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:
- Assess the state of biopharmaceutical development in China
- Understand general business practices
- Analyze business opportunities and identify potential partners
Published by BioPlan Associates, Inc., and Society for Industrial Microbiology and Biotechnology (SIMB)
October 2018
ISBN: 978-1-934106-34-1
By the Numbers:
- 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
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.