In 1989, under the support of the Ministry of Health, Beijing Institute of Biological Products and Shenzhen Kangtai Biological Products Co., Ltd. negotiated with Merck & Co Inc the introduction of the full set of production technology of recombinant hepatitis B vaccine.
Beijing Institute of Biological Products Co., Ltd. obtained the official approval for the production of recombinant hepatitis B vaccine in 1996. The project kicked off in the same year with an annual capacity of 30 million doses. The purity of the recombinant hepatitis B vaccine was 99%, a great improvement from 90% of purity of the blood-plasma derived hepatitis B vaccine, which greatly improved the safety and efficacy of hepatitis B vaccine. With reference to the GMP standards of FDA, EU, WHO and China (2010), the company built Asia’s largest biological products production base in Yizhuang Economic and Technological Development Zone, with a designed annual capacity of 60 million doses.
The hepatitis B vaccine was included in China’s planned immunization system in 1992 and was officially incorporated into the National Immunization Program in 2002. Results of the 2006 National Hepatitis B Seroepidemiological Survey by the Ministry of Health showed that the prevalence of hepatitis B surface antigen in the Chinese population was 7.18%, 26.36% lower than the 1992 figure, among whom the prevalence in children between one to four years of age was 0.96%, a decrease of 90% from 9.67% in 1992, and the prevalence in children younger than 15 years of age was 2.08%, a decrease of 80% from 10.52% in 1992. Based on the results of two seroepidemiological surveys in 1992 and 2006, 80 million people were prevented from being infected by the hepatitis B virus, and nearly 20 million hepatitis B surface antigen carriers were reduced in the whole country.
The goal of reducing the infection rate of chronic HBV in children under five years of age to less than one percent has been achieved, which is a great achievement China has made in public health. China’s successful strategy of including hepatitis B vaccine in the national immunization program could be a good example for other developing countries.
CNBG is continuing with its efforts for more lives to be cared and protected.