biotechnology and life science in china and s t cooperation between china and canada n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Biotechnology and Life Science in China and S&T Cooperation Between China and Canada PowerPoint Presentation
Download Presentation
Biotechnology and Life Science in China and S&T Cooperation Between China and Canada

Loading in 2 Seconds...

play fullscreen
1 / 127

Biotechnology and Life Science in China and S&T Cooperation Between China and Canada - PowerPoint PPT Presentation


  • 180 Views
  • Uploaded on

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.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Biotechnology and Life Science in China and S&T Cooperation Between China and Canada' - sabin


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
biotechnology and life science in china and s t cooperation between china and canada

Biotechnology and Life Science in Chinaand 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 canada1

Biotechnology and Life Science in Chinaand 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

content
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 china1
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 china2
Mission of Biotech and Life Science in China
  • Biotech: an essential support in ensuring the safety of the country

Bio-terror

B T

Severe infectious diseases

Bio-safety of the country

Public safety

Foreign invading organism

B T

Gene resources loss and

gene patents contest

mission of biotech and life science in china3
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 china4
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 china5
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 Five-

Year Plan for National Economic and Social

Development, P. R. China”

mission of biotech and life science in china6
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.

.

slide13

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

slide14

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.

slide15

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.
slide16

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.
slide17

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
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.
progresses in biopharma1

Hepatitis B

Hepatitis A

Flu

hives

Progresses in Biopharma
  • 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.

China

Globe

progresses in biopharma2
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

slide21

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.

slide22

P53 injection

Type Ⅱdiabetes therapy drug ---Tailuo

Progresses in Biopharma

  • 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 - recombinanthuman

p53 glandulose virus injection

was successful manufactured

Type Ⅱdiabetes therapy drug

Tailuo was successful

manufactured.

slide23

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

slide24

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.

slide25

Progresses in Biopharma

  • New anti-tumor drug: Recombinant humanized Monoclonal

antibodies h-R3

The national class 1 new drug, Taixinsheng-Nituozhu monoclonal antibodiesdeveloped 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

slide26

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.

slide27

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.

slide28

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

slide29

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 of biotech life science in china
Vision of Biotech & Life Science in China

Objectives and targets

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.

Achieve the leap- forward 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,

priorities and key technology of biotech life science in china
Priorities and key technologyof 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 china1
Priorities and key technologyof 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 china2
Priorities and key technologyof 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 china3
Priorities and key technologyof 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 china4
Priorities and key technologyof 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 communicationplatform for BT, significantly enhance the comprehensive ability of utilizing international science and technology resources .

strategies and approaches of biotech and 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 development1
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 development2
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 development3
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 development4
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 development5
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 development6
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 china1
Opportunities of Biotech & Life Science in China
  • Bio-resources Opportunities
  • R&D and Trial Opportunities
  • Market Opportunities
  • Entrepreneur Opportunities
bio resources 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 opportunities1
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 opportunities2
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

Eucommia

Rhoipteleaceae

Bretschneideraceae

bio resources opportunities3
Bio-resources Opportunities
  • Animalresources

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 opportunities4
Bio-resources Opportunities
  • Microbe resources

General situation of microorganism reservation in China

Total 113604

Data source: Report and World Data Centre for Microorganisms (WDCM)

bio resources opportunities5
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
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 opportunities1
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
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 opportunities1
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 opportunities2
Market Opportunities

China accounts for 20% of the world’s population but only 1.5% of the global drug market. China's changing health-care 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 opportunities3
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
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.
slide60

China International Innovation Zone of

Biotechnology and Medicine

BioMed Zone

slide61

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.

slide62

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,

slide63

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

国家生物医药国际创新园BioMed Zone

企业孵化区

The Incubation 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.

slide64

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.

slide65

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 canada1
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 canada2
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
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 canada1
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
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 non-governmental 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 canada1
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
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
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
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 funding1
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 funding2
Eligibility for Funding
  • Federal(continue)

In China

Companies, organizations and associations incorporated under People’s Republic of China national law.

eligibility for funding3
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
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 20071
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 20072
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 20073
Projects Approved in 2007
  • Federal(continue)

5.Project: Enhancement of potato trade by adapting Canadaseed potato technology to meet Chinarequirements 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 20074
Projects Approved in 2007
  • Federal(continue)

7. Project: Research on constructing the breeding system for the Chinese dairy industry applying advanced breeding technologyPartners

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 20075
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 20076
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 20077
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 20078
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 bio-augmentation and biosurfactant

BC Partner:Dr.Jianbing Li

University of Northern British Columbia

China Partner:Dr. Yuefei Huang

Tsinghua University

projects approved in 20079
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 200710
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 200711
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 200712
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 canada3
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 co-research projects conducted by Universities, research hospitals and institutes.
s t cooperation between china and canada4
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 canada5
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 canada6
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 canada7
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 science1
Potential Cooperation Ways in the field of Biotechnology and Life Science
  • R&D Cooperation
  • Clinical Trial in China
  • Manufacturing in China
r d cooperation
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
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 china1
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 china2
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 china3
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 china4
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 china5
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 china6
Clinical Trial in China

Opportunities in China

--Large patient pool

Prevalence of Cancers

Disease Incidence(per 100,000) Number

Lung Cancer 67.5 877,500

Stomach 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

clinical trial in china7
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 china8
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 china9
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 china10
Clinical Trial in China

Opportunities in China

-- Large patient pool

Prevalence of GI and Other Diseases

Disease Incidence Number

Hepatitis B 66.1 per 100,000 859,300

Gastric Ulcer 4% 52 M

Chronic Gastritis

& Enteritis 12.1% 157 M

Rheumatoid

Arthritis 9.6% 125M

Diebetes 3.9% 50M

HIV 1M

clinical trial in china11
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 china12
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 china13
Clinical Trial in China

Opportunities in China

--Lower cost

clinical trial in china14
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 china15
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 china16
Clinical Trial in China

Opportunities in China

--Government’s efforts

  • More transparent regulations
  • Trying to improve regulatory process
  • IP
clinical trial in china17
Clinical Trial in China

Challenges in China

  • Slow regulatory process
  • Problems in conducting clinicaltrials
  • Blood/tissue sample export
clinical trial in china18
Clinical Trial in China

Challenges in China

--Slow regulatory process

Type of Application Track Time

(Working days)

Application for CTA*

of imported product Regular 160-200

Application for CTA

of global trial Fast 140-165

*CTA: clinical trial approval

clinical trial in china19
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 china20
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 china21
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
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 china1
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
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 china1
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

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