biotechnology and life science in china and s&t cooperation between china and canada
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Biotechnology and Life Science in Chinaand S&T Cooperation Between China and
Canada
March 25, 2009Long Shen
Consul for Science and TechnologyConsulate 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
Mission of Biotech and Life Science in China
Biotech: a essential technology for the improvement of people’s health 0.84 million AIDS sufferers 4.5 million patients with active pulmonary tuberculosis more than 120 million patients with hepatitis B virus infection more than 20 million patients with diabetes mellitus 0.8 million people with schistosomiasis the mortality of cardio-cvascular diseases and
malignancies is increasing continually anually4-6% of newborns having birth defects
Mission of Biotech and Life Science in China
Biotech: an essential support in ensuring the safety of the country
Bio-terror
Severe infectious diseases
Public safetyBio-safety of the country
Foreign invading organism
Gene resources loss and gene patents contest
B T
Mission of Biotech and Life Science in China
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
Mission of Biotech and Life Science in China
“We should try to seize the commanding elevation in biotechnology, and strengthen the application of BT in agriculture, industry, population, and health sectors, especially the research and development of grains and food safety, prevention of severe infectious diseases and innovation medicine. We should improve our capability of innovation and development levels in the related industries and secure the health of our people.”
——Speech delivered by Premier Wen Jiabao at the National Congress of Science and Technology, 2006
Mission of Biotech and Life Science in China
“In developing bioindustry, it is necessary to bring into full play our advantages in resources and technology to meet the significant needs in the field of health, agriculture, environmental protection, energy and materials etc., and try to fulfill new breakthrough in key technologies and important products development.”
——Extracted from “Guidelines of the 11th Five- Year Plan for National Economic and Social Development, P. R. China”
Mission of Biotech and Life Science in China
Nation’s focus: the development of Biotech National Development and Reform Commission together with
other 18 commissions and ministries such as the Ministry of Finance, Science and Technology, Education, Health and so on , constituted 《 11th Five-Year Plan for BT of China 》 , relative work started up in Jun 2005..
Mission of Biotech and Life Science in China
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.
Status of advanced Biotech and Life Science in China
The International HapMap Project is another distinguish feat after the accomplishment of HGP, scientists from Canada,USA, UK, China, German, Japan, Nigeria participated in this project. China is in charge of 10 % of the whole project, including the construction of the monomer map of number 3,number 21 and number 8 chromosome short arm.
Status of advanced Biotech and Life Science in China
On Dec.15, 2003, another significant plan in life sciences after the accomplishment of HGP, International Human Proteome Project (HPP) formally started up. It was also announced that the International Human Plasma Proteome Project (HPPP) and International Human Liver Proteome Project (HLPP) would be implemented firstly, and the International Human Liver Proteome Project’ Headquarters would set up in Beijing, China would be the leader country, Chinese scientist would head the list. It was the first time in scientific history that China lead a significant international cooperation plan and Chinese scientists play a leading role in such a project.
Status of advanced Biotech and Life Science in China
The research group headed by Professor Xia Jiahui, an academician of CAS, is the earliest in the world that accurately located human testicle decision gene in chromosome Yp11.32;The group established “Chinese Novel Human Abnormal Chromosomal Karyotype Database”, “Database of the Family Collection of Genetic Disease in China ” . They also successfully cloned the pathogenic genes of human hereditary diseases of high-frequency hearing impairment (GJB3), thus fulfilled a breakthrough in pathogenic genes clone in China.
Status of advanced Biotech and Life Science 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%
Gro
wth
rate
China Globe
Hepatitis BHepatitis AFluhives
…
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 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
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.
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 - recombinant human p53 glandulose virus injection was successful manufactured Type diabetes therapy drug Ⅱ Tailuo was successful manufactured.
Progresses in Biopharma P53 injection
Type Ⅱdiabetes therapy drug ---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
Progresses in Biopharma
Recombinant human vascular endostatin injection
Recombinant human vascular endostatin injection, a first class new drug for anti-tumor, is developed by Dr Luo Yongzhang of Yantai Maidejin Biologic engineering Inc. It is the first recombinant human vascular endostatin injection used for anti-tumor new in the world. The new drug has obtained several invention patent grants.
Progresses in Biopharma
New anti-tumor drug: Recombinant humanized Monoclonal antibodies h-R3
The national class 1 new drug, Taixinsheng-Nituozhu monoclonal antibodies developed by Baitai Biopharmaceutical Corporation Ltd., can restrain multiplication and differentiation of tumor cell, promote cell apoptosis, thus inhibit tumor blood vessel generation, enhance chemotherapy and radiotherapy efficacy.
It is the first human monoclonal antibodies drugs approved in China. The use of Taixinsheng in combination with radiotherapy can increase the complete remission rate of nasopharyngeal carcinoma patients by over 30 % in comparison with single radiotherapy
Progresses in Biopharma
Key technology of gene therapy
Shanghai Cancer Institute firstly invented receptor-mediated non-viral vector in the world. It can achieve targeted delivery and gene transfer with high efficiency. China Medical University developed herpes non-viral vectors. It can introduce foreign gene along olfactory nerve channel into the pathological central nervous cells. It initiated a novel approach for gene therapy.
Progresses in Biopharma
Gene therapy of Hemophilia
Fudan University is the first to carry out clinical trials of gene therapy for hemophilia.
This technology is in the leading position in the world.
Progresses in Biopharma
Encouraging progresses in tissue engineering product
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
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
Progresses in Biopharma
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.
Priorities and key technology of Biotech & Life Science in China
Implement bioresources science and technology actions, foster distinctive biological industry
Accelerate exploitation and utilization of special
bioresources, lay a foundation of new drugs exploitation,
new animal and plant breeding and construction of
microorganism strains with new functions; foster a group of
new distinctive bioresources industry, form 100 billion RMB
output value.
Priorities and key technology of Biotech & Life Science in China
Implement biological safety science and technology actions, promote the BS in China
Accelerate science and technology innovations in biosafety (BS),
establish and perfect the monitoring and administration system for lab
BS, transgenic BS, food safety as well as biohazard defending
system; promote our BS guarantee and bioterrorism defending ability.
Vaccine, biosensor, fingerprint identification and other biotechnology
will play an irreplaceable role in monitoring and controlling foreign
invading organism, defending bioterrorism, ensuring people’s health
and bioresources safety.
Priorities and key technology of Biotech & Life Science in China
Implement biotech international cooperation actions, make China among the biotech advanced countries
Accelerate introduction and utilization of human talents, capital, technology, product, induct and promote international cooperation, promote a passel of major international cooperation projects, establish joint research institution, construct international communication platform for BT, significantly enhance the comprehensive ability of utilizing international science and technology resources .
Priorities and key technology of Biotech & Life Science in China
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.
Strategies and approaches of Biotech and Life Science development
Establish centers of world excellence To consolidate and enhance the status and functions of the existing
public research institutes and universities on BT innovation First key effort is to build up 10 to 15 state (key) laboratories. Second key effort is establish 30 to 35 state engineering technology
centers in the BT field(including health). Third key efforts is set up and accurate 10 to 15 reserve centers and R&D
centers for national biological genetic resources. Establish and build up 10-15 or so internationalized, standardized, scale
production, world top-ranking platforms and bases for BT innovation. Build up and consummate 80 to 100 state of the art representative
enterprises in the country and all over the world and 10-15 BT representative industrial parks.
Strategies and approaches of Biotech and Life Science development
Increasing capital investment Increase the public investment in Biotech and Health R&D
and industrialization. The public investment should support primarily the original innovative research, the key technology R&D, the construction of the infrastructure and the common technology platform, so as to build the national Biotech and Health innovation system. Establish and consummate investment mechanism and system of multiple sources and full society engagement, which means to encourage and attract the enterprises and finance to invest in Biotech and Health research.
Strategies and approaches of Biotech and Life Science development
Strengthening BS development and evaluation Establish and build our technology evaluation standards and systems of biological safety relating to agriculture, environment protection, food, import and export quarantine. Improve the uniform planning and administration on the construction of high-level BS laboratories (Level 3 and Level 4) Establish technology administration and evaluation system of the laboratory animals.
Strategies and approaches of Biotech and Life Science development
Strengthening international cooperation and exchanges It is encouraged to strengthen international communication and cooperation through multiple ways. It is encourage and support to establish cooperation between domestic institutes and oversea institutes. It is necessary to establish joint-laboratories abroad on frontier
and core technology of Biotech and Life Science.
Strategies and approaches of Biotech and Life Science development
Improving organizational structure and leadership
At the disposal of the national leading group of Biotech R&D and industrialization, take full advantage of the functions of various departments like Science and Technology, Development and Reform, Finance, Education, Agriculture, Quality Control, Environment Protection, Forestry, and Military in stimulating Biotech and industry development. All of resources should be redistributed more scientifically, more reasonably, and more efficiently, which will mobilize all powers to boost Biotech and its development towards industrialization.
Strategies and approaches of Biotech and Life Science development
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
Bio-resources Opportunities
Unique plant resources China has 243 genera and around 527 species of unique
seed plants Among 666 species of artificial cultivation crops of important
economic value, at least 136 species originates from China.
Ginkgo Branch Rhoipteleaceae Eucommia Bretschneideraceae
Bio-resources Opportunities
Animal resources China has abundant animal resources
180000 species of invertebrate 2500 species of fish 550 species of amphibians and reptiles 1320 species of birds About 600 species of mammalia
Without effective protection, animal resources are extinguishing quickly.
Bio-resources Opportunities
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
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.
Bio-resources Opportunities
R&D and Trial Opportunities300 research academes and institutes are undertaking medical
BT R&D300 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.
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 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.
Market 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.
Entrepreneur Opportunities
China International Innovation Zone of Biotechnology and
Medicine
BioMed Zone
国家生物医药国际创新园定位 Planned Functions of BioMed Zone
国家生物医药国际创新园坐落在滨海新区,以高标准、高起点、系列化、标准化和和国际化为准则,研究开发、企业孵化、生产制造、贸易流通统筹并举,构建开放、共享、联合的生物技术与创新药物技术平台和孵化平台,吸引聚集高水平的人才、项目、研发机构和企业。 BioMed Zone is located in the Binhai New Area. Guided by the principles of high standard, high start-up, catena, standardization and internationalization, it will lay its emphasis on research and development, industrial incubation as well as manufacturing and trade and build an opening, sharing and joint platform for biological technology and innovative medicines as well as an incubation platform to attract and accumulate senior research personnel, projects, R&D organizations and enterprises.
天津滨海新区成为第三增长极 Tianjin Binhai New Area is a Third Economic Growth Pole in China
天津滨海新区产业基础雄厚,增长潜力巨大,成为继上个世纪 80年代的广东深圳特区、 90 年代上海浦东新区之后, 21 世纪带动区域发展的新的经济增长极。With a solid industrial basis and great development potential, Tianjin Binhai New Area is becoming a new economic growth pole with the function of stimulating China’s regional development in the 21 century after Shenzhen Special Zone in Guangdong Province in 1980s and Pudong New Area of Shanghai in 1990s,
国家生物医药国际创新园一园三区 Three Zones in BioMed Zone
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
完善的服务体系 Complete Service System
创业风险投资体系:建立规模不少于 5 亿元的创业投资引导基金,吸引国内外生物医药风险投资机构和企业,最终形成 100 亿元规模的风险投资资金,扶持生物医药产业发展。争取国家支持,对投资于中小生物医药企业创业孵化的风险投资企业,实行一定的税收优惠政策。Venture Capital System for Startups: In order to give support to the biomedical industry, BioMed Zone will set up a Venture Capital Fund with more than RMB 500 million to attract VC organizations and enterprises both at home and abroad in the field which finally develop into a fund with RMB 10 billion; give some preferential tax policies to VC enterprises investing in incubation of small and medium sized biomedical companies.
在国家部委的支持下,力争在国际创新园开展为上市股份制生物医药企业进入证券公司代办股份转让系统进行股份转让试点,支持技术与产权交易市场开展为上市生物医药企业股权流通试点。Supported by relevant ministries and committees, BioMed Zone will make its efforts to carry on pilot business of stock transfer for listed biomedical enterprises with joint stock system entering into the Agency Share Transfer System; support Assets and Equity Exchange market through carrying out pilot business of stock circulation for listed biomedical enterprises.
国家生物医药国际创新园的优惠政策 Preferential Policies in BioMed Zone
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 enterprises2 、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 入园优惠政策 Preferential Policies
S&T Cooperation Between China and Canada
S&T Cooperation Between China and Canada
Federal Level The Government of P.R.China and the
Government of Canada signed the Agreement of S&T Cooperation in January 2007 and set up a cooperation fund. Both governments promised to allocate one million Canadian dollars to support joint research projects.
S&T Cooperation Between China and Canada
Provincial level The Ministry of Science and Technology of
P.R.China and B.C. Innovation Council signed MOU of S&T Cooperation in March 2006 and set up cooperation fund in 2007. Both promised to allocate two million Canadian dollars to support joint research projects.
Priorities of S&T Cooperation Between China and Canada
Federal Areas of Cooperative Activities shall be jointly decoded
on writing from time to time by the Parties. The following priority areas have been identified below in
2007; however, application for Partnership Development Activities in other areas will also be considered:
--Agriculture Foods and Bio-products --Energy --Environment --Health & Life Sciences/Biotechnology Information and Communication Technologies and
Nanotechnology are identified as enabling sectors to the four selected areas.
Priorities of S&T Cooperation Between China and Canada
Provincial --oceans technology; --biotechnology, medical devices and food
testing; --forestry, forest products and wood building
materials; --information technology including software,
telecommunications and multimedia; --aquaculture and aquatic sciences; --environment, clean energy and waste
management; --research, innovation and business training and
education.
Mechanism of S&T Cooperation Between China and Canada
Federal For Canada, funding and other services
will be provided through International Science and Technology Partnerships Canada Inc. (ISTPCanada), a 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.
Eligibility for Funding
Federal(continue) In Canada Agencies of the Crown (including Crown corporations,
government institutes, government laboratories, etc.) may be participants of ISTPCanada-funded Activities but are not eligible as recipients of ISTPCanada funding.
Eligibility for Funding
Federal(continue) In China Companies, organizations and associations incorporated
under People’s Republic of China national law.
Eligibility for Funding
Provincial ISCD funds may be provided to British
Columbia-based non-profit organizations such as post-secondary and government research institutions, industry associations, regional development organizations etc. Private companies may not receive funds directly, however, they are encouraged to be partners in the project and may perform work for the project based on agreed intellectual property arrangements.
Projects Approved in 2007
Federal ISTPCanada and the Chinese Ministry of
Science and Technology have agreed to fund eight initial joint research projects and two projects are related with health. The total value of these projects is $10.574 million.
Projects Approved in 2007
Federal(continue)1. Project: Use of seal oil and seal products in the
diet of hospital patients Partners Participants: North Atlantic Biopharma Inc.; the
Government of Newfoundland and Labrador; and Sun Yat-sen University, Guangzhou
2. Project: Application of high-yield pulps in the production of high-quality coated paper for multicolour offset and digital printing Partners
Participants: University of New Brunswick; FP Innovations-Paprican Division, Pointe Claire; Tembec Inc., Montreal; University of Toronto; Tianjin University of Science and Technology, Tianjin
Projects Approved in 2007
Federal(continue)3. Project: Selective Asphaltene ExtractionPartners Participants: Well Resources; MEG Energy
Corp.; Sunshine Oilsands Ltd.; Alberta Energy Research Institute; State Key Laboratory of Heavy Oil Processing; China University of Petroleum, Beijing
4. Project: Development of microfluidic chip-based electrophoresis platform and approaches for rapid and high-resolution disease diagnosis Partners
Participants: University of Waterloo; Convergent Bioscience Ltd., Toronto; Nanjing University, Nanjing
Projects Approved in 2007
Federal(continue)5. Project: Enhancement of potato trade by adapting
Canada seed potato technology to meet China requirements for increased productionPartners
Participants: New Brunswick Department of Agriculture and Aquaculture; Agriculture and Agri-Food Canada; Hunan Agricultural University, Changsha
6. Project: Broadband wireless access terminals: analysis, deployment and air interface evolution strategiesPartners
Participants: Ecole de technologie superieure, Montreal; Wavesat, Montreal; Shanghai Research Center for Wireless Communication, Shanghai
Projects Approved in 2007
Federal(continue)7. Project: Research on constructing the breeding
system for the Chinese dairy industry applying advanced breeding technology Partners
Participants: Alta Genetics Inc., Balzac, Alberta; China Agriculture University, Beijing
8. Project: Research on the linear generator system for oceanic tidal and wave energyPartners
Participants: DynaGen Technologies Inc., Halifax; Dalhousie University, Halifax; China University of Mining & Technology, Xuzhou
Projects Approved in 2007
Provincial The British Columbia Innovation Council and the
People’s Republic of China’s Ministry of Science and Technology has announced recipients of the Innovation and Commercialization Strategic Development Program. The Program provides a total of $4 million in joint funding to support 13 collaborative projects in order to support excellence in research, technology development and commercialization projects of interest to both jurisdictions. UBC involves 8 projects and two projects are related with health.
Projects Approved in 2007
Provincial(continue)1. Project: Cathepsins and lung fibrosisBC Partner: Dr. Dieter BrommeThe University of British ColumbiaChina Partner: Dr. Jifeng WangBeijing University of Chinese Medicine 2. Project: High-speed transistor microring lasers BC Partner: Dr. Lukas Chrostowski The University of British ColumbiaChina Partner: Dr. Zigang Duan Shenzhen University
Projects Approved in 2007
Provincial(continue)3. Project:Development and demonstration of advanced
polarimetric SAR technology for forestry BC Partner:Dr. David Goodenough Canadian Forest Service China Partner: Dr. Wen Hong Chinese Academy of Sciences 4. Project:Raman scattering in a clinical instrument for the
diagnosis of cancer by metabolomic imaging BC Partner:Dr. Edward Grant The University of British Columbia China Partner:Mr. Xuegang Shao Nankai University
Projects Approved in 2007
Provincial(continue)5. Project:Reliable and trusted networking for data-centric
wireless access with applications to vehicular telematics BC Partner:Dr. Victor Leung The University of British Columbia China Partner: Dr. Yanheng Liu Jilin University 6. Project:Development of integrated remediation technologies
for petroleum contaminated soils and sludge through bio-augmentation and biosurfactant
BC Partner:Dr. Jianbing Li University of Northern British Columbia China Partner:Dr. Yuefei Huang Tsinghua University
Projects Approved in 2007
Provincial(continue)7. Project:Innovation in organic greenhouse production in
China BC Partner:Mr. Blair McHenryCanadian Organic Greenhouse Association China Partner: Mr. An Li HongTianjin Academy of Agricultural Sciences 8. Project:Ultrasound 3D imaging combined with MEMS-based
optical coherence tomography BC Partner:Dr. Robert Rohling The University of British Columbia China Partner:Dr. Dai Enguang Peking University
Projects Approved in 2007
Provincial(continue)9. Project:Development of low cost perfluorosulfonic (PFSA) ionomer
membranes BC Partner:Dr. Ken Shi Dr. Steven Holdcroft National Research Council Canada & Simon Fraser University China Partner: Dr. Yongming Zhang Shanghai Jiao Tong University 10. Project:Development of ocean assimilation techniques for Argo and
other oceanic observations BC Partner:Dr. Robert Rohling The University of British Columbia China Partner:Dr. Dai Enguang Peking University
Projects Approved in 2007Provincial(continue)10. Project: Development of ocean assimilation
techniques for Argo and other oceanic observations BC Partner:Dr. Youmin Tang University of Northern British Columbia China Partner: Dr. Guihua Wang Second Institute of Oceanography 11. Project:Contamination effects and durability
studies of PEM fuel cells BC Partner:Dr. Haijiang Wang National Research Council Canada China Partner:Dr. Jianxin Ma Shanghai Tongji University
Projects Approved in 2007 Provincial(continue)12. Project:Application of FORECAST software to assess sustainable
productivity and carbon equestration in major Chinese forests BC Partner:Dr. Adam Wei Dr. Hamish Kimmins The University of British Columbia China Partner: Dr. Jiang Hong Zhejiang Forestry University 13. Project:Development of the Chinese National Sustainable Forest
Management Systems and the National Forest Certification Standard BC Partner:Dr. Yongyuan Yin Environment Canada China Partner:Mr. Jiafu Lei
State Forest Administration
S&T Cooperation Between China and Canada
The National Nature Science Fund of China(NSFC) signed MOU with the Canadian Institute of Health Research(CIHR) in 2005. Both organizations agreed to support the co-research projects conducted by Universities, research hospitals and institutes.
S&T Cooperation Between China and Canada
Key areas supported by NSFC-CIHR program:
1 、 Neurosciences : to provide support for basic research in neuroscience, mental health, addiction and the senses ;
2 、 Diabetes and Obesity : to provide support for research on the measures, causes, prevention, treatment and consequences of diabetes and obesity ;
3 、 Cardiovascular System : to provide support for basic and translational research on the pathogenesis, treatment and ultimate of cardiovascular diseases, including myocardial infarction, stroke, cardiomyopathy and atherosclerosis ;
S&T Cooperation Between China and Canada
Key areas supported by NSFC-CIHR program(continue):
4 、 Genetics : to provide support for research on the human and other genomes and on all aspects of genetic, basic biochemistry and cell biology related to health and disease ;
5 、 Infection and immunity : to provide support for basic research on viral and bacterial diseases and development of vaccines ;
6 、 Child and youth health : to provide support for research on fertility, pregnancy, maternal health, healthy child development and the etiology, prevention, and treatment of diseases in infants, children, and youth ;
S&T Cooperation Between China and Canada
Key areas supported by NSFC-CIHR program(continue):
7 、 Aging : Gerontology and Geriatrics: to encourage research on aging processes, on functional limitations in older adults as a consequence of disease, and on determinants of healthy aging within the context of one or more of the following priority areas: healthy and successful aging, biological mechanisms of aging, cognitive impairment in aging, aging and maintenance of functional autonomy, and health services relating to older people.
S&T Cooperation Between China and Canada
Both organizations have approved to fund 53 research projects during 2006-2008. Each project can get 50,000 Canadian dollars in Canada and 150,000 RMB in China each year within three years after approved.
Potential Cooperation Ways in the field of Biotechnology and Life Science
Potential Cooperation Ways in the field of Biotechnology and Life Science
R&D 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
Clinical Trial in ChinaDifficulties in New Drug Development Especially in
Clinical Trial in West Delay of Time -Difficulty in patient recruitment 86 % of all US clinical studies fail to recruit the required
number of patients on time and as a result are delayed on average 366 days. Canada has the same problem.
Clinical Trial in China
Difficulties in New Drug Development Especially in Clinical Trial in West
Higher Cost • Direct cost: Caused by the delay of the study. When failing to meet recruitment timelines, the cost of
drug development rises. Daily out-of-pockets alone are estimated at US$37,000.
• Indirect cost: Caused by the delay of product launching, which is huge! For a billion-dollar drug, 83M/Month, 2.8M/day
Clinical Trial in China
Overview of Clinical Trial in 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.
Clinical Trial in China
Opportunities in China Large patient pool, especially for treatment
native patients --Solution of patient recruitment Many GCPs Lower cost Inclusion of Asian Data Government’s efforts on improving regulations
and IP
Clinical Trial in China
Opportunities in China Large patient pool, especially for treatment native
patients Population of 1.3 Billion 250 million covered by insurance 250 million partially covered by insurance 800 million not covered by insurance Large number of “treatment native” patients in China
Clinical Trial in China
Opportunities in China --Large patient pool Prevalence of CancersDisease Incidence(per 100,000) NumberLung Cancer 67.5 877,500Stomach Cancer M: 39.2 F: 19.1 378,000Liver Cancer M: 35 F: 9.7 290,550Colorectal Cancer M: 22 F: 12 221,000Breast Cancer F: 13.3 172,000Cervix Cancer F: 12.3 159,900
Clinical Trial in China
Opportunities in China --Large patient pool Shanghai Cancer Hospital 600 Beds (100% occupancy) Lung Cancer (20%); Stomach Cancer (20%); Breast Cancer (20%);
Intestinal Cancer (10%) Out-Patient - 20,000 per month of which GI cancer is the largest
percentage. Beijing Cancer Hospital 580 Beds (>100% occupancy) Intestinal Cancer (20%); Stomach Cancer (20%); Lung Cancer
(15%); Breast Cancer (15%); Esophageal Cancer (10%) Out-Patient – 11,000 per month
Clinical Trial in China
Opportunities in China --Large patient pool Prevalence of Cardiovascular and Respiratory DiseasesDisease Incidence(per 100,000) NumberHyperlipidemia 4.7% 61.1 MCoronary Heart Disease 4.4% 57.2 MHypertension 13.3% 173 MCOPD/Chronic Bronchitis 9.7% 126 MTuberculosis 43 per 100,000 562,600
Clinical Trial in China
Opportunities in China -- Large patient pool Prevalence of CNS and Psychiatric Diseases Disease Incidence NumberStroke 202 per 100,000 2.6 MDepression 5.8% 75.5 MAlzheimer’s Disease 1.35% 17.5 MSchizophrenia 0.66% 8.5M
Clinical Trial in China
Opportunities in China -- Large patient pool Prevalence of GI and Other DiseasesDisease Incidence NumberHepatitis B 66.1 per 100,000 859,300Gastric Ulcer 4% 52 MChronic Gastritis & Enteritis 12.1% 157 MRheumatoid Arthritis 9.6% 125MDiebetes 3.9% 50MHIV 1M
Clinical Trial in China
Opportunities in China --Many GCPs To ensure scientifically accurate reflection and reliability
of results as well as test subjects' rights and interests during clinical trials, China promulgated the Good Clinical Practice (GCP) for pharmaceutical products in 1999, and began the work of GCP certification on March 1, 2004.
By the end of 2007, a total of 178 institutions conducting clinical trials had obtained GCP certification, and GCP certification has greatly improved the quality of drug clinical trials in China.
Clinical Trial in China
Opportunities in China --Lower cost Pre-Clinical(estimates) Chemestry—30 to 60% of the cost of theWest Other Pre-clinical Toxicology—30% of the cost of the West Animal testing—30% of the cost of the West Clinical(estimates) Phase I—25% of the cost of the West Phase II/III—30% of the cost of the West
Clinical Trial in China
Opportunities in China --Lower cost
Item US Cost China Cost1 day stay in Hospital $750 to $1000 $40 to $100
1 day stay in ICU $1500 to $2000 $80 to $150
CT Scan $300 to $550 $100 to $150
Pet Scan $2,750 to $4,500 $900 to $1200
MRI $1,500 to $3,500 $150 to $300
EKG $30 $4 to $6
Colonoscopy $375 or Diagnostic;$550 for therapy with ablation
$50 to $100
CT Directed Biopsy $325 to $450 $100 to $200
Senior Oncologist Annual Salary
$225,000+ $40,000+for key opinion leaders
Clinical Trial in China
Opportunities in China --Lower cost
Don’t forget the huge saving due to rapid recruitment and earlier launch of the product.
Clinical Trial in China
Opportunities in China --Inclusion of Asian Data
Data for some therapeutic areas are accepted by US FDA such as hepatitis, oncology, etc.
Clinical Trial in China
Opportunities in China --Government’s efforts More transparent regulationsTrying to improve regulatory processIP
Clinical Trial in China
Challenges in China Slow regulatory processProblems in conducting clinical trialsBlood/tissue sample export
Clinical Trial in China
Challenges in China --Slow regulatory processType of Application Track Time (Working days)
Application for CTA* of imported product Regular 160-200 Application for CTAof global trial Fast 140-165*CTA: clinical trial approval
Clinical Trial in China
Challenges in China --- Problems in clinical trialsManagement Time/resource allocation Lack of study coordinator ConfidentialityFacility Communication Storage of drug, files
Clinical Trial in China
Challenges in China --- Problems in clinical trials Compliance to protocol and ICH/GCP
Clinical studies should be carried out according to International Conference on Harmonization (ICH) / WHO Good Clinical Practice standards. This provides a unified standard for the European Union (EU), Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO). Thus, any country that adopts this guideline technically follows this same standard.
Quality of data ICF(Informed Consent Forms)
Clinical Trial in China
Challenges in China --- Problems in clinical 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
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