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

1. 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

2. Biotechnology and Life Science in Chinaand S&T Cooperation Between China and Canada Biotechnology and Life Science in China S&T Cooperation Between China and Canada Potential Cooperation Ways in the field of Biotechnology and Life Science

3. Biotechnology and Life Science in China

4. CONTENT Mission of Biotech and Life Science in China Status of Biotech and Life Science in China Vision and priorities of Biotech and Life Science in China Strategies and approaches of Biotech and Life Science development in China Opportunity of Biotech and Life Science in China

5. Mission of Biotech and Life Science in China

6. 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

7. Mission of Biotech and Life Science in China • Biotech: an essential support in ensuring the safety of the country Bio-terror B T Severe infectious diseases Bio-safety of the country Public safety Foreign invading organism B T Gene resources loss and gene patents contest

8. Mission of Biotech and Life Science in China “Biotechnology should be our focus that we catch up with the advanced level in future high-tech industry, and its applications should be strengthened in such fields as agriculture, industry, population and health, etc.” ——Speech delivered by President Hu Jintao at the National Congress of Science and Technology, 2006

9. 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

10. 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”

11. 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. .

12. Status of Biotech and Life Science in China

13. Status of advanced Biotech and Life Science in China China, as the only member from the developing countries in the International Human Genome Project, has completed sequencing 1% of human genome Chinese scientists undertook and completed 10% of the International HapMap Project Chinese scientists led and implemented the International Human Liver Proteome Project (HLPP) Chinese scientists cloned the pathogenic genes of hereditary diseases such as sensorineural and high-frequency hearing impairment

14. 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.

15. 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.

16. 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.

17. 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.

18. Progresses in Biopharma • During the 10th Five-Year Plan period, 45 drugs have acquired certificates for new drugs, 41 drugs are declaring the new drug certificates,109 drugs have been put into clinic trials, 206 innovative drugs with promising prospect will accomplish their research work before clinical trials. At the same time, a series of models for drug screening and technique platforms used for safety evaluation before clinic trials have been established, tens thousand times of drugs compound screening have been performed, thousands of active compounds acquired.

19. Hepatitis B Hepatitis A Flu hives … Progresses in Biopharma • Genetically engineered drugs and vaccine More than 20 genetic engineered drugs and vaccines such as recombinant person interferonα-1b are on the market. Several tens kinds of genetic engineered drugs are in different clinical trial phases. More than tens of genetically engineered vaccine are in clinical trial phase or pre-clinical trial phase. China vaccine market has a tremendous potential, the growth rate per year exceeds the average level of the world. China Globe

20. Progresses in Biopharma • Antibody drugs R&D In 1987, antibody drug became a special theme in biologic field in the 863 plan. Now 31 diagnostic antibodies have been authorized, 7 therapeutic monoclonal antibody products have been authorized to put into the market, 3 of them are manufactured in China. Antibody drugs made in China

21. 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.

22. P53 injection Type Ⅱdiabetes therapy drug ---Tailuo Progresses in Biopharma • Gene therapy drugs China is one of the countries which initiated earlier basic research and clinical trials of gene therapy. In 2004, the first gene therapy product - recombinanthuman p53 glandulose virus injection was successful manufactured Type Ⅱdiabetes therapy drug Tailuo was successful manufactured.

23. Progresses in Biopharma • The first non-peptide small molecular drug in the world: Glucagon like peptide-1 receptor (GLP-1R ) agonists It can promote isolated rat pancreatic islet cells to excrete insulin at high concentration of sugar conditions. It can make haemoglobin A1C and gucose tolerance test of diabetic mice back to normal. It can control the feeding of normal mice and diabetic mice, reduce the weight of diabetic mice It can enhance the sensitivity of diabetic mice to insulin Chinese patent : 1 granted International patent: 2 applications by Shanghai Institute of Materia Medica（SIMM） 1 of them is under substantive examination in 48 countries and regions

24. 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.

25. Progresses in Biopharma • New anti-tumor drug: Recombinant humanized Monoclonal antibodies h-R3 The national class 1 new drug, Taixinsheng-Nituozhu monoclonal antibodiesdeveloped by Baitai Biopharmaceutical Corporation Ltd., can restrain multiplication and differentiation of tumor cell, promote cell apoptosis, thus inhibit tumor blood vessel generation, enhance chemotherapy and radiotherapy efficacy. It is the first human monoclonal antibodies drugs approved in China. The use of Taixinsheng in combination with radiotherapy can increase the complete remission rate of nasopharyngeal carcinoma patients by over 30 % in comparison with single radiotherapy

26. 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.

27. 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.

28. Progresses in Biopharma • Encouraging progresses in tissue engineering product Several tissue engineering R&D bases and laboratories A considerable young researcher teams for tissue engineering Several relatively mature products and technology, some of them reach or near to clinic trial phase

29. 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

30. Vision and priorities of Biotech & Life Science in China

31. Vision of Biotech & Life Science in China Objectives and targets Significantly enhance the economic development, to improve people’s health, to improve the ecological environment substantially, to substantially strengthen the ability of ensuring the national security. Achieve the leap- forward development of BT, to promote the new revolution in science and technology, to take the lead in the world in BT, to bring China into a powerful country in BT Accelerate the industrialization of scientific and technological achievements and, to develop new BI, to make BI as one of the pillar industries in the national economy,

32. Priorities and key technologyof Biotech & Life Science in China • Implement life science and technology research actions, promote new scientific revolution Accelerate innovation in the frontier of life sciences, make comprehensive breakthrough in genomics, proteomics, stem cell technologies, systems biology, brain and cognitive sciences, gene therapy etc., lay a firm scientific foundation for prolonging human life and enhancing our understanding, reconstruction and utilization level of life principles and promoting new science and technology innovation.

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

34. Priorities and key technologyof Biotech & Life Science in China • Implement bioresources science and technology actions, foster distinctive biological industry Accelerate exploitation and utilization of special bioresources, lay a foundation of new drugs exploitation, new animal and plant breeding and construction of microorganism strains with new functions; foster a group of new distinctive bioresources industry, form 100 billion RMB output value.

35. Priorities and key technologyof Biotech & Life Science in China • Implement biological safety science and technology actions, promote the BS in China Accelerate science and technology innovations in biosafety (BS), establish and perfect the monitoring and administration system for lab BS, transgenic BS, food safety as well as biohazard defending system; promote our BS guarantee and bioterrorism defending ability. Vaccine, biosensor, fingerprint identification and other biotechnology will play an irreplaceable role in monitoring and controlling foreign invading organism, defending bioterrorism, ensuring people’s health and bioresources safety.

36. Priorities and key technologyof Biotech & Life Science in China • Implement biotech international cooperation actions, make China among the biotech advanced countries Accelerate introduction and utilization of human talents, capital, technology, product, induct and promote international cooperation, promote a passel of major international cooperation projects, establish joint research institution, construct international communicationplatform for BT, significantly enhance the comprehensive ability of utilizing international science and technology resources .

37. Strategies and approaches of Biotech & Life Science development

38. Strategies and approaches of Biotech and Life Science development • Establish favorable policy Patent strategy and standardization strategy should be implemented Intellectual property protection should be reinforced. Domestic market should be protected while international market is exploited. Environment in favor of the development of BT industry should be built up. BT agencies should be developed so as to bring into full play the government’s functions of support, leading and market guiding. In order to offer guarantee for the BT and healthy and well-ordered development of the industry, the establishment of laws and regulations concerning BT should be reinforced.

39. 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.

40. 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.

41. 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.

42. 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.

43. 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.

44. 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.

45. Opportunities of Biotech & Life Science in China

46. Opportunities of Biotech & Life Science in China • Bio-resources Opportunities • R&D and Trial Opportunities • Market Opportunities • Entrepreneur Opportunities

47. Bio-resources Opportunities • China is one of the countries with most abundant bio-resources in the world Total land area :9.6million km2 Length from west to east: 5200 km Length from south to north: 5500 km Shorelines length :18000 km Inland altitude : -155～8844m China territory has a wide latitude span from south to north. Frigid zone, temperate zone, torrid zone are all included in China. Various crops are suitable for farming in China. China also has abundant biomass resources for developing biofuels.

48. Bio-resources Opportunities • Plant resources China has more than 30000 species of plants, ranked the third in the world, only behind Malaysia and Brazil. China has: 106 families of mosses, 70% of the total families in the world 52 families and 2600 species of ferns, 80% and 26% of the total in the world, respectively. 8000 species of woody plants, including 2000 species of arbors. 11 families, 34 genera and 240 species of gymnosperm. The conifer species account for 37.8% of the total species in the world Data from the website of the State Forestry Bureau, China

49. Bio-resources Opportunities • Unique plant resources China has 243 genera and around 527 species of unique seed plants Among 666 species of artificial cultivation crops of important economic value, at least 136 species originates from China. Ginkgo Branch Eucommia Rhoipteleaceae Bretschneideraceae

50. Bio-resources Opportunities • Animalresources China has abundant animal resources • 180000 species of invertebrate • 2500 species of fish • 550 species of amphibians and reptiles • 1320 species of birds • About 600 species of mammalia Without effective protection, animal resources are extinguishing quickly.