Dual Specific Antitumor Recombinant Adenovirus Preparation Production Project

Dual Specific Antitumor Recombinant Adenovirus Preparation Production Project

of Changchun City

 

1. Introduction to the Project

1.1 Project Background

1.1.1 Product Introduction

The dual specific antitumor recombinant adeno virus preparation is a kind of total new antitumor biological preparation, it can significantly inhibit and kill cancer cells and improve the body's ability of resistance to tumor, and can be used for treatment of various tumor. In the technology, mainly use the technologies and methods of molecular biology, virology, immunology and etc. and means to explore existing problem of safety and efficacy in the process of antitumor, so as to achieve the aim of effective treatment.

1.1.2 Market Prospects

Traditional tumor therapy methods including: surgical treatment, radiotherapy and chemotherapy. Malignant tumor has features of easy infiltration, early transfer, so when some of the patients have been diagnosed, they have been basically lost the timing of surgery. At the same time, due to the limit of growth place and histological type, some patients can't do surgery. When radiation therapy and chemotherapy kill tumor cells, they also kill the normal cells; have big damage to human body. Targeting property of radiation therapy is poor, it affects the treatment effect, and tumor’s drug resistance largely limits the application and curative effect of chemical treatment.

Along with the development of cell biology, immunology and the molecular biology, tumor biological treatment becomes new hope to cancer patients. It includes gene therapy, somatic cell therapy, cytokine therapy, monoclonal antibodies, tumor vaccines, dendritic cells, molecular targeted therapy, radiation immune targeted therapy, biological reaction regulator and biological chemotherapy. The study of gene therapy is the widest. One of the key technologies to tumor gene therapy is selecting efficient and safe gene carriers. Adenovirus vector has advantages of host cell widely, high transduction efficiency, high expression level, easy breeding and purification, high virus titer, so it is suitable for use in the body. The characteristics of not integrated into the host cell genome, has gradually become the widest used carrier in gene therapy. But with the gradual in-depth study of adenovirus vector, it constantly exposed some defects, for example, in the process of construction of the recombinant adenovirus, it is easy to generate wild virus pollution, thus affects the appraisal and purification. Adenovirus host range is wide, so it is lack of specificity and etc. Another key technology of cancer gene therapy is selection of specificity anti-tumor gene. The dual specific antitumor recombinant adeno virus preparation can solve the problem of replicated adenovirus pollution and significant inhibition and kill cancer cells and improve the body's ability of resistance to tumor while producing resistance, it can be used for treatment of various tumor.

According to estimates of the world health organization (WHO), there are 10 million new cancer patients and 6-7 million patients died of cancer. According to the current trend of the pathogenesis of tumor in related reports, in 2020 the world’s cancer incidence of a disease will be increased by 50% than it is now, the number of new cancer patients each year will reach 15 million. In our country, the tumor has ranked in top one in cause of death in the urban, ranked in top two in the countryside. There are more than 1.4 million of new tumor patients per year, death of more than 1 million; cancer has become the top one killer which threat life. Compared with the high demand of cancer drugs in domestic and international market, tumor’s medical level is very limited. Most of the early patients can be cured, and terminal cancer patients rarely can survive for more than 5 years after treatment. Effective antitumor products will have good market prospects. At the same time, the cost of a period treatment of biological agents is only more than ten yuan, the retail price for hundreds yuan. If there are 10% of cancer patients in domestic use the gene vaccine, the annual sales will be several hundred million yuan.

For market positioning, mainly develop in domestic market.

For market sales channels, mainly go through the agent, medicine business companies and etc.

This project is medium scale investment, it can integrate the existing resources, the construction period is short, and has advantages of labor, technology, manufacturing cost and etc., also can adopt differentiation of the low cost market strategy.

1.1.3 Technical Analysis

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. In the technology, mainly use the technologies and methods of molecular biology, virology, immunology and etc. and means to explore existing problem of safety and efficacy in the process of antitumor, so as to achieve the aim of effective treatment.

1.1.4 Advantageous Conditions of Project Construction

（1）Policy conditions

The "the 12^th Five-Year Plan" of our province puts forward to comprehensively implement characteristic resource industry of Jilin Province, including unique ecological resources industry. Relying on ginseng, mineral water, sika deer, Rana etc. ecological resources, it actively promotes the protection of geographically marked products, adheres to characteristics, implements standardization, promotes industrialization, and achieves economies of scale. It seizes the significant opportunity of homology of medicine and food of the country, accelerates the implementation of revitalization of the ginseng industry, actively promotes the construction of key industrial parks, nurtures the “Changbai Mountain Ginseng” brand, and builds 100 billion yuan industry. The output value will reach 50 billion yuan in 2015. For pharmaceutical industry, it puts forward relying on the biological drug research and talent advantage of the province, promotes the upgrading of current vaccine production technology and expansion of production capacity, make efforts to expand the domestic market share and exports of recombinant human insulin, recombinant human growth hormone etc. biotechnological drugs, accelerates the development and industrialization of AIDS vaccine etc. a number of new varieties, and seizes the commanding height of future development of biomedicine. We can see that the development of the bio-pharmaceutical industry is facing unprecedented opportunities.

Changchun High-Tech Zone has developed the “measures of Changchun High-tech Zone for preferential policies in investment attraction of strategic emerging industries”. Favorable policy support will be given according to the investment amount and construction scale of the project.

（2）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.

The preliminary project location is in the Changchun northeast core area of Changchun High-tech Industrial Development Zone. In the north district, the “seven connections and one leveling” has basically been completed, with basic conditions for project construction and operation. Changchun High-tech Zone is the first batch of state-level development zone approved by the State Council in 1991, with an area of ​​150 square kilometers. After 21 years of development, Changchun High-tech Zone has formed good industrial base, strong ability to innovate and prominent brand advantage. The High-tech Zone has been the advanced State High-tech Zone appraised by the Ministry of Science and Technology, and owns 12 national parks and bases.

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.

（3）Technical advantage

Changchun High-tech Zone is settled by over 100 pharmaceutical companies, 13 enterprises have output value exceeding 100 million yuan. The produced variety covers over 400, with more than 150 under-research projects. There are a number of biopharmaceutical companies, and a large batch of biological vaccines and genetically engineered products account for a considerable share on the domestic and foreign markets. Of the ten genetically engineered drugs approved by the city, there are six 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. For example, chicken pox vaccine accounts for over one third of the South Korean market. The zone owns Asia's largest vaccine and cytokine production base. The production capacity of interferon 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. The AIDS vaccine developed by enterprises in the zone first enters clinical research in the country.

In Changchun High-tech Zone, there is Changchun Biological Products Institute, Genetic Engineering Institute of Quartermaster University of the PLA, Changchun College of Traditional Chinese Medicine, Research Center of Combinatorial Chemistry of Jilin University, Enzyme Engineering State Key Laboratory of Jilin University, Genetics and Cytology Institute of Northeast Normal University, and Herbal Medicines College of Jilin Agricultural University etc. medical research institutions. This constitutes a multidisciplinary technology integration advantage, which is rare in the country.

This project has independent intellectual property rights, mainly use technologies of molecular biology, virology and immunology, designs to explore the safety and efficacy problem in antitumor process, so as to achieve effective therapeutic purposes.

（4）Human resource advantage

Changchun High-tech Zone is a famous high-level talents concentration area in China. In the field of bio-medicine, it has a number of high-level technical experts and overseas returnee elite. In 2009, it had 24 academicians, including eight in the field of biomedicine and related fields, 146 experts enjoy the special allowance of the nation and province, 190 doctoral tutors, and over 100 senior overseas returnees in biomedicine

It has the cultivation ability of various talents in the fields of biology and medicine. There are 15 higher institutions in Changchun that sets biotechnology and pharmaceutical and related programs. The majors cover biochemistry, bio-pharmaceutical, biotechnology, bio-engineering, Chinese medicine etc. more than 40 majors. There are 93 postgraduate programs, 18 doctoral programs and six postdoctoral workstations. The body of undergraduate students in related field is more than 10,000, and a perfect bio-technology and pharmaceutical personnel training system has formed. Each year, over 4000 professional and technical personnel will enter the society. JilinUniversity, NortheastNormalUniversity is designated by the Ministry of Education as national bio-technology training base.

It has experienced, strong biopharmaceutical industry workforce. Currently, staff of Changchun pharmaceutical industry has reached more than 20,000 people, including more than 100 doctors, more than 500 masters; junior college graduates account for more than 35% of the total number of employees, and biomedical sciences professional and technical personnel account for more than 10% of the total number of workers. The company has a group of entrepreneurs with management and technology skill, which ensures the healthy development of pharmaceutical industry.

（5）Industrial foundation 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.

Of the 87 pharmaceutical companies in Changchun, there are 20 enterprises with annual output value exceeding 100 million yuan, and 26 enterprises with single variety of over 10 million yuan. Currently, in the city's 4,036 registered pharmaceutical varieties, there are more than 120 biopharmaceutical varieties. In 2008, the output value of the city’s biopharmaceutical industry accounted for 79% of the output value of the city's pharmaceutical industry, and bio-pharmaceutical profits and taxes account for 81% of the total profits and taxes of the city's pharmaceutical industry, which has laid the industrial foundation for biopharmaceutical industry in Changchun. The distinctive bio-pharmaceutical enterprise group, led by Changchun Institute of Biological Products, Changchun Changsheng Technology, Changchun Kinsey Pharmaceutical, Jilin Xiuzheng Pharmaceutical, has been formed.

ChangchunCity has a large batch of fresh meat slaughtering and processing enterprises, such as Haoyue Group, Huazheng Group, Deda Group etc. The enterprises not only provide delicious food for the people, more importantly, they can provide more experimental animal samples for biological and pharmaceutical enterprises. Thus they are favorable resource backing for developing genetic engineering, and serum extraction industry.

1.2 Construction Content and Scale

1.2.1 Product Project and Scale

Annual output of dual specific antitumor recombinant adeno virus preparation of 3 million

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 and intending to purchase the equipment 50 sets.

1.3 Total Investment of the Project

The total investment is 200 million yuan, including construction investment of 106 million yuan, interest incurred in construction period of 4 million yuan, and working capital of 90 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 200 million yuan, the financial internal rate of return of total investments is 17%, the payback period (after tax) of total investments is 3 years, and the investment profit rate is 85%.

   Table 2   List of Major Indexes for Financial Benefits Forecast

Note: the “100 million yuan” in the table is RMB.

1.4.2 Social Evaluation

Along with continuous development of our economic, health problems have been universal attention in society. In our country, the tumor has ranked in top one in cause of death in the urban, ranked in top two in the countryside. There are more than 1.4 million of new tumor patients per year, death of more than 1 million; cancer has become the top one killer which threat life. The product of this project is committed to fight against tumor which is the world-class problem, it will have a positive impact on the health of human society.

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 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