Transcript China

Biotechnology and Life Science in China
and S&T Cooperation Between China and
Canada
March 25, 2009
Long Shen
Consul for Science and Technology
Consulate General of P.R.China
Biotechnology and Life Science in China
and S&T Cooperation Between China
and Canada
Biotechnology and Life Science in
China
S&T Cooperation Between China and
Canada
Potential Cooperation Ways in the
field of Biotechnology and Life Science
Biotechnology and Life Science in China
CONTENT
Mission of Biotech and Life Science in China
Status of Biotech and Life Science in
China
Vision and priorities of Biotech and Life Science
in China
Strategies and approaches of Biotech and Life Science
development in China
Opportunity of Biotech and Life Science in China
Mission of Biotech and Life Science in China
Mission of Biotech and Life Science in
China
 Biotech: a essential technology for the improvement of people’s
health
 0.84 million AIDS sufferers
 4.5 million patients with active pulmonary tuberculosis
 more than 120 million patients with hepatitis B virus infection
 more than 20 million patients with diabetes mellitus
 0.8 million people with schistosomiasis
 the mortality of cardio-cvascular diseases and
malignancies is increasing continually
 anually4-6% of newborns having birth defects
Mission of Biotech and Life Science in
China
Biotech: an essential support in ensuring the safety of the
country
Bio-terror
BT
Severe infectious diseases
Public safety
Bio-safety of
the country
Foreign invading organism
Gene resources loss and
gene patents contest
BT
Mission of Biotech and Life Science in
China
“Biotechnology should be
our focus that we catch up
with the advanced level in
future high-tech industry, and
its applications should be
strengthened in such fields
as agriculture, industry,
population and health, etc.”
——Speech delivered by President Hu
Jintao at the National Congress of
Science and Technology, 2006
Mission of Biotech and Life Science in
China
“We should try to seize the
commanding elevation in biotechnology,
and strengthen the application of BT in
agriculture, industry, population, and
health sectors, especially the research
and development of grains and food
safety, prevention of severe infectious
diseases and innovation medicine. We
should improve our capability of
innovation and development levels in the
related industries and secure the health
of our people.”
——Speech delivered by Premier Wen Jiabao at
the National Congress of Science and
Technology, 2006
Mission of Biotech and Life Science in
China
“In developing bioindustry, it is
necessary to bring into full play our
advantages in resources and
technology to meet the significant
needs in the field of health,
agriculture, environmental protection,
energy and materials etc., and try to
fulfill new breakthrough in key
technologies and important products
development.”
——Extracted from “Guidelines of the 11th FiveYear Plan for National Economic and Social
Development, P. R. China”
Mission of Biotech and Life Science in
China
Nation’s focus: the development of Biotech
.
National Development and Reform Commission together with
other 18 commissions and ministries such as the Ministry of
Finance, Science and Technology, Education, Health and so
on , constituted《 11th Five-Year Plan for BT of China 》,
relative work started up in Jun 2005.
Status of Biotech and Life Science
in China
Status of advanced Biotech and Life
Science in China
China, as the only member from the developing countries in the
International Human Genome Project, has completed sequencing 1% of
human genome
Chinese scientists undertook and completed 10% of the International
HapMap Project
Chinese scientists led and implemented the International Human Liver
Proteome Project (HLPP)
Chinese scientists cloned the pathogenic genes of hereditary diseases
such as sensorineural and high-frequency hearing impairment
Status of advanced Biotech and Life
Science in China
Human genome project (HGP) formally started up in 1990. Chinese
scientists together with scientists from USA, UK, France, German, Japan
participated in this human genome project which was worth 3 billions US
dollars. The work undertaken by Chinese scientists focused on the short
arm of human beings number 3 chromosome. Through the efforts of
Chinese scientists, Chinese part in HGP has been finished two years
ahead of schedule.
Status of advanced Biotech and Life
Science in China
The International HapMap Project is another distinguish feat
after the accomplishment of HGP, scientists from Canada,USA,
UK, China, German, Japan, Nigeria participated in this project.
China is in charge of 10 % of the whole project, including the
construction of the monomer map of number 3,number 21 and
number 8 chromosome short arm.
Status of advanced Biotech and Life
Science in China
 On Dec.15, 2003, another significant plan in life sciences after the
accomplishment of HGP, International Human Proteome Project (HPP)
formally started up. It was also announced that the International
Human Plasma Proteome Project (HPPP) and International Human
Liver Proteome Project (HLPP) would be implemented firstly, and the
International Human Liver Proteome Project’ Headquarters would set
up in Beijing, China would be the leader country, Chinese scientist
would head the list. It was the first time in scientific history that China
lead a significant international cooperation plan and Chinese scientists
play a leading role in such a project.
Status of advanced Biotech and Life
Science in China
 The research group headed by Professor Xia
Jiahui, an academician of CAS, is the earliest in
the world that accurately located human testicle
decision gene in chromosome Yp11.32;The
group established “Chinese Novel Human
Abnormal Chromosomal Karyotype Database”,
“Database of the Family Collection of Genetic
Disease in China ” . They also successfully
cloned the pathogenic genes of human
hereditary diseases of high-frequency hearing
impairment (GJB3), thus fulfilled a
breakthrough in pathogenic genes clone in
China.
Progresses in Biopharma
 During the 10th Five-Year Plan period, 45 drugs have
acquired certificates for new drugs, 41 drugs are
declaring the new drug certificates,109 drugs have been
put into clinic trials, 206 innovative drugs with promising
prospect will accomplish their research work before
clinical trials. At the same time, a series of models for
drug screening and technique platforms used for safety
evaluation before clinic trials have been established,
tens thousand times of drugs compound screening have
been performed, thousands of active compounds
acquired.
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Progresses in Biopharma
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 Genetically engineered drugs and vaccine
More than 20 genetic engineered drugs and vaccines such as
recombinant person interferonα-1b are on the market.
Several tens kinds of genetic engineered drugs are in different clinical
trial phases.
More than tens of genetically engineered vaccine are in clinical trial phase
or pre-clinical trial phase.
China vaccine market has a tremendous potential, the growth rate per
year exceeds the average level of the world.
Growth rate
20%
15%
10%
5%
China
Globe
Progresses in Biopharma
 Antibody drugs R&D
In 1987, antibody drug became a special theme in biologic field in the 863 plan.
Now 31 diagnostic antibodies have been authorized, 7 therapeutic monoclonal
antibody products have been authorized to put into the market, 3 of them are
manufactured in China.
Antibody drugs made in China
Antibody
Manufacturer
Purpose
Monoclonal antibody CD3 (OKT3)
Wuhan Institute of Biologic Product
Immunity
inhibition
Antihuman interleukin-8
monoclonal antibody cream
Dongguan Hongyuan Yishi BT
Pharmaceutical Company
Psoriasis
therapy
Iodine [131I] Tumor Necrosis
Therapy Monoclonal Antibody
Injection
Shanghai Huachen Cancer Therapy
Pharmaceutical Company, Ltd.
Solid tumor
therapy
Progresses in Biopharma
 Iodine [131I] Metuximab Injection
(Trade name:Licartin)
Iodine [131I] Metuximab Injection (Trade name: Licartin) is the first drug
for the treatment of primary liver cancer in the world, and also the first
antibody drug with Intellectual property rights owned only by China.
Licartin, a novel 131I-labeled HAb18G/CD147-specific monoclonal
antibody Fab'2 fragment, is a first grade new drug in China. It brings
radioactive ¹³¹I to liver cancer, and utilizes radial β emitted from ¹³¹I to treat
tumor cells closely and persistently, thus kills tumor cells specifically
without hurting the normal tissue. It can be regarded as the first innovative
biological missile for liver cancers in China.
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Progresses in Biopharma
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China
is one of the countries which initiated earlier
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basic
research and clinical trials of gene therapy.
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 Gene therapy drugs
p53 glandulose virus injection
was successful manufactured
Type Ⅱdiabetes therapy drug
Tailuo was successful
manufactured.
Progresses in Biopharma
The first non-peptide small molecular drug in the world:
Glucagon like peptide-1 receptor (GLP-1R ) agonists
It can promote isolated rat pancreatic islet cells to excrete insulin at high
concentration of sugar conditions.
It can make haemoglobin A1C and
gucose tolerance test of diabetic
mice back to normal.
It can control the feeding of normal
mice and diabetic mice, reduce the
weight of diabetic mice
It can enhance the sensitivity of diabetic
mice to insulin
Chinese patent : 1 granted
International patent: 2 applications by Shanghai Institute of Materia Medica(SIMM)
1 of them is under substantive examination in 48 countries and regions
Progresses in Biopharma
 Recombinant human vascular endostatin injection
Recombinant human vascular endostatin injection, a first class new
drug for anti-tumor, is developed by Dr Luo Yongzhang of Yantai
Maidejin Biologic engineering Inc. It is the first recombinant human
vascular endostatin injection used for anti-tumor new in the world.
The new drug has obtained several invention patent grants.
Progresses in Biopharma
 New anti-tumor drug: Recombinant humanized Monoclonal
antibodies h-R3
The national class 1 new drug, Taixinsheng-Nituozhu
monoclonal antibodies developed by Baitai
Biopharmaceutical Corporation Ltd., can restrain
multiplication and differentiation of tumor cell, promote
cell apoptosis, thus inhibit tumor blood vessel generation,
enhance chemotherapy and radiotherapy efficacy.
It is the first human monoclonal
antibodies drugs approved in China.
The use of Taixinsheng in combination
with radiotherapy can increase the
complete remission rate of
nasopharyngeal carcinoma patients by
over 30 % in comparison with single
radiotherapy
Progresses in Biopharma
 Key technology of gene therapy
Shanghai Cancer Institute firstly
invented receptor-mediated non-viral
vector in the world. It can achieve
targeted delivery and gene transfer
with high efficiency.
China Medical University developed
herpes non-viral vectors. It can
introduce foreign gene along olfactory
nerve channel into the pathological
central nervous cells. It initiated a
novel approach for gene therapy.
Progresses in Biopharma
 Gene therapy of Hemophilia
Fudan University is the
first to carry out clinical
trials of gene therapy
for hemophilia.
This technology is in the
leading position in the
world.
Progresses in Biopharma
 Encouraging progresses in tissue engineering product
Several tissue
engineering R&D
bases and
laboratories
A considerable
young researcher
teams for tissue
engineering
Several relatively
mature products and
technology, some of
them reach or near to
clinic trial phase
Progresses in Biopharma
Chinese scientist carried out in
vivo research in model animals
using tissue engineered cartilage,
bone, tendon, vein, nerve,
cornea, urethra etc.
A breakthrough was made in
research of surface defection
repair of arthrosis cartilage
Vision and priorities of Biotech & Life
Science in China
Vision of Biotech & Life Science in China
Objectives and targets
Achieve the leapforward development
of BT, to promote the
new revolution in
science and
technology, to take
the lead in the world
in BT, to bring China
into a powerful
country in BT
Accelerate the
industrialization of
scientific and
technological
achievements and,
to develop new BI, to
make BI as one of
the pillar industries in
the national economy,
Significantly enhance
the economic
development, to
improve people’s health,
to improve the
ecological environment
substantially, to
substantially
strengthen the ability of
ensuring the national
security.
Priorities and key technology of Biotech & Life
Science in China

Implement life science and technology research
actions, promote new scientific revolution
Accelerate innovation in the frontier of life sciences, make
comprehensive breakthrough in genomics, proteomics,
stem cell technologies, systems biology, brain and cognitive
sciences, gene therapy etc., lay a firm scientific foundation
for prolonging human life and enhancing our understanding,
reconstruction and utilization level of life principles and
promoting new science and technology innovation.
Priorities and key technology of Biotech & Life
Science in China

Implement biomedical science and technology
actions, promote the fourth medical revolution
Accelerate biomedical science and technology innovation, enhance
health level of Chinese people; promote the fourth medical revolution
represented by gene therapy and regenerative medicine, drive and
form a100 billion yuan RMB biomedical industry; Biological products
such as vaccine will continue to play the most important role in the
prevention and elimination of major infectious diseases, endeavor to
increase remarkably the proportion of biological medicine in drugs
and gradually form a new drug market shared by chemical drugs,
biological drugs, natural medicine, just like the three legs of a tripod;
bring our biomedical industry into the advanced rank in the world.
Priorities and key technology of Biotech & Life
Science in China

Implement bioresources science and technology
actions, foster distinctive biological industry
Accelerate exploitation and utilization of special
bioresources, lay a foundation of new drugs exploitation,
new animal and plant breeding and construction of
microorganism strains with new functions; foster a group of
new distinctive bioresources industry, form 100 billion RMB
output value.
Priorities and key technology of Biotech & Life
Science in China

Implement biological safety science and technology
actions, promote the BS in China
Accelerate science and technology innovations in biosafety (BS),
establish and perfect the monitoring and administration system for lab
BS, transgenic BS, food safety as well as biohazard defending
system; promote our BS guarantee and bioterrorism defending ability.
Vaccine, biosensor, fingerprint identification and other biotechnology
will play an irreplaceable role in monitoring and controlling foreign
invading organism, defending bioterrorism, ensuring people’s health
and bioresources safety.
Priorities and key technology of Biotech & Life
Science in China

Implement biotech international cooperation
actions, make China among the biotech advanced
countries
Accelerate introduction and utilization of human talents,
capital, technology, product, induct and promote
international cooperation, promote a passel of major
international cooperation projects, establish joint research
institution, construct international communication platform
for BT, significantly enhance the comprehensive ability of
utilizing international science and technology resources .
Strategies and approaches of Biotech & Life
Science development
Strategies and approaches of Biotech and Life
Science development
 Establish favorable policy
Patent strategy and standardization strategy should be implemented
Intellectual property protection should be reinforced. Domestic market
should be protected while international market is exploited.
Environment in favor of the development of BT industry should be
built up.
BT agencies should be developed so as to bring into full play the
government’s functions of support, leading and market guiding.
In order to offer guarantee for the BT and healthy and well-ordered
development of the industry, the establishment of laws and
regulations concerning BT should be reinforced.
Strategies and approaches of Biotech and Life
Science development
 Introducing and training qualified scientists
Set up a group of high level qualified research personnel consisting of
200 outstanding research leaders, 20,000 principal scientists and
50,000 senior technicians
Cultivate 2000 advanced research professional administrators and
5000 general business managers
Introduce 2000 best advanced oversea talents in R&D and
industrialization to rapidly enhance the whole team strength in
biotechnology study(including health) and industrialization.
Encourage the institutes to build up dynamic talent competition and
mobilizing system. Besides, encourage the departments, locals,
enterprises to set up bonus system and special financing for the
excellent talents.
Strategies and approaches of Biotech and Life
Science development
 Establish centers of world excellence
To consolidate and enhance the status and functions of the existing
public research institutes and universities on BT innovation
First key effort is to build up 10 to 15 state (key) laboratories.
Second key effort is establish 30 to 35 state engineering technology
centers in the BT field(including health).
Third key efforts is set up and accurate 10 to 15 reserve centers and R&D
centers for national biological genetic resources.
Establish and build up 10-15 or so internationalized, standardized, scale
production, world top-ranking platforms and bases for BT innovation.
Build up and consummate 80 to 100 state of the art representative
enterprises in the country and all over the world and 10-15 BT
representative industrial parks.
Strategies and approaches of Biotech and Life
Science development
 Increasing capital investment
Increase the public investment in Biotech and Health R&D
and industrialization. The public investment should
support primarily the original innovative research, the key
technology R&D, the construction of the infrastructure
and the common technology platform, so as to build the
national Biotech and Health innovation system.
Establish and consummate investment mechanism and
system of multiple sources and full society engagement,
which means to encourage and attract the enterprises
and finance to invest in Biotech and Health research.
Strategies and approaches of Biotech and Life
Science development
 Strengthening BS development and evaluation
Establish and build our technology evaluation
standards and systems of biological safety relating to
agriculture, environment protection, food, import and
export quarantine.
Improve the uniform planning and administration on
the construction of high-level BS laboratories (Level 3
and Level 4)
Establish technology administration and evaluation
system of the laboratory animals.
Strategies and approaches of Biotech and Life
Science development
 Strengthening international cooperation and
exchanges
It is encouraged to strengthen international communication
and cooperation through multiple ways.
It is encourage and support to establish cooperation
between domestic institutes and oversea institutes. It is
necessary to establish joint-laboratories abroad on frontier
and core technology of Biotech and Life Science.
Strategies and approaches of Biotech and Life
Science development
 Improving organizational structure and leadership
At the disposal of the national leading group of Biotech R&D
and industrialization, take full advantage of the functions of
various departments like Science and Technology,
Development and Reform, Finance, Education, Agriculture,
Quality Control, Environment Protection, Forestry, and Military
in stimulating Biotech and industry development. All of
resources should be redistributed more scientifically, more
reasonably, and more efficiently, which will mobilize all powers
to boost Biotech and its development towards industrialization.
Opportunities of Biotech & Life Science in
China
Opportunities of Biotech & Life
Science in China
Bio-resources Opportunities
R&D and Trial Opportunities
Market Opportunities
Entrepreneur Opportunities
Bio-resources Opportunities
 China is one of the countries with most abundant
bio-resources in the world
Total land area :9.6million km2
Length from west to east: 5200 km
Length from south to north: 5500 km
Shorelines length :18000 km
Inland altitude : -155~8844m
China territory has a wide latitude span from south to north.
Frigid zone, temperate zone, torrid zone are all included in
China. Various crops are suitable for farming in China.
China also has abundant biomass resources for developing
biofuels.
Bio-resources Opportunities
 Plant resources
China has more than 30000 species of plants, ranked
the third in the world, only behind Malaysia and Brazil.
China has:
106 families of mosses, 70% of the total families in the world
52 families and 2600 species of ferns, 80% and 26% of the
total in the world, respectively.
8000 species of woody plants, including 2000 species of
arbors.
11 families, 34 genera and 240 species of gymnosperm.
The conifer species account for 37.8% of the total species in
the world
Data from the website of the State Forestry Bureau, China
Bio-resources Opportunities
 Unique plant resources
China has 243 genera and around 527 species of unique
seed plants
Among 666 species of artificial cultivation crops of important
economic value, at least 136 species originates from China.
Ginkgo Branch
Rhoipteleaceae
Eucommia
Bretschneideraceae
Bio-resources Opportunities
 Animal resources
China has abundant animal resources
 180000 species of invertebrate
 2500 species of fish
 550 species of amphibians and reptiles
 1320 species of birds
 About 600 species of mammalia
Without effective protection, animal resources are
extinguishing quickly.
Bio-resources Opportunities
 Microbe resources
General situation of microorganism reservation in China
Bacterium reservation organization
Quantity
Bacterium reservation organization
Quantity
CGMCC
15929
Sichuan antibiotic institute
13956
ACCC
4254
IANP
14500
CICC
1705
LNWSW
1255
CMCC
4500
GIMCC
2446
CVCC
4530
CCDM
5000
CFCC
1429
MDKIof ccdc
460
CDCC
5980
IAM of HAS
1011
AS-IV
915
IME of BMI
2798
CTCC
4267
Fujian Microbiology Institute
3000
Yunnan Microbiology Institute
9021
SAGC
1200
BRCC(Taiwan)
10398
HKUCC
5050
Total 113604
Data source: Report and World Data Centre for Microorganisms (WDCM)
Bio-resources Opportunities
 Human genetic resources
Through exploitation and utilization of human genetic resources,
research on the functional genes related to the major human
diseases and single gene inherited disease gene has been
performed and remarkable achievements have been obtained.
Human genetic resources collection and administration network has
been established in China, which can provide essential resources
and materials for the R &D of the functional genome associated with
human health.
In China, more than one thousand new genes have been isolated
and full-length of cDNA of the new genes cloned using human
genetic resources acquired, the total number obtained is more than
2% of the total human genes.
R&D and Trial Opportunities
300 research academes and institutes are undertaking medical
BT R&D
300 companies are undertaking medical BT R&D
More than 20 key labs are undertaking life sciences and medical
BT R&D
3 research centres for genetic engineering
Large Sciences Education Pool
Est. Undergrad/Grad Students Enrolled:
Chemistry: 100,000/20,000
Medical Sciences: 120,000/15,000
Biological Sciences: 60,000/15,000
R&D and Trial Opportunities
There are 183 animal trial labs in China.
Some of them are national level.
There are 19,900 hospitals in China by the
end of 2007.
Market Opportunities
The total output value of medical industry in 2007 reached
667.9 billions RMB(about 126 billion Canadian dollars),
with an increase of 20.6%. That’s about 5 times of which
in 1998.
The total export value of medical industry in 2007 reached
24.6 billions RMB(about 4.6 billion Canadian dollars).
That’s over 7 times of which in 1998.
The total import value of medical industry in 2007 reached
14 billions RMB(about 2.6 billion Canadian dollars). That’s
over 9 times of which in 1998.
The total output value of medical industry during Jan. to
Nov. 2008 reached 748.7 billions RMB(about 141.3
billion Canadian dollars), with an increase of 26.3%.
Market Opportunities
There are 800 million people to be treated in
hospital and 2.2 billion person-times needing
clinic services each year.
The total expenditure of health care system
in 2010 will be 220 billion RMB more than in
2007. It will lead to 18% annual medical
industry increasing in China.
Market Opportunities
China accounts for 20% of the world’s
population but only 1.5% of the global
drug market. China's changing healthcare environment is designed to extend
basic health insurance to a larger portion
of the population and give individuals
greater access to products and services.
Following this period of change, the
pharmaceutical industry is expected to
continue its expansion.
Market Opportunities
The Chinese pharmaceutical market is
projected to increase by about 16-18%
per annum for now and the foreseeable
future.
As of 2008, China is the 8th largest
pharmaceutical market in the world and
will be the 5th by 2010, the 2nd by 2020.
Entrepreneur Opportunities
There are 53 national High-Tech Parks in
China.
There are several innovation zone of
biotechnology and medicine such as China
International Innovation Zone of
Biotechnology and Medicine in Tianjin.
China International Innovation Zone
of Biotechnology and
Medicine
BioMed Zone
国家生物医药国际创新园定位
Planned Functions of BioMed
Zone
国家生物医药国际创新园坐落在
滨海新区,以高标准、高起点、
系列化、标准化和和国际化为准
则,研究开发、企业孵化、生产
制造、贸易流通统筹并举,构建
开放、共享、联合的生物技术与
创新药物技术平台和孵化平台,
吸引聚集高水平的人才、项目、
研发机构和企业。
BioMed Zone is located in the Binhai New Area. Guided by the principles of
high standard, high start-up, catena, standardization and internationalization,
it will lay its emphasis on research and development, industrial incubation as
well as manufacturing and trade and build an opening, sharing and joint
platform for biological technology and innovative medicines as well as an
incubation platform to attract and accumulate senior research personnel,
projects, R&D organizations and enterprises.
天津滨海新区成为第三增长极Tianjin Binhai
New Area is a Third Economic Growth Pole in
China
天津滨海新区产业基础雄厚,
增长潜力巨大,成为继上个世纪80
年代的广东深圳特区、90年代上海
浦东新区之后,21世纪带动区域发
展的新的经济增长极。
With a solid industrial basis and great
development potential, Tianjin Binhai New
Area is becoming a new economic growth
pole with the function of stimulating
China’s regional development in the 21
century after Shenzhen Special Zone in
Guangdong Province in 1980s and
Pudong New Area of Shanghai in 1990s,
国家生物医药国际创新园一园三区
Three Zones in BioMed Zone
研究开发区
The Research & Development Zone
企业孵化区
The Incubation Zone
国家生物医药
国际创新园
BioMed Zone
生产贸易区
The Manufacturing and Trading Zone
通过3-5年,国际创新园聚集国内外创新资源,开发一批具有市场竞争力的创新药物,聚集一批
生物医药企业,成为中国生物医药企业的领航区、生物经济发展的标志区。
Through accumulating both national and international innovative resources, BioMed Zone will
develop a series of market competitiveness innovative medicines, bring in a number of biomedical
enterprises and thus making it as a pilot zone of Chinese biomedical enterprises as well as a symbol
of the development of biological economy within 3 to 5 years.
国家生物医药国际创新园的环境
Environment of BioMed Zone
完善的公共技术平台和孵化器体系
A Complete System for Public Technological Platforms and Incubators
完善的服务体系 Complete Service System
创业风险投资体系:建立规模不少于5亿元的创业投资引导基金,吸引国内外生物医药风
险投资机构和企业,最终形成100亿元规模的风险投资资金,扶持生物医药产业发展。争
取国家支持,对投资于中小生物医药企业创业孵化的风险投资企业,实行一定的税收优惠
政策。
Venture Capital System for Startups: In order to give support to the biomedical industry, BioMed Zone
will set up a Venture Capital Fund with more than RMB 500 million to attract VC organizations and
enterprises both at home and abroad in the field which finally develop into a fund with RMB 10 billion;
give some preferential tax policies to VC enterprises investing in incubation of small and medium sized
biomedical companies.
在国家部委的支持下,力争在国际创新园开展为上市股份制生物医药企业进入证券公司代
办股份转让系统进行股份转让试点,支持技术与产权交易市场开展为上市生物医药企业股
权流通试点。
Supported by relevant ministries and committees, BioMed Zone will make its efforts to carry on pilot
business of stock transfer for listed biomedical enterprises with joint stock system entering into the
Agency Share Transfer System; support Assets and Equity Exchange market through carrying out pilot
business of stock circulation for listed biomedical enterprises.
国家生物医药国际创新园的优惠政策
Preferential Policies in BioMed Zone
国际创新园的创新创业环境:The Innovation Environment of BioMed Zone
入园优惠政策 Preferential Policies
1、入园的研发、生产和服务型企业均享受高新技术企业的优惠政策。
All enterprises in the zone specializing in research, production and services will
share the preferential policies same as the Hi-tech enterprises
2、入园企业享受用地、资金、贷款、关税等一系列优惠政策。
All enterprises in the zone will share the serial preferential policies in land, funds,
loans and tariff.
3、国家和省部级研发机构落户滨海新区,可获得一次性一定额度的资金补贴。
All national and provincial as well as ministerial research institutes in Binhai
New Area will enjoy certain amount of one-off capital subsidy
4、国际知名生物医药企业和机构入园建立研发机构,可获得一次性一定额度的
资金补贴。
All internationally well-know biomedical enterprises and institutions will enjoy
certain amount of one-off capital subsidy.
S&T Cooperation Between China and
Canada
S&T Cooperation Between China and Canada
Federal Level
The Government of P.R.China and the
Government of Canada signed the
Agreement of S&T Cooperation in January
2007 and set up a cooperation fund. Both
governments promised to allocate one
million Canadian dollars to support joint
research projects.
S&T Cooperation Between China and Canada
Provincial level
The Ministry of Science and Technology of
P.R.China and B.C. Innovation Council
signed MOU of S&T Cooperation in March
2006 and set up cooperation fund in 2007.
Both promised to allocate two million
Canadian dollars to support joint research
projects.
Priorities of S&T Cooperation Between China and
Canada
 Federal
Areas of Cooperative Activities shall be jointly decoded
on writing from time to time by the Parties.
The following priority areas have been identified below in
2007; however, application for Partnership
Development Activities in other areas will also be
considered:
--Agriculture Foods and Bio-products
--Energy
--Environment
--Health & Life Sciences/Biotechnology
Information and Communication Technologies and
Nanotechnology are identified as enabling sectors to
the four selected areas.
Priorities of S&T Cooperation Between China and
Canada
Provincial
--oceans technology;
--biotechnology, medical devices and food testing;
--forestry, forest products and wood building
materials;
--information technology including software,
telecommunications and multimedia;
--aquaculture and aquatic sciences;
--environment, clean energy and waste
management;
--research, innovation and business training and
education.
Mechanism of S&T Cooperation Between China and
Canada
Federal
For Canada, funding and other services
will be provided through International
Science and Technology Partnerships
Canada Inc. (ISTPCanada), a nongovernmental organization selected by the
Government of Canada for this purpose,
and for China, through the Ministry of
Science and Technology (MOST).
Mechanism of S&T Cooperation Between China and
Canada
Provincial
For BC, funding and other services will be
provided through BC Innovation Council,
and for China, through the Ministry of
Science and Technology (MOST).
Forms of Cooperative Activities
a) joint research and development activities;
b) pooling of research and development;
projects, already underway in each Party, into
Joint Research Activities;
c) facilitation of commercially viable research
and development;
d) organization of scientific seminars,
conferences, symposia and workshops, as well
as participation of experts in those activities;
e) exchanges and loans of equipment and
materials;
Forms of Cooperative Activities
(continue)
f) exchanges of information on practices, laws,
regulations and programs relevant to the
Cooperative Activities undertaken pursuant to
the Agreement;
g) funding of Cooperative Activities on the basis
of equal contributions from each Party;
h) demonstrations of technologies and
applications development;
i) visits and exchanges of scientists, technical
experts and academics;
j) any other mode of cooperation jointly
decided in writing by the Parties.
Eligibility for Funding
Federal
In Canada
Eligible applicants will be researchers and managers
representing Canadian companies, academic institutions,
research hospitals, other institutes, or associations which
operate and are headquartered in Canada. Subsidiaries
of firms headquartered and owned outside Canada are
normally not eligible for support. However, recognizing
that the overriding consideration is "benefit to Canada",
an exception can occur if ISTPCanada is satisfied that
clear economic benefit will accrue to Canada because
the product or the technology will be substantially
produced in, exported from or utilized in Canada.
Eligibility for Funding
Federal(continue)
In Canada
Agencies of the Crown (including Crown corporations,
government institutes, government laboratories, etc.)
may be participants of ISTPCanada-funded Activities but
are not eligible as recipients of ISTPCanada funding.
Eligibility for Funding
Federal(continue)
In China
Companies, organizations and associations incorporated
under People’s Republic of China national law.
Eligibility for Funding
Provincial
ISCD funds may be provided to British
Columbia-based non-profit organizations
such as post-secondary and government
research institutions, industry associations,
regional development organizations etc.
Private companies may not receive funds
directly, however, they are encouraged to
be partners in the project and may perform
work for the project based on agreed
intellectual property arrangements.
Projects Approved in 2007
Federal
ISTPCanada and the Chinese Ministry of
Science and Technology have agreed to
fund eight initial joint research projects and
two projects are related with health. The
total value of these projects is $10.574
million.
Projects Approved in 2007
Federal(continue)
1. Project: Use of seal oil and seal products in the
diet of hospital patients Partners
Participants: North Atlantic Biopharma Inc.; the
Government of Newfoundland and Labrador; and
Sun Yat-sen University, Guangzhou
2. Project: Application of high-yield pulps in the
production of high-quality coated paper for
multicolour offset and digital printing Partners
Participants: University of New Brunswick; FP
Innovations-Paprican Division, Pointe Claire;
Tembec Inc., Montreal; University of Toronto;
Tianjin University of Science and Technology,
Tianjin
Projects Approved in 2007
Federal(continue)
3. Project: Selective Asphaltene ExtractionPartners
Participants: Well Resources; MEG Energy
Corp.; Sunshine Oilsands Ltd.; Alberta Energy
Research Institute; State Key Laboratory of
Heavy Oil Processing; China University of
Petroleum, Beijing
4. Project: Development of microfluidic chip-based
electrophoresis platform and approaches for
rapid and high-resolution disease diagnosis
Partners
Participants: University of Waterloo; Convergent
Bioscience Ltd., Toronto; Nanjing University,
Nanjing
Projects Approved in 2007
Federal(continue)
5. Project: Enhancement of potato trade by adapting
Canada seed potato technology to meet China
requirements for increased productionPartners
Participants: New Brunswick Department of Agriculture
and Aquaculture; Agriculture and Agri-Food Canada;
Hunan Agricultural University, Changsha
6. Project: Broadband wireless access terminals: analysis,
deployment and air interface evolution strategiesPartners
Participants: Ecole de technologie superieure, Montreal;
Wavesat, Montreal; Shanghai Research Center for
Wireless Communication, Shanghai
Projects Approved in 2007
Federal(continue)
7. Project: Research on constructing the breeding
system for the Chinese dairy industry applying
advanced breeding technology
Partners
Participants: Alta Genetics Inc., Balzac, Alberta;
China Agriculture University, Beijing
8. Project: Research on the linear generator system
for oceanic tidal and wave energyPartners
Participants: DynaGen Technologies Inc., Halifax;
Dalhousie University, Halifax; China University of
Mining & Technology, Xuzhou
Projects Approved in 2007
Provincial
The British Columbia Innovation Council and the
People’s Republic of China’s Ministry of Science
and Technology has announced recipients of the
Innovation and Commercialization Strategic
Development Program. The Program provides a
total of $4 million in joint funding to support 13
collaborative projects in order to support
excellence in research, technology development
and commercialization projects of interest to
both jurisdictions. UBC involves 8 projects and
two projects are related with health.
Projects Approved in 2007
Provincial(continue)
1. Project: Cathepsins and lung fibrosis
BC Partner: Dr. Dieter Bromme
The University of British Columbia
China Partner: Dr. Jifeng Wang
Beijing University of Chinese Medicine
2. Project: High-speed transistor microring lasers
BC Partner: Dr. Lukas Chrostowski
The University of British Columbia
China Partner: Dr. Zigang Duan
Shenzhen University
Projects Approved in 2007
 Provincial(continue)
3. Project:Development and demonstration of advanced
polarimetric SAR technology for forestry
BC Partner:Dr. David Goodenough
Canadian Forest Service
China Partner: Dr. Wen Hong
Chinese Academy of Sciences
4. Project:Raman scattering in a clinical instrument for the
diagnosis of cancer by metabolomic imaging
BC Partner:Dr. Edward Grant
The University of British Columbia
China Partner:Mr. Xuegang Shao
Nankai University
Projects Approved in 2007
 Provincial(continue)
5. Project:Reliable and trusted networking for data-centric
wireless access with applications to vehicular telematics
BC Partner:Dr. Victor Leung
The University of British Columbia
China Partner: Dr. Yanheng Liu
Jilin University
6. Project:Development of integrated remediation technologies
for petroleum contaminated soils and sludge through bioaugmentation and biosurfactant
BC Partner:Dr. Jianbing Li
University of Northern British Columbia
China Partner:Dr. Yuefei Huang
Tsinghua University
Projects Approved in 2007
 Provincial(continue)
7. Project:Innovation in organic greenhouse production in
China
BC Partner:Mr. Blair McHenry
Canadian Organic Greenhouse Association
China Partner: Mr. An Li Hong
Tianjin Academy of Agricultural Sciences
8. Project:Ultrasound 3D imaging combined with MEMS-based
optical coherence tomography
BC Partner:Dr. Robert Rohling
The University of British Columbia
China Partner:Dr. Dai Enguang
Peking University
Projects Approved in 2007
 Provincial(continue)
9. Project:Development of low cost perfluorosulfonic (PFSA) ionomer
membranes
BC Partner:Dr. Ken Shi
Dr. Steven Holdcroft
National Research Council Canada & Simon Fraser University
China Partner: Dr. Yongming Zhang
Shanghai Jiao Tong University
10. Project:Development of ocean assimilation techniques for Argo and
other oceanic observations
BC Partner:Dr. Robert Rohling
The University of British Columbia
China Partner:Dr. Dai Enguang
Peking University
Projects Approved in 2007
Provincial(continue)
10. Project: Development of ocean assimilation
techniques for Argo and other oceanic observations
BC Partner:Dr. Youmin Tang
University of Northern British Columbia
China Partner: Dr. Guihua Wang
Second Institute of Oceanography
11. Project:Contamination effects and durability
studies of PEM fuel cells
BC Partner:Dr. Haijiang Wang
National Research Council Canada
China Partner:Dr. Jianxin Ma
Shanghai Tongji University
Projects Approved in 2007
 Provincial(continue)
12. Project:Application of FORECAST software to assess sustainable
productivity and carbon equestration in major Chinese forests
BC Partner:Dr. Adam Wei
Dr. Hamish Kimmins
The University of British Columbia
China Partner: Dr. Jiang Hong
Zhejiang Forestry University
13. Project:Development of the Chinese National Sustainable Forest
Management Systems and the National Forest Certification Standard
BC Partner:Dr. Yongyuan Yin
Environment Canada
China Partner:Mr. Jiafu Lei
State Forest Administration
S&T Cooperation Between China and Canada
The National Nature Science Fund of
China(NSFC) signed MOU with the
Canadian Institute of Health
Research(CIHR) in 2005. Both
organizations agreed to support the coresearch projects conducted by
Universities, research hospitals and
institutes.
S&T Cooperation Between China and Canada
Key areas supported by NSFC-CIHR
program:
 1、Neurosciences:to provide support for basic
research in neuroscience, mental health, addiction and
the senses;
 2、Diabetes and Obesity:to provide support for
research on the measures, causes, prevention,
treatment and consequences of diabetes and obesity;
 3、Cardiovascular System:to provide support for basic
and translational research on the pathogenesis,
treatment and ultimate of cardiovascular diseases,
including myocardial infarction, stroke, cardiomyopathy
and atherosclerosis;
S&T Cooperation Between China and Canada
Key areas supported by NSFC-CIHR
program(continue):
 4、Genetics:to provide support for research on the
human and other genomes and on all aspects of genetic,
basic biochemistry and cell biology related to health and
disease;
 5、Infection and immunity:to provide support for basic
research on viral and bacterial diseases and
development of vaccines;
 6、Child and youth health:to provide support for
research on fertility, pregnancy, maternal health, healthy
child development and the etiology, prevention, and
treatment of diseases in infants, children, and youth;
S&T Cooperation Between China and Canada
Key areas supported by NSFC-CIHR
program(continue):
 7、Aging:Gerontology and Geriatrics: to encourage
research on aging processes, on functional limitations in
older adults as a consequence of disease, and on
determinants of healthy aging within the context of one
or more of the following priority areas: healthy and
successful aging, biological mechanisms of aging,
cognitive impairment in aging, aging and maintenance of
functional autonomy, and health services relating to
older people.
S&T Cooperation Between China and Canada
Both organizations have approved to fund
53 research projects during 2006-2008.
Each project can get 50,000 Canadian
dollars in Canada and 150,000 RMB in
China each year within three years after
approved.
Potential Cooperation Ways in the field of
Biotechnology and Life Science
Potential Cooperation Ways in the field of
Biotechnology and Life Science
R&D Cooperation
Clinical Trial in China
Manufacturing in China
R&D Cooperation
 Government Program
 Federal Program
 Provincial Program
 NSFC-CIHR Program
 Private Program
In recent years, more and more western pharmaceutical
corporations have come to China and set up R&D
centers. For instance, Roche of Switzerland opened its
R&D center in Shanghai recently, GSK has established
its OTC research and development center in Tianjin.
AstraZeneca, Bayer, Eli Lili, and Hoffman-La Roche,
have also set up R&D or clinical trial centers in China.
Clinical Trial in China
Difficulties in New Drug
Development Especially in Clinical
Trial in West
Overview of Clinical Trial in China
Opportunities in China
Challenges in China
Strategies in China
Clinical Trial in China
Difficulties in New Drug Development Especially in
Clinical Trial in West
 Delay of Time
-Difficulty in patient recruitment
86 % of all US clinical studies fail to recruit the required
number of patients on time and as a result are delayed
on average 366 days. Canada has the same problem.
Clinical Trial in China
Difficulties in New Drug Development Especially in
Clinical Trial in West
 Higher Cost
• Direct cost:
Caused by the delay of the study.
When failing to meet recruitment timelines, the cost of
drug development rises. Daily out-of-pockets alone are
estimated at US$37,000.
• Indirect cost:
Caused by the delay of product launching, which is huge!
For a billion-dollar drug, 83M/Month, 2.8M/day
Clinical Trial in China
Overview of Clinical Trial in China
Up to June 2008, there are 428 clinical
trials which are on going in China and 870
drugs have finished the clinical trials.
China will be one of clinical trial centres in
the world in future.
Contract Research Organization(CRO)
In 2008,The market value of CRO reached
260 million USD in China. Some experts expect
that It will reach 430 million USD by 2010.
Clinical Trial in China
Opportunities in China
 Large patient pool, especially for treatment
native patients
--Solution of patient recruitment
 Many GCPs
 Lower cost
 Inclusion of Asian Data
 Government’s efforts on improving regulations
and IP
Clinical Trial in China
Opportunities in China
Large patient pool, especially for treatment native
patients
Population of 1.3 Billion
 250 million covered by insurance
 250 million partially covered by insurance
 800 million not covered by insurance
Large number of “treatment native” patients in China
Clinical Trial in China
Opportunities in China
--Large patient pool
Prevalence of Cancers
Disease
Incidence(per 100,000)
Lung Cancer
67.5
Stomach Cancer M: 39.2 F: 19.1
Liver Cancer
M: 35 F: 9.7
Colorectal Cancer M: 22 F: 12
Breast Cancer
F: 13.3
Cervix Cancer
F: 12.3
Number
877,500
378,000
290,550
221,000
172,000
159,900
Clinical Trial in China
Opportunities in China
--Large patient pool
 Shanghai Cancer Hospital
600 Beds (100% occupancy)
Lung Cancer (20%); Stomach Cancer (20%); Breast Cancer (20%);
Intestinal Cancer (10%)
Out-Patient - 20,000 per month of which GI cancer is the largest
percentage.
 Beijing Cancer Hospital
580 Beds (>100% occupancy)
Intestinal Cancer (20%); Stomach Cancer (20%); Lung Cancer
(15%); Breast Cancer (15%); Esophageal Cancer (10%)
Out-Patient – 11,000 per month
Clinical Trial in China
Opportunities in China
--Large patient pool
Prevalence of Cardiovascular and Respiratory Diseases
Disease
Incidence(per 100,000)
Number
Hyperlipidemia
4.7%
61.1 M
Coronary Heart
Disease
4.4%
57.2 M
Hypertension
13.3%
173 M
COPD/Chronic
Bronchitis
9.7%
126 M
Tuberculosis
43 per 100,000
562,600
Clinical Trial in China
Opportunities in China
-- Large patient pool
Prevalence of CNS and Psychiatric Diseases
Disease
Incidence
Number
Stroke
202 per 100,000
2.6 M
Depression
5.8%
75.5 M
Alzheimer’s
Disease
1.35%
17.5 M
Schizophrenia
0.66%
8.5M
Clinical Trial in China
Opportunities in China
-- Large patient pool
Prevalence of GI and Other Diseases
Disease
Incidence
Hepatitis B
66.1 per 100,000
Gastric Ulcer
4%
Chronic Gastritis
& Enteritis
12.1%
Rheumatoid
Arthritis
9.6%
Diebetes
3.9%
HIV
Number
859,300
52 M
157 M
125M
50M
1M
Clinical Trial in China
Opportunities in China
--Many GCPs
 To ensure scientifically accurate reflection and reliability
of results as well as test subjects' rights and interests
during clinical trials, China promulgated the Good
Clinical Practice (GCP) for pharmaceutical products in
1999, and began the work of GCP certification on March
1, 2004.
 By the end of 2007, a total of 178 institutions conducting
clinical trials had obtained GCP certification, and GCP
certification has greatly improved the quality of drug
clinical trials in China.
Clinical Trial in China
Opportunities in China
--Lower cost
 Pre-Clinical(estimates)
Chemestry—30 to 60% of the cost of theWest
Other Pre-clinical
Toxicology—30% of the cost of the West
Animal testing—30% of the cost of the West
 Clinical(estimates)
Phase I—25% of the cost of the West
Phase II/III—30% of the cost of the West
Clinical Trial in China
Opportunities in China
--Lower cost
Item
US Cost
China Cost
1 day stay in Hospital
$750 to $1000
$40 to $100
1 day stay in ICU
$1500 to $2000
$80 to $150
CT Scan
$300 to $550
$100 to $150
Pet Scan
$2,750 to $4,500
$900 to $1200
MRI
$1,500 to $3,500
$150 to $300
EKG
$30
$4 to $6
Colonoscopy
$375 or Diagnostic;
$550 for therapy
with ablation
$50 to $100
CT Directed Biopsy
$325 to $450
$100 to $200
Senior Oncologist
Annual Salary
$225,000+
$40,000+for key
opinion leaders
Clinical Trial in China
Opportunities in China
--Lower cost
Don’t forget the huge saving due to rapid
recruitment and earlier launch of the
product.
Clinical Trial in China
Opportunities in China
--Inclusion of Asian Data
Data for some therapeutic areas
are accepted by US FDA such as
hepatitis, oncology, etc.
Clinical Trial in China
Opportunities in China
--Government’s efforts
More transparent regulations
Trying to improve regulatory process
IP

Clinical Trial in China
Challenges in China
Slow regulatory process
Problems in conducting clinical trials
Blood/tissue sample export
Clinical Trial in China
Challenges in China
--Slow regulatory process
Type of Application Track
Time
(Working days)
Application for CTA*
of imported product
Application for CTA
of global trial
*CTA: clinical trial approval
Regular 160-200
Fast
140-165
Clinical Trial in China
Challenges in China
--- Problems in clinical trials
Management
Time/resource allocation
Lack of study coordinator
Confidentiality
Facility
Communication
Storage of drug, files
Clinical Trial in China
Challenges in China
--- Problems in clinical trials
 Compliance to protocol and ICH/GCP
Clinical studies should be carried out according to
International Conference on Harmonization (ICH) / WHO
Good Clinical Practice standards. This provides a unified
standard for the European Union (EU), Japan, and the
United States, as well as those of Australia, Canada, the
Nordic countries and the World Health Organization
(WHO). Thus, any country that adopts this guideline
technically follows this same standard.
Quality of data
ICF(Informed Consent Forms)
Clinical Trial in China
Challenges in China
--- Problems in clinical trials
Safety reporting
Some AEs are neglected
Safety reporting to EC is not sufficient
Clinical Trail in China
Challenges in China
--- Samples export
Lack of qualified central lab
Samples export is difficult and complicated
Whole Blood or Tissue Samples
Permission Required from China Human Genome
Resource Administrative Office & MOH
Plasma or Serum Samples
Special Permit From MOH (Per Batched shipment)
Clinical Trail in China
Strategies
---Cost saving on early stage study
General Rules for New Drugs
International companies can not conduct trials in
China unless they have already entered into Phase II
trials in another major market.
Strategies:
Include China in the phase II study to save time and money
Find ways for early stage studies(Phase I-II/prove of concept)
Out-license
JV
Branch manufacturer in
Manufacturing in China
As of 2007, there were already
1,800 foreign-funded pharmaceutical
enterprises in China. Currently, all the
top 20 pharmaceutical companies in
the world have set up joint ventures
or wholly owned facilities in China.
Manufacturing in China
 Pfizer produces and markets more than 40 innovative
drugs in China. Pfizer has GMP manufacturing facilities
in Dalian, Suzhou and Wuxi. Pfizer has invested more
than $500 million in China.
 Merck set up its first joint venture in China in 1994.
 Novartis has invested about 100 million in China, with
four manufacturing facilities in Beijing and Shanghai. Its
core businesses involve patented drugs, generic drugs,
eye protection drugs and health products.
 AstraZeneca Pharmaceutical Co. has its headquarters in
Shanghai, with 25 branch offices in major cities across
China’s mainland. In 2001, the company established its
largest manufacturing site in Asia with a total investment
of $170 million in Wuxi.
Several Useful Websites
www.istpcanada.ca
www.bcinnovationcoouncil.com
www.most.cn
www.moh.gov.cn
www.sda.gov.cn
www.chictr.org
www.cncbd.org.cn