By Yibing Zhou, BioPlan Associates, Inc.
“We opened the first CRO in China in 1996 for clinical laboratory functions, Phase III multi-center trials and site management,” says James McClurg, Ph.D., senior vice president and CSO at MDS Pharma Services. “We’ve been in business there for 10 years. The Chinese authorities have brought pharmaceutical regulations forward 20 years in the past six. That is an impressive achievement.”
Meanwhile, an increasing number of multinational pharmas, including Novo Nordisk, AstraZeneca, Eli Lilly, Roche and Pfizer, have established or plan to establish R&D centers in China. Each is looking for Chinese CRO partners.
Chinese domestic pharma companies are also seeking CRO partners to provide them with new products. Even as Chinese pharmas have completed GMP modifications, 45% of their production facilities are idle, [8] presenting a significant financial challenge. As a result of this excess capacity, Chinese pharmas are essentially operating under a CMO model, and some are aggressively seeking contract manufacturing opportunities overseas to keep their facilities running. They are also looking to CROs to facilitate the development of new products domestically.
Chinese pharmas are making progress toward entering world markets. Currently, 259 products associated with 130 Chinese manufacturers have obtained U.S. FDA cGMP certificates, and 50 manufacturers have obtained 90 European COS certificates. Among them, 10 finished drug manufacturers have received the FDA CMP certification. [9]
The 300-plus CROs in China have formed an integrated service chain addressing every process associated with the pharmaceutical industry. Their services include new drug R&D, pre-clinical trials, pharmacogenomics, clinical trials, new drug applications, new drug transfers and product exporting. The majority of Chinese CROs are small and simply provide regulatory consultation, drug application and clinical trial assistance to overseas pharma firms. However, more than 100 Chinese CROs are capable of conducting R&D. 2004 statistics showed that the current CRO market in China is small, around RMB 500 million (US$62.6 million). [10]
Major Chinese CROs are concentrated in the two largest cities in China, Shanghai and Beijing, especially in two large biotech parks: Shanghai Zhangjiang Biopharmaceutical Park (part of the Zhangjiang Hi-tech Park) and Beijing Zhonguancun Life Science Park (see Table 1). More than 100 CROs are located in Beijing alone. In Shanghai and Beijing, biopharmaceutical CROs have formed solid syndications to provide all-around services to the global biopharma industry.
Table 1: Major CROs in China
MULTINATIONAL CROs Owner Location Service
Pharmaron (Beijing) Pharm. Tech. Sino-U.S Beijing Organic synthesis, R&D
Quintiles Transnational Corp. U.S. Beijing, Shanghai Clinical study, regulatory
MDS Pharma Services U.S. Beijing Clinical study
Beijing KendleWit Medical Consulting Co. Sino-U.S Beijing Clinical study, regulatory
Shanghai InCROM Pharma Dev. Co. Japan Shanghai Clinical study
CCBR Denmark Beijing Clinical study
Bridge Pharmaceuticals U.S. Beijing Animal experiment
VenturePharm CRO Service Sino-U.S-Canada Beijing Clinical study
Beijing Oriental Xianduan Pharma Tech Japan Beijing Clinical study
Source: BioPlan Associates, Inc.
CHINESE CROs Owner Location Service
Wuxi Pharma Tech Chinese Shanghai Pudong Drug R&D
Shanghai Genomics Inc. Chinese Shanghai Zhangjiang Drug & gene R&D
Shanghai LeadDiscovery Pharma Chinese Shanghai Zhangjiang Drug R&D
2Y-Chem, Ltd. Chinese Shanghai Zhangjiang Drug R&D
Zensun Sci &Tech Co., Ltd. Chinese Shanghai Zhangjiang Drug R&D
Shanghai Hua Xin Biotech Inc. Chinese Shanghai Zhangjiang Biotech R&D, mfg.
Shanghai GenMed Ltd. Chinese Shanghai Zhangjiang Gene R&D
Shanghai IgCon Therapeutics Inc. Chinese Shanghai Zhangjiang Monoclonal R&D
Shanghai ChemPartner Co. Ltd. Chinese Shanghai Zhangjiang Drug R&D
Shanghai Pharma-pro Service Co. Chinese Shanghai Zhangjiang Drug R&D
Shanghai Allist Pharmaceutical Chinese Shanghai Zhangjiang Drug R&D
Shanghai Pharma Engine (CRO) Co. Chinese Shanghai Zhangjiang Regulatory, clinical trial
Shanghai Res. Center for Biomodel Organism Chinese Shanghai Zhangjiang Gene tech
Shanghai Newsummit Biopharma Institute Chinese Shanghai Xuhui Drug R&D
Shanghai SLG CRO Co., Ltd Chinese Shanghai Clinical study, regulatory
Beijing Huaxi United Tech Dev. Co. Ltd. Chinese Beijing R&D, clinical study, regulatory
Giant Med-Pharma Services, Inc. Chinese Beijing Clinical study, regulatory
Vector Gene Technology Co., Ltd. Chinese Beijing Gene vector R&D
Excel PharmaStudies Inc. Chinese Beijing Clinical study, regulatory
Nanjing Chemzam Pharm Tech Co. Chinese Nanjing R&D, regulatory
Guangzhou Pudu Pharma Sci. & Tech. Dev. Chinese Guangzhou Drug R&D
Guangzhou Boji Clinical Research Center Chinese Guangzhou Clinical study
Source: BioPlan Associates, Inc.
China has more than 1,000 domestic research institutions associated with biotech and pharmaceutical science. In addition to CROs, numerous research institutes supported by the Chinese government or by pharmaceutical companies are open to contract research opportunities. For example, Tianjin Pharmaceutical Institute specializes in drug metabolism studies. Shanghai Pharmaceutical Industry Institute specializes in toxicology studies.
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