Advances in Biopharmaceutical Technology in China
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Chapter 14:   Current Status and Future Prospect of Biogeneric Companies in China

Hajimu Jim Morioka, PhD
TechNova Medical Services
1139 Tsujidotaiheidai Fujisawa,
Japan 251-0044
Tel: +81-466-35-6027
E-Mail:Jimmorioka@hotmail.com

About the Author:
Dr Hajimu Jim Morioka is director of scientific affairs at TechNova Medical Services, Japan. Dr Morioka established the TechNova Medical Products Company to conduct the preclinical and clinical development of several compounds. He is currently engaged with affairs of intellectual property rights in pharmaceutical drugs. He is also involved in licensing deals such as Starlix with Novartis and Actonel with P&GP. Majoring in microbiology and molecular biology, Dr Morioka graduated from Kyoto University in 1975, earning a PhD from the same university in 1988. He also studied molecular biology at the National Institutes of Health in the US.

Abstract:
Chinese biological drug production surpassed about 25 billion yuan RMB (US$3.1 billion) in 2004 and will likely exceed 73 billion yuan RMB (US$9.1 billion) in 2010. Due to the current poor intellectual property system in China, many biological drugs, which are still tightly regulated by authorities in the Western countries, are produced and sold by many small biotechnology companies in China. Therefore, many Chinese biologics manufacturers have been called biogeneric companies, even though the term ´biogeneric' means something slightly different in China compared to Western countries. For example, G-CSF and its polyethylene-modified version are manufactured and sold by many small biotech companies along with subsidiaries of big Western pharmaceutical companies in China. Firstly, the Chinese state and local governments are investing heavily in an attempt to boost development of the biotechnology industry in China. Since China is governed by the communist party, direct and indirect support from local and state governments are well-planned and controlled in science and technology sectors. Such support is often provided to universities and military institutions. Many biotech ventures have emerged from universities and military institutions and have been supported through research bases (biotech parks) where these start-ups are supported through direct financial supports and tax incentives. Secondly, the Chinese governments (regional and national) are focusing on increasing the scientific potential in China through life science education. They have determined a strategy that puts biotechnology on a course to become one of China's strongest technologies in the 21st century; more so than IT and nanotechnologies. Under the strategy, the government provides money to universities and military institutions related to biological and medical sciences. Thirdly, China's talent pool for biotechnology is quickly achieving world-class status. Many highly skilled Chinese biotech researchers who have contributed to advances in molecular and cellular biology in the U.S.A. have returned to China and established their own biotech ventures. Returnees have kept contact with prominent researchers in the U.S.A. and have up-dated their biotechnology knowledge. Some of them have opened branch laboratories in the U.S.A. to conduct advanced research activities. Some of big Western pharmaceutical companies entering into the China drug market are starting R&D activities in China because of the availability of highly talented researchers. Even Western generic companies have collaborated with Chinese biotech companies to attempt manufacturing biogeneric products. Within several years, it is likely they will establish their own manufacturing facilities with Chinese biotech companies to supply lower-cost biogeneric drugs to the Western countries.

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Eric Langer
BioPlan Associates, Inc.
2275 Research Blvd, Suite 500
Rockville, MD 20850
Phone: 301-921-5979; Fax: 301-926-2455
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