Advances in Biopharmaceutical Technology in China
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Chapter 22:   Vaccines in China: Status of the Chinese Vaccine Industry

Dr. Jianyuan LIU and Ning WANG, et al.
National Vaccine & Serum Institute
No. 4 Nanli, Sanjianfang, Chaoyang District, Beijing, P. R. China 100024
Tel: +86-10-65710311, +86-13601001982
Fax: 86-10-65710311

About the Author:
Dr Liu Jianyuan is a researcher at the National Vaccine & Serum Institute. Dr Liu is also Director of the Chinese Society of Microbiology, and Vice-Chairman of the Beijing Society of Virology of the Chinese Medical Association. He has been engaged in R&D, production, and quality control of biological products since graduation from the Chinese Academy of Sciences in 1991. He took charge of many national and regional key scientific research projects, including the Serial of Researches of SARS Etiology: its Prevention and Control for which he won a second class prize of national scientific and technical progress; the R&D of Gene Recombination of Interferon-_ 1b for which he won the second class prize of achievement by the China National Biotec Corporation; the Research of Replicative-type Recombinant Vaccinia Virus Carrier HIV Polyvalent Vaccine which received new drug certification. He has accumulated experience in biological products manufacturing and quality control; organized the introduction of quality control systems for genetically engineered hepatitis B vaccine from Merck, USA. He set up two quality control systems for different companies, and organized the applications for five new drugs, and GMP certification of two production departments. He has published more than 10 papers.

Vaccine inoculations have been extensively used to prevent and control infectious diseases, and the vaccine industry has provided great benefits to human health. Vaccines have played an irreplaceable role in addressing public health crises, preventing and curing diseases, and overcoming serious diseases. In China, this has been done by traditional chemical medicines and Chinese traditional medicines. In 1919, China founded its first vaccines institute, the "National Epidemic Prevention Bureau," specifically to engage in epidemic prevention & vaccine production. After nearly a century of diligent work, we have built an effective system for vaccine R&D and production. This system is composed primarily of six government institutes and private-owned corporations for biological products. By the end of 2005, our country owned 30 vaccine-producing corporations and could produce 41 kinds of vaccines to prevent 26 kinds of diseases. Currently, the vaccine production and supply situation in our country is healthy. Organizations have multiple layers of strengths whose reputations are growing both here and abroad. The China National Biotec Corporation is leading domestic suppliers, and efforts are underway to collectivize and improve management; private-owned corporations are growing rapidly; international major companies have entered the Chinese market and have begun occupying increasingly large market shares of high-end vaccines. During the past twenty years, the Chinese vaccine industries have seen higher profit margins, market expansion, and product line extensions. The total vaccine markets have reached 3 billion RMB (US$375 million), and the annual market demand for vaccines in China appears to be continuing its 15% annual increase. It is predicated that the market scale of vaccines for human use will reach as much as 15 billion RMB (US$1.88 billion) in 2010. With the development of China's Regulations and Rules for Distribution and Protective Inoculation of Vaccines and other regulatory measures, the monopoly situation where markets are controlled the Ministry of Health will be broken, more medicine-wholesale enterprises may participate into the distribution of vaccines, which will increase the overall vaccine market. In recent years, the spreading of hepatitis B has been successfully inhibited via the use of this vaccine. In 2004, Hepatitis B lost its place as the highest morbidity-causing disease; however, there is still little optimism that fully preventing and controlling infectious diseases in our country is close at hand. The epidemic of pulmonary tuberculosis is growing, new AIDS cases are constantly rising, and new infectious diseases such as SARS and avian influenza are occurring. This chapter covers the scientific advances in vaccine technology in China, and it includes many of the policy and regulatory aspects of this important healthcare function. The chapter discusses China's heavy investments and funding of these efforts to strengthen research of infectious disease. It also covers manufacturers and manufacturing of vaccine production, and describes areas where additional investment in scientific research is required. We provide information about the current situation and trends in development of Chinese local vaccine industries and illustrate and analyze the fundamental state of the vaccine industries in China. We also cover the status of Chinese vaccine-producing corporations, the market condition of vaccines, and the unique characteristics China's vaccine industries.

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