This co-publication with the Society for Industrial Microbiology provides an authoritative analysis of the biopharmaceutical industry and the state of China's technology. With 102 recognized authors in 55 chapters and 7 briefs, this study provides the most objective view of the opportunities in China today.
Readers will be able to:
- Assess the state of biopharmaceutical development in China
- Understand general business practices
- Analyze business opportunities and identify potential partners
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.
SECTION 1: INTRODUCTION TO ADVANCES IN CHINA BIOPHARMACEUTICALS
1. Intro Introduction: A China Biopharmaceuticals Strategy
SECTION 2: INNOVATION IN CHINA BIOPHARMACEUTICALS: HISTORICAL AND CURRENT CLIMATE
2. Intro 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.
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
3. Intro 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
3.5 Approval Process for Biologics: A US-China Comparison
SECTION 4: BIOPHARMACEUTICAL MANUFACTURING IN CHINA: OPERATIONAL AND QUALITY TRENDS
4. Intro 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
5. Intro 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
6. Intro 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
7. Intro 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
8. Intro 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. Future Prospects for China Biopharma
Appendix A Directory of Biologics on Market & Clinical Development in China
Appendix B Directory: Top 60 Biopharmaceutical Facilities in China
China aspires to become one of, if not the leading, country contributor to the global pharmaceutical and biopharmaceutical industry by 2030. Large companies in this sector - both international firms expanding their own footprint within China and indigenous Chinese firms establishing both their internal and their global footprints - have witnessed double-digit growth for much of the past five to seven years. The major successful pharmaceutical firms operate their business as a unified whole. Strategies for growth may be and are tailored to suit the dynamics of a particular region, but all of the elements of that strategy are also part of a coordinated overall plan. The factors driving the overall pharmaceutical and biopharmaceutical industry are uniform and apply to every company doing business in this sector, with some companies being further ahead (or behind).
The development curve in certain key areas such as the creation of new product pipelines or the establishment of operations in emerging markets may differ from company to company, but the driving factors behind those changes apply to all companies. The global pharmaceutical and biopharmaceutical industry itself, not just that within China, has entered a period of substantial change. Drivers for success in the past decade will not in all cases be the drivers for success for the future. Some factors that drove success for our industry in the past decade may indeed be factors that could contribute to failure in the future if they are managed without considering the new context of the industry.
Changes that our industry is dealing with include factors that have a material impact on our risk versus value structures and strategies. Our supply structures that were designed for the realities of the past 10 to 15 years have to be adapted for the expected realities of the next 10 to 15 years. Enterprise and supply chain strategies based upon old paradigms may well fail in this new future. The changes most affecting the industry today include:
- Robust research and development pipelines and increasing new product launches
- A shift to biologics from small molecules
- A shift from a focus on primary care to specialty care product segments
- Continued growth of emerging market sectors
- High patient population specialty care markets
- Largely aligned global quality standards applied to products and raw materials
- Growth of the oncology, especially the immuno-oncology therapy area
While the impact of each of these changes has a unique origin, many of them have in common the fact that they potentially drive a substantial increase in the risk of supply versus cost equation used to set strategy for pharmaceutical and biopharmaceutical manufacturing supply chain design. Old models now may be high-risk models. This trend will be exacerbated through the next decade.
- Amgen Asia Research and Development Center
- Anhui Anke Biotechnology (Group) Co., Ltd.
- 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
- 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.
- 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.