中国创新药研发：

中国创新药研发：现状与未来

Innovative Drug R&D in China

By Jim J. Zhang, Ph.D.

October, 2009
 Scope of the Report

As Chinese pharmaceutical industry is rapidly rising, a growing number of Chinese drug

companies and organizations (including pharma and biotech companies, research
institutions and even outsourcing service providers) pay attention to innovative drug
R&D. Their attempts are also encouraged by Chinese government who promise to
provide financial support and further fueled by the growing abundance of venture capitals
that are gradually becoming readily available to Chinese companies. However, to a large
extent, the innovative drug R&D activities in Chinese companies still remain a myth to
many companies outside China, including the scope and scale of their research, current
state of their research capability and development stage of their product pipelines, etc.

To reveal the real state of the innovative drug R&D in China, we conducted a broad and
in-depth investigation on the innovative drug R&D activities in China. This report
summarized our latest research results on this subject.

The report is composed of four chapters and supported with 53 tables, 18 figures and 12
case studies. Each chapter focuses on one area and provides detail and in-depth
description and analysis.

Chapter One describes the overall situation of innovative drug R&D in China at present,
including the composition of players, their current research capability, the funding
sources of their R&D programs and the potential impacts of this Chinese industry on the
global pharma industry.

Chapter Two analyzes in detail those players conducting innovative drug R&D, including
their R&D experience, development stages of their product pipelines, their research
strength and therapeutic focus.

In Chapter Three, an in-depth analysis of all drug candidates obtained during our
investigation was presented, including their development stage, molecular structure,
mechanism of action, distribution in each therapeutic area, etc.

The last chapter presents our in-depth analysis of the future development and growth of
this Chinese industry, including the analysis of a series of growth drivers and the roles
each of them will play in determining the future move of this Chinese industry, and the
latest development of Chinese companies in other frontier pharmaceutical research.

The report is a must-read book to all those professionals and organizations that are
interested in learning how the innovative drug R&D in China is currently going and will
likely develop in the future.
 About Author

Jim J. Zhang, Ph. D.

Jim J. Zhang currently is president and managing director of JZMed, Inc., a leading
pharmaceutical outsourcing service provider that specializes in market research on
Chinese pharmaceutical and biotechnology industries. Before founding the company,
Jim worked for nine years with Albany Molecular Research, Inc. (AMRI), a US-based
and currently one of the world largest CROs. During his tenure at AMRI Jim was
responsible for managing and overseeing multiple drug R&D projects that involved the
international cooperation of AMRI’s multiple sites (USA, Singapore and Hungary). He
played key roles in helping numerous pharma and biotech companies discover and
develop a series of drug candidates that later entered preclinical and clinical development
including advanced clinical trials. He was also the key contributor to the development of
chemical production process for several developmental drugs. Prior to pursuing his Ph.D.
program in the US, Jim worked for six years in a China-based CMO as process engineer
and developed production process for a number of pharma products.

Jim’s technical expertise spans from chemical process research and development to drug
discovery and development for viral infection, cancer, chronic obstructive pulmonary
disease (COPD) and cystic fibrosis. Currently he holds 18 patents. He is also the
principal author of 12 peer-reviewed research articles.

Jim has authored a series of industry reports about Chinese pharmaceutical outsourcing.
He was also invited by a number of market research firms such as Business Insights to
author/co-author industry reports.

Jim received his master’s degree in Chemical Engineering from East China University of
Science & Technology (Shanghai), and his Ph.D. degree in Synthetic Organic Chemistry
from the University of Iowa. He also received additional trainings in Medicinal
Chemistry through working at Research Triangle Institute (Research Triangle Park, North
Carolina).
 Report Description

As Chinese pharmaceutical industry is rising rapidly, a growing number of Chinese drug

companies pay attention to investing in research of innovative medicines. Their attempts
are encouraged by government who promises to provide financial support and improve
industry infrastructure. Their programs are infused with increasing numbers of returnees.
Their progress is also accelerated by the growing abundance of venture capitals.

Their efforts have now started yielding fruitful results. There have been a variety of drug
candidates in various development stages in the product pipelines of these Chinese drug
companies for a broad range of therapeutic targets. More significantly, driven by a
number of positive factors, this sector of the Chinese pharmaceutical industry has gained
an extraordinary growth momentum and will thus continue to develop in the future.

However, to a large extent, it is still a myth to many companies/organizations outside

China about the R&D activities in these Chinese drug companies and the progress of their
programs.

The report “Innovative Drug R&D in China” is designed to reveal the real state of the
innovative drug R&D in China including their research scope and scale, their current
focus and capability in innovative drug R&D and the development stage of their product
pipelines.

Based on a broad and in-depth investigation, the report provides a clear insight into the
current situation of the innovative drug R&D in China. It also provides the in-depth
analysis of the future growth potential and drivers of this Chinese industry.

The report is a must-read book to global pharmaceutical and biotech companies that are
seeking research collaborations with Chinese companies, venture capital investors
interested in investment opportunities in Chinese pharmaceutical and biotech industries,
market research/consultancy companies seeking the information of the development
situation of China’s drug R&D, and even the government agencies of those countries that
are interested in learning the current and future development of China’s biotech industry.
 Key Findings of the Report

Largely due to the short history of its modern pharmaceutical industry, innovative
drug R&D in China is just beginning, but it has truly taken off. The sustained fast
growth of China’s economy has made the innovative drug research affordable to the
country.

At present there are three groups of companies playing key roles in this Chinese
industry. The first group contains those top tier pharma companies. However, within
this group of companies only a small fraction of them are conducting truly innovative
drug R&D. The second group is composed of those young, R&D-oriented biotech
companies. The majority of them are founded by returnees who received higher
education in the West and further gained direct experience during their prolonged stay
in the Western pharma or biotech industry. This is currently the main force of
China’s innovative drug R&D. The third group includes those top tier state-owned
research institutions including those research universities that have life science
schools/departments.

Interestingly, a small number of China-based outsourcing service providers (mainly

those top tier CROs) are also conducting innovative drug R&D internally. On the
other hand, the number of state-owned research institutes focusing on the innovative
drug R&D is actually small. Our study revealed that it was only a perception that the
top tier research institutions are the main force of the innovative drug R&D in China.
In fact, the majority of these research institutions are primarily focusing on the basic
type of medical research.

The growing funding sources that now become more readily available to Chinese
companies are the key driving force for their innovative drug R&D programs.
Combined together, these companies support their R&D programs through four major
funding sources: venture capitals, public offering (or IPO), government grants and
self-funded (through either selling products or providing outsourcing services). The
availability of government grants from both central and local provincial or municipal
government is increasing. Opportunities of venture capital investment are also
rapidly growing. Meanwhile, the exit channels for venture capital investment also
gradually become mature.

The current strengths of Chinese companies in research of innovative medicines

almost equally reside in both small molecule and macro compound-based drugs.
Their research approaches for small molecule drugs primarily focus on the structural
modifications of natural products that are derived from the medicinal herbs of
traditional Chinese medicines (TCMs). Their research methodologies for novel
biologic drugs are, however, more diverse and advanced, including all types of
biologically derived proteins.

Nearly 65% of drug candidates are in early development stages (either preclinical or
phase I clinical trials), an indication that the innovative drug R&D in China is just
beginning. However, a decent number of novel medicines such as TCMs, gene
therapy drugs and a variety of vaccines have proceeded to the advanced development
stages. Some of them have been approved for marketing.

Of all these Chinese drug R&D companies, about 45% of them either have programs
for development of anti-cancer agents or entirely focus on the novel cancer drug
development as their sole therapeutic area. Cancer drugs based on a variety of
treatment mechanisms are also the largest group of drug candidates in their product
pipelines. The situation is well in line with the current development state of the
global drug R&D.

The formation of a positive environment of innovative drug R&D in China also

fosters the growing research activities in other pharmaceutical research areas such as
the development of new drug delivery technologies, novel molecular diagnostic and
imaging tools, biomarkers and frontier research such as stem cell and RNA
interference. New technologies and products in these areas also start emerging.

Largely attracted by the growth potential of China’s pharmaceutical market and the
advantage of a large talent pool coupled with the still low labor cost, growing
numbers of pharma and biotech companies from around the world are conducting
innovative drug R&D in China or collaborating with local Chinese drug companies.

However, the R&D collaborations between the major Chinese pharma companies and
the R&D-oriented Chinese biotech companies are very rare. Unlike in the Western
pharma industry, those major Chinese pharma companies do not rely on the emerging
Chinese biotech companies to fill out their product pipelines. In fact, many of them
do not have an established product pipeline filled with innovative medicines yet.

Because of the short history in innovative drug R&D, there are a number of
limitations associated with this Chinese industry primarily in such areas as the
research skills and experience.

On the other hand, driven by a number of factors, this sector of the Chinese pharma
industry has gained an extraordinary growth momentum. The main growth driver is
the determination of Chinese government to convert the Chinese pharmaceutical
industry from a generic drug-focused industry to an innovation-driven drug
development powerhouse.
 Key Features of the Report

The report is the first time ever in the history of pharmaceutical industry that
describes in depth the most mysterious part of the Chinese pharmaceutical industry.

The report depicted a whole picture of the innovative drug R&D in China at present.
It revealed the real development state of this Chinese industry.

The report also conducted in-depth analysis on the future development of this Chinese
industry including all drivers and the roles each of them will play in steering this
Chinese industry.

The report contains forty (40) Chinese drug companies that have the most advanced
programs in innovative drug research. It analyzed in depth the research focuses and
capabilities and the product pipelines for each of these companies.

The report also contains 110 drug candidates in various stages of preclinical and/or
clinical development in the product pipelines of these Chinese companies. It
described in detail the features of their molecular structure, the mechanisms of their
action and the current stages of their development.

The report is composed of four chapters (a total of 230 pages) and supported with 53
tables, 18 figures and 12 case studies. Each chapter focuses on one area and provides
detailed and in-depth description and analysis.

The report also contains a detailed company profile for each of these forty companies
studied in the report.

The report is currently the sole source available on the market to all types of
companies and organizations that are interested in learning the development state of
China’s innovative drug R&D.
 Your Questions Are Answered

The report provides complete and detail answers to a variety of questions such as:

What is the current state of China’s R&D on innovative medicines? How many
companies are conducting innovative drug R&D in China?

Who are the major players in China’s innovative drug R&D? How are their current
R&D capabilities?

What is the main driver encouraging Chinese companies to conduct research on

innovative medicines?

What are the major funding sources for innovative drug R&D programs in Chinese
companies? To what extent are the Western VCs involved?

What are the feasible exit strategies in China? Did they work? Which one is most
popular at present?

What is the development state of the product pipelines of these Chinese drug
companies?

What are the most active therapeutic areas currently pursued by Chinese companies?
How do the drug candidates distribute in development stages of each therapeutic area?

What are the strengths and weakness of Chinese companies in innovative drug R&D?

What are the current state and capability of Chinese companies in the frontier
pharmaceutical research areas?

How about the research collaborations between domestic Chinese companies and
between Chinese companies and experienced international pharma or biotech
companies?

What is the future prospect of China’s innovative drug R&D? What are the main
drivers of its future development?

Are there any Western companies that are interested in licensing drug candidates
developed by Chinese companies?
 Table of Contents

Scope of the Report

About Author
Executive Summary

Current state of innovative drug R&D in China

Chinese companies conducting innovative drug R&D
Innovative drugs in development pipelines of Chinese drug companies
Future prospect of innovative drug R&D in China

Chapter 1. Current State of Innovative Drug R&D in China

Summary
1.1 Introduction
1.2 Innovative drug R&D in China: Possible?!
1.2.1 The lost history of innovative drug R&D in China
1.2.2 R&D activities on innovative medicines do exist in China now
1.2.3 Examples of Western pharma companies licensing drug candidates from
China
1.3 Current state of innovative drug R&D in China’s pharma-related industries
1.3.1 Innovative drug R&D in Chinese pharma and biotech industries
1.3.2 Innovative drug R&D in state-owned research institutions
1.4 Current state of R&D on traditional Chinese medicines (TCM)
1.5 Current capability of China’s innovative drug R&D
1.5.1 China’s general capability in pharmaceutical research
1.5.2 Capability of Chinese companies in innovative drug R&D
1.5.3 Capability of Chinese companies in development of new drug delivery
technologies
1.5.4 Key strengths of Chinese drug companies in innovative drug R&D
1.5.5 Current situation of patent applications in China for innovative drugs
1.6 Current funding sources for innovative drug R&D in China
1.6.1 Initial public offering (IPO)
1.6.2 Self-funded
1.6.3 Venture capitals
1.6.4 Government grants
1.7 Importance of China’s innovative drug R&D to the world pharma industry
1.7.1 Western pharma companies desperately need novel drugs to fill out their
product pipelines
1.7.2 Novel drug candidates discovered and developed by Chinese companies
could become alternative resources to Western companies
1.7.3 Financial crisis has enhanced the importance of China’s innovative drug
R&D to Western companies
Chapter 2. Chinese Companies Conducting Innovative Drug R&D

Summary
2.1 Introduction
2.2 Searching and selection criteria
2.3 Analysis of Chinese companies conducting innovative drug R&D
2.3.1 Business nature of the companies conducting innovative drug R&D in China
2.3.2 Experience of Chinese companies in innovative drug R&D
2.3.3 Analysis of financial support of all China-based innovative drug R&D
companies
2.3.4 Analysis of physical locations of innovative drug R&D companies in China
2.4 Analysis of product pipelines of all Chinese companies conducting innovative drug
R&D
2.4.1 Listing of product pipelines of Chinese drug companies
2.4.2 Analysis of product pipelines of Chinese drug companies
1. Distributions of drug candidates in various development stages in each
group of companies
2. Distributions of innovative drug R&D companies focusing on small
molecule drugs and macro compound-based drugs
3. Which companies own the most drug candidates
4. Analysis of innovative drug R&D companies according to therapeutic
areas

Chapter 3. Innovative Drugs in Development Pipelines of Chinese Drug Companies

Summary
3.1 Introduction
3.2 Analysis of development stages of drug candidates in the product pipelines of
Chinese drug companies
3.2.1 Distributions of development stages of all drug candidates
3.2.2 Detailed listing of all drug candidates in each development stage
3.3 Analysis of molecular structures of all drug candidates in development pipelines
3.3.1 Distributions of all drug candidates of different types of molecular structure
3.3.2 Detailed listing of drug candidates according to their molecular structure
3.4 Analysis of drug candidates in each therapeutic area
3.4.1 Analysis of drug candidates according to their therapeutic functions
3.4.2 Analysis of drug candidates in each therapeutic area according to their
development stages
3.4.3 Detailed listing of drug candidates in each therapeutic area

Chapter 4. Future Prospect of Innovative Drug R&D in China

Summary
4.1 Introduction
4.2 Drivers of future development of innovative drug R&D in China
 4.2.1 Attraction of China as one of the world largest pharmaceutical markets
1. Future development potentials of Chinese pharmaceutical market
2. Future market growth potentials of some key therapeutic areas
a. Market growth potential of anticancer drugs in China
b. Market growth potential of various vaccines in China
3. Key future growth drivers of Chinese pharmaceutical market
a. On-going nationwide healthcare reform
b. Westernization of living style has changed disease patterns
c. Growing middle class population that are able to afford high-
end medicines
d. Rapid urbanization makes more Chinese able to afford high-
end medicines
4.2.2 Government encouragement and support for innovative drug R&D
4.2.3 Increasing sources and availabilities of R&D funding
1. Various funding sources from government agencies
2. Increasing opportunities of venture capital (VC) investment
4.2.4 Gradual establishment of exit channels for investment
4.2.5 Advantages of conducting innovative drug R&D in China
1. Rich natural products
2. A large, treatment-naïve patient pool
3. Abundant animal species
4. Large, well-trained workforce
4.2.6 Entrance of multinational companies
4.2.7 Collaborations between local Chinese drug R&D companies/organizations
and between Chinese companies and experienced international drug
companies
4.2.8 Summary of the future growth drivers of innovative drug R&D in China and
analysis of the roles each of them will play
4.3 Latest development in other frontier pharmaceutical research in China
4.3.1 Development of novel molecular diagnostic tools and biomarkers
4.3.2 Stem cell research
4.4 Existing issues in China’s innovative drug R&D
4.5 The future perspective of China’s innovative drug R&D

List of Tables

Table 1. Representative state-owned research institutes in life science

Table 2. Representative state key labs in life science
Table 3. Representative top research universities having life science schools/colleges
Table 4. Products under development in Chinese biotech companies using new drug
delivery/formulation techniques
Table 5. List of representative companies/research organizations in China conducting
innovative drug R&D
Table 6. Classifications and distributions of China-based innovative drug R&D
companies
Table 7. Years of innovative drug R&D experience of Chinese companies
Table 8. Classifications of founders of Chinese companies conducting innovative drug
R&D
Table 9. Innovative drug R&D companies founded by returnees or Chinese scholars
Table 10. Analysis of funding sources of China-based drug R&D companies
Table 11. Analysis of locations of China-based innovative drug R&D companies
Table 12. Major Chinese pharma companies conducting innovative drug R&D and their
product pipelines
Table 13. Chinese biotech companies conducting innovative drug R&D and their
product pipelines
Table 14. State-owned research institutes conducting innovative drug R&D and their
product pipelines
Table 15. Chinese CROs conducting innovative drug R&D and their product pipelines
Table 16. Analysis of drug product pipelines in each group of innovative drug R&D
companies
Table 17. Analysis of the numbers of the innovative drug R&D companies in each drug
development stage
Table 18. Analysis of molecular structure of drug candidates in each group of Chinese
companies conducting innovative drug R&D
Table 19. Top 10 companies having most innovative drug candidates
Table 20. Analysis and distributions of innovative drug R&D companies according to
therapeutic areas
Table 21. China-based Innovative drug R&D companies having cancer drugs in various
development stages
Table 22. China-based innovative drug R&D companies having anti-viral drugs in
various development stages
Table 23. Analysis of the numbers of drug candidates in each development stage
Table 24. Drug candidates in preclinical development
Table 25. Drug candidates in phase I development
Table 26. Drug candidates in phase II (IIa/IIb) development
Table 27. Drug candidates in phase III development
Table 28. Drugs approved or waiting for approval
Table 29. Classifications and distributions of drug candidates according to their
molecular structures
Table 30. Distributions of small molecule drugs in various development stages
Table 31. Distributions of macro compound-based drugs in various development stages
Table 32. List of small molecule drugs in various development stages
Table 33. List of macro compound-based drugs in various development stages
Table 34. List of vaccines in development for different purposes
Table 35. List of new TCMs in development
Table 36. Distributions of drug candidates in each therapeutic area
Table 37. Summary of the mechanisms of action of all cancer drugs in development
Table 38. Numbers of drugs in various development stages of each therapeutic area
Table 39. Drug candidates in development for cancer
Table 40. Drug candidates in development for anti-viral diseases
Table 41. Drug candidates in development for cardiovascular diseases
Table 42. Anti-biotic drugs in development
Table 43. Drug candidates in development for metabolic diseases
Table 44. Drug candidates in development for inflammatory diseases
Table 45. Drug candidates in development for CNS diseases
Table 46. Drug candidates in development for COPD
Table 47. Drug candidates in development for all other diseases
Table 48. Current Chinese pharmaceutical market and its future growth forecasts
Table 49. Representative venture capital investors in China
Table 50. Examples of recent investment activities of Western VCs in China
Table 51. Analysis of the roles of growth drivers in determining the future development
of China’s innovative drug R&D
Table 52. Diagnostic products under development
Table 53. Stem cell research in China

List of Figures

Figure 1. Distributions of different types of innovative drug R&D companies in China

Figure 2. Distributions of innovative drug R&D companies in term of the years of their
research experience
Figure 3. Graphic display of funding sources of China-based innovative drug R&D
companies
Figure 4. Location distributions of innovative drug R&D companies in China
Figure 5. Distributions of the number of drug candidates and their development stages in
each group of companies
Figure 6. Distributions of companies in each development stage of drug R&D
Figure 7. Comparison of the numbers between small molecule drugs and macro
compound drugs in each group of innovative drug R&D companies
Figure 8. Company distributions in each therapeutic area
Figure 9. Distributions of development stages of all drug candidates
Figure 10. Comparison of the numbers between small molecule drugs and macro
compound-based drugs in development pipelines
Figure 11. Distributions of small molecule drugs in various development stages
Figure 12. Distributions of macro compound-based drugs in various development stages
Figure 13. Numbers of drug candidates in each therapeutic area
Figure 14. Distributions of drug product pipelines in each therapeutic area
Figure 15. Development of Chinese pharmaceutical market: Past, present and future
Figure 16. Current market value and forecasted future growth of cancer drug market in
China
Figure 17. Current market value and forecasted future growth of vaccine market in China
Figure 18. Major Western pharma and biotech companies conducting innovative drug
R&D in China

List of Case Studies

Case study 1. Chinese biotech company focusing on development of new drug delivery
technologies
Case study 2. Example of application for Chinese patent by international drug companies
Case study 3. Example of patent application by Chinese company for new formulation of
existing drugs
Case study 4. GSK looking at the Chinese vaccine market
Case study 5. Latest announcement of more R&D funding by Beijing Municipal
Government
Case study 6. Latest announcement by Shanghai Municipal Government for availability
of new R&D funding
Case study 7. The interest of major Western pharma companies in natural products
derived from medicinal herbs of TCMs
Case study 8. Collaboration between Chinese drug company and research institution on
innovative drug R&D
Case study 9. R&D collaboration between a Chinese pharma company and a US biotech
company
Case study 10. Chinese research institute collaborating with a US-based non-profit
organization on development of novel anti-TB agents
Case study 11. Chinese pharma company establishing R&D centers in the Western
countries
Case study 12. Chinese company developing diagnostic tools for detection of early stage
bladder cancer

Company Profile
Company profiles of 40 Chinese companies conducting innovative drug R&D

Appendix
Appendix I. Research methodology
Appendix II. About JZMed
 About JZMed, Inc.

JZMed, Inc. (www.jzmedi.com) is a leading pharmaceutical outsourcing service provider

that specializes in market research on Chinese pharmaceutical and biotechnology
industries. The company’s primary focus is to provide intelligence and market research
services to global pharmaceutical and biotech companies to help them tap the resources
in the Chinese pharmaceutical industry and explore the opportunities in the Chinese
pharmaceutical market. Meanwhile, it also provides assistance to these companies to
facilitate their entrance into the Chinese pharmaceutical market or collaborations with
any Chinese companies. The company has provided this type of services to a variety of
companies worldwide including those world major pharma companies. It also has a
network of preferred pharma and biotech companies in China.
 To Order

Information about the Report:

Author: Jim J. Zhang, Ph.D.

Publisher: JZMed, Inc.
Total number of pages: 230
Date published: October, 2009

Readers interested in the report can contact JZMed, Inc. at order@jzmedi.com.

Report ordering can also be processed through PayPal, secured online payment, directly
at the website of JZMed, Inc. (www.jzmedi.com). All major credit cards are accepted.