Biotechnology to China

Trends and opportunities

The market

China is focused and determined to play a global role in the biotechnology industry. China currently accounts for 16 per cent of the Asia Pacific pharmaceutical market and has over 3500 manufacturers (Source: BMI).

The current market value is estimated at US$8.5 billion with 60 per cent of this generated from sales into the local medical sector.

The government sees biotechnology as a high priority sector, with the nation already a world leader in adult stem cell research. China is also the world’s largest producer of antibiotics, glumatic acid, citric acid, vitamin C and beer.

Some leading Chinese biotechnology firms include:

• SiBono Genetech Ltd. – the first company in the world to receive regulatory approval for gene therapy.
• Jingmei Biotech – produces instrumentation and reagents.
• Beijing Triprime Genetic Engineering – molecular cloning and vaccines.
• Sinovac Biotech – vaccines and diagnostics devices, and has alliances with leading Asian companies. First company in the world to conduct phase I trials on a SARS vaccine. Company has visited Australia and interested in partnering.

China is already committed to bioparks - the major ones include:

• China Beijing Bioengineering and Pharmaceutical Industrial Park
• Shanghai Pudong New Area
• Tiajin Economic-Technological Development Area
• Guangzhou Hi-tech Industrial Development Zone
• Shenzhen Hi-tech Industrial Park
• Hunan Changsa National Economic and Technical Development Zone

Tariffs, regulations and customs

The State Food & Drug Administration (SFDA) is the Chinese Government agency under the State Council with broad responsibility for the safety management of food, health, cosmetics and is the administration authority for drug regulation and medical devices in China.

The SFDA implemented GMP on pharmaceutical production, but it was not until 2004 that GMP became mandatory, with IVD and reagents required since January 2006.

Contact details

The Australian Trade Commission (Austrade) is the Federal Government agency that helps Australian companies win overseas business for their products and services by reducing the time, cost and risk involved in selecting, entering and developing international markets.

Austrade offers practical advice, market intelligence and ongoing support (including financial) to Australian businesses looking to develop international markets. Austrade also provides advice and guidance on overseas investment and joint venture opportunities, and helps put Australian businesses in contact with potential overseas investors.

A list of Austrade offices (in alphabetical order of country) is available.

More information

For further information please contact Austrade on 13 28 78 or email info@austrade.gov.au