biotechnology and life science in china and s&t cooperation between china and canada march 25,...

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 ChinaS&T Cooperation Between China and CanadaPotential Cooperation Ways in the field of Biotechnology and Life Science

Biotechnology and Life Science in Chinaand S&T Cooperation Between China

and Canada

Biotechnology and Life Science in China

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

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


Biotech: an essential support in ensuring the safety of the country

Bio-terror

Severe infectious diseases

Public safetyBio-safety of the country

Foreign invading organism

Gene resources loss and gene patents contest

B T


B T

“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


“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


“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”


Nation’s focus: the development of Biotech National Development and Reform Commission together with

other 18 commissions and ministries such as the Ministry of Finance, Science and Technology, Education, Health and so on , constituted 《 11th Five-Year Plan for BT of China 》 , relative work started up in Jun 2005..


Status of Biotech and Life Science in China

China, as the only member from the developing countries in the

International Human Genome Project, has completed sequencing 1% of human genome

Chinese scientists undertook and completed 10% of the International HapMap Project

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

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

Status of advanced Biotech and Life Science in China

Human genome project (HGP) formally started up in 1990. Chinese scientists together with scientists from USA, UK, France, German, Japan participated in this human genome project which was worth 3 billions US dollars. The work undertaken by Chinese scientists focused on the short arm of human beings number 3 chromosome. Through the efforts of Chinese scientists, Chinese part in HGP has been finished two years ahead of schedule.


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.


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.


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.


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

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.

5%

10%

15%

20%

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rate

China Globe

Hepatitis B

Hepatitis A

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…


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 Manufacturer PurposeMonoclonal 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 tumortherapy

Antibody drugs made in China


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.


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 diabetes therapy drug Ⅱ Tailuo was successful manufactured.


P53 injectionType diabetes therapy drug Ⅱ---Tailuo

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


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.


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


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.


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.


Encouraging progresses in tissue engineering product

A considerable young researcher teams for tissue engineering

Several tissue engineering R&D bases and laboratories

Several relatively mature products and technology, some of them reach or near to 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


Vision and priorities of Biotech & Life Science in China

Vision of Biotech & Life Science in China

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

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.

Objectives and targets

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,

Implement life science and technology research actions, promote new scientific revolution

Accelerate innovation in the frontier of life sciences, make comprehensive breakthrough in genomics, proteomics, stem cell technologies, systems biology, brain and cognitive sciences, gene therapy etc., lay a firm scientific foundation for prolonging human life and enhancing our understanding, reconstruction and utilization level of life principles and promoting new science and technology innovation.

Priorities and key technology of Biotech & Life Science in China

Implement biomedical science and technology actions, promote the fourth medical revolution

Accelerate biomedical science and technology innovation, enhance health level of Chinese people; promote the fourth medical revolution represented by gene therapy and regenerative medicine, drive and form a100 billion yuan RMB biomedical industry; Biological products such as vaccine will continue to play the most important role in the prevention and elimination of major infectious diseases, endeavor to increase remarkably the proportion of biological medicine in drugs and gradually form a new drug market shared by chemical drugs, biological drugs, natural medicine, just like the three legs of a tripod; bring our biomedical industry into the advanced rank in the world.


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.


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.


Implement biotech international cooperation actions, make China among the biotech advanced countries

Accelerate introduction and utilization of human talents, capital, technology, product, induct and promote international cooperation, promote a passel of major international cooperation projects, establish joint research institution, construct international communication platform for BT, significantly enhance the comprehensive ability of utilizing international science and technology resources .


Strategies and approaches of Biotech & Life Science development

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.

Establish favorable policy

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.


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.


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.


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.


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.


Improving organizational structure and leadership

At the disposal of the national leading group of Biotech R&D and industrialization, take full advantage of the functions of various departments like Science and Technology, Development and Reform, Finance, Education, Agriculture, Quality Control, Environment Protection, Forestry, and Military in stimulating Biotech and industry development. All of resources should be redistributed more scientifically, more reasonably, and more efficiently, which will mobilize all powers to boost Biotech and its development towards industrialization.


Opportunities of Biotech & Life Science in China

Opportunities of Biotech & Life Science in China

Bio-resources OpportunitiesR&D and Trial OpportunitiesMarket OpportunitiesEntrepreneur 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 kmShorelines length :18000 kmInland altitude : -155 ～ 8844mChina 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.

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


Unique plant resources China has 243 genera and around 527 species of unique

seed plants Among 666 species of artificial cultivation crops of important

economic value, at least 136 species originates from China.

Ginkgo Branch Rhoipteleaceae Eucommia Bretschneideraceae


Animal resources China has abundant animal resources

180000 species of invertebrate 2500 species of fish 550 species of amphibians and reptiles 1320 species of birds About 600 species of mammalia

Without effective protection, animal resources are extinguishing quickly.


Bacterium reservation organization Quantity Bacterium reservation organization Quantity

CGMCC 15929 Sichuan antibiotic institute 13956

ACCC 4254 IANP 14500

CICC 1705 LNWSW 1255

CMCC 4500 GIMCC 2446

CVCC 4530 CCDM 5000

CFCC 1429 MDKIof ccdc 460

CDCC 5980 IAM of HAS 1011

AS-IV 915 IME of BMI 2798

CTCC 4267 Fujian Microbiology Institute 3000

Yunnan Microbiology Institute 9021 SAGC 1200

BRCC （ Taiwan ） 10398 HKUCC 5050

General situation of microorganism reservation in China

Microbe resources

Data source: Report and World Data Centre for Microorganisms (WDCM)Total 113604


Human genetic resources Through exploitation and utilization of human genetic resources,

research on the functional genes related to the major human diseases and single gene inherited disease gene has been performed and remarkable achievements have been obtained.

Human genetic resources collection and administration network has been established in China, which can provide essential resources and materials for the R &D of the functional genome associated with human health.

In China, more than one thousand new genes have been isolated and full-length of cDNA of the new genes cloned using human genetic resources acquired, the total number obtained is more than 2% of the total human genes.


R&D and Trial Opportunities

300 research academes and institutes are undertaking medical BT R&D

300 companies are undertaking medical BT R&DMore than 20 key labs are undertaking life sciences and medical

BT R&D3 research centres for genetic engineering Large Sciences Education Pool Est. Undergrad/Grad Students Enrolled: Chemistry: 100,000/20,000 Medical Sciences: 120,000/15,000 Biological Sciences: 60,000/15,000

R&D and Trial Opportunities

There are 183 animal trial labs in China. Some of them are national level.

There are 19,900 hospitals in China by the end of 2007.

The total output value of medical industry in 2007 reached 667.9 billions RMB(about 126 billion Canadian dollars), with an increase of 20.6%. That’s about 5 times of which in 1998.

The total export value of medical industry in 2007 reached 24.6 billions RMB(about 4.6 billion Canadian dollars). That’s over 7 times of which in 1998.

The total import value of medical industry in 2007 reached 14 billions RMB(about 2.6 billion Canadian dollars). That’s over 9 times of which in 1998.The total output value of medical industry during Jan. to

Nov. 2008 reached 748.7 billions RMB(about 141.3 billion Canadian dollars), with an increase of 26.3%.

Market Opportunities

There are 800 million people to be treated in hospital and 2.2 billion person-times needing clinic services each year.

The total expenditure of health care system in 2010 will be 220 billion RMB more than in 2007. It will lead to 18% annual medical industry increasing in China.


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.


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.


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.

Entrepreneur Opportunities

China International Innovation Zone of China International Innovation Zone of Biotechnology and Medicin

e Biotechnology and Medicine

BioMed ZoneBioMed Zone

国家生物医药国际创新园定位 Planned Functions of BioMed Zone

国家生物医药国际创新园坐落在滨海新区，以高标准、高起点、系列化、标准化和和国际化为准则，研究开发、企业孵化、生产制造、贸易流通统筹并举，构建开放、共享、联合的生物技术与创新药物技术平台和孵化平台，吸引聚集高水平的人才、项目、研发机构和企业。

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

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

天津滨海新区成为第三增长极 Tianjin Binhai New Area is a Third Economic Growth Pole in China

天津滨海新区产业基础雄厚，增长潜力巨大，成为继上个世纪 80 年代的广东深圳特区、 90 年代上海浦东新区之后， 21 世纪带动区域发展的新的经济增长极。With a solid industrial basis and great development potential, Tianjin Binhai New Area is becoming a new economic growth pole with the function of stimulating China’s regional development in the 21 century after Shenzhen Special Zone in Guangdong Province in 1980s and Pudong New Area of Shanghai in 1990s,

国家生物医药国际创新园一园三区 Three Zones in BioMed Zone

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.

通过 3-5 年，国际创新园聚集国内外创新资源，开发一批具有市场竞争力的创新药物，聚集一批生物医药企业，成为中国生物医药企业的领航区、生物经济发展的标志区。Through accumulating both national and international innovative resources, BioMed Zone will develop a series of market competitiveness innovative medicines, bring in a number of biomedical enterprises and thus making it as a pilot zone of Chinese biomedical enterprises as well as a symbol of the development of biological economy within 3 to 5 years.

国家生物医药国际创新园

BioMed Zone

研究开发区 The Research & Development Zone

企业孵化区The Incubation Zone

生产贸易区The Manufacturing and Trading Zone

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.

创业风险投资体系：建立规模不少于 5 亿元的创业投资引导基金，吸引国内外生物医药风险投资机构和企业，最终形成 100 亿元规模的风险投资资金，扶持生物医药产业发展。争取国家支持，对投资于中小生物医药企业创业孵化的风险投资企业，实行一定的税收优惠政策。Venture Capital System for Startups: In order to give support to the biomedical industry, BioMed Zone will set up a Venture Capital Fund with more than RMB 500 million to attract VC organizations and enterprises both at home and abroad in the field which finally develop into a fund with RMB 10 billion; give some preferential tax policies to VC enterprises investing in incubation of small and medium sized biomedical companies.

在国家部委的支持下，力争在国际创新园开展为上市股份制生物医药企业进入证券公司代办股份转让系统进行股份转让试点，支持技术与产权交易市场开展为上市生物医药企业股权流通试点。Supported by relevant ministries and committees, BioMed Zone will make its efforts to carry on pilot business of stock transfer for listed biomedical enterprises with joint stock system entering into the Agency Share Transfer System; support Assets and Equity Exchange market through carrying out pilot business of stock circulation for listed biomedical enterprises.

国家生物医药国际创新园的优惠政策 Preferential Policies in BioMed Zone

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.

国际创新园的创新创业环境：The Innovation Environment of BioMed Zone The Innovation Environment of BioMed Zone 入园优惠政策 Preferential Policies

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.


Provincial level

The Ministry of Science and Technology of P.R.China and B.C. Innovation Council signed MOU of S&T Cooperation in March 2006 and set up cooperation fund in 2007. Both promised to allocate two million Canadian dollars to support joint research projects.

Priorities of S&T Cooperation Between China and Canada

Federal Areas of Cooperative Activities shall be jointly decoded

on writing from time to time by the Parties. The following priority areas have been identified below in

2007; however, application for Partnership Development Activities in other areas will also be considered:

--Agriculture Foods and Bio-products --Energy --Environment --Health & Life Sciences/Biotechnology Information and Communication Technologies and

Nanotechnology are identified as enabling sectors to the four selected areas.

Priorities of S&T Cooperation Between China and Canada

Provincial --oceans technology; --biotechnology, medical devices and food

testing; --forestry, forest products and wood building

materials; --information technology including software,

telecommunications and multimedia; --aquaculture and aquatic sciences; --environment, clean energy and waste

management; --research, innovation and business training and

education.

Mechanism of S&T Cooperation Between China and Canada

Federal

For Canada, funding and other services will be provided through International Science and Technology Partnerships Canada Inc. (ISTPCanada), a 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 Canada

Provincial

For BC, funding and other services will be provided through BC Innovation Council, and for China, through the Ministry of Science and Technology (MOST).

Forms of Cooperative Activities

a) joint research and development activities;

b) pooling of research and development; projects, already underway in each Party, into Joint Research Activities;

c) facilitation of commercially viable research and development;

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

e) exchanges and loans of equipment and materials;

Forms of Cooperative Activities (continue)

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

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

h) demonstrations of technologies and applications development;

i) visits and exchanges of scientists, technical experts and academics;

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

Eligibility for Funding

Federal In Canada

Eligible applicants will be researchers and managers representing Canadian companies, academic institutions, research hospitals, other institutes, or associations which operate and are headquartered in Canada. Subsidiaries of firms headquartered and owned outside Canada are normally not eligible for support. However, recognizing that the overriding consideration is "benefit to Canada", an exception can occur if ISTPCanada is satisfied that clear economic benefit will accrue to Canada because the product or the technology will be substantially produced in, exported from or utilized in Canada.


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.


Federal(continue) In China

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


Provincial ISCD funds may be provided to British

Columbia-based non-profit organizations such as post-secondary and government research institutions, industry associations, regional development organizations etc. Private companies may not receive funds directly, however, they are encouraged to be partners in the project and may perform work for the project based on agreed intellectual property arrangements.

Projects Approved in 2007

Federal

ISTPCanada and the Chinese Ministry of Science and Technology have agreed to fund eight initial joint research projects and two projects are related with health. The total value of these projects is $10.574 million.


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


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


Federal(continue)5. Project: Enhancement of potato trade by adapting

Canada seed potato technology to meet China requirements for increased productionPartners

Participants: New Brunswick Department of Agriculture and Aquaculture; Agriculture and Agri-Food Canada; Hunan Agricultural University, Changsha

6. Project: Broadband wireless access terminals: analysis, deployment and air interface evolution strategiesPartners

Participants: Ecole de technologie superieure, Montreal; Wavesat, Montreal; Shanghai Research Center for Wireless Communication, Shanghai


Federal(continue)

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

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

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

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


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.


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


China Partner: Dr. Zigang Duan

Shenzhen University



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


China Partner:Mr. Xuegang Shao

Nankai University


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



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


China Partner:Dr. Dai Enguang

Peking University



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


China Partner:Dr. Dai Enguang

Peking University


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



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


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


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.


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 ；


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 ；


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.


Both organizations have approved to fund 53 research projects during 2006-2008. Each project can get 50,000 Canadian dollars in Canada and 150,000 RMB in China each year within three years after approved.

Potential Cooperation Ways in the field of Biotechnology and Life Science

Potential Cooperation Ways in the field of Biotechnology and Life Science

R&D CooperationClinical Trial in ChinaManufacturing in China

R&D Cooperation

Government Program Federal Program Provincial Program NSFC-CIHR Program Private Program

In recent years, more and more western pharmaceutical corporations have come to China and set up R&D centers. For instance, Roche of Switzerland opened its R&D center in Shanghai recently, GSK has established its OTC research and development center in Tianjin. AstraZeneca, Bayer, Eli Lili, and Hoffman-La Roche, have also set up R&D or clinical trial centers in China.

Clinical Trial in China

Difficulties in New Drug Development Especially in Clinical Trial in West

Overview of Clinical Trial in ChinaOpportunities in ChinaChallenges in ChinaStrategies in China



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.



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


Overview of Clinical Trial in ChinaUp 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.


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


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


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


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


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


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


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


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.


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


Opportunities in China --Lower cost

Item US Cost China Cost

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

1 day stay in ICU $1500 to $2000 $80 to $150

CT Scan $300 to $550 $100 to $150

Pet Scan $2,750 to $4,500 $900 to $1200

MRI $1,500 to $3,500 $150 to $300

EKG $30 $4 to $6

Colonoscopy $375 or Diagnostic;$550 for therapy with ablation

$50 to $100

CT Directed Biopsy $325 to $450 $100 to $200

Senior Oncologist Annual Salary

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


Opportunities in China

--Lower cost

Don’t forget the huge saving due to rapid recruitment and earlier launch of the product.


Opportunities in China --Inclusion of Asian Data

Data for some therapeutic areas are accepted by US FDA such as hepatitis, oncology, etc.


Opportunities in China --Government’s efforts More transparent regulationsTrying to improve regulatory processIP


Challenges in China

Slow regulatory processProblems in conducting clinical trialsBlood/tissue sample export


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


Challenges in China

--- Problems in clinical trialsManagement Time/resource allocation

Lack of study coordinator

Confidentiality

Facility Communication

Storage of drug, files


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)


Challenges in China

--- Problems in clinical trialsSafety reporting Some AEs are neglected

Safety reporting to EC is not sufficient

Clinical Trail in China

Challenges in China

--- Samples exportLack of qualified central labSamples export is difficult and complicated

Whole Blood or Tissue Samples Permission Required from China Human Genome

Resource Administrative Office & MOH

Plasma or Serum Samples Special Permit From MOH (Per Batched shipment)

Clinical Trail in China

Strategies

---Cost saving on early stage studyGeneral Rules for New Drugs

International companies can not conduct trials in

China unless they have already entered into Phase II

trials in another major market.

Strategies:

Include China in the phase II study to save time and money

Find ways for early stage studies(Phase I-II/prove of concept)

Out-license

JV

Branch manufacturer in

Manufacturing in China

As of 2007, there were already 1,800 foreign-funded pharmaceutical enterprises in China. Currently, all the top 20 pharmaceutical companies in the world have set up joint ventures or wholly owned facilities in China.

Manufacturing in China

Pfizer produces and markets more than 40 innovative drugs in China. Pfizer has GMP manufacturing facilities in Dalian, Suzhou and Wuxi. Pfizer has invested more than $500 million in China.

Merck set up its first joint venture in China in 1994. Novartis has invested about 100 million in China, with

four manufacturing facilities in Beijing and Shanghai. Its core businesses involve patented drugs, generic drugs, eye protection drugs and health products.

AstraZeneca Pharmaceutical Co. has its headquarters in Shanghai, with 25 branch offices in major cities across China’s mainland. In 2001, the company established its largest manufacturing site in Asia with a total investment of $170 million in Wuxi.

Several Useful Websites

www.istpcanada.cawww.bcinnovationcoouncil.comwww.most.cnwww.moh.gov.cnwww.sda.gov.cnwww.chictr.orgwww.cncbd.org.cn

biotechnology and life science in china and s&t cooperation between china and canada march 25,...

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