease Control (CDCs),
so the Company expects to achieve rapid market penetration of BiliveTM in China.
Sinovac has recently launched marketing of Bilive(TM) and expects to record the
first sales in May 2005.
After completing clinical trials of its split flu vaccine in April 2004, Sinovac
filed a New Drug Application with China's SFDA. Sinovac's split flu vaccine
received approval of its New Drug Certificate in Feb 2005. Final approval for
sales of the Company's flu vaccine is expected in 2005 after GMP certification
by the Chinese FDA of the new flu vaccine production line.
Sinovac's flu production line has now nearly been completed at a new
manufacturing facility next to the Company's existing Beijing headquarters. The
2600 square meter facility is being built to meet international Good
Manufacturing Practice (GMP) standards at a fraction of Western costs: the
investment for construction and equipment is about US $4million. This initial
manufacturing facility is designed with a production capacity of 2 million doses
of flu vaccine per year. Sinovac also intends to build another, much larger flu
vaccine production facility if the Company can obtain necessary financing.
Sinovac is the first company in the world to prove the safety and immunogenicity
of a SARS vaccine. As previously announced, Sinovac's SARS vaccine induced
SARS-neutralizing antibodies in tests of the human volunteers' blood serum. The
preliminary results showed that the SARS vaccine Phase I clinical trial had
already attained a positive outcome. The observation period of the SARS Phase I
clinical trial ended in March 2005, after every volunteer has been observed for
210 days after inoculation. It is expected that the SFDA will continue to
fast-track the drug approval process for Sinovac's SARS vaccine.
According to the China Daily on 15 January 2005, "in the event of a sudden and
widespread SARS outbreak, some high-risk groups, such as doctors might be
immunized ahead of completion of the second and third round trials, said Dr. Lin
Jiangtao of Beijing's Sino-Japanese Friendship Hospital, where the first tests
were conducted." High-risk groups further include first responders, medical
personnel, laboratory technicians, or anyone helping to control a potential SARS
Avian Flu (Bird Flu)
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The Company is co-developing a human vaccine targeting the avian flu virus in
partnership with the China Center of Disease Control (CDC). CDC controls the
Chinese vaccine market through its two main functions: as both the commercial
sales agency and the governmental department in the pharmaceutical sector for
Sinovac is currently advancing its recombinant New Human Influenza (H5N1)
vaccine (also referred to as Pandemic Influenza Vaccine) through the later
stages of pre-clinical studies.
National Institute of Biological Standards and Control (the World Health
Organization influenza network) began providing the strain of recombinant bird
flu virus early in 2004 to vaccine makers around the world. Sinovac received the
virus in April 2004.
World health authorities have recently warned that if the current avian flu
virus mutates into a form that spreads easily among people it could lead to the
next global flu pandemic, which could kill tens of millions of people worldwide.
Pandemics occur when a completely new flu strain emerges for which humans have
Influenza experts and world health authorities are concerned that the recent
appearance and widespread distribution of an avian influenza virus, H5N1, has
the potential to ignite the next flu pandemic. Given the current threat, world
health authorities are currently urging all countries to develop or update their
influenza pandemic preparedness plans for responding to the widespread
socioeconomic disruptions that would result from having large numbers of people
2004 Financial Statements
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The Company will release its full 2004 financial statements in a 20F filing with
the SEC within one month.
About Sinovac Biotech Ltd.
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Sinovac Biotech Ltd. specializes in the research, development,
commercialization, and sales of human vaccines for infectious illnesses such as
hepatitis A and hepatitis B, influenza, "SARS", and avian flu. Sinovac is one of
the leading emerging biotechnology companies in China.
Sinovac now has two vaccines fully approved for sale in China - Healive(TM) for
Hepatitis A and Bilive(TM) for Hepatitis A&B combined. The Hepatitis A vaccine,
Healive(TM), is currently experiencing strong sales growth in China. Sinovac's
Hepatitis A&B combined vaccine, Bilive(TM), received approval in China in
January 2005 and is expected to achieve similar sales growth to Healive(TM).
Sinovac's split flu vaccine received approval of its New Drug Certificate in
March 2005. Final approval of the Company's flu vaccine is expected in 2005
after GMP certification of the new flu vaccine production line.
Sinovac is currently the world leader in the development of a SARS vaccine.