Advances in Biopharmaceutical Technology in China, 2nd Ed
Society for Industrial Microbiology and Biotechnology and BioPlan Associates
Advances in Biopharmaceutical Technology, 2nd ed - A new opportunity exists in working with Chinese companies to establish scientific and business partnerships, and to create effective strategies. However, success in Asia will require changes in partnerships between Western and Asian companies.
Every company faces the question “What should our China strategy be?”
This volume, published by BioPlan Associates, Inc., in cooperation with the Society for Industrial Microbiology and Biotechnology (SIMB) provides an overview of the biopharmaceutical industry, and the state of technology in China. A peer-reviewed, ready reference for all aspects of biopharmaceuticals in China, including an understanding of the China biopharma current situation, and future opportunities. Readers receive a comprehensive assessment of the state-of-the-industry, trends and analysis. information on all types of organizations involved in biopharma in China, whether they are domestic. multinational or government.
Readers will be able to:
Lynn Johnson-Langer, Advisory Member.
Dr. Lynn Johnson-Langer has her PhD from Antioch University in management; she graduated Johns Hopkins University, MBA, Business Management; University of Maryland, BS Microbiology. She works with biotechnology and life sciences organizations to improve clients' management systems, including human resources and marketing management.
Eric Langer, Managing Partner.
Eric Langer, President and Managing Partner, has over 20 years experience in biotechnology and life sciences international marketing, management, market assessment, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He is an experienced biotechnology strategist, marketing practitioner, publisher, and researcher.
Advances in Biopharmaceutical Technology, 2nd ed - A new opportunity exists in working with Chinese companies to establish scientific and business partnerships, and to create effective strategies. However, success in Asia will require changes in partnerships between Western and Asian companies.
Every company faces the question “What should our China strategy be?”
This volume, published by BioPlan Associates, Inc., in cooperation with the Society for Industrial Microbiology and Biotechnology (SIMB) provides an overview of the biopharmaceutical industry, and the state of technology in China. A peer-reviewed, ready reference for all aspects of biopharmaceuticals in China, including an understanding of the China biopharma current situation, and future opportunities. Readers receive a comprehensive assessment of the state-of-the-industry, trends and analysis. information on all types of organizations involved in biopharma in China, whether they are domestic. multinational or government.
Readers will be able to:
- Assess the state of biopharmaceutical development in China
- Understand general business practices
- Analyze business opportunities and identify potential partners
- 102 Internationally Recognized Authors
- 9 Sections, 55 Chapters
- 21 Peer-Reviewers
- 1,139 Pages
- 70 Translated Sections
- 7 Case Studies and China Briefs
- 200+ Tables and Figures
- 300+ References
- Over 2,000 Index Entries
- Amgen Asia Research and Development Center
- Anhui Anke Biotechnology (Group) Co., Ltd.
- AstraZeneca/MedImmune
- AutekBio
- BeiGene (Suzhou) Co., Ltd.
- Beijing Minhai Biotechnology Co., Ltd.
- Beijing University
- Betta Pharma Co., Ltd.
- Boehringer Ingelheim China
- CanSino Biologics Inc.
- Celgene Pharma
- Cellyan Therapeutics (Wuhan) Co., Ltd.
- Changzhou High-Tech Research Institute of Nanjing University
- China National Center for Biotechnology Development (CNCBD)
- China Technology Exchange
- Chinese Academy of Sciences
- Chinese Pharmacopoeia Commission
- Complya Asia Co., Ltd.
- CStone Pharmaceuticals
- Dacheng LLP
- Doer Bio
- Fudan University
- Genor BioPharma
- Guangzhou Nanotides Pharmaceuticals, Co. Ltd.
- Hengrui Pharma
- Hua Medicine
- Huaota Biopharma
- ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd.
- Innova Med Biotechnology Co., Ltd.
- Innovent Biologics
- Jiangsu TargetPharma Laboratories Inc.
- Jiayu (Suzhou) Biomedical Incorporated
- Jilin University
- L.E.K. Consulting
- Macau University of Science and Technology
- Nanjing University
- Peking University
- Perkins Coie, LLP
- PersonGen
- Pharmcodia
- Pullan Consulting
- Qiming Venture Partners
- Quacell Biotechnology Company Ltd.
- Renmin University
- SDIC Fund
- Shanghai Institutes for Biological Sciences
- Shenzhen Polytechnic University
- Shenzhen Research Institute of Nanjing University
- Sichuan University
- Sinolink Securities Institute
- Suzhou Sirnaomics Pharmaceuticals, Co. Ltd.
- Tasly Sants Pharmaceutical
- Tianjin International Joint Academy of Biomedicine
- Tot Biopharm Co., Ltd.
- VenturePharma
- Walter Biotech Consultancy
- Wuhan YZY Biopharma Co., Ltd.
- WuXi Biologics
- Xiamen Wantai Canghai
- XingYe Securities
- Yusen Capital
- Zai Lab.
- Zensun (Shanghai) Sci & Tech Co., Ltd.
- Zhejiang Hisun Pharmaceutical Co., Ltd.
- Zhejiang Teruisi Pharmaceutical Inc.
Lynn Johnson-Langer, Advisory Member.
Dr. Lynn Johnson-Langer has her PhD from Antioch University in management; she graduated Johns Hopkins University, MBA, Business Management; University of Maryland, BS Microbiology. She works with biotechnology and life sciences organizations to improve clients' management systems, including human resources and marketing management.
Eric Langer, Managing Partner.
Eric Langer, President and Managing Partner, has over 20 years experience in biotechnology and life sciences international marketing, management, market assessment, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He is an experienced biotechnology strategist, marketing practitioner, publisher, and researcher.
SECTION 1: INTRODUCTION TO ADVANCES IN CHINA
Biopharmaceuticals
CHAPTER 1: INTRODUCTION: A CHINA BIOPHARMACEUTICALS STRATEGY
Andrew D. Skibo
SECTION 2: INNOVATION IN CHINA BIOPHARMACEUTICALS: HISTORICAL AND
Current Climate
CHAPTER 2: BIOLOGICS INNOVATION IN CHINA: HISTORICAL AND CURRENT DRIVERS
Vicky (Qing) Xia and Leo (Yang) Cai
2-1. Review of Chinese Innovation in Biopharma: 2007-2016
CHEN Daming, MA Zhengyuan, MAO Kaiyun, and JIANG Hongbo, PhD
2-2. Scientific Strategies in China: Starting with Biosimilar Platforms
YUAN Jun, GANG Hai, WANG Jing, LIU Moli, WU Haofei, KUBIN Zachary, FANG WeiJie, and POON H. Fai
2-3. Development of Innovative Therapeutics in China
Dr. DING Lieming and Dr. KUANG Licong
2-4. Opportunities and Challenges for Drug Innovation in China
Dr. Frank Jiang
2-5. Pathway for Access to China Markets for Innovative Therapeutics
Dr. SHAN Guohong
2-6. China on the Biopharmaceutical Fast Track? Challenges to Innovation
Dr. HUANG Yanshan
2-7. Advances in R&D for mAb Therapeutics Development
WANG Li and Dr. HU Siyi
2-8. Current Status and Future of China's mAb Therapeutics
ZHANG Meiyun and ZHANG Mingqiang
Brief 2-9. Challenges and Opportunities in Innovative Drug Development in China
Dr. CAO Guoqing and CHEN Kan
Brief 2-10. Launching Biologics in China: From Biosimilar to Innovative Molecules
Key Considerations for MABs and Biologicals
Joe Zhou, PhD and SHI Jinhai, PhD
Brief 2-11. Accelerating R&D of Biological Drugs in China
Dr. LUO Jiali
Brief 2-12. China's Biopharma Innovation--Creating Opportunities
LI Kechun
Brief 2-13. International Biopharma Expansion into China: A Survey of
Market Entry Interest
Helen Chen
SECTION 3: BIOPHARMACEUTICALS AND HEALTHCARE SYSTEMS AND STRUCTURE IN CHINA
CHAPTER 3: OVERVIEW AND REVIEW OF THE CHINESE BIOLOGICAL PHARMACEUTICAL MARKETS
Vicky (Qing) Xia and Leo (Yang) Cai
3-1. Reform of Drug and Medical Device Review and Approval Systems
Dr. LIN Hui
3-2. China's Healthcare Reform: How China is Increasing Domestic Access to Healthcare
Prof. HU Shanlian
3-3. China's Regulatory Reform in Healthcare and its Impact on Biopharma Industry Growth
HEI Yong-jiang, M.D., PhD
3-4. Reforms and Trends in China's Healthcare Insurance System
Professor QIU Yulin
3-5. New Drug Evaluation System in China
Dr. XU Jiaxi and Dr. ZHANG Jiabo
3-6. Approval Process for Biologics: A US-China Comparison
YU Wen-Liang, LI Jia-Huang, and HUA Zi-Chun
SECTION 4: BIOPHARMACEUTICAL MANUFACTURING IN CHINA: OPERATIONAL AND QUALITY TRENDS
CHAPTER 4: INTRODUCTION TO BIOMANUFACTURING IN CHINA
Vicky (Qing) Xia and Leo (Yang) Cai
4-1. Manufacturing of Biopharmaceuticals in China
Scott M Wheelwright, PhD
4-2. Historical Development of Good Manufacturing Practices in China
YI Jizu, YAO Lan, and YUAN Jianrong
4-3. Current Challenges in Biopharma Quality Management in China
Claudia (Qiao) Lin, PhD
4-4. National Standards for Chinese Biological Products
GUO Zhongping
4-5. Advances in China Pharma Manufacturing
Dr. WANG Baoyi and WANG Tingting
4-6. Recombinant Protein Drug Quality Control
Dr. YI Jizu and XIONG Hui
4-7. GMP Implementation: The “Made in China 2025” Plan
ZHOU Jingtao
4-8. Single Use Technology in China's Biomanufacturing
Dr. Joachim K Walter
4-9. Biologics Manufacturing Costs in China
XU Wei
4-10. Impact of CFDA Reform on CMC Strategy at IND Stage
Dr. LUO Xiaoyu
4-11. Overview of Biopharmaceuticals Contract Manufacturing
Organizations in China
ZHOU Weichang, Jill Cai, and WANG Fenglin
4-12. Establishing a Management Pattern for Pharmaceuticals Using the
Enterprise Resource Planning System
HUANG Sanshan
4-13. Bioprocessing Equipment Strategy in mAb Manufacturing in China
HUANG Sanshan
4-14. Tech Transfer in mAb Manufacturing
LIU Ziliang
Brief 4-15. Advances in the Biopharmaceutical Manufacturing Industry in China
XU Bo, PhD
SECTION 5: ADVANCES IN BIOLOGICAL DEVELOPMENT IN CHINA
CHAPTER 5: INTRODUCTION TO BIOLOGICAL DEVELOPMENT IN CHINA
Vicky (Qing) Xia and Leo (Yang) Cai
5-1. Monoclonal Antibody Drug Development in China
Dr. DU Yi and Dr. ZHU Xiangyang
5-2. Development of Antibody-Drug Conjugates in China
Dr. SONG Hongbin
5-3. Therapeutic Developments for Rare Diseases in China
JIN Xiaowei and CHEN Li
5-4. CarT-China: Advances in Personalized Medicine
Dr. YANG Lin
5-5. RNAi in China: Novel Therapeutics in China
Patrick Lu, Parker J. Guan, Danny Tang, Jeffery Y Cai, Tom TY Zhong, and Grace YH Gao
5-6. Clinical Trials and Regulatory Oversight of Mesenchymal Stem Cell Therapies in China
WANG Yan, PhD
SECTION 6: VACCINE INDUSTRY IN CHINA
CHAPTER 6: INTRODUCTION TO CHINA'S VACCINE INDUSTRY
Vicky (Qing) Xia and Leo (Yang) Cai
6-1. Historical Review of China Vaccines: 2007-2016
WANG Yan, PhD
6-2. Innovative Developments in China's Vaccine Industry
Dr. PAN Huirong
6-3. China's Vaccine Industry: Current Landscape and Key Product Segments Dr. WANG Huan
6-4. Current State and Overview of the Chinese Vaccine Market
ZHENG Haifa
SECTION 7: BIOPHARMA CONTRACT SERVICES AND CLINICAL TRIALS IN CHINA
CHAPTER 7: INTRODUCTION TO CHINA'S CHALLENGES AND OPPORTUNITIES IN SERVICES OFFERINGS IN CHINA
Vicky (Qing) Xia and Leo (Yang) Cai
7-1. Conducting International Multicenter Clinical Trials in China
Dr. WANG Haibo and Dr. ZHANG Xiaofang
7-2. Current and Future Development of CROs in China
SONG Xue Mei
7-3. Future of CRO's in China: An Investor's Point of View
SUN Xiaoyue and LI Jinglei
SECTION 8: DOING BUSINESS IN CHINA: INVESTMENT AND INTELLECTUAL PROPERTY
CHAPTER 8: INTRODUCTION TO INVESTING IN CHINA PHARMA AND BIOPHARMA INDUSTRY
Vicky (Qing) Xia and Leo (Yang) Cai
8-1. IP and Biopharma in China
Michael Wise, Dr. WANG Yingli, and YANG Tang
8-2. Trends and Characteristics of Intellectual Property in China's Biopharmaceutical Industry
JIANG Zhenggang
8-3. Investing in the Biopharmaceutical Industry in China
YIN Zheng and XU Yuxin
8-4. An Invitation to Invest in Biomedicine in China
Dr. HUA Zhaozhe
8-5. China's Investment Outbound in the Global Biopharmaceutical Industry
Dr. LIN Hui
8-6. International Status and Path Analysis of China's Pharmaceutical Products
ZHU Xun, LIANG Bo, QIAN Wanying, CUI Yi, and DING Hongxia
8-7. China Licensing Deals for Biologics
Linda M. Pullan, PhD
8-8. Legal Issues: Commercial Bribery in Pharmaceutical Companies in China
DENG Yong
8-9. Marketing Authorization Holder Options Under Cost Control
Dr. LI Zhiliang
8-10. Industrial Policy and Tech Transfer in China's Biopharma Industry
Mr. HUA Yutao and Dr. LI Pingping
8-11. Slow Transformation: An Overview of China Pharmaceutical Business Vicky (Qing) Xia, Leo (Yang) Cai
Brief 8-12. Intellectual Property Trading in China's Pharmaceutical Industry
LI Zhonghua
8-13. Case Study: Doing Business in China
Vicky (Qing) Xia, Leo (Yang) Cai
SECTION 9: FUTURE OF CHINA'S BIOPHARMA INDUSTRY
Brief 9. Future Prospects for China Biopharma
Chris Chen and Kevin Huang
Appendix A
Directory of Biologics on Market & Clinical Development in China
Appendix B
Directory Top 60 Biopharmaceutical Facilities in China
Index
Biopharmaceuticals
CHAPTER 1: INTRODUCTION: A CHINA BIOPHARMACEUTICALS STRATEGY
Andrew D. Skibo
SECTION 2: INNOVATION IN CHINA BIOPHARMACEUTICALS: HISTORICAL AND
Current Climate
CHAPTER 2: BIOLOGICS INNOVATION IN CHINA: HISTORICAL AND CURRENT DRIVERS
Vicky (Qing) Xia and Leo (Yang) Cai
2-1. Review of Chinese Innovation in Biopharma: 2007-2016
CHEN Daming, MA Zhengyuan, MAO Kaiyun, and JIANG Hongbo, PhD
2-2. Scientific Strategies in China: Starting with Biosimilar Platforms
YUAN Jun, GANG Hai, WANG Jing, LIU Moli, WU Haofei, KUBIN Zachary, FANG WeiJie, and POON H. Fai
2-3. Development of Innovative Therapeutics in China
Dr. DING Lieming and Dr. KUANG Licong
2-4. Opportunities and Challenges for Drug Innovation in China
Dr. Frank Jiang
2-5. Pathway for Access to China Markets for Innovative Therapeutics
Dr. SHAN Guohong
2-6. China on the Biopharmaceutical Fast Track? Challenges to Innovation
Dr. HUANG Yanshan
2-7. Advances in R&D for mAb Therapeutics Development
WANG Li and Dr. HU Siyi
2-8. Current Status and Future of China's mAb Therapeutics
ZHANG Meiyun and ZHANG Mingqiang
Brief 2-9. Challenges and Opportunities in Innovative Drug Development in China
Dr. CAO Guoqing and CHEN Kan
Brief 2-10. Launching Biologics in China: From Biosimilar to Innovative Molecules
Key Considerations for MABs and Biologicals
Joe Zhou, PhD and SHI Jinhai, PhD
Brief 2-11. Accelerating R&D of Biological Drugs in China
Dr. LUO Jiali
Brief 2-12. China's Biopharma Innovation--Creating Opportunities
LI Kechun
Brief 2-13. International Biopharma Expansion into China: A Survey of
Market Entry Interest
Helen Chen
SECTION 3: BIOPHARMACEUTICALS AND HEALTHCARE SYSTEMS AND STRUCTURE IN CHINA
CHAPTER 3: OVERVIEW AND REVIEW OF THE CHINESE BIOLOGICAL PHARMACEUTICAL MARKETS
Vicky (Qing) Xia and Leo (Yang) Cai
3-1. Reform of Drug and Medical Device Review and Approval Systems
Dr. LIN Hui
3-2. China's Healthcare Reform: How China is Increasing Domestic Access to Healthcare
Prof. HU Shanlian
3-3. China's Regulatory Reform in Healthcare and its Impact on Biopharma Industry Growth
HEI Yong-jiang, M.D., PhD
3-4. Reforms and Trends in China's Healthcare Insurance System
Professor QIU Yulin
3-5. New Drug Evaluation System in China
Dr. XU Jiaxi and Dr. ZHANG Jiabo
3-6. Approval Process for Biologics: A US-China Comparison
YU Wen-Liang, LI Jia-Huang, and HUA Zi-Chun
SECTION 4: BIOPHARMACEUTICAL MANUFACTURING IN CHINA: OPERATIONAL AND QUALITY TRENDS
CHAPTER 4: INTRODUCTION TO BIOMANUFACTURING IN CHINA
Vicky (Qing) Xia and Leo (Yang) Cai
4-1. Manufacturing of Biopharmaceuticals in China
Scott M Wheelwright, PhD
4-2. Historical Development of Good Manufacturing Practices in China
YI Jizu, YAO Lan, and YUAN Jianrong
4-3. Current Challenges in Biopharma Quality Management in China
Claudia (Qiao) Lin, PhD
4-4. National Standards for Chinese Biological Products
GUO Zhongping
4-5. Advances in China Pharma Manufacturing
Dr. WANG Baoyi and WANG Tingting
4-6. Recombinant Protein Drug Quality Control
Dr. YI Jizu and XIONG Hui
4-7. GMP Implementation: The “Made in China 2025” Plan
ZHOU Jingtao
4-8. Single Use Technology in China's Biomanufacturing
Dr. Joachim K Walter
4-9. Biologics Manufacturing Costs in China
XU Wei
4-10. Impact of CFDA Reform on CMC Strategy at IND Stage
Dr. LUO Xiaoyu
4-11. Overview of Biopharmaceuticals Contract Manufacturing
Organizations in China
ZHOU Weichang, Jill Cai, and WANG Fenglin
4-12. Establishing a Management Pattern for Pharmaceuticals Using the
Enterprise Resource Planning System
HUANG Sanshan
4-13. Bioprocessing Equipment Strategy in mAb Manufacturing in China
HUANG Sanshan
4-14. Tech Transfer in mAb Manufacturing
LIU Ziliang
Brief 4-15. Advances in the Biopharmaceutical Manufacturing Industry in China
XU Bo, PhD
SECTION 5: ADVANCES IN BIOLOGICAL DEVELOPMENT IN CHINA
CHAPTER 5: INTRODUCTION TO BIOLOGICAL DEVELOPMENT IN CHINA
Vicky (Qing) Xia and Leo (Yang) Cai
5-1. Monoclonal Antibody Drug Development in China
Dr. DU Yi and Dr. ZHU Xiangyang
5-2. Development of Antibody-Drug Conjugates in China
Dr. SONG Hongbin
5-3. Therapeutic Developments for Rare Diseases in China
JIN Xiaowei and CHEN Li
5-4. CarT-China: Advances in Personalized Medicine
Dr. YANG Lin
5-5. RNAi in China: Novel Therapeutics in China
Patrick Lu, Parker J. Guan, Danny Tang, Jeffery Y Cai, Tom TY Zhong, and Grace YH Gao
5-6. Clinical Trials and Regulatory Oversight of Mesenchymal Stem Cell Therapies in China
WANG Yan, PhD
SECTION 6: VACCINE INDUSTRY IN CHINA
CHAPTER 6: INTRODUCTION TO CHINA'S VACCINE INDUSTRY
Vicky (Qing) Xia and Leo (Yang) Cai
6-1. Historical Review of China Vaccines: 2007-2016
WANG Yan, PhD
6-2. Innovative Developments in China's Vaccine Industry
Dr. PAN Huirong
6-3. China's Vaccine Industry: Current Landscape and Key Product Segments Dr. WANG Huan
6-4. Current State and Overview of the Chinese Vaccine Market
ZHENG Haifa
SECTION 7: BIOPHARMA CONTRACT SERVICES AND CLINICAL TRIALS IN CHINA
CHAPTER 7: INTRODUCTION TO CHINA'S CHALLENGES AND OPPORTUNITIES IN SERVICES OFFERINGS IN CHINA
Vicky (Qing) Xia and Leo (Yang) Cai
7-1. Conducting International Multicenter Clinical Trials in China
Dr. WANG Haibo and Dr. ZHANG Xiaofang
7-2. Current and Future Development of CROs in China
SONG Xue Mei
7-3. Future of CRO's in China: An Investor's Point of View
SUN Xiaoyue and LI Jinglei
SECTION 8: DOING BUSINESS IN CHINA: INVESTMENT AND INTELLECTUAL PROPERTY
CHAPTER 8: INTRODUCTION TO INVESTING IN CHINA PHARMA AND BIOPHARMA INDUSTRY
Vicky (Qing) Xia and Leo (Yang) Cai
8-1. IP and Biopharma in China
Michael Wise, Dr. WANG Yingli, and YANG Tang
8-2. Trends and Characteristics of Intellectual Property in China's Biopharmaceutical Industry
JIANG Zhenggang
8-3. Investing in the Biopharmaceutical Industry in China
YIN Zheng and XU Yuxin
8-4. An Invitation to Invest in Biomedicine in China
Dr. HUA Zhaozhe
8-5. China's Investment Outbound in the Global Biopharmaceutical Industry
Dr. LIN Hui
8-6. International Status and Path Analysis of China's Pharmaceutical Products
ZHU Xun, LIANG Bo, QIAN Wanying, CUI Yi, and DING Hongxia
8-7. China Licensing Deals for Biologics
Linda M. Pullan, PhD
8-8. Legal Issues: Commercial Bribery in Pharmaceutical Companies in China
DENG Yong
8-9. Marketing Authorization Holder Options Under Cost Control
Dr. LI Zhiliang
8-10. Industrial Policy and Tech Transfer in China's Biopharma Industry
Mr. HUA Yutao and Dr. LI Pingping
8-11. Slow Transformation: An Overview of China Pharmaceutical Business Vicky (Qing) Xia, Leo (Yang) Cai
Brief 8-12. Intellectual Property Trading in China's Pharmaceutical Industry
LI Zhonghua
8-13. Case Study: Doing Business in China
Vicky (Qing) Xia, Leo (Yang) Cai
SECTION 9: FUTURE OF CHINA'S BIOPHARMA INDUSTRY
Brief 9. Future Prospects for China Biopharma
Chris Chen and Kevin Huang
Appendix A
Directory of Biologics on Market & Clinical Development in China
Appendix B
Directory Top 60 Biopharmaceutical Facilities in China
Index
