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news.Sinovac Biotech, one of the leading emerging biotechnology companies in China, has received final approval for the marketing and sales of its proprietary combined hepatitis A and B vaccine, Bilive, by the Chinese FDA.
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The Bilive 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, which is not currently available in China and retails at a higher price than Bilive in countries where it is for sale.
R&D for the combined hepatitis A&B vaccine 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 expects the domestic sales proceeds of Bilive to gross approximately RMB65 ($7 to $8 per dose), with a standard primary vaccination course consisting off three of these doses. The company intends to use the sales team that marketed Healive, and is projecting domestic sales growth rates similar to Healive.
Bilive will be sold in two forms based on the age of the patient. Bilive junior for use in non-immune infants, children and adolescents from one to 15 years of age, and Bilive adult for use in non-immune adults and adolescents aged 16 years and older.