News and Research on Sinovac Biotech, Ltd. (SVA)
Business Description
Sinovac Biotech, Ltd., a biopharmaceutical company, engages in the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. The company’s portfolio of regulatory-approved products consists of vaccines against the hepatitis A, hepatitis B and influenza viruses.
In 2005, the company received regulatory approvals in China for the production and sales of its Bilive and Anflu vaccines. Bilive is a combined hepatitis A and B vaccine and Anflu is a flu vaccine. The company is developing vaccines against the SARS virus, the H5N1 strain of pandemic influenza virus, and the Japanese Encephalitis virus.
Products
Healive: Healive is an inactivated hepatitis A vaccine that is administered intramuscularly. Available in different doses for use by both adults (1.0 ml dose) and children (0.5 ml dose), Healive is an inactivated hepatitis A vaccine developed in China. In 2006, there are approximately 9.59 million doses of hepatitis A vaccine released by the China SFDA, among which 3.0 million doses are Healive. As of December 31, 2006, various post-marketing clinical trials had been conducted on Healive.
Bilive: Bilive is a combination vaccine formulated with purified inactivated hepatitis A virus antigen, which it manufactures, and recombinants (yeast) hepatitis B surface antigen. Bilive is used to prevent the infection of hepatitis A and hepatitis B. Bilive is available in different doses for use in both adults and children. 1.0ml dose is for non-immune adults and adolescents 16 years of age and older. It produces hepatitis A used in producing Bilive on its own and the hepatitis B is sourced from Beijing Temple of Heaven Biological Products Co., Ltd., one of its major suppliers. The standard Bilive vaccination schedule consists of three doses. The second dose is administered one month after the first dose and the third dose is administered six months after the first dose. Booster vaccinations of hepatitis B vaccines are recommended five years after the initial immunization.
Anflu: The split virus vaccine, containing specially treated virus particles, is the primary type of influenza vaccines used worldwide. The company’s Anflu vaccine is an inactivated split flu vaccine formulated from three split inactivated virus solutions. In October 2005, it received final PRC regulatory approval for the production of its Anflu vaccine against influenza. In September 2006, Anflu was for sale in China. In 2006, it sold approximately 77,000 doses.
Product Pipeline
Pandemic Influenza vaccine: The pandemic influenza virus, or H5N1 virus, is a flu virus that is contagious and deadly to birds. H5N1 virus does not usually infect people, but infections in humans with these viruses can and have occurred. It began human clinical trials for the pandemic influenza vaccine in December 2005. In April 2006, it announced the completion of the immunization schedule of the phase I clinical trial of H5N1 in which 120 volunteers aged from 18 to 60 have completed the two shot regimen of either the vaccine or a placebo. It completed the phase I clinical trial of H5N1 in June 2006 after it took blood samples from volunteers to analyze the antibody growth and effectiveness of the vaccine. It applied for authorization from the China SFDA to begin its phase II trial in November 2006.
Japanese Encephalitis (JE): JE is a significant public health problem in Southeast Asia and the western Pacific. The company is in pre-clinical stage of development for a cell-based JE vaccine using its micro-carrier technology for the cultivation of viruses.
SARS Vaccine: The company has suspended its clinical trials of SARS vaccine as there are no new reported cases of SARS. If the disease reemerges, it intends to resume the remaining process required to obtain an approval to market and sell the SARS vaccine.
Collaborations
In May 2005, the company entered into a letter of intent with LG Life Sciences, Ltd., a pharmaceutical company in Korea, concerning a possible collaboration between its two companies where LG Life Sciences expressed interest in marketing its Healive vaccine worldwide and it expressed interest in the possibility of using LG Life Sciences’ hepatitis B vaccines in its production of Bilive. In February 2006, it entered into a distribution agreement with LG Life Sciences, Ltd. under which LG Life Sciences granted it a right to market and distribute its hepatitis B vaccine, Euvax B, in mainland China.
In August 2005, the company entered into a distribution agreement with Glovax C.V., a Dutch biopharmaceutical company with operations in Mexico, pursuant to which it appointed Glovax to be the distributor of its vaccine products in the Mexican market.
In December 2004, the company entered into a pandemic influenza vaccine co-development agreement with the China CDC to jointly develop a pandemic influenza vaccine.
Subsidiaries
The company’s subsidiaries include Sinovac Biotech Co., Ltd. (Sinovac Beijing), and Tangshan Yian Biological Engineering Co., Ltd.
Customers
The company’s customers are primarily government agencies.
Competition
The company's major competitors include GlaxoSmithKline Biologicals S.A.; MSD; Berna Biotech AG; Institute of Medical Biology; Chinese Academy of Medical Sciences; Kunming Institute of Biological Products; Aventis Pasteur S.A.; Chiron Corporation; Zhejiang Hangzhou Tianyuan Biological Products Co., Ltd.; Changchun Changsheng Life Sciences Limited; Shanghai Institute of Biological Products; Changchun Institute of Biological Products; Jiangsu Changzhou Yanshen; and Lanzhou Institute of Biological Products.
History
Sinovac Biotech, Ltd. was founded in 1999.
