TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY 4
Scope of the report 4
IMS caveat 5
Datamonitor’s insights into the Chinese pharmaceutical market, 2006 5
China – a place for drug discovery and clinical trial partnerships? 6
A changing focus in the Chinese pharmaceutical market? 7
China – a land of opportunity for Western pharmaceutical manufacturers 8

CHAPTER 2 MACRO-ENVIRONMENTAL ISSUES AFFECTING THE CHINESE PHARMACEUTICAL INDUSTRY 23
Key findings 23
General country information – China 24
A changing economy 25
An overview of China’s healthcare system 30
The current scenario 30
Administrative and regulatory bodies of the healthcare system in China 35
SFDA’s increased focus on improving drug safety 37
China’s health reforms – hope for the future? 37
Healthcare expenditure and funding in China 39
Healthcare expenditure and financing set to improve 39
Health insurance coverage – increasing, but still insufficient 41

CHAPTER 3 REGULATORY ISSUES IN CHINA 46
Key findings 46
Reimbursement is negotiated with local authorities rather than at national level 47
Pharmaceutical Catalog classification 48
Continuing national price cuts pose significant dilemmas for manufacturers 49
A complex distribution system in China 52
Despite ongoing IP improvements, counterfeiting provides a significant threat to public health and drug development 54
Implications – China is too risky for the manufacturing of on-patent APIs 60
GMP – improving but still some way to go before Western manufacturers and regulatory agencies are fully satisfied 60
Drug approvals 62
Priority review procedures – public health crises 65

CHAPTER 4 CHINESE MARKET ASSESSMENT – PERFORMANCE BENCHMARKING 67
Key findings 67
The Chinese pharmaceutical market 68
China compared to the seven major markets 70
Other emerging countries – stressing China’s advantages and challenges 73
Which therapy classes are growing? 80
Competitive positioning of the top Chinese pharmaceutical players 82
Traditional Chinese Medicine (TCM) – a strong past and bright future 92
Regulation and GMP – the way forward for TCMs 94
Joint ventures are increasingly popular, driving TCM R&D 95
OTC in China set to increase further in the coming decades 98
Bayer acquires OTC cough and cold portfolio from Topsun Science and Technology 101
Internet pharmacy is playing an increasing role in the OTC market 102
OTC market entry recommendations 102

CHAPTER 5 CHINESE DOMESTIC PHARMACEUTICAL COMPANY OVERVIEW 103
Key findings 103
Chinese Pharma companies have traditionally driven growth through the API and generics business 104
Bulk manufacturing continues to drive China’s export industry 104
Overview of China’s R&D pipeline 107
Generics and biosimilars 108
There is little incentive for MNCs to enter the generics market 108
Chinese biosimilars players 110
Dragon Pharmaceutical – China’s leading biosimilar company 112

CHAPTER 6 OPPORTUNITIES FOR WESTERN MANUFACTURERS IN CHINA 116
China – a land of opportunity for Western pharmaceutical manufacturers 117
China – a place for drug discovery and clinical trial partnerships? 119
China’s Key R&D attractions 121
Foreign companies’ drug discovery outsourcing activity in China 127
MNCs are increasingly entering clinical trial partnerships for drugs for domestic and worldwide use 131
Key Western players in China – case studies 133
Key differences between AstraZeneca, Novo Nordisk and GSK operations in China 134
AstraZeneca – rejuvenated growth in recent years 137
Novo Nordisk – continued high growth rate 143
GSK – flat revenues due to increased generic competition on old drugs 149

CHAPTER 7 CHINESE PHARMACEUTICAL COMPANY PROFILES 156
Previously highly fragmented and regionalized 156
Leading domestic manufacturers sales in China 157
Yangtze River Pharmacy Group 158
Overview 158
Strategy 159
Therapy area focus and revenue generation 159
Partners 161
The Harbin Pharmaceutical Group 162
Overview 162
Strategy 163
Therapy area focus and revenue generation 164
HRP in the news 166
Jiangsu Hengrui Medicine Company 167
Overview 167
Strategy 168
Therapy area focus and revenue generation 169
R&D investment and pipeline focus 171
Partners 172
Shandong Qilu Medicines 173
Shanghai Pharmaceutical Group - Asia Pioneer 174
Shanxi Pude Pharmaceuticals 175
JL Weiwei Pharmaceuticals 176
Guangzhou Tian Xin 177
TH James-Andy 178
Shandong Lunan Better Pharmaceutical 179
Chongqing Yaoyou Pharmaceutical Company 180
Shandong Reyoung Pharmaceutical Company 181

CHAPTER 8 BIBLIOGRAPHY 182
Bibliography 182
Websites 182
Journals and press articles 195
Scrip 196
APPENDIX 198
IMS caveat 198
Exchange rate 198

LIST OF TABLES
Table 1: Economic statistics – China, 2005 25
Table 2: Main economic indicators for seven of the world’s largest economies (2003) 27
Table 3: China, country-specific healthcare information of interest, 2005 30
Table 4: Selected Chinese national health accounts indicators, 2003 31
Table 5: Ministry level agencies with health authority in China, 2006 36
Table 6: Distribution of drug products in the 2004 Pharmaceutical Catalog 49
Table 7: Chamber of Commerce’s report recommendations, September 2006 58
Table 8: Prescription pharmaceutical sales per capita across the US, 5EU, Japan and China, 2005 71
Table 9: Top five ATC classes by revenue in China, the US and 5EU, 2005 77
Table 10: Top five ATC classes by volume in China, the US and 5EU, 2005 78
Table 11: Top domestic and Western pharmaceutical manufacturers in China, 2005 84
Table 12: Average (mean) sales characteristics of manufacturer groupings, 2004–05 87
Table 13: Top OTC players in China by value ($m), 2004 102
Table 14: Dragon Pharmaceutical’s biosimilar product portfolio and pipeline, 2006 113
Table 15: Advantages and disadvantages of clinical trials and R&D in China, 2006 120
Table 16: Key R&D investments by the top global pharmaceutical companies in China, 2005–06 121
Table 17: State Governmental scientific support programs 125
Table 18: Key drug discovery outsourcing deals involving Chinese service providers, 2005-2006 128
Table 19: Mean price comparison between domestically produced and imported products, 2005 136
Table 20: AstraZeneca’s product portfolio in China, 2004–05 139
Table 21: Novo Nordisk’s product portfolio in China, 2004–05 144
Table 22: GSK’s therapy franchises in China, 2004–05 150
Table 23: GSK’s product portfolio in China, 2004–05 151
Table 24: Leading domestic manufacturers in China ($m), 2004–05 157
Table 25: Yangtze River Pharmaceutical Group’s Chinese revenue breakdown by therapy area, 2004–05 158
Table 26: Yangtze River Pharmaceutical Group’s top 10 products in China, 2004–05 160
Table 27: Harbin Pharmaceutical Group’s Chinese revenue breakdown by therapy area ($m), 2004–05 162
Table 28: Harbin Pharmaceutical Group’s top 10 products in China, 2004–05 164
Table 29: Harbin Pharmaceutical Group news, 2005–06 166
Table 30: Jiangsu Hengrui Medicine Company’s total Chinese revenue breakdown by therapy area, 2004–05 167
Table 31: Jiangsu Hengrui Medicine Company’s top 10 products in China ($m), 2004–05 169
Table 32: Jiangsu Hengrui Medicine Company‘s patent list, 2004–06 171
Table 33: Shandong Qilu Medicines total Chinese revenue breakdown by therapy area ($m), 2004–05 173
Table 34: Shanghai Pharmaceutical Group – Asia Pioneer total Chinese revenue breakdown by therapy area ($m), 2004–05 174
Table 35: Shanxi Pude Pharmaceuticals total Chinese revenue breakdown by therapy area ($m), 2004–05 175
Table 36: JL Weiwei Pharmaceuticals total Chinese revenue breakdown by therapy area ($m), 2004–05 176
Table 37: Guangzhou Tian Xin Pharmaceuticals total Chinese revenue breakdown by therapy area ($m), 2004–05 177
Table 38: TH James-Andy total Chinese revenue breakdown by therapy area ($m), 2004–05 178
Table 39: Shandong Lunan Better Pharmaceutical total Chinese revenue breakdown by therapy area ($m), 2004–05 179
Table 40: Chongqing Yaoyou Pharmaceutical Company total Chinese revenue breakdown by therapy area ($m), 2004–05 180
Table 41: Shandong Reyoung Pharmaceutical Company total Chinese revenue breakdown by therapy area ($m), 2004–05 181
Table 42: Exchange rates* 198

LIST OF FIGURES
Figure 1: Pros and cons of drug discovery and clinical trials in China 6
Figure 2: Marketed biosimilar products from Chinese manufacturers, 2006 8
Figure 3: Size and revenue growth by therapy in the Chinese pharmaceutical market, 2001–05 9
Figure 4: China’s major trading partners 29
Figure 5: Total expenditure on health as percentage of GDP, 2003 32
Figure 6: Rise in cost of healthcare versus income in China, 1989–2001 34
Figure 7: Proportion of healthcare expenditure versus GDP, 1978-2004 39
Figure 8: Drug reimbursement in China, 2005 48
Figure 9: Branded drug price breakdown in China, 2006 51
Figure 10: Drug distribution channels in China, 2006 53
Figure 11: WTO timeline for revamping of China’s pharmaceutical distribution networks, 2001–07 54
Figure 12: Protection of pharmaceutical products in China with or without a patent, 2006 59
Figure 13: Key steps for drug approval in China, 2006 62
Figure 14: Comparison of Approvals of New Drug Applications (NDAs) in the US and China, 2004 63
Figure 15: Comparison of the number of BLA and NME submissions in the US and China, 2000–04 64
Figure 16: Manufacturing and distribution in China, 2005 69
Figure 17: The Chinese pharmaceutical market size in comparison with the seven major markets, 2005 70
Figure 18: Estimates of China’s prescription pharmaceutical market, 2004 71
Figure 19: Growth of the Chinese pharmaceutical market, 2001–05 72
Figure 20: Comparison of the Chinese, major seven developed, and emerging pharmaceutical markets, 2001–05 73
Figure 21: Positioning of emerging countries compared to China, 2006 74
Figure 22: Distribution of therapy area (ATC class) by revenue in China, the US and EU, 2005 76
Figure 23: Positioning of therapy classes by revenue from the leading domestic and Western manufacturers in China, 2005 79
Figure 24: Domestic manufacturers only lead the Western players in anti-infectives, 2006 80
Figure 25: Distribution of revenues by therapy area (ATC code) for the top 10 domestic and Western manufacturers in China, 2005 81
Figure 26: Leading domestic manufacturers have outstripped Western players in terms of product launches during 2004–05 82
Figure 27: Revenue growth of the top 10 leading Western and domestic manufacturers in China, 2001–05 85
Figure 28: Competitive positioning of top domestic and Western pharmaceutical companies in China, 2005 86
Figure 29: Competitive positioning of top Western pharmaceutical companies in China and the rest of the world by revenue ($), 2005 88
Figure 30: Competitive positioning of top pharmaceutical companies in China and the rest of the world by revenue growth (%), 2004–05 89
Figure 31: Competitive positioning of top pharmaceutical companies in China and the rest of the world by CAGR, 2001–05 90
Figure 32: Number of new product launches in China by Western manufacturers, 2002–05 91
Figure 33: Number of new product launches in China by domestic manufacturers, 2002–05 92
Figure 34: R&D expenditure on Traditional Chinese Medicine, 2002–04 94
Figure 35: China OTC market value and growth ($), 2000–04 98
Figure 36: China OTC market by segmentation, 2004 99
Figure 37: Distribution of OTC medicines in China, 2004 101
Figure 38: China’s pharmaceutical imports versus exports, 2004 105
Figure 39: Pipeline drug candidates in China by franchise, 2006 107
Figure 40: Segmentation of the Chinese pharmaceutical market revenues by license status, 2005 109
Figure 41: Marketed biosimilar products from Chinese manufacturers, 2006 111
Figure 42: Size and revenue growth by therapy in the Chinese pharmaceutical market, 2001–05 118
Figure 43: Competitive positioning of top domestic and Western pharmaceutical companies in China, 2005 134
Figure 44: Revenue growth of AstraZeneca’s, GSK’s and Novo Nordisk’s imported and domestic products, 2001–05 136
Figure 45: Revenues and growth of AstraZeneca’s lead franchises in China, 2001–05 138
Figure 46: Growth and share of revenues and SUs between AstraZeneca and AZ-Wuxi in China, 2001–05 141
Figure 47: Novo Nordisk – the largest and one of the fastest growing diabetes franchises in China, 2005 145
Figure 48: Growth and share of revenues and volume between Novo Nordisk and Novo Nordisk Tianjin in China, 2001–05 146
Figure 49: Revenues and growth of GSK’s lead franchises in China, 2001–05 153
Figure 50: GSK China – declining revenues and volume, 2001–05 154