Influenza Virus Multi-Subtype Universal Vaccine Production Project

Influenza Virus Multi-Subtype Universal Vaccine Production Project

of Changchun City

 

1. Introduction to the Project

1.1 Project Background

1.1.1 Product Introduction

In recent years, the bird flu virus infect human events appear constantly, these infections of the bird flu virus, any individual one of them can lead to possibility of pandemic flu in certain conditions, so it is unprecedented urgent to develop the universal vaccine of multi-subtype influenza. Universal vaccine is a new type of vaccine, it not only has advantages of attenuated live vaccine induced humoral immune response and induce cell immune response, but also has advantages of subunit vaccine safety, easy fabrication, economy, low consumption, easy to store and transportation, so it is one of research hot spots of vaccine. The vaccine formed by making the antigen active site (including B cell epitope and T cell epitope) of pathogen antigen gene series together and inserting into eukaryotic expression plasmid. It has more advantages than conventional DNA vaccine and can deal with the variation of the influenza virus and provide immune protection to multi-subtypes influenza virus. To avoid the difficulties of multiple antigen gene clone the same carrier and the problem of transcription interference. In early stage, the research of flu DNA vaccines mainly focus on surface antigen HA and NA, and now the development strategy of flu vaccine has realized the importance of flu virus conservative internal protein (NP, M) in inducing the cellular immunity. The successful development of universal gene recombination vaccine of multi-subtype influenza will become a new leading of genetic engineering vaccine restructuring influenza, it will have a great market prospect and economic and social benefits.

1.1.2 Market Prospects

Influenza is acute respiratory infectious diseases which caused by influenza virus, it cause great loss of manpower and material resources during its popular period every year. In 1933, flu virus was first used to experimental animal ferret which was infected. It was the beginning that human knows about influenza virus. For decades, the popularity of the influenza virus has brought immeasurable loss to human society. There were four global pandemic influenzas in the middle of twentieth century, the result was disastrous. Since 1952, WHO recommends to produce vaccine to next year for influenza virus vaccine strains based on virus variation law of influenza. In recent years, the bird flu virus breakthrough species to limit infected humans constantly, this makes the flu epidemic has become more complicated.

The flu antigen changes very quickly, every year the vaccine companies have to update the vaccine strains, the production cycle of ready for the new vaccine often need 9 months, but people should vaccinate every year. If a pandemic strain appears, such as the H5N1 bird flu variant, the period of production process of preparation of matching the vaccine, it may have caused several million deaths. The product in this project is "universal influenza vaccine”, inoculate it once time can resist various subtypes influenza attack in several years or even a lifetime, this is the original intention of research and development. Universal influenza vaccine is specifically targeted at the flu virus caused by acute respiratory infection disease, most vaccines are effective for specific kind of virus on prevention, and universal flu vaccine can direct to prevent all common flu but not guess what kind of flu will be before the flu season.

The vaccine formed by making the antigen active site (including B cell epitope and T cell epitope) of pathogen antigen gene series together and inserting into eukaryotic expression plasmid. It has more advantages than conventional DNA vaccine and can deal with the variation of the influenza virus and provide immune protection to multi-subtypes influenza virus. Calculated by 1.3 billion people the population of our country, and immune rate even by 3%, total market capacity will reach 39 million person-times, expected economic scale is over 10 billion yuan. It has a broad market prospect.

1.1.3 Technical Analysis

The vaccine in this project is formed by making the antigen active site (including B cell epitope and T cell epitope) of pathogen antigen gene series together and inserting into eukaryotic expression plasmid. It has more advantages than conventional DNA vaccine and can deal with the variation of the influenza virus and provide immune protection to multi-subtypes influenza virus. All the techniques used in this project are our owned technologies which developed by our scientific research institution and all have proprietary intellectual property rights, and there is no technical risk.

1.1.4 Advantageous Conditions of Project Construction

（1）Policy conditions

（2）Scientific research advantage

Changchun High-tech Zone owns "one academy, four institutes and four universities”, that is, Changchun Branch of Chinese Academy of Sciences, Jilin University, Northeast Normal University, Changchun University of Science and Technology, Changchun University of Technology, Optics Institute, Applied Chemistry Institute, Biology Institute, and Geography Institute. It establishes “technology innovation strategic alliance”, adopts government investment pulling, diversified investment, market-oriented operation, enterprise management mode. The joint construction area is seven square kilometers. ChangchunNortheastTechnologyInnovationCenter, with a total investment of 17.2 billion yuan, will mainly construct incubator area, research and education area, commercial and residential supporting area etc. three major functional areas. Changchun Hi-tech Zone gathers 14 full-time colleges such as JilinUniversity, Changchun University of Science and Technology, 39 research institutes such as the CAS Changchun Institute of Optics, 29 national key laboratories, and 76 above the city level enterprise technical centers. The institutions involving biological and pharmaceutical industries are: Changchun Biological Products Institute, College of Chemistry of Jilin University, College of Pharmacy of Jilin University, Changchun Chinese Medicine Hospital, and Jilin Province TCM and Chinese Medicine Institute etc.12 science and technology institutions, 13 key provincial and ministerial labs in the field of medicine, 5 professional national testing organization laboratories in the field of medicine, and 10 above the city level enterprise technical centers of pharmaceutical companies. It is the most concentrated area of JilinProvince in the aspect of science and education resources, and research and development institutions.

（3）Advantage of infrastructure

Since 2009, The High-Tech Zone has invested accumulated 30 billion yuan in development and construction, newly built 190km roads. In the south district and Changchun northeast core area of 86 km², the supporting facilities are complete, creating a miracle in urban construction. Within 30 km² of the highway in south district, the infrastructure supporting facilities are all in place, basically realizing "eleven connections and one leveling" (water connection, electricity connection, road connection, communications, gas,  internet, radio and television, heating, post, drainage and sewage on construction site, and site leveling), reaching the first class standard in China. Around the goal of building green, ecological and livable modern city, it will accelerate greening, landscaping, lighting and other environmental constructions. The landscape characteristics, with the natural scenery of ChangbaiMountain as main body, combined with Suzhou garden style, integrating greening, landscaping, lighting and sculpture has formed.

 The Changchun High-tech Zone Changchun northeast core area has a planned area of 96 km², and is the forefront for ChangchunCity to integrate into the Chang-Ji-Tu. The planning and construction of the core area takes industrial development as the main line, takes technology innovation and high-end service as supplement, and will be constructed according to international metropolis standard. Four universities have entered Changchun northeast core area and started construction; the Sixth People’s Hospital of Jilin Province has entered the zone; an internationally first-class nursing home is under planning and construction. In order to improve the living quality of residents in the core area, the core area has a total of two world-class parks, of which the BeihuWetlandPark has been opened. The Longfor, CESL-based real estate projects have started construction consecutively. In the aspect of transportation lines, the bus line leading to Changchun Station has been opened. In the subway project under the planning of ChangchunCity, the number 7 subway line will pass through Changchun northeast core area. Thus the supporting infrastructure is excellent.

（4）Location advantage

ChangchunCity, where Changchun High-tech Zone is located, is the geographic center of Northeast Asia and China's three northeastern provinces. It is the inland port for Chang-Ji-Tu to lead the pilot area, with favorable location conditions. Changchun High-tech Zone is located in the key area for future urban development of Changchun: the Southern District of Hi-tech Zone is near the Southern New City of Changchun, which is the future city center; the Northern District of the Zone is the core area of Changchun Northeast Development and Opening Pilot Zone, the key area for industrial development of Changchun City in the future. Changchun High-tech Zone is located in important location of ChangchunCity, making Changchun High-tech Zone have more superior regional conditions than ChangchunCity. These superior geographic conditions not only create favorable conditions for a new round of rapid development of High-tech Zone, but also are conducive to for the High-tech Zone to further play the radiation, driving and demonstration role of the High-tech Zone.

 Moreover, Changchun has developed three-dimensional traffic network. In the aspect of railways, Changchun is an important railway transportation hub in northern China. With Beijing-Dalian line, Chang-Bai line, and Chang-Tu line as the backbone, an east-west-north-south railway network has been formed, with direct access to nearly 40 cities across the country; in highways, Beijing-Harbin high-speed highway, Chang-Ha high-speed highway, Chang-Si high-speed highway, Chang-Ji high-speed highway, Chang-Ping high-speed highway, Chang-Ying high-speed highway, and around-city highway etc. many highways, as well as 302, 102 etc. State Road criss-cross, extending in all directions; in the aspect of aviation, ChangchunLongjiaInternationalAirport is an important regional hub airport in the northeast region, with more than 60 direct flights to more than 20 cities across the country every day. Many international routes lead to Seoul of South Korea, Erkucike of Russia etc. important cities in northeast Asian countries. Developed transportation network lays an excellent location foundation for Changchun High-tech Zone to become the regional economic center of Northeast China and an important platform for Northeast Asia Cooperation.

（5）Industrial cluster advantage

In the context of a new round of development strategy, to better develop bio-pharmaceutical industry, Changchun High-tech Zone plans Changchun Northeast Biological and Medical Science and TechnologyIndustrial Park in the Changchun northeast core area. The park covers an area of ​​6 square kilometers, and stage one construction will cover 3 square kilometers. It will focus on the construction of bio-industry, pharmaceutical industry and irradiation industry etc. three bases. The High-tech Zone will provide great policy support for the first phase of settled projects. In 2011, the pharmaceutical enterprises above designated size in Changchun High-tech Zone realized output value of 3.8 billion yuan, profits of 310 million yuan; the total industrial output value accounted for 1.3% of the zone. According to statistics in late 2011, the High-Tech Zone currently has 176 biological and pharmaceutical enterprises, including 127 pharmaceutical enterprises (including genetic engineering drugs), 49 biotech companies (including bio-medicine).  Of the 127 pharmaceutical companies, there are 19 pharmaceutical class manufacturing enterprise. (including two genetic engineering enterprises, seven modern Chinese medicine enterprises, ten western medicine or chemical drug enterprises); 14 medical equipment production enterprises, five medical accessory material production enterprises, 24 pharmaceutical R & D enterprises and 65 pharmaceutical services sales enterprises. Of the 49 bio-pharmaceutical enterprises, there are seven biological pharmaceutical enterprises, and four biological agriculture enterprises (including biological food); 34 R & D enterprises, and four distribution services enterprises. In the whole zone, the existing bio-pharmaceutical companies produce over 600 varieties, including four class one new drugs such as hepatitis A vaccine, interleukin, 11 class two new drugs such as human growth hormone, interferon and 17 protected Chinese medicine type such as Weilexin. The industrial cluster advantage is obvious.

（6）Platform advantage

Changchun High-tech Zone exerts the advantage of R & D and innovation, promotes industrial agglomeration, strives to improve the international competitiveness of the bio-pharmaceutical industry, drives the regional industrial structure optimization and upgrading, and constructs nine public platforms. First: experimental animal breeding and experimental center; second: test center of genetically engineered drugs; third: technology center of biological enzyme engineering; fourth: vaccine research and development engineering center; fifth: drugs screen center; sixth: research center of Chinese medicine formulations; seventh: food and drug inspection and information consulting service center; eighth: public platform for Chinese medicine pretreatment; ninth: irradiation and sterilization device center. The construction of the nine platforms will play a crucial role for improving the biological and pharmaceutical industrial chains, and is conducive for enterprises to settle in the zone and invest in factories. In addition, the High-tech Zone also sets up specialized departments and Industry Bureau to serve related businesses and projects. Thus it has outstanding platform advantage.

1.2 Content and Scale of Project Construction

1.2.1 Product Scheme and Scale

Estimated annual output of 3 million, intending to purchase the equipment over 20 sets

1.2.2 Construction Content

The project has planning area of 20,000 square meters, with construction area of 14,000 square meters; the main buildings include R&D building and production workshop.

1.3 Total Investment and Funds Raising Plan of the Project

1.3.1 Total Investment of the Project (detailed in table 1)

The total investment is 100 million yuan, including construction investment of 65 million yuan, interest incurred in construction period of 3.9 million yuan, and working capital of 31.1 million yuan.

Table 1      List of Total Investments of Project     Unit: 10,000 yuan

Note: the “10,000 yuan” in the table is RMB.

1.4 Financial Analysis and Social Evaluation

1.4.1 Major Financial Indexes

In normal year of this project, the annual operating income is 1 billion yuan, profit of 2 billion yuan, the financial internal rate of return of total investments is 37%, the payback period (after tax) of total investments is 2.5 years, and the investment profit rate is 200%.

   Table 2   List of Major Indexes for Financial Benefits Forecast

Note: the “10,000 yuan” in the table is RMB.

1.4.2 Social Evaluation

Influenza is a high contagious disease, caused by the influenza virus, usually hit the respiratory tract and cause cough, sore throat, runny nose or nasal obstruction, and fever, extreme fatigue and muscle pain. Influenza can also cause bacterial pneumonia, dehydration, chronic complications and deterioration of disease, including congestive heart failure, asthma and diabetes etc., so it will cause a huge clinical damage and economic impact. In United States only, about 60 million patients suffering from the flu and lead to 200000-400000 patients must be hospitalized for treatment, and 35000 - 70000 patients died of it, among these patients, most of them are old military and children. The number of patients who die of flu is almost the same as patients who die of breast cancer. It is even 2-3 times than patients who die of HIV infection. The virus of flu brings vast suffering and disaster to the mankind. The vaccine formed by making the antigen active site (including B cell epitope and T cell epitope) of pathogen antigen gene series together and inserting into eukaryotic expression plasmid. It has more advantages than conventional DNA vaccine and can deal with the variation of the influenza virus and provide immune protection to multi-subtypes influenza virus. The implement of this project, not only has good economic efficiency, but also good for the health of human beings. It made great contribution to the great social benefits. In addition, the investment is big and the implement of project will bring a lot of employment opportunities for local city and it contributes to the stability of the region.

1.5 Cooperative Ways of the Project

Joint venture cooperation.

1.6 What to be Invested by Foreign Party

Capital.

1.7 Construction Site of the Project

The Changchun Northeast Core Area of Changchun High-Tech Development Zone

1.8 The On-going Condition of Project

Project cooperation plan has been compiled.

2. Introduction to Partner

2.1 Basic Conditions

Name: Administrative Committee of Changchun National High-Tech Industrial Development Zone

Address: 3333 of Silicon Valley Street, Changchun City

Legal representative: Sun Yaming

2.2 Overview

Changchun High-Tech Industrial Development Zone is the first batched of state-level high-tech industrial development zone approved by the State Council in 1991. It is the first development zone in JilinProvince, and the first state-level development zone. It is located in the southwest of ChangchunCity, known as "City of Science and Technology", “CulturalCity", with a total area of ​​78.6 square kilometers.

Changchun High-tech Zone has created a BiomedicalPark, Modernized Science and Technology Industrial Park of Traditional Chinese Medicine, PhotovoltaicTechnologyIndustrial Park, Automotive Research and DevelopmentPark, ChangchunSoftwarePark, and New Material Industrial Park etc. The development pattern of multi-parks in one zone has formed. The Biomedical Park and Modernized Science and Technology Industrial Park of Traditional Chinese Medicine is settled by 110 pharmaceutical enterprises, and 13 enterprises have output value of over 100 million yuan, with over 400 varieties, and more than 150 research projects. There are many biopharmaceutical companies, and a large number of biological vaccines and genetically engineered products account for a considerable share of the domestic and foreign markets. Of the 10 genetically engineered drugs approved by the city, 6 are from the High-tech Zone. Of the 26 kinds of vaccine products with production capacity in ChangchunCity, 24 kinds are from the High-tech Zone. The zone has Asia's largest vaccine and cytokine production base. The production capacity of interferon suppositories ranks the first in the country. The sales of attenuated hepatitis A vaccine account for more than 40% of the domestic market. Interleukins, human growth hormone and other biological drugs are sold in the domestic and foreign markets. AIDS vaccine developed by enterprises in the region enters the clinical research first. The Modernized Science and Technology Industrial Park of Traditional Chinese Medicine, as the main park of the National Modernization of Traditional Chinese Medicine Industry (Jilin) base, has been settled by Jilin Tian Pharmaceutical, Xiuzheng Pharmaceutical and Chenguang Pharmaceutical etc., which produce 21 varieties of national protected Chinese medicine.

In 2010, the total revenue and total industrial output value of Changchun High-tech Development Zone had exceeded 200 billion yuan, realizing 239.6 billion yuan, 237.4 billion yuan respectively, which is 1.8 times that of 2008, of which: the disposable financial resources exceeded 9 billion yuan, 25 times of 2008. Changchun High-tech Zone will create two trillion yuan economic uplift belt around “five industrial parks” of advanced equipment manufacturing, biological medicine, new materials, and new energy etc. It will accelerate the construction of Changchun Northeast Technology Innovation Center, Business Center, production means logistics center of science and technology, as well as sports and leisure center in the south district of Changchun High-Tech Zone, and construct high-end service area; it will also pay close attention to professional investment attraction, and begin targeted investment attraction around the cultural and creative industrial park in the south district of Changchun High-Tech Zone, Comprehensive Technological Enterprise Incubator in the north district, Olympic Park, as well as Cultural Tourism Industrial Park. It will strive to introduce three Fortune 500 companies and ten 10 central enterprises.

Sun Yaming, director of the Administrative Committee, male, born in August 1957, Han, member of the Chinese Communist Party, postgraduate degree from the Provincial Party School, was member of the standing committee of Changchun Lvyuan Party Committee, secretary of Commission for Discipline Inspection, member of the standing committee of Lvyuan District Committee, director of the Organization Department, deputy secretary and mayor of Lvyuan District Committee, secretary of Kuancheng District Committee. Currently, he is assistant mayor of ChangchunCity, director (Vice municipal level of ChangchunCity) of the administrative committee of Changchun Hi-tech Industrial Development Zone. On July 22, 2011, the 13^th session of the Standing Committee of NPC of Changchun held the 28^th meeting. On the meeting, Sun Yaming was appointed vice mayor of ChangchunCity.

2.3 Contact Method

Contact person of project undertaker: Li Tiangang

Tel：13578712560

Fax: 86-431-85542548

E-mail：lee-66666@163.com

Website: http://www.chida.gov.cn/

 

Contact person of city (prefecture) of project：Lou Huimin

Tel：0431-82715338  13943008496

Fax：0431-82715338

E-mail：cc82715338@126.com

Website：www.ccmbc.com