New Genetically Engineered Anti-Tumor Therapeutic Vaccine Production Project

New Genetically Engineered Anti-Tumor Therapeutic Vaccine Production Project of Changchun City

 

1. Introduction to the Project

1.1 Project Background

1.1.1 Product Introduction

Anti-tumor vaccine, the product of the project is one of the hot research topics in recent years. The principle is to enhance the body's ability to fight cancer by activating the patient's own immune system through inducing the specific cellular and humoral immune response of tumor cells or tumor antigen substance to prevent tumor growth, proliferation and recurrence, in order to achieve the purpose of removal or control of tumor. The anti-cancer vaccine is derived from autologous or allogeneic tumor cells or crude extract thereof it has tumor-specific antigen or tumor associated antigen. It can attack tumor cells through stimulating specific immune function, overcome the immune suppression caused by tumor products, enhance the immunogenicity of TAA, and improve its own immunity and destroy the tumor. The TSA immunotherapy can start the anti-tumor effect based on tumor-specific cytotoxic T lymphocyte response, effectively combat tumor, prevent metastasis, recurrence and not injure unrelated tissue. Its anti-tumor specific feature and immune memory can not be compared. It can not only independently treat tumors, but also can combine with surgery, radiotherapy, and chemotherapy. Thus it has merits of high efficacy, strong specificity, and small adverse reactions. Especially for advanced metastatic malignant tumor, it has a unique treatment role. Therefore, it plays an important role in comprehensive cancer treatment. The product of this project is a completely new type anti-tumor biological agent, which can significantly inhibit and kill tumor cells, improve the body's anti-tumor ability, and can be used for the treatment of a variety of tumors. Tumor vaccine immunotherapy is to stimulate and enhance the body’s active tumor-specific immune response by using tumor antigen for active immunization. This new anti-tumor gene vaccine is mainly applied in molecular biology technique. It screens and clones new anti-tumor gene, constructs anti-tumor gene vaccine with it, and is suitable for cancer patients.

1.1.2 Market Prospects

Research and development of anticancer drugs in China began in the late 1950s of the last century, and in the early 1960s, there had been produced varieties. The anticancer drug in China has developed from scratch, from small number of variety to series production. For more than 30 years, especially in the past 10 years, the development of anticancer drugs in China has made remarkable achievements. In 2010, China's anticancer drug production enterprises have grown to nearly three hundred. “Forecast report on the anti-tumor market trend of China in 2011” shows: there are 7 categories, more than 160 varieties of anticancer drugs in China. There are 50-60 varieties of internationally commonly used anticancer drugs with recognized efficacy. Of the 49 commonly used anticancer drugs announced by WHO, China can produce more than 40 kinds, accounting for more than 86%. At present, China's annual production of anticancer drugs are more than 30 tons, mainly in Shanghai, Jiangsu, Zhejiang, Shandong and other places.

“Forecast report on the anti-tumor market trend of China in 2011” shows: in 2010, the sales revenue of anticancer drugs achieved 5.845 billion yuan, jumped by 67% compared to 2009; during 2005--2011, the annual average compound growth of anti-tumor drugs also reached 42.7%. Anti-tumor drugs have become the category with the fastest growth speed among the drugs used in hospitals of China. Malignant tumor has become China's second largest fatal disease (the first fatal disease for urban residents). The new incidence of male and female malignant tumor is 130.3～305.4/100,000 people and 39.5～248.7/100,000 people respectively, and the incidence is increasing year by year.  Lung cancer and breast cancer respectively possesses the first among the malignant tumors in men and women. “Forecast report on the anti-tumor market trend of China in 2011” predicts that to 2020, China will have 5.5 million new cancer cases, and the death toll will reach 4 million. 

According to forecast of “Forecast report on the anti-tumor market trend of China in 2011”, in the future, the annual growth rate of anti-tumor market will reach 15% in the world, far exceeding the growth rate of other drugs. Till 2012, the total sales revenue of anti-tumor drugs in the world market will reach about 80 billion USD, the sales volume in the market will have been more than 100 billion USD by 2015, while the "BRIC" will become the world's fastest-growing market for anti-tumor drugs in the world.

The product produced in this project is a new type anti-tumor biological agent. It can significantly inhibit and kill tumor cells, improve the body's anti-tumor ability, can be used for the treatment of a variety of tumors, and is suitable for cancer patients. Thus it has very broad market prospects.

1.1.3 Technical Analysis

Tumor vaccine immunotherapy uses tumor antigen for active immunization to stimulate and enhance the body’s active tumor-specific immune response. The product of this project is a new type anti-tumor biological agent. It can significantly inhibit and kill tumor cells, improve the body's anti-tumor ability, and can be used for the treatment of a variety of tumors. The new anti-tumor gene vaccine produced in this project is mainly applied in molecular biology technique, and it screens and clones new type anti-tumor gene. All the technologies used in this project are independently researched by the research institutions in the park, with independent intellectual property rights, and there is no technical risk.

1.1.4 Advantageous Conditions of Project Construction

（1）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.

（2）Human resource advantage

ChangchunCity is a famous cultural city of China. The per capita number of college students in Changchun ranks the 6^th in the country. Changchun High-tech Zone has total human resources of about 90,000 people, including high-end creative talents of 30000, accounting for more than 60% of the city; more than 2,400 doctors, masters, and 1,000 overseas returnees, as well as 242 people who lead the founding of corporations, 21 academicians, 23 experts that obtain the subsidy of talent development fund of the provincial government, accounting for 62.5% of the city's total. A team of high-level personnel that covers all fields, with reasonable echelon, good quality, convergence of old and new, and can meet the development needs of innovative enterprises has been formed. Around the strategic emerging industries and high-end services, within five years, it will introduce 30 overseas high-end and leading talents, introduce and cultivate 200 high-level innovative talents that will start business, 300 senior management personnel, and 1000 highly skilled personnel. By 2015, the total amount of human resources in the region will reach 145,000 people, and over 100 star enterprises led by high-level personnel, and that have an important support and leading role in regional development will be cultivated.

（3）Policy conditions

（4）Scientific research advantage

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. Changchun High-tech Zone cooperates with "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, to establish “strategic alliance in technological innovation”. It 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. Thus it has obvious advantage in scientific research.

（5）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.

（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.

（7）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.

1.2 Content and Scale of Project Construction

1.2.1 Product Scheme and Scale

After the project is completed, it will reach the capacity of annually producing 3 million pieces per year.

1.2.2 Construction Content

The project covers an area of 30,000 square meters, including 21,000 square meters of construction area. The construction contents are mainly the R & D building, production workshop.

1.3 Total Investment and Funds Raising of the Project

1.3.1 Total Investment（detailed in table 1）

Total investment of the project is 300 million yuan, including construction investment of 120 million yuan, interest incurred in construction period of 7.8 million yuan, and working capital of 72.2 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 1.2 billion yuan, profit of 200 million yuan, financial internal rate of return of total investment of 21%, payback period (after tax) of all investment of 3.0 years, and profit rate of investment of 100%.

 

List of Major Indexes for Financial Benefits Forecast

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

1.4.2 Social Evaluation

Malignant tumor has become the number one killer endangering the health of people. According to related information, every year in the world, about 870,000 people are infected with tumor, and 6900,000 people die of it; only in China, there are 1.05 million people dying from advanced malignant tumor each year. Therefore, it is imperative to seek effective means for cancer treatment. With the rapid development of immunology, cell biology and molecular biology, following tumor surgery, radiotherapy and chemotherapy three treatment methods, new type genetically engineered anti-tumor therapeutic vaccine has become the fourth treatment method of tumor. The product of this project is a new type of anti-tumor biological agent. It can significantly inhibit and kill tumor cells, improve the body's anti-tumor ability, and can be used for the treatment of a variety of tumors. Tumor vaccine immunotherapy uses tumor antigen for active immunization to stimulate and enhance the body’s active tumor-specific immune response. This new anti-tumor gene vaccine is mainly applied in molecular biology technique. It screens and clones new anti-tumor gene, constructs anti-tumor gene vaccine with it, and is suitable for cancer patients. The implementation of this project not only has good economic returns, but also makes great contributions to human health, with 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 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