Biotech Life Science in China and S T Cooperation Between China and Canada

8/8/2019 Biotech Life Science in China and S T Cooperation Between China and Canada

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Biotechnology and Life Science in China

and S&T Cooperation Between China and

Canada

March 25, 2009

Long ShenConsul for Science and Technology

Consulate General of P.R.China


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Biotechnology and Life Science in

China

S&T Cooperation Between China and

CanadaPotential Cooperation Ways in the

field of Biotechnology and Life Science


and S&T Cooperation Between Chinaand Canada


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CONTENT

Strategies and approaches of Biotech and Life Science

development in China

Vision and priorities of Biotech and Life Science in

China

Status of Biotech and Life Science in China

Mission of Biotech and Life Science in China

Opportunity of Biotech and Life Science in China


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Mission of Biotech and Life Science in China


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Biotech: a essential technology for the improvement of peopleshealth

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 inChina


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Biotech: an essential support in ensuring the safety of thecountry

Bio-terror

Severe infectious diseases

Public safetyBio-safety of

the country

Foreign invading organism

Gene resources loss andgene patents contest

B T


B T


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Biotechnology should be

our focus that we catch up

with the advanced level in

future high-tech industry, andits 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



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We should try to seize thecommanding elevation in biotechnology,

and strengthen the application of BT in

agriculture, industry, population, and

health sectors, especially the research

and development of grains and foodsafety, 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 healthof our people.

Speech delivered by PremierWen Jiabao at

the National Congress of Science and

Technology, 2006



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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 Five-

Year Plan for National Economic and Social

Development, P. R. China



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Nations focus: the development of Biotech

National Development and Reform Commission together withother 18 commissions and ministries such as the Ministry of

Finance, Science and Technology, Education, Health and soon , constituted 11th Five-Year Plan for BT of China,relative work started up in Jun 2005.

.



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Status of Biotech and Life Sciencein China


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China, as the only member from the developing countries in theInternational Human Genome Project, has completed sequencing 1% ofhuman genome

Chinese scientists undertook and completed 10% of the International

HapMap Project

Chinese scientists led and implemented the International Human LiverProteome Project (HLPP)

Chinese scientists cloned the pathogenic genes of hereditary diseasessuch as sensorineural and high-frequency hearing impairment

Status of advanced Biotech and LifeScience in China


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Human genome project (HGP) formally started up in 1990. Chinesescientists together with scientists from USA, UK, France, German, Japanparticipated in this human genome project which was worth 3 billions USdollars. The work undertaken by Chinese scientists focused on the shortarm of human beings number 3 chromosome. Through the efforts of

Chinese scientists, Chinese part in HGP has been finished two yearsahead of schedule.



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The International HapMap Project is another distinguish featafter 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 andnumber 8 chromosome short arm.



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On Dec.15, 2003, another significant plan in life sciences after theaccomplishment 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 setup 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.



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The research group headed by Professor XiaJiahui, 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 HumanAbnormal 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.



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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.

Progresses in Biopharma


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Genetically engineered drugs and vaccineMore than 20 genetic engineered drugs and vaccines such asrecombinant person interferon-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 phaseor pre-clinical trial phase.

China vaccine market has a tremendous potential, the growth rate per

year exceeds the average level of the world.

10

1

20

Growthrate

China Globe

titis Batitis Aluhives



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Antibody drugs R&DIn 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 Manufacturer

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

Antibody drugs made in China



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Iodine [131I] Metuximab Injection(Trade nameLicartin)

Iodine [131

I] Metuximab Injection (Trade name: Licartin) is the first drugfor 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 I to liver cancer, and utilizes radial emitted from I to treattumor 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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Gene therapy drugsChina is one of the countries which initiated earlierbasic research and clinical trials of gene therapy.

In 2004, the first gene therapy

product - recombinant human

p53 glandulose virus injection

was successful manufactured

Typediabetes therapy drug

Tailuo was successful

manufactured.

Progresses in BiopharmaP5

3

in

jec

tion

Type

diabetes

therapy

d

rug

--

-T


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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 andgucose tolerance test of diabetic

mice back to normal.

It can control the feeding of normal

mice and diabetic mice, reduce the

weight of diabetic miceIt can enhance the sensitivity of diabetic

mice to insulinChinese patent : 1 granted

International patent: 2 applications by Shanghai Institute of Materia MedicaSIMM

1 of them is under substantive examination in 48 countries and regions



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Recombinant human vascular endostatin injection

Recombinant human vascular endostatin injection, a first class newdrug for anti-tumor, is developed by Dr Luo Yongzhang of YantaiMaidejin Biologic engineering Inc. It is the first recombinant humanvascular endostatin injection used for anti-tumor new in the world.The new drug has obtained several invention patent grants.



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New anti-tumor drug: Recombinant humanized Monoclonalantibodies 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



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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 canintroduce foreign gene along olfactory

nerve channel into the pathological

central nervous cells. It initiated a

novel approach for gene therapy.



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Gene therapy of Hemophilia

Fudan University is the

first to carry out clinical

trials of gene therapy

for hemophilia.

This technology is in theleading position in the

world.



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Encouraging progresses in tissue engineering product

A considerableyoung researcher

teams for tissue

engineering

Several tissueengineering R&D

bases and

laboratories

Several relativelymature products and

technology, some of

them reach or near to

clinic trial phase



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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 defectionrepair of arthrosis cartilage



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Vision and priorities of Biotech & Life

Science in China


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Vision of Biotech & Life Science in China

Achieve the leap-

forward development

of BT, to promote the

new revolution in

science and

technology, to takethe lead in the world

in BT, to bring China

into a powerful

country in BT

Significantly enhance theeconomic development,

to improve peoples

health, to improve the

ecological environment

substantially, to

substantially strengthenthe ability of ensuring the

national security.

Objectives and targets

Accelerate the

industrialization of

scientific and

technological

achievements and,

to develop new BI, tomake BI as one of

the pillar industries in

the national economy,


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Implement life science and technology researchactions, 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 & LifeScience in China


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Implement biomedical science and technologyactions, 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 drugsand 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.



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Implement bioresources science and technologyactions, 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 ofnew distinctive bioresources industry, form 100 billion RMB

output value.



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Implement biological safety science and technologyactions, 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 peoples health

and bioresources safety.



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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 researchinstitution, construct international communication platform

for BT, significantly enhance the comprehensive ability of

utilizing international science and technology resources .



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Strategies and approaches of Biotech & Life

Science development


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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

governments 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.

Establish favorable policy

Strategies and approaches of Biotech and LifeScience development


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Introducing and training qualified scientistsSet 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 and5000 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.



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Establish centers of world excellenceTo 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, scaleproduction, 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.



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Increasing capital investmentIncrease the public investment in Biotech and Health R&D

and industrialization. The public investment should

support primarily the original innovative research, the keytechnology 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 andsystem of multiple sources and full society engagement,

which means to encourage and attract the enterprises

and finance to invest in Biotech and Health research.



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Strengthening BS development and evaluation

Establish and build our technology evaluation

standards and systems of biological safety relating to

agriculture, environment protection, food, import andexport 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.



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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 frontierand core technology of Biotech and Life Science.



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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, morereasonably, and more efficiently, which will mobilize all powers

to boost Biotech and its development towards industrialization.



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Opportunities of Biotech & Life Science in

China


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Opportunities of Biotech & LifeScience in China

Bio-resources Opportunities

R&D and Trial Opportunities

Market Opportunities

Entrepreneur Opportunities


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China is one of the countries with most abundantbio-resources in the world

Total land area :9.6million km2

Length from west to east: 5200 kmLength from south to north: 5500 kmShorelines length :18000 kmInland altitude : -1558844mChina territory has a wide latitude span from south to north.

Frigid zone, temperate zone, torrid zone are all included inChina. Various crops are suitable for farming in China.China also has abundant biomass resources for developingbiofuels.


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Plant resourcesChina has more than 30000 species of plants, rankedthe third in the world, only behind Malaysia and Brazil.China has:

106 families of mosses, 70% of the total families in the world52 families and 2600 species of ferns, 80% and 26% of thetotal 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 inthe world

Data from the website of the State Forestry Bureau, China



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Unique plant resourcesChina has 243 genera and around 527 species of unique

seed plants

Among 666 species of artificial cultivation crops of importanteconomic value, at least 136 species originates from China.

Ginkgo Branch Rhoipteleaceae Eucommia Bretschneideraceae



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Animal resourcesChina 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 areextinguishing quickly.



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Bacterium reservation organization Quantity Bacterium reservation organization Quantity

CGMCC 15929 Sichuan antibiotic institute 13956

ACCC 4254 IANP

CICC 1705 LNWSW 1255

CMCC 4500 GIMCC 2446

CVCC 4530 CCDM 5000

CFCC 1429 MDKIof ccdc 460

CDCC 5980 IAM of HAS 1011AS-IV 915 IME of BMI 2798

CTCC 4267 Fujian Microbiology Institute 3000

Yunnan Microbiology Institute 9021 SAGC 1200

BRCCTaiwan 10398 HKUCC 5050

General situation of microorganism reservation in China

Microbe resources

Datasource: Reportand WorldDataCentre forMicroorganisms (WDCM)Total 113604



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Human genetic resourcesThrough exploitation and utilization of human genetic resources,research on the functional genes related to the major humandiseases and single gene inherited disease gene has beenperformed and remarkable achievements have been obtained.

Human genetic resources collection and administration network hasbeen established in China, which can provide essential resourcesand materials for the R &D of the functional genome associated withhuman health.

In China, more than one thousand new genes have been isolatedand full-length of cDNA of the new genes cloned using humangenetic resources acquired, the total number obtained is more than2% of the total human genes.



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300 research academes and institutes are undertaking medicalBT 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


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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.


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The total output value of medical industry in 2007 reached667.9 billions RMB(about 126 billion Canadian dollars),with an increase of 20.6%. Thats about 5 times of whichin 1998.

The total export value of medical industry in 2007 reached24.6 billions RMB(about 4.6 billion Canadian dollars).Thats over 7 times of which in 1998.

The total import value of medical industry in 2007 reached14 billions RMB(about 2.6 billion Canadian dollars). Thatsover 9 times of which in 1998.

The total output value of medical industry during Jan. toNov. 2008 reached 748.7 billions RMB(about 141.3billion Canadian dollars), with an increase of 26.3%.



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There are 800 million people to be treated inhospital and 2.2 billion person-times needingclinic services each year.

The total expenditure of health care systemin 2010 will be 220 billion RMB more than in2007. It will lead to 18% annual medicalindustry increasing in China.



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China accounts for 20% of the worldspopulation but only 1.5% of the globaldrug market. China's changing health-care environment is designed to extend

basic health insurance to a larger portionof the population and give individualsgreater access to products and services.Following this period of change, the

pharmaceutical industry is expected tocontinue its expansion.



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The Chinese pharmaceutical market isprojected to increase by about 16-18%per annum for now and the foreseeablefuture.

As of 2008, China is the 8th largestpharmaceutical market in the world andwill be the 5th by 2010, the 2nd by 2020.



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There are 53 national High-Tech Parks inChina.

There are several innovation zone of

biotechnology and medicine such as ChinaInternational Innovation Zone ofBiotechnology and Medicine in Tianjin.

Entrepreneur Opportunities


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China International Innovation Zone

of

China International Innovation Zone

of BiotechnologyandMedicineBiotechnologyandMedicine

BioMed ZoneBioMed Zone


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Planned Functionsof BioMed

Zone

BioMed Zone is located in the Binhai New Area. Guided by the principles ofhigh standard, high start-up, catena, standardization and internationalization,it will lay its emphasis on research anddevelopment, industrial incubation aswell as manufacturing and trade and build an opening, sharing and jointplatform for biological technology and innovative medicines as well as anincubation platform to attract and accumulate senior research personnel,projects, R&D organizations and enterprises.

BioMed Zone is located in the Binhai New Area. Guided by the principles ofhigh standard, high start-up, catena, standardization and internationalization,it will lay its emphasis on research anddevelopment, industrial incubation aswell as manufacturing and trade and build an opening, sharing and jointplatform for biological technology and innovative medicines as well as anincubation platform to attract and accumulate senior research personnel,projects, R&D organizations and enterprises.


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Tianjin BinhaiNew Areaisa Third EconomicGrowthPolein

China

80

90

21

With a solid industrial basis and greatdevelopment potential, Tianjin Binhai NewArea is becoming a new economic growthpole with the function of stimulating

Chinas regional development in the 21century after Shenzhen Special Zone inGuangdong Province in 1980s andPudong New Area of Shanghai in 1990s,


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Three Zonesin BioMed Zone

3-5

Through accumulating both national and international innovative resources, BioMed Zone willdevelop a series of market competitiveness innovative medicines, bring in a number of biomedicalenterprises and thus making it as a pilot zone of Chinese biomedical enterprises as well as a symbolof the development of biological economy within 3 to 5 years.

3-5

Through accumulating both national and international innovative resources, BioMed Zone willdevelop a series of market competitiveness innovative medicines, bring in a number of biomedicalenterprises and thus making it as a pilot zone of Chinese biomedical enterprises as well as a symbolof the development of biological economy within 3 to 5 years.

BioMed Zone

The Research & Development Zone

The Incubation Zone

The Manufacturingand Trading Zone


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Environmentof BioMed Zone

A Complete System for Public Technological Platforms and IncubatorsA Complete System for Public Technological Platforms and Incubators

Complete Service System Complete Service System

5

100

Venture Capital System for Startups: In order to give support to the biomedical industry, BioMed Zonewill set up a Venture Capital Fund with more than RMB500 million to attract VC organizations andenterprises 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 sizedbiomedical companies.

Supported by relevant ministries and committees, BioMed Zone will make its efforts to carry on pilotbusiness of stock transfer for listed biomedical enterprises with joint stock system entering into theAgency Share Transfer System; support Assets and Equity Exchange market through carrying out pilotbusiness of stock circulation for listed biomedical enterprises.

5

100

Venture Capital System for Startups: In order to give support to the biomedical industry, BioMed Zonewill set up a Venture Capital Fund with more than RMB500 million to attract VC organizations andenterprises 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 sizedbiomedical companies.

Supported by relevant ministries and committees, BioMed Zone will make its efforts to carry on pilotbusiness of stock transfer for listed biomedical enterprises with joint stock system entering into theAgency Share Transfer System; support Assets and Equity Exchange market through carrying out pilotbusiness of stock circulation for listed biomedical enterprises.


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PreferentialPoliciesin BioMed Zone

1

All enterprises in the zone specializing in research, production and services willshare the preferential policies same as the Hi-tech enterprises

2

All enterprises in the zone will share the serial preferential policies in land, funds,loans and tariff.

3

All national and provincial as well as ministerial research institutes in BinhaiNew Area will enjoy certain amount of one-off capital subsidy

4

All internationally well-know biomedical enterprises and institutions will enjoy

certain amount of one-off capital subsidy.

The Innovation Environment ofBioMed ZoneThe Innovation Environment ofBioMed Zone PreferentialPolicies


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S&T Cooperation Between China and

Canada

S&T C i B Chi d C d


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S&T Cooperation Between China and Canada

Federal LevelThe Government ofP.R.China and theGovernment of Canada signed the

Agreement of S&T Cooperation in January2007 and set up a cooperation fund. Bothgovernments promised to allocate onemillion Canadian dollars to support joint

research projects.

S&T C i B Chi d C d


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Provincial levelThe Ministry of Science and Technology ofP.R.China andB.C. Innovation Council

signed

MOU of S&T Cooperation in March2006 and set up cooperation fund in 2007.Both promised to allocate two millionCanadian dollars to support joint research

projects.

Priorities of S&T Cooperation Between China and


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Canada

Federal

Areas of Cooperative Activities shall be jointly decodedon writing from time to time by the Parties.

The following priority areas have been identified below in2007; however, application forPartnership

Development Activities in other areas will also beconsidered:

--Agriculture Foods andBio-products

--Energy

--Environment

--Health & Life Sciences/Biotechnology

Information and Communication Technologies andNanotechnology are identified as enabling sectors tothe four selected areas.



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p

Canada

P

rovincial--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


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p

Canada

FederalFor Canada, funding and other serviceswill be provided through International

Science and

TechnologyP

artnershipsCanada Inc. (ISTPCanada), a non-governmental organization selected by theGovernment of Canada for this purpose,

and for China, through the Ministry ofScience and Technology (MOST).

Mechanism of S&T Cooperation Between China and


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p

Canada

ProvincialForBC, funding and other services will beprovided through BC Innovation Council,

and

for China, through the Ministry ofScience and Technology (MOST).

Forms of Cooperative Activities


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Forms ofCooperative Activities

a) joint research anddevelopment activities;

b) pooling of research anddevelopment;projects, already underway in each Party, intoJoint Research Activities;

c) facilitation of commercially viable researchanddevelopment;

d) organization of scientific seminars,conferences, symposia and workshops, as wellas participation of experts in those activities;

e) exchanges and loans of equipment andmaterials;

Forms ofCooperative Activities


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p

(continue)

f) exchanges of information on practices, laws,regulations and programs relevant to theCooperative Activities undertaken pursuant tothe Agreement;

g) funding of Cooperative Activities on the basisof equal contributions from each Party;

h) demonstrations of technologies andapplications development;

i) visits and exchanges of scientists, technicalexperts and academics;

j) any other mode of cooperation jointlydecided in writing by the Parties.

Eligibility for Funding


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Fe

deral

InCanada

Eligible applicants will be researchers and managersrepresenting Canadian companies, academic institutions,research hospitals, other institutes, or associations whichoperate and are headquartered in Canada. Subsidiariesof firms headquartered and owned outside Canada arenormally not eligible for support. However, recognizingthat the overriding consideration is "benefit to Canada",an exception can occur if ISTPCanada is satisfied thatclear economic benefit will accrue to Canada becausethe product or the technology will be substantiallyproduced in, exported from or utilized in Canada.



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Federal(continue)InCanada

Agencies of the Crown (including Crown corporations,government institutes, government laboratories, etc.)

may be participants of ISTPCanada-funded Activities butare not eligible as recipients of ISTPCanada funding.



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Federal(continue)InChina

Companies, organizations and associations incorporatedunderPeoples Republic of China national law.



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ProvincialISCD funds may be provided to British

Columbia-based non-profit organizationssuch as post-secondary and government

research institutions, industry associations,regional development organizations etc.Private companies may not receive fundsdirectly, however, they are encouraged to

be partners in the project and may performwork for the project based on agreedintellectual property arrangements.

Projects Approved in 2007


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FederalISTPCanada and the Chinese Ministry ofScience and Technology have agreed tofund eight initial joint research projects andtwo projects are related with health. Thetotal value of these projects is $10.574million.



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Fed

eral(continue)1. Project: Use of seal oil and seal products in thediet of hospital patients Partners

Participants: North Atlantic Biopharma Inc.; theG

overnment of Newfoundlan

dand

Labrador; an

dSun Yat-sen University, Guangzhou

2. Project: Application of high-yield pulps in theproduction of high-quality coated paper formulticolour offset anddigital printing Partners

Participants: University of New Brunswick; FPInnovations-Paprican Division, Pointe Claire;Tembec Inc., Montreal; University of Toronto;Tianjin University of Science and Technology,

Tian in



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Federal(continue)

3. Project: Selective Asphaltene ExtractionPartners

Participants: Well Resources; MEG EnergyCorp.; Sunshine Oilsands Ltd.; Alberta Energy

Research Institute; State Key Laboratory ofHeavy Oil Processing; China University ofPetroleum, Beijing

4. Project: Development of microfluidic chip-basedelectrophoresis platform and approaches forrapid and high-resolution disease diagnosisPartners

Participants: University ofWaterloo; ConvergentBioscience Ltd., Toronto; Nanjing University,

Nan in



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Fe

deral(continue)

5. Project: Enhancement of potato trade by adaptingCanada seed potato technology to meet Chinarequirements for increased productionPartners

Participants: New Brunswick Department of Agricultureand 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 forWireless Communication, Shanghai



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Fe

deral(continue)

7. Project: Research on constructing the breedingsystem for the Chinese dairy industry applyingadvanced breeding technology Partners

Participants: Alta Genetics Inc., Balzac, Alberta;China Agriculture University, Beijing

8. Project: Research on the linear generator systemfor oceanic tidal and wave energyPartners

Participants: DynaGen Technologies Inc., Halifax;Dalhousie University, Halifax; China University ofMining & Technology, Xuzhou



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Provincial

The British Columbia Innovation Council and thePeoples Republic of Chinas Ministry of Scienceand Technology has announced recipients of theInnovation and Commercialization StrategicDevelopment Program. The Program provides atotal of $4 million in joint funding to support 13collaborative projects in order to supportexcellence in research, technology development

and commercialization projects of interest toboth jurisdictions. UBC involves 8 projects andtwo projects are related with health.



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Provincial(continue)

1. Project: Cathepsinsandlung fibrosis

BCPartner: Dr. DieterBromme

The University ofBritish Columbia

ChinaPartner: Dr. Jifeng Wang

Beijing University of Chinese Medicine

2. Project: High-speed transistor microring lasers

BCPartner: Dr. Lukas ChrostowskiThe University ofBritish Columbia

ChinaPartner:Dr. Zigang Duan

Shenzhen University



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3. Project:Development anddemonstration of advancedpolarimetric SAR technology for forestry

BCPartner:Dr.DavidGoodenough

Canadian Forest Service

ChinaPartner: Dr. Wen Hong

Chinese Academyof Sciences

4. Project:Raman scattering in a clinical instrument for thediagnosis of cancer by metabolomic imaging

BCPartner:Dr. EdwardGrant

The Universityof BritishColumbia

ChinaPartner:Mr. Xuegang Shao

Nankai University



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5. Project:Reliable and trusted networking fordata-centricwireless access with applications to vehicular telematics

BCPartner:Dr. VictorLeung


ChinaPartner: Dr. Yanheng LiuJilin University

6. Project:Development of integrated remediation technologiesfor petroleum contaminated soils and sludge through bio-augmentation and biosurfactant

BCPartner:Dr. Jianbing Li

Universityof Northern BritishColumbia

ChinaPartner:Dr. Yuefei Huang

Tsinghua University



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7. Project:Innovation in organic greenhouse production inChina

BCPartner:Mr. BlairMcHenry

Canadian OrganicGreenhouse Association

ChinaPartner: Mr. An Li Hong

Tianjin Academyof Agricultural Sciences

8. Project:Ultrasound3D imaging combined with MEMS-basedoptical coherence tomography

BCPartner:Dr. Robert Rohling


ChinaPartner:Dr.Dai Enguang

Peking University



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9. Project:Development of low cost perfluorosulfonic (PFSA) ionomermembranes

BCPartner:Dr. Ken Shi

Dr. Steven Holdcroft

National ResearchCouncilCanada & Simon FraserUniversity

ChinaPartner: Dr. Yongming Zhang

ShanghaiJiao Tong University

10. Project:Development of ocean assimilation techniques for Argo andother oceanic observations

BCPartner:Dr. Robert RohlingThe Universityof BritishColumbia

ChinaPartner:Dr.Dai Enguang

Peking University



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10. Project: Development of ocean assimilationtechniques for Argo and other oceanic observations

BCPartner:Dr. Youmin Tang

Universityof Northern BritishColumbia

ChinaPartner: Dr.Guihua Wang

Second Instituteof Oceanography

11. Project:Contamination effects anddurability

studies of

PEM fuel cellsBCPartner:Dr. Haijiang Wang

National ResearchCouncilCanada

ChinaPartner:Dr.Jianxin Ma

Shan hai Ton i Universit



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12. Project:Application of FORECAST software to assess sustainableproductivity and carbon equestration in major Chinese forests

BCPartner:Dr. Adam Wei

Dr. Hamish Kimmins


ChinaPartner: Dr.Jiang Hong

Zhejiang Forestry University

13. Project:Development of the Chinese National Sustainable ForestManagement Systems and the National Forest Certification Standard

BCPartner:Dr. Yongyuan Yin

EnvironmentCanada

ChinaPartner:Mr.Jiafu Lei

State Forest Administration



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The National Nature Science Fun

dofChina(NSFC) signed MOU with the

Canadian Institute of HealthResearch(CIHR) in 2005. Both

organizations agreed to support the co-research projects conducted byUniversities, research hospitals and

institutes.



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p

Key areas supporte

dby NSFC-CIHRprogram:

1Neurosciencesto provide support for basicresearch in neuroscience, mental health, addiction and

the senses 2Diabetes and Obesityto provide support for

research on the measures, causes, prevention,treatment and consequences ofdiabetes and obesity

3Cardiovascular Systemto provide support for basicand translational research on the pathogenesis,treatment and ultimate of cardiovasculardiseases,including myocardial infarction, stroke, cardiomyopathyand atherosclerosis



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p

Key areas supporte

dby NSFC-CIHRprogram(continue):

4Geneticsto provide support for research on thehuman and other genomes and on all aspects of genetic,

basic biochemistry and

cell biology related

to health and

disease

5Infection and immunityto provide support for basicresearch on viral and bacterial diseases anddevelopment of vaccines

6Child and youth healthto provide support forresearch on fertility, pregnancy, maternal health, healthychilddevelopment and the etiology, prevention, andtreatment ofdiseases in infants, children, and youth



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p

Key areas supporte

dby NSFC-CIHRprogram(continue):

7AgingGerontology andGeriatrics: to encourageresearch on aging processes, on functional limitations in

older a

dults as a consequence of

disease, an

dondeterminants of healthy aging within the context of one

or more of the following priority areas: healthy andsuccessful aging, biological mechanisms of aging,cognitive impairment in aging, aging and maintenance of

functional autonomy, and health services relating toolder people.



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p

Both organizations have approve

dto fun

d

53 research projects during 2006-2008.Each project can get 50,000 Canadiandollars in Canada and 150,000 RMB in

China each year within three years afterapproved.


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Potential Cooperation Ways in the field of

Biotechnology and Life Science

Potential Cooperation Ways in the field of



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R&D CooperationClinical Trial in China

Manufacturing in China

R&D Cooperation


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R&D Cooperation

Government Program

Federal Program

Provincial Program

NSFC-CIHR Program

P

rivateP

rogramIn recent years, more and more western pharmaceuticalcorporations have come to China and set up R&Dcenters. For instance, Roche of Switzerland opened itsR&D center in Shanghai recently, GSK has established

its OTC research anddevelopment center in Tianjin.AstraZeneca, Bayer, Eli Lili, andHoffman-La Roche,have also set up R&D or clinical trial centers in China.

Clinical Trial in China


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Difficultiesin NewDrugDevelopment EspeciallyinClinical

Trialin West

OverviewofClinical TrialinChinaOpportunitiesinChina

ChallengesinChina

StrategiesinChina



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Difficultiesin NewDrugDevelopment Especiallyin

Clinical Trialin West

Delay of Time

-Difficulty in patient recruitment

86 % of all US clinical studies fail to recruit the requirednumber of patients on time and as a result are delayedon average 366 days. Canada has the same problem.



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Difficultiesin NewDrugDevelopment Especiallyin

Clinical Trialin West

Higher Cost

Direct cost:

Caused by the delay of the study.

When failing to meet recruitment timelines, the cost ofdrug development rises. Daily out-of-pockets alone areestimated at US$37,000.

Indirect cost:

Caused by the delay of product launching, which is huge!

Forabillion-dollardrug, 83M/Month, 2.8M/day



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OverviewofClinical TrialinChinaUp to June 2008, there are 428 clinical

trials which are on going in China and 870drugs have finished the clinical trials.China will be one of clinical trial centres inthe world in future.

Contract Research Organization(CRO)

In 2008The market value of CRO reached260 million USD in China. Some experts expectthat It will reach 430 million USD by 2010.



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OpportunitiesinChinaLarge patient pool, especially for treatment

native patients

--Solution of patient recruitment

Many GCPs

Lower cost

Inclusion of Asian Data

Governments efforts on improving regulationsand IP



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OpportunitiesinChinaLarge patient pool, especially for treatment nativepatients

Population of 1.3Billion

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



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OpportunitiesinChina--Largepatientpool

Prevalence of Cancers

Disease Incidence(per100,000) Number

Lung Cancer 67.5 877,500Stomach Cancer M: 39.2 F: 19.1 378,000

Liver Cancer M: 35 F: 9.7 290,550

Colorectal Cancer M: 22 F: 12 221,000

Breast Cancer F: 13.3 172,000

Cervix Cancer F: 12.3 159,900



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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 largestpercentage.

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



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Prevalence of Cardiovascular and Respiratory Diseases

Disease Incidence(per100,000) Number

Hyperlipidemia 4.7% 61.1 MCoronary 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



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OpportunitiesinChina-- Largepatientpool

Prevalence of CNS andPsychiatric Diseases

Disease Incidence Number

Stroke 202 per 100,000 2.6 MDepression 5.8% 75.5 M

Alzheimers

Disease 1.35% 17.5 M

Schizophrenia 0.66% 8.5M



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OpportunitiesinChina-- Largepatientpool

Prevalence ofGI and Other Diseases

Disease Incidence Number

Hepatitis B 66.1 per 100,000 859,300Gastric Ulcer 4% 52 M

Chronic Gastritis

& Enteritis 12.1% 157 M

Rheumatoid

Arthritis 9.6% 5M

Diebetes 3.9% 50M

HIV 1M



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OpportunitiesinChina--ManyGCPs

To ensure scientifically accurate reflection and reliabilityof results as well as test subjects' rights and interests

during clinical trials, China promulgated the GoodClinical Practice (GCP) for pharmaceutical products in1999, and began the work ofGCP certification on March1, 2004.

By the end of 2007, a total of 178 institutions conductingclinical trials had obtainedGCP certification, andGCPcertification has greatly improved the quality ofdrugclinical trials in China.



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OpportunitiesinChina--Lowercost

Pre-Clinical(estimates)

Chemestry30 to 60% of the cost of theWest

OtherPre-clinicalToxicology30% of the cost of theWest

Animal testing30% of the cost of the West

Clinical(estimates)

Phase I25% of the cost of the West

Phase II/III30% of the cost of the West



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OpportunitiesinChina --Lowercost

Item US Cost ChinaCost

1 day stay in Hospital $750 to $1000 $40 to $100

1 day stay in ICU $1500 to $2000 $80 to $150CT 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 therapywith ablation

$50 to $100

CT DirectedBiopsy $325 to $450 $100 to $200

Senior Oncologist

Annual Salary

$225,000+ $40,000+for key

opinion leaders



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OpportunitiesinChina--Lowercost

Dont forget the huge saving due to rapidrecruitment and earlier launch of theproduct.



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OpportunitiesinChina--Inclusionof AsianData

Data for some therapeutic areasare accepted by US FDA such ashepatitis, oncology, etc.



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OpportunitiesinChina--Governmentsefforts

More transparent regulations

Trying to improve regulatory processIP



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ChallengesinChina

Slow regulatory process

Problems in conducting clinical trialsBlood/tissue sample export



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ChallengesinChina--Slowregulatoryprocess

Typeof Application Track Time

(Workingdays)

Application for CTA*

of imported product Regular 160-200

Application for CTAof global trial Fast 140-165

*CTA: clinical trial approval



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ChallengesinChina--- Problemsinclinicaltrials

Management

Time/resource allocationLack of study coordinator

Confidentiality

Facility

Communication

Storage ofdrug, files



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ChallengesinChina

--- Problemsinclinicaltrials

Compliance to protocol and ICH/GCP

Clinical studies should be carried out according to

International Conference on Harmonization (ICH) /W

HOGood Clinical Practice standards. This provides a unifiedstandard for the European Union (EU), Japan, and theUnited States, as well as those of Australia, Canada, theNordic countries and theWorld Health Organization

(WHO). Thus, any country that adopts this guidelinetechnically follows this same standard.

Quality ofdata

ICF(Informed Consent Forms)



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ChallengesinChina--- Problemsinclinicaltrials

Safety reporting

Some AEs are neglectedSafety reporting to EC is not sufficient

Clinical Trail in China


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ChallengesinChina--- Samplesexport

Lack of qualified central lab

Samples export is difficult and complicatedWhole BloodorTissue Samples

Permission Required from China Human Genome

Resource Ad

ministrative Office & MOHPlasmaorSerum Samples

Special Permit From MOH (PerBatched shipment)

Clinical Trail in China


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Strategies

---Costsavingonearlystagestudy

General Rules for New Drugs

International companies can not conduct trials in

China unless they have already entered into Phase IItrials in another major market.

Strategies:

Include China in the phase II study to save time and moneyFind ways for early stage studies(Phase I-II/prove of concept)

Out-license

JV

Branch manufacturer in



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As of 2007, there were alread

y1,800 foreign-funded pharmaceuticalenterprises in China. Currently, all the

top 20 pharmaceutical companies inthe world have set up joint venturesor wholly owned facilities in China.



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Pfizer produces and markets more than 40 innovative

drugs in China. Pfizer has GMP manufacturing facilitiesin Dalian, Suzhou andWuxi. Pfizer has invested morethan $500 million in China.

Merck set up its first joint venture in China in 1994.

Novartis has invested about 100 million in China, withfour manufacturing facilities in Beijing and Shanghai. Itscore businesses involve patenteddrugs, generic drugs,eye protection drugs and health products.

AstraZeneca

Pharmaceutical Co. has its hea

dquarters inShanghai, with 25 branch offices in major cities across

Chinas mainland. In 2001, the company established itslargest manufacturing site in Asia with a total investmentof $170 million in Wuxi.


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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


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Biotech Life Science in China and S T Cooperation Between China and Canada

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Transcript of Biotech Life Science in China and S T Cooperation Between China and Canada