Most of the CMOs in China today are not yet directly involved in biopharmaceuticals. Many have been developing or acquiring
the expertise, regulatory knowledge, and technical ability to participate in this arena. The Chinese manufacturers with the
largest number of Chinese drug master files include:
- Zhejiang Hisun Pharmaceutical Co.
- Shanghai Pharmaceutical (Group) Co.
- Shangdong Xinhua Pharmaceutical Co., and
- Tianjin Pharmaceutical (Group) Co.
Other major API (small molecule) CMOs in China include Shangdong Meiji Lukang Pharmaceutical Co. (Colistin Sulfate), Dalian
Pfizer Pharmaceutical Co. (Cefoperazone), and Aurobindo (Datong) Biopharmaceutical Co. (6 -APA).
BIOPHARMACEUTICAL MANUFACTURERS IN CHINA
Since the founding of the first modern biopharmaceutical company in China (Shenzhen Kexing Biotech) in 1989, Chinese biopharmaceutical
companies have experienced rapid growth. By the end of 2005, China had around 400 biopharmaceutical manufacturers, among which
40 are capable of manufacturing genetically engineered drugs, 30 manufacturing vaccines, and 34 manufacturing blood products.
Over 20 listed companies in the Chinese stock market have been involved in the biopharmaceutical industry. These listed companies
include the Shanghai Fosun Pharmaceutical Group, Ginwa Group, Beijing Tiantan Biological Co., Ltd., Beijing Four-rings Biopharma,
Guangxi Beisheng Pharma, Beijing SL Pharma, Shenzhen Neptunus Bioengineering, and Changchun High-tech. In 2005, the domestic
annual sales revenue of biopharmaceuticals in China reached $3.8 billion, accounting for 7.5% of the total pharmaceutical
revenue (including blood products, intermediaries, and vaccines). The majority of Chinese biotech pharmaceuticals remain small.
CHALLENGES AND OPPORTUNITIES
Challenges for the Chinese contract manufacturers include establishing quality management and passing relevant EU and US FDA
inspections. Chinese contract manufacturers recognize that they will need to modify their facilities and train their staff
to meet US cGMP standards and EU COS certification. So far, very few Chinese drug preparation manufacturers have met these
hurdles. The US FDA sponsors cGMP training programs in China and provides the latest updates from the FDA on current regulations
and guidance. In a recent program, 270 people from over 100 Chinese manufacturers attended the training. Over 90 Chinese drug
manufacturers have obtained the cGMP certification issued by the FDA. After China's entry into the World Trade Organization
in 2001, Chinese drug manufacturers have been seeking international partners, and contract manufacturing is becoming one of
the more promising business approaches that Chinese producers have been evaluating. This approach may expand as western biopharmaceutical
companies recognize the technical resources and relatively lower costs available in China.
Eric Langer is president of BioPlan Associates, Rockville, MD, 301.921.9074, elanger@bioplanassocicates.com
.
REFERENCES:
1. Advances in biopharmaceutical technology in China. Society for Industrial Microbiology and BioPlan Associates, Inc., 2006.
2. Announcement concerning regulations on drug production in different places and entrusted drug processing [in Chinese].
State Drug Administration Office [1999] 300. 1999; Oct. 8.
3. Order of the president of the People's Republic of China, No. 45. Drug Administration Law of the PRC [in Chinese and English].
2001; Dec. 1.
4. Regulations on processing drug exports (trial version) [in Chinese]. SFDA [2003] No.189. 2003; July 29.
5. Provisions for the supervision of drug manufacturing [in Chinese]. SFDA [2004] No. 14. 2004; Aug. 5.
6. SFDA. Requirements for record-keeping of pharmaceutical processing entrusted by overseas drug manufacturers [in Chinese].
SFDA [2005] 541. 2005; Nov. 5.
7. China pharmaceutical facility utilization survey report: To encourage pharmaceutical contract manufacturing [in Chinese].
Based on a survey conducted by the China Pharmaceutical Enterprise Management Association in 2005 showing utilization rates.
2005; July.
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