China Today: Vaccine Development in China - Improvements in China's regulatory and technology scenario are creating an optimistic outlook for its vaccine industry - BioPharm International

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China Today: Vaccine Development in China
Improvements in China's regulatory and technology scenario are creating an optimistic outlook for its vaccine industry


BioPharm International
Volume 20, Issue 4

SARS and bird flu have activated the market


Table 2. Vaccine manufacturers in China
The outbreak of SARS, avian flu, and the spread of hepatitis B across China have been directly responsible for energizing the vaccine industry in China. In addition, polio, which was almost eliminated, has reappeared in the country. The prevalence of measles is also increasing. China has set aggressive goals to eliminate diseases such as poliomyelitis in the country by 2012, and measles by 2010. Consequently, polio and measles vaccines are legally allowed a 20–60% price increase by the authorities. Moreover, new generations of traditional planned immunization vaccines may be reclassified as "charged" vaccines. This will permit manufacturers to raise their prices as much as ten times. These developments are fueling the expansion of the Chinese vaccine industry.

Government protection and support


Table 3. Major vaccine products in the Chinese market
The Chinese government has considerably increased its investment in epidemic prevention systems after the SARS outbreak of 2003. The state invested 5 billion RMB ($646 million) on anti-epidemic system in 2005, equivalent to the total investment for the previous five years. The year 2005 was a turning point in China's vaccine development industry. In March of that year, the State Council issued "Administrative Regulations on Vaccine Distribution and Inoculation," which became effective on June 1, 2005. For the first time in history, the regulations dismantled the long-term market monopoly controlled by the provincial disease control centers. Sales outlets increased significantly from the former 54 provincial centers to 5,700 county-level anti-epidemic stations. Qualified drug wholesalers were also permitted to distribute "charged" vaccines. This has removed the supply-demand bottleneck, thereby giving a boost to the Chinese vaccine industry.

In the same year, the National Development and Reform Commission (NDRC) published its China Bioindustry Development Strategies, which states: "to develop new types of vaccines to protect national public hygiene safety is the number one project in the biopharmaceutical industry." The government will grant tax privileges to vaccine developers and manufacturers. NDRC is also planning to set up and subsidize special high-tech projects for vaccine development. As a result, the vaccine industry in China is poised to become the most promising high-tech industry in China's biotech sector.

MAJOR PLAYERS AND PRODUCTS

China is home to more than 30 vaccine manufacturers, which produce more than 1 billion dose units of vaccines each year, including 41 kinds of vaccines against 26 viruses. According to China's State Food and Drug Administration (SFDA) product database, there are more than 300 domestic and 130 imported vaccine products of various doses, forms, or specifications in the Chinese market. Although domestic companies have been protected by government policies and have thus dominated the planned immunization vaccines, imported products are becoming increasingly competitive in the charged vaccine market. For instance, all the influenza vaccines purchased by the Chinese Disease Control Center (CDC) in 2005 were imported products.2


Table 4. Pipeline Products1
The largest Chinese vaccine developer and manufacturer is the China National Biotec Group (CNBG), which controls six former state-owned biological product institutes in Beijing, Shanghai, Changchun, Lanzhou, Chengdu and Wuhan, and two biopharmaceutical companies in Beijing and Chengdu. CNBG employs nearly 10,000 people across China. The six institutes affiliated to CNBG currently supply 90% of planned immunization vaccines to the Chinese market, with an annual output of 300 million doses of vaccines.


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