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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 `hina
Mission of Biotech and Life Science in
`hina

V 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
`hina

VBiotech: an essential support in ensuring the safety of the


country

Bio-terror |

Severe infectious diseases


Bio-safety of
Public safety
the country
Foreign invading organism
Gene resources loss and |
gene patents contest
Mission of Biotech and Life Science in
`hina

ÿBiotechnology 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.´
²²Speech delivered by President Hu
Jintao at the National Congress of
Science and Technology, 2006
Mission of Biotech and Life Science in
`hina
ÿ¢e 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. ¢e
should improve our capability of
innovation and development levels in the
related industries and secure the health
of our people.´

²²Speech delivered by Premier ¢en Jiabao at


the National Congress of Science and
Technology, 2006
Mission of Biotech and Life Science in
`hina

ÿIn 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.´
²²Extracted from ³Guidelines of the 11th Five-
Year Plan for National Economic and Social
Development, P. R. China´
Mission of Biotech and Life Science in
`hina

VNation¶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 , constitutedå 11th Five-Year Plan for BT of China ,
relative work started up in Jun 2005.
Status of Biotech and Life Science
in `hina
Status of advanced Biotech and Life
Science in `hina

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 `hina
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 `hina
VThe 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 `hina
V 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 `hina

V 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 ³Chinese Novel Human
Abnormal Chromosomal Karyotype Database´,
³Database 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.
=  

V 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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V Genetically engineered drugs and vaccine


More than 20 genetic engineered drugs and vaccines such as
recombinant person interferonĮ-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.

20
Growth rate

10

`  
=  

V 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) ¢uhan Institute of Biologic Product Immunity
inhibition
Antihuman interleukin-8 Dongguan Hongyuan Yishi BT Psoriasis
monoclonal antibody cream Pharmaceutical Company therapy
Iodine [131I] Tumor Necrosis Shanghai Huachen Cancer Therapy Solid tumor
Therapy Monoclonal Antibody Pharmaceutical Company, Ltd. therapy
Injection
=  

V 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 ¹ ¹I to liver cancer, and utilizes radial ȕ emitted from ¹ ¹I 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.


 = =  



È




V Gene therapy drugs

 

China

is one of the countries which initiated earlier

 basic

research and clinical trials of gene therapy.
In 2004, the first gene therapy
 


product - recombinant human
  p53 glandulose virus injection

 was successful manufactured
 Type Èdiabetes therapy drug

 Tailuo was successful

manufactured.





=  

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

V 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.
=  

V 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
=  

V 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.
=  

V 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.
=  

V Encouraging progresses in tissue engineering product

Several relatively
Several tissue A considerable
mature products and
engineering R&D young researcher
technology, some of
bases and teams for tissue
them reach or near to
laboratories engineering
clinic trial phase
=  

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
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Objectives and targets

Achieve the leap- Accelerate the Significantly enhance the


forward development industrialization of economic development,
to improve people¶s
of BT, to promote the scientific and
health, to improve the
new revolution in technological ecological environment
science and achievements and, substantially, to
technology, to take to develop new BI, to substantially strengthen
the lead in the world make BI as one of the ability of ensuring the
in BT, to bring China the pillar industries in national security.
into a powerful the national economy,
country in BT
=    
 




V 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.
=    
 




V 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.
=    
 




V 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.
=    
 




V 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.
=    
 




V 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 .
     


  
     

  
  

V 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.
     

  
  

V 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.
     

  
  

V 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.
     

  
  

V 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.
     

  
  

V 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.
     

  
  

V 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.
     

  
  

V 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.
ortunities of Biotech & Life Science in
`hina
ortunities of Biotech & Life
Science in `hina

V|  
   
V     
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Bio-resources ortunities

V 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 : -155Ƿ8844m
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 ortunities

V 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 ortunities

V 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.

 |
    
 
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Bio-resources ortunities

V Animal resources
China has abundant animal resources
ð 180000 species of invertebrate
ð 2500 species of fish
ð 550 species of amphibians and reptiles
ð 1320 species of birds
ð About 600 species of mammalia
¢ithout effective protection, animal resources are
extinguishing quickly.
Bio-resources ortunities

V 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 LN¢S¢ 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
BRCCßTaiwan 10398 HKUCC 5050
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Total 113604
Bio-resources ortunities

V 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.
ï&D and rial ortunities

V300 research academes and institutes are undertaking medical


BT R&D
V300 companies are undertaking medical BT R&D
VMore than 20 key labs are undertaking life sciences and medical
BT R&D
V3 research centres for genetic engineering
VLarge 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
ï&D and rial ortunities

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Market ortunities

VThe 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.
VThe 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.
VThe 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 ortunities

VThere are 800 million people to be treated in


hospital and 2.2 billion person-times needing
clinic services each year.
VThe 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 ortunities



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VThere are 53 national High-Tech Parks in


China.
VThere are several innovation zone of
biotechnology and medicine such as China
International Innovation Zone of
Biotechnology and Medicine in Tianjin.
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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.
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www.istcanada.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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