Publications and Reports

• 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

Download Table of Contents [PDF 1 MB]

Chapters:

PREFACE – Study Overview

SECTION 1: Introduction to Advances in China Biopharmaceuticals
• Introduction: A China Biopharmaceuticals Strategy

SECTION 2: Innovation in China Biopharmaceuticals: Historical and Current Climate
• Chapter 2: Biologics Innovation in China: Historical and Current Drivers
• 2-1: Chinese Innovation in the Biopharmaceutical Industry, 2007 to 2016
• 2-2: Scientific Strategy in China: Starting with Biosimilar Platforms
• 2-3: Development of Innovative Therapeutics in China
• 2-4: Opportunities and Challenges for Drug Innovation in China
• 2-5: Pathway for Access to China Markets for Innovative Therapeutics
• 2-6: China on the Biopharmaceutical Fast Track? Challenges to Innovation
• 2-7: Advances in R&D for mAb Therapeutics Development
• 2-8: Current Status and Future of China’s mAb Therapeutics
• 2-9 Brief: Challenges and Opportunities in Innovative Drug Development in China
• 2-10 Brief: Launching Biologics in China: From Biosimilar to Innovative Molecules. Key Considerations for MABs and Biologicals
• 2-11 Brief: Accelerating R&D of Biological Drugs in China
• 2-12 Brief: China’s Biopharma Innovation–Creating Opportunities
• 2-13 Brief: Tech Advances in Biopharma

SECTION 3: Biopharmaceuticals and Healthcare Systems and Structure in China
• Chapter 3: Overview and Review of the Chinese Biological Pharmaceutical Markets
• 3-1: Reform of Drug and Medical Device Review and Approval Systems
• 3-2: China’s Regulatory Reform in Healthcare: Achievements and Challenges
• 3-3: China Food and Drug Administration Reform in China
• 3-4: Reforms and Trends in China’s Healthcare Insurance System
• 3-5: New Drug Evaluation Systems in China
• 3-6: Approval Process for Biologics: A US-China Comparison

SECTION 4: Biopharmaceutical Manufacturing in China: Operational and Quality Trends
• Chapter 4: Introduction to BioManufacturing in China
• 4-1: Manufacturing of Biopharmaceuticals in China
• 4-2: Historical Development of Good Manufacturing Practices in China
• 4-3: Current Challenges in Biopharma Quality Management in China
• 4-4: National Standards for Chinese Biological Products
• 4-5: Advances in China Pharma Manufacturing
• 4-6: Recombinant Protein Drug Quality Control
• 4-7: GMP Implementation: The “Made in China 2025” Plan
• 4-8: Single-Use Technology in China’s Biomanufacturing
• 4-9: Biologics Manufacturing Costs in China
• 4-10: Impact of CFDA Reform on CMC Strategy at IND Stage
• 4-11: Overview of Biopharmaceutical Contract Manufacturing Organizations in China
• 4-12: Establishing a Management Pattern for Pharmaceuticals Using the Enterprise Resource Planning System
• 4-13: Bioprocessing Equipment Strategy in mAb Manufacturing in China
• 4-14: Tech Transfer in mAb Manufacturing
• 4-15 Brief: Advances in the Biopharmaceutical Manufacturing Industry in China

SECTION 5: Advances in Biological Development in China
• Chapter 5: Introduction to Biological Development in China
• 5-1: Monoclonal Antibody Drug Development in China
• 5-2: Development of Antibody-Drug Conjugates in China
• 5-3: Therapeutic Developments for Rare Diseases in China
• 5-4: CarT-China: Advances in Personalized Medicine
• 5-5: RNAi in China: Novel Therapeutics in China
• 5-6: Clinical Trials and Regulatory Oversight of Mesenchymal Stem Cell Therapies in China

SECTION 6: Vaccine Industry in China
• Chapter 6: Introduction to China’s Vaccine Industry
• 6-1: Historical Review of China Vaccines: 2007-2016
• 6-2: Innovative Developments in China’s Vaccine Industry
• 6-3: China’s Vaccine Industry: Current Landscape and Key Product Segments
• 6-4: Current State and Overview of the Chinese Vaccine Market

SECTION 7: Biopharma Contract Services and Clinical Trials in China
• Chapter 7: Introduction to China’s Services to the Biopharma Industry
• 7-1: Conducting International Multicenter Clinical Trials in China
• 7-2: Current and Future Development of CROs in China
• 7-3: Future of CRO’s in China: An Investor’s Point of View

SECTION 8: Doing Business in China: Investment and Intellectual Property
• Chapter 8: Introduction to Investing in China Pharma and Biopharma Industry
• 8-1: IP and Biopharma in China
• 8-2: Trends and Characteristics of Intellectual Property in China’s Biopharmaceutical Industry
• 8-3: Investing in the Biopharmaceutical Industry in China
• 8-4: An Invitation to Invest in Biomedicine in China
• 8-5: China’s Investment Outbound in the Global Biopharmaceutical Industry
• 8-6: International Status and Path Analysis of China’s Pharmaceutical Products
• 8-7: China Licensing Deals for Biologics
• 8-8: Legal Issues: Commercial Bribery in Pharmaceutical Companies in China
• 8-9: Marketing Authorization Holder Options Under Cost Control
• 8-10: Industrial Policy and Technology Transfer in China’s Biopharma Industry
• 8-11: Slow Transformation: An Overview of China Pharmaceutical Business
• 8-12 Brief: Intellectual Property Trading in China’s Pharmaceutical Industry
• 8-13 Case Study: Doing Business in China

SECTION 9: Future of China’s Biopharma Industry
• 9-1 Brief: Future Prospects for China Biopharma

Appendices
• Appendix A: Directory of Biologics on Market & Clinical Development in China
• Appendix B: Directory: Top 60 Biopharmaceutical Manufacturers in China

Author Organizations

• 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.