The fast growth of the Chinese biopharmaceutical market has been prompting the rapid development of the entire Chinese biopharmaceutical industry, including R&D on biological medicines. In the recent several years growing numbers of Chinese pharma and biopharma companies have been steadily increasing their investment in innovative drug R&D, including the discovery and development of novel biologics. The current domestic environment in China, including a series of positive factors, is also favoring the development of this sector of the Chinese biopharmaceutical industry. The R&D capabilities of the Chinese companies are thus being rapidly enhanced, which has drawn the increasing attention of multinational drug companies.

The report, “Biologic Drug R&D in China - Current State and Future Development”, published by JZMed, Inc, a world renowned market research firm specialized in pharmaceutical and biotechnology industries, has conducted so far the most complete survey and investigation about the current state of the Chinese biopharmaceutical industry in biologic drug R&D. It has revealed the current capabilities of the Chinese companies in development of novel biologics and their current pipelines. It also presents a clear picture of how this Chinese industry will likely develop in the foreseeable future.

The report will greatly help global pharmaceutical and biopharmaceutical companies as well as venture capital investors better understand not only the current state but also the future growth potential of biologic drug R&D in China. It is thus a must-read book to these companies if they are interested to have the best opportunities in the Chinese biopharmaceutical market, including licensing, investment and partnership.

Key Findings of the Report

• With the growing abundance of a variety of funding opportunities, including both government grants and private investments, the R&D activities on biologic drugs in China have gained strong development momentum at present. Growing numbers of Chinese pharma and biopharma companies have been increasing their investment in discovery and development of novel biologics. Their R&D capabilities have thus been enhanced greatly and rapidly.
• Compared with our last investigation which was conducted about four years ago, the number of the biologic drug candidates in the pipeline of the Chinese biopharmaceutical industry has been more than doubled. The most significant increase has occurred to novel therapeutic mAbs. We have identified more than 100 biologic drug candidates, including biosimilars of both therapeutic proteins and mAbs, that are currently under clinical and/or preclinical development in the pipelines of a fairly large group of Chinese companies, including the traditional small molecule-focused pharmaceutical companies, the newly emerging biotechnology companies, and even the China R&D divisions of multinational companies.
• Besides, there are another large number of biological compounds that are currently in advanced discovery or early preclinical screening stage. Many of them are expected to enter the development in near future.
• At present the R&D activities on therapeutic mAbs, including biosimilar mAbs, are most intensive. Therapeutic mAbs have emerged to be the largest group among all types of biologic drug candidates in the current pipeline of the Chinese biopharma industry, followed by recombinant proteins.
• The biologic drug R&D in China is just beginning at present but it has already gained an extraordinarily strong growth momentum. Although the R&D capabilities of the Chinese companies still need improvements, a number of positive factors, including the natural advantages China still possess and the favorable local and global environments, etc., are presently driving this sector of the Chinese biopharmaceutical industry forward.
• Our analysis has revealed that China’s biologic drug R&D is expected to grow in a much faster pace in the following years than in the past. China may also soon become a focal point for global drug companies to look for interesting novel biologic drug candidates for licensing or co-development. Moreover, it is expected that in not a long distance there will be novel biologic drugs marketed worldwide that are discovered and developed in China.

Key Features of the Report

• The report first time analyzed both in detail and in depth the current state and environment of biologic drug R&D in China, including the necessary industrial infrastructure for conducting innovative biologic drug R&D in the country, the local companies’ motivations, their R&D investment and activity scales, the funding sources and opportunities to their R&D effort, government’s support and encouragement, etc.
• The report also analyzed the current R&D capabilities of the Chinese companies in each type of biologic drugs including therapeutic proteins, mAbs and vaccines, the current states of their pipelines and the distributions of each type of biologics among all drug candidates, etc.
• The report includes abundant examples of the partnerships between a variety of multinational companies and local Chinese organizations on biologic drug R&D collaborations and our in-depth analysis on their significance. It thus provides a real and vivid picture of how this Chinese industry has been moving forward.
• The report has not only presented a full picture of the current state and capability of biologic drug R&D in China but also depicted a clear future of this Chinese industry. Moreover, it has also analyzed all future growth factors, both positive and negative ones, that will likely affect this Chinese industry. It is the first time that a complete picture of both the current state and the future growth potentials of the Chinese biologic drug R&D industry is presented in a report.
• More importantly, the report also includes a complete list of all identified biologic drug candidates currently in various development stages in Chinese companies, including their mechanisms of action (MOA).

Table Of Contents

Table of Contents

Scope of the Report

About Author

Executive Summary

• Fast growing global and Chinese biopharmaceutical markets prompting Chinese companies to focus on biologic drug RandD
• Current state of biologic drug RandD in China
• Outlook of future development potentials of biologic drug RandD in China

Chapter One - Fast Growing Global and Chinese Biopharmaceutical Markets Prompting Chinese Companies to Focus on Biologic Drug RandD

Summary
1.1 Introduction
1.2 Increasing importance of biologic drugs in global pharmaceutical market
1.2.1 Global major pharma companies increasing their RandD focus on biologic drugs
1.2.2 Global biopharmaceutical market is fast growing - Analysis of current global biopharmaceutical market and its growth history
1.3 Fast growing Chinese biotechnology industry - Analysis of current state of biotechnology industry in China
1.3.1 Current state and structural compositions of Chinese biotechnology industry
1.3.2 Current total output of Chinese biotechnology industry and its growth trends
1.4 Attraction of fast growing Chinese biopharmaceutical market - Analysis of its current market value and past growth history
1.5 Analysis of future growth potentials of Chinese biopharmaceutical market
1.5.1 Future growth forecast of output of Chinese biotechnology industry
1.5.2 Forecast of future growth potentials of Chinese biopharmaceutical market
1. Analysis of key future growth drivers of Chinese biopharmaceutical market
2. Future growth forecasts of Chinese biopharmaceutical market

Chapter Two - Current State of Biologic Drug RandD in China

Summary
2.1 Introduction
2.2 Current overall state of drug RandD in China
2.3 Current RandD state and capabilities of Chinese biopharma companies in therapeutic mAbs
2.4 Current RandD state and capabilities of Chinese biopharma companies in novel therapeutic proteins
2.5 Current state and capabilities of Chinese biopharma companies in vaccine RandD
2.6 Current state and capabilities of Chinese biopharma companies in biosimilar RandD

Chapter Three - Outlook of Future Development Potentials of Biologic Drug RandD in China

Summary
3.1 Introduction
3.2 Analysis of China’s current strengths and advantages in biologic drug RandD
3.3 Chinese government’s determination to develop biopharmaceutical industry including biologic drug RandD
3.4 Increasing sources and availabilities of RandD funding
3.4.1 Various funding sources from government agencies
3.4.2 Increasing private funding opportunities for drug RandD
3.4.3 Gradual establishment of exit channels for investment
3.5 Multinational companies conducting biologic drug RandD in China fostering a positive environment for innovation
3.5.1 Major pharma companies committed heavy investment in innovative drug RandD in China
3.5.2 Multinational biotech companies conducting biologic drug RandD directly in China or partnering with local Chinese companies
3.6 Analysis of future growth hurdles of China’s biologic drug RandD industry
3.6.1 Competition from Indian biopharma companies - Comparison of Chinese companies’ biologic drug RandD capabilities with their Indian counterparts
3.6.2 China’s current regulatory state on biologic drug clinical trials
3.6.3 Analysis of shortcomings of Chinese biopharma companies’ current capabilities in biologic drug RandD
3.7 Analysis of opportunities of Chinese biopharma companies in global biosimilar market
3.7.1 Outlook of global biosimilar market
1. Current global biosimilar market and its future growth potentials
2. Current global biosimilar regulatory status
3. Challenges of developing biosimilars
3.7.2 Analysis of China’s opportunities in global biosimilar market
3.7.3 Chinese biopharma companies facing strong competitions in global biosimilar market from biopharma companies of their neighboring Asian countries
3.8 Analysis of future prospect of biologic drug RandD in China - Summary

Company Profiles

Company Profiles of Major Chinese Companies Focusing on Biologic Drug RandD

Appendix

Appendix I. List of All Identified Biologic Drug Candidates Currently in Preclinical or Clinical Development in China
Appendix II. List of All Identified Biologics Currently in Discovery or Preclinical Screening Stage in China
Appendix III. Research Methodology
Appendix IV. About JZMed, Inc.



List of Tables

Table 1. New development trends of global biopharmaceutical industry
Table 2. Recent acquisitions of biopharma companies by major pharma companies
Table 3. Classifications of therapeutic biologic products
Table 4. Current market value and growth history of global biopharmaceutical products
Table 5. Current structural composition of Chinese biotechnology industry
Table 6. Growth history of total output of Chinese biotechnology industry
Table 7. Current Chinese biopharmaceutical market and its growth history
Table 8. Future growth drivers of Chinese biopharmaceutical industry
Table 9. Forecasted future growth of Chinese biopharmaceutical market
Table 10. Forecasted future growth of Chinese therapeutic mAb market
Table 11. Forecasted future growth of Chinese therapeutic protein market
Table 12. Forecasted future growth of Chinese vaccine market
Table 13. Drivers prompting China to be determined to increase investment in and focus on RandD of new medicines
Table 14. Barriers retarding Chinese biopharma companies to gain ability to develop therapeutic mAbs
Table 15. Major pharma companies having (or planning to have) Asia-Pacific operating (or RandD) headquarters in China
Table 16. Current RandD pipeline state of innovative drugs in China
Table 17. List of novel mAb drug candidates currently under development through partnership between Chinese companies and multinational companies
Table 18. List of new therapeutic mAbs currently under development independently by Chinese companies/research institutions
Table 19. List of all mAb drugs currently under development in China
Table 20. List of therapeutic mAbs currently in discovery stages
Table 21. List of new therapeutic proteins currently under development in China
Table 22. List of novel peptide drugs currently under development in China
Table 23. List of vaccines currently under development in China
Table 24. List of therapeutic vaccines currently under development in China
Table 25. Chinese companies developing DNA vaccines or therapeutic oligonucleotides
Table 26. List of vaccines currently in early development stages
Table 27. List of biosimilar therapeutic proteins currently under development in China
Table 28. List of all therapeutic proteins currently under development in China
Table 29. List of biosimilar mAbs currently under development in China
Table 30. List of biosimilar therapeutic proteins currently in early stages
Table 31. Future growth drivers of biologic drug RandD in China
Table 32. China’s current advantages for conducting biologic drug RandD
Table 33. Current focuses of Chinese government to promote Chinese biopharmaceutical industry
Table 34. Factors gradually improving innovative drug RandD investment environment in China
Table 35. Investment history and planned future investments of Chinese government in innovative drug RandD
Table 36. Major pharma companies having corporate venture investment offices in China
Table 37. Representative venture capital investors in China (both domestic investors and international investors)
Table 38. VC investment trends in RandD-focused Chinese drug companies
Table 39. Growth trend of total VC investments in Chinese life science industry
Table 40. Private funding sources for innovative drug RandD in China
Table 41. Motivations of major pharma companies’ RandD activities in China
Table 42. China is ready to play important roles in global drug RandD
Table 43. RandD strategies currently practiced by Chinese biotech companies
Table 44. Analysis of licensing deals between multinational drug companies and Chinese companies
Table 45. Comparisons of current state and capability of innovative biologic drug RandD between China and India
Table 46. Factors limiting Chinese companies to fast develop novel biologic drugs
Table 47. Current shortcomings of Chinese biopharma industry
Table 48. Current distributions of global biosimilar market
Table 49. Current states of global biosimilar regulations
Table 50. Timelines of regulatory guidelines approved for biosimilars in countries around the world
Table 51. FDA’s requirements for biosimilar marketing approval in the US
Table 52. Technical challenges of developing biosimilars
Table 53. Financial challenges of developing biosimilars
Table 54. Major pharma/biopharma companies having biosimilar programs
Table 55. Analysis of the roles of growth drivers in determining the future development of China’s biologic drug RandD



List of Figures

Figure 1. FDA approval rate of biologic drugs in recent eight years
Figure 2. Growth trend of global biopharmaceutical market in past six years
Figure 3. Analysis of structural compositions of Chinese biotechnology industry
Figure 4. Growth trend of total output of Chinese biotechnology industry in past six years
Figure 5. Analysis of product compositions of Chinese biotechnology industry’s output
Figure 6. Growth trend of China-made biologic drugs marketed overseas
Figure 7. Growth trend of Chinese biopharmaceutical market in past six years
Figure 8. Forecasted future growth trend of Chinese biopharmaceutical market
Figure 9. Forecasted future growth trend of Chinese therapeutic mAb market
Figure 10. Forecasted future growth trend of Chinese therapeutic protein market
Figure 11. Forecasted future growth trend of Chinese vaccine market
Figure 12. Growth trends of China’s drug RandD pipeline



List of Case Studies

Case Study 1. Pfizer’s new RandD strategy focusing on biologic drugs
Case Study 2. Roche’s new RandD strategy focusing on both small molecule drugs and biologics
Case Study 3. Examples of major pharma companies collaborating with Chinese organizations on drug RandD
Case Study 4. Major pharma companies licensing drug candidates to Chinese drug companies for co-development in China
Case Study 5. Multinational biotech companies partnering with Chinese companies to conduct drug RandD in China
Case Study 6. US-based biotech companies out-licensing innovative mAb drug candidates to Chinese companies
Case Study 7. Current novel mAb drug RandD programs of Shanghai CP Guojian Pharmaceutical
Case Study 8. Growing numbers of Chinese companies involved in mAb drug development
Case Study 9. Cancer gene therapies developed and marketed by Chinese companies
Case Study 10. Novel therapeutic proteins currently under development by 3SBio
Case Study 11. Collaborations of Chinese vaccine makers with multinational companies
Case Study 12. Examples of current RandD approaches of Chinese companies for therapeutic vaccines
Case Study 13. Biosimilar products developed by 3SBio
Case Study 14. Multinational companies building mAb manufacturing facility in China
Case Study 15. Examples of multinational VC investors establishing investment offices in China focusing on Chinese life science industry
Case Study 16. Growing abundance of local venture funding opportunities for Chinese biotech companies focusing on innovative drug RandD
Case Study 17. Examples of Chinese RandD-focused biotech companies founded by successful Chinese businessmen in other industries
Case Study 18. Examples of VC investment in Chinese biopharma companies
Case Study 19. More major pharma companies deciding to move RandD centers from the West to China
Case Study 20. Major pharma companies deciding to establish full-scale RandD centers in China
Case Study 21. MedImmune forming JV with WuXi PharmaTech to co-develop mAb drug in China
Case Study 22. Multinational biotech companies establishing RandD centers in China
Case Study 23. Multinational biotech companies conducting mAb drug RandD in China
Case Study 24. More recent biologic drug licensing/co-development examples between multinational drug companies and Chinese companies
Case Study 25. Multinational biopharma companies developing biosimilars in China
Case Study 26. Examples of blockbuster mAb drugs losing or expected to come off patent protection
Case Study 27. Key competitors of Chinese biopharma companies in Asian biosimilar market

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