Sinovac Biotech Ltd. Announces Final Approval by the Chinese FDA (SFDA) for Bilive"TM", its Proprietary Combined Hepatitis A&B Vaccine
BEIJING--(BUSINESS WIRE)--Jan. 12, 2005--Sinovac Biotech Ltd. ("Sinovac") ("the Company") (AMEX:SVA - News) announces that it has received final approval for the marketing and sales of its combined Hepatitis A & B vaccine, Bilive(TM), by the Chinese FDA.
The Bilive(TM) production license has now been issued by the SFDA and sales of the vaccine will commence in China shortly. 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 Twinrix(TM), which is not currently available in China and sells for a much higher price than Bilive(TM) in countries where it is for sale.
The combined Hepatitis A&B vaccine R&D was started at the end of 1999 and clinical trials were completed in 2003. Sinovac used its proprietary Hepatitis A vaccine in combination with genetically engineered hepatitis B vaccine to develop the combined vaccine.
Sinovac president, Dr. Wei Dong Yin stated, "I would again like to thank our shareholders for their patience and continued support of our efforts towards becoming a major vaccine developer and manufacturer for the domestic Chinese and international markets. We are excited to add the second key vaccine to our product sales portfolio. The domestic sales proceeds of Bilive(TM) that Sinovac grosses will be approximately 65 RmB, which is between US $7 to US $8 per dose. The standard primary vaccination course consists of 3 of these doses. We have built a successful sales team of about 40 people that has already been selling Healive(TM) to each of the individual local Centers of Disease Control (CDCs), so we expect to achieve rapid market penetration of Bilive(TM) in China. Moreover, we are projecting high domestic sales growth rates similar to Healive(TM)."
Sinovac management believes that Bilive(TM) will dramatically improve the quality of life in China, especially for the 15-20 million infants born each year and an increasing elderly population.
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.
Bilive(TM) is a state-of-the-art combined hepatitis A and B vaccine. It can be recommended to protect people against Hepatitis A or Hepatitis B. Bilive(TM) will be sold in two forms based on the age of the patient. Bilive(TM) junior for use in non-immune infants, children and adolescents from ages 1 to 15 years, and Bilive(TM) adult for use in non-immune adults and adolescents 16 years of age and older.
Bilive(TM) is a combined vaccine formulated by purified inactivated Hepatitis A virus antigen and recombinant (yeast) hepatitis B surface (HBsAg), absorbed into aluminum hydroxide. The vaccine induces the body's immune system to generate antibodies as a reaction against hepatitis A and hepatitis B viruses. Hepatitis B is one of the major diseases of mankind and continues to be a serious global public health issue. It is preventable with safe effective vaccines.
The standard primary course of vaccination with Bilive(TM) consists of 3 doses. The first dose is administered at the selected date, the second one month later and the third six months after the first dose. Once initiated, the primary course of vaccination should be completed with the same vaccine. Booster vaccination with the combined vaccine can be recommended 5 years after initiation of the primary course.
Bilive(TM) side effects are rare and low intensity. The most common reactions were those at the site of injection. They included transient pain, redness and swelling. Systemic adverse effects seen were fever headache, fatigue, nausea, and vomiting. These events were transient, only rarely reported and were considered by the subjects as mild.
About Hepatitis B
Hepatitis B is a very common infection. Each year in the United States, an estimated 200,000 persons are newly infected with hepatitis B virus. More than 11,000 of these people are hospitalized, and 20,000 remain chronically infected. Overall, an estimated 1.25 million people in the United States have chronic hepatitis B virus infection, and 4,000 to 5,000 people die each year from liver disease or liver cancer related to hepatitis B. Nearly 300 million persons in the world are chronically infected with hepatitis B virus. High rates of chronic infection are found in some parts of China, Southeast Asia, Africa, the Pacific islands, the Amazon Basin in South America, and the Middle East.
Of the 2 billion people who have been infected with the hepatitis B virus (HBV), more that 350 million have chronic (lifelong) infections. These chronically infected people are at high risk of death from cirrhosis of the liver and liver cancer, diseases that kill about one million people each year.
Global Immunization Programs for Children
In 1991, the WHO called for all children to receive the hepatitis B vaccine and 116 countries have added this vaccine to their routine immunization programs.
Children in the poorest countries, who need the vaccine the most, have not been receiving it because their governments cannot afford it. More hepatitis B vaccine will be available in these countries with the assistance of the Global Alliance for Vaccines and Immunization (GAVI) and the Global fund for Children's Vaccines.
Sinovac's safe and effective Bilive(TM) products can be priced to support such international programs and still provide significant net profit to the Company.
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 immediately target this domestic issue and eventually the international marketplace.
About Sinovac Biotech Ltd.
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 and applications have been filed for its sale in nine other countries to date. Sinovac's Hepatitis A&B combined vaccine, Bilive(TM), has just received approval to commence sales in China and is expected to achieve similar sales growth to Healive(TM). The Company's flu vaccine completed clinical trials in April 2004 and a New Drug Application has been filed with the Chinese FDA (SFDA). Approval of Sinovac's flu vaccine is expected in 2005 upon completion of a new flu vaccine production line.
Sinovac is currently the only company in the world to be conducting clinical trials for a vaccine to prevent SARS. Preliminary Phase I results show that this SARS vaccine is safe and induces SARS-neutralizing antibodies in the human body. In addition, the Company is co-developing a human vaccine targeting the avian flu virus in partnership with China CDC.
For further information please refer to the Company's filings with the SEC on EDGAR or refer to Sinovac's website at www.sinovac.com.
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Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of biomedical products that protect against human diseases.
SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected hand-foot-mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, mumps, etc.
The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine under "Category 1 Preventative Biological Products" and commercialized in China in 2016. In 2022, SINOVAC's Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.
SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.
SINOVAC continually dedicates itself to pipeline development including but not limited to new technology, new vaccines as well as other biomedical products. We will constantly explore global opportunities of strategic expansion.
For more information, please visit the Company’s website at www.sinovac.com.
Sinovac Biotech Ltd.