Recombinant Vaccine Production Project in AIDS Genetic Engineering Treatment and Prevention

Recombinant Vaccine Production Project in AIDS Genetic Engineering Treatment and Prevention of Changchun City

 

1. Introduction to the Project

1.1 Project Background

1.1.1 Product Introduction

AIDS is called “plague of the century”. Human has not yet found the ideal way to heal this chronic problem. The commonly used "Cocktail" therapy lets the patients take antiretroviral enzymes etc. antiviral drugs to control the further development of the disease, but it can not completely kill the virus, and also produces toxic side effects. The new idea of inhibiting HIV by “therapeutic vaccines” was first proposed by Professor Lu Wei, a Chinese origin scholar from the University of Paris, France, and its principle is: Since the major problem of AIDS patients is the loss of immune function, so long as we can find a method to effectively trigger and restore its own immunity, the disease should be controlled.  Under the situation that a number of people living with AIDS or HIV infection often can not withstand a series of chemical anti-retroviral drug therapy for a long time, the purpose of vaccine treatment is let patients not receive or receive less the threat imposed by virus proliferation under the condition of stopping using antiretroviral therapy. In the current period of increasing number of HIV-infected people and high-risk groups, combined with the HIV epidemic strains, it is imperative to develop therapeutic vaccine for HIV-infected persons by using genetic engineering means. This project is to use genetic engineering means to produce AIDS treatment and prevention recombinant vaccine. The products mainly solve the joint immunization and treatment of HIV-infected people and healthy people. Starting from research on AIDS pathogen, with viral genome structure and function research as entry point, it will make full use of the research results and comprehensive knowledge of modern molecular virology, molecular biology, immunology, infectious disease, bio-informatics etc., carry on research on new genetic engineering, and develop a vaccine to effectively trigger and restore its immunity, thus controlling the disease.  

1.1.2 Market Prospects

At present AIDS epidemic is rampant worldwide, particularly in Africa and Asia. WHO reports that worldwide, there are 34 million HIV carriers and AIDS patients in 2011, new infections of 2.7 million, and 1.8 million people die of it throughout the year. There are more than 7,000 new infections daily, spread in all regions of the world. But more than 97% occur in low-income countries, especially Africa. Experts estimate that the serious epidemic area in the world may be moved from Africa to Asia. The China CDC estimates that, until the end of 2011, China living HIV carriers and AIDS patients are about 780,000 people, with 48,000 new infections and 28,000 people dying of it. The epidemic has covered all the country's provinces, autonomous regions and municipalities directly under the Central Government, and at present, China faces the peak period of AIDS morbidity and mortality. And it has spread from drug abusers and unlicensed prostitute etc. high-risk groups to the general population. According to the statistical analysis of the Ministry of Health, in recent years, AIDS transmission in China shows rapid growth tendency, and the major transmission is injecting drug use, accounting for 68% of the total. There is 9.7% of infection transmitting through blood collection, plasma, 1.5% transmitting through blood products. For other transmission means, sexual contact accounts for 7.2%, mother-to-child transmission accounts for 0.2%, and the remaining 13.4% of transmission means are unknown.

At present in the world, several drugs have been approved for the clinical treatment of AIDS, but they are expensive, and globally, only about 5% of HIV-infected persons can afford to receive treatment. On the other hand, these AIDS drugs have side effects, resistance, and do not apply to China as well as developing countries. At home and abroad in recent years, most scientists once again focus on research and development of new AIDS genetically engineered recombinant vaccines, and consider that a safe, effective vaccine is the only possible way to stop the AIDS epidemic. Vaccine includes preventive vaccine and therapeutic vaccine. The role of preventive vaccine is to prevent virus infection, but the role of therapeutic vaccine is to induce the human immune system to resist the damage of virus to the human body, or enhance the virus resistance ability of the immune system. It is targeted to the people who have been infected with the virus. The (AIDS) gene therapy and prevention vaccine is the new type anti-HIV-infected genetically engineered recombinant vaccine, which is developed through nearly 20 years of exploration, research and screening, identification by more than 40 doctors and masters in the project team, with prevention and treatment dual effects. It belongs to the state class one biological product. The product, through inoculation body, is able to induce the body to produce specific cellular and humoral immune response, reaching the purpose of preventing virus infection or excellently killing the free virus in the body and virus-infected cells, thus clearing the virus in the body. It can not only be used for immunization among healthy people as a preventive vaccine, also be used as therapeutic vaccine among the HIV-infected people or AIDS patients. The project group starts from research on AIDS pathogen, with virus genome structure and function research as the starting point. It makes full use of the research results and comprehensive knowledge in modern molecular virology, molecular biology, immunology, infectious disease, bio-informatics to carry on research on new genetic engineering, and has developed a way to effectively trigger and restore its own immunity and control the disease. Compared to other AIDS clinical treatment method, this project not only has cost advantage, but also is safe, effective and has very broad market prospects.

1.1.3 Technical Analysis

The products mainly solve the joint immunization and treatment of HIV-infected people and healthy people. Starting from research on AIDS pathogen, with viral genome structure and function research as entry point, it will make full use of the research results and comprehensive knowledge of modern molecular virology, molecular biology, immunology, infectious disease, bio-informatics etc., carry on research on new genetic engineering, and develop a vaccine to effectively trigger and restore its immunity, thus controlling the disease. The technologies used by the project are all self-owned technologies of research institutions within the park, with independent intellectual property rights, without technical risk. The product uses advanced technology and equipment, designs according to the new GMP requirements, and fully meets the strict production process standards of the country.

1.1.4 Advantageous Conditions of Project Construction

（1）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. ChangchunCity 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.

（2）Policy conditions

In a new round of development strategy of Changchun High-tech Zone, bio-pharmaceutical industry will be considered as one of the key developed pillar industries. Combined with the resources in JilinProvince and ChangchunCity, the human resource advantage, and the unique industrial features of Changchun High-tech Zone, Northeast Biological and Medical Science and TechnologyIndustrial Park in Changchun High-tech Zone Changchun Northeast Core Area is planned. It will be created into the core area of bio-pharmaceutical industry of JilinProvince, and Asia's largest bio-vaccine industry base. The country, province, and municipalities as well as industrial park all have supportive policies on the development of the industry.

（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, 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.

Changchun northeast core area carries on planning and design by adhering to the standard of international metropolis and large city center area. It has carefully established Yuanda Street, the longest across-lake railway bridge—Beihu Bridge, the Yuanda  interchange overpass, known as “first bridge in northeast”, the special railway line with a total investment of 1.14 billion yuan, and container freight station etc. a series of major infrastructure projects. In addition, water, electricity, gas, heat, and communications and other utilities follow up synchronously. 56km east of the railway, infrastructure basically has full coverage.

（4）Transport 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.

In addition, 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 foundation advantage

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.

（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

This project will introduce over 30 sets of advanced experiment equipments, with expected annual output of 3 million pieces.

1.2.2 Construction content

The planned area of project is 20,000 square meters, mainly building R & D building, production workshop etc. with a construction area of 14,000 m².

1.3 Total Investment and Funds Raising of the Project

Total investment of the project is 200 million yuan, including construction investment of 110 million yuan, interest incurred in construction period of 3.9 million yuan, and working capital of 86.1 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, it will realize operating income of 1 billion yuan, profit of 200 million yuan, financial internal rate of return of total investment of 70%, payback period (after tax) of all investment of 3.2 years, and profit rate of investment of 85%.

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

Since 1983 when human first discovered HIV, AIDS has become a serious public health problem that threatens the health of the people in the world. Until the end of 2011, China's living HIV carriers and AIDS patients are about 780,000 people, with 48,000 new infections and 28,000 people dying of it. The epidemic has covered all the country's provinces, autonomous regions and municipalities directly under the Central Government. Currently, our country faces the peak period of AIDS morbidity and mortality. The implementation of this project not only has good economic returns, but also makes a great contribution to human health, thus it has great social benefits. In addition, due to the huge investment of the project, the implementation of the project will bring a lot of employment opportunities for the local place, thus making some contribution 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 Condition

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 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 of city or prefecture：www.ccmbc.com