Recombinant Fowlpox VirusAnti-TumorCandidate Drug Production Project

Recombinant Fowlpox VirusAnti-TumorCandidate Drug Production Project of ChangchunCity

 

1. Introduction to the Project

1.1 Project Background

1.1.1 Product Introduction

According to medical studies, after surgery, radiotherapy and chemotherapy, the body of patients still has remnant “testable” tumor stem cells, whose growth ability is 200 times that of ordinary cancer cells, and are more prone to metastasis. In addition, radiation and chemotherapy has strong side effects. Because the various parts of the patient's body organs are damaged, the immune function drops sharply, showing the imbalance of counting of red and white blood cells, loss of appetite, nausea, vomiting, weight loss, lack of energy, fatigue , anxiety, irritability and other symptoms. It seriously impacts on the survival and quality of life. Radiotherapy and chemotherapy often does not distinguish between good and bad cells. When killing tumor cells, it also kills a large number of normal immune cells. It deteriorates the already fragile immune system of tumor patients. Once human immune system declines, the static cells and Mg carcinoma on other parts of the body loses regulation and form new tumor site. Another reason why the current anti-cancer therapy approach can not "exterminate" the tumor cells is because these therapies target to the majority of non-proliferating cells in the outer periphery of the tumor. It can not affect the internal proliferation cell of tumor (cancer stem cells). Thus it only cures the symptoms, not the disease. The recombinant fowlpox virus anti-tumor candidate drug produced in this project only inhibits and kills tumor cells, without toxic side effects on normal tissue cells. And its live vector only causes the necessary abortion infection (only infection, no proliferation) for inhibiting tumor, thus it has highly safety. Technically, it adopts molecular biology, virology and immunology, aims to explore the safety and efficacy problem in anti-tumor process, so as to achieve the purpose of effective treatment.

1.1.2 Market Prospects

Due to the changes of living environment and lifestyle, as well as population aging, increase of survival pressure etc. objective factors, the incidence rate of malignant tumors in China rises, and it has become the number one lethal disease. 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 over 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%, 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, while the "BRIC" will become the world's fastest-growing market for anti-tumor drugs in the world. The recombinant fowlpox virus anti-tumor drug candidate produced in this project can inhibit and kill tumor cells, without toxic side effects on normal tissue cells, and the live vector only causes necessary abortion infection (infection not only proliferation) in inhibiting tumor. It has a higher level of safety, is suitable for cancer patients, and has very broad market prospects.

1.1.3 Technical Analysis

The recombinant fowlpox virus anti-tumor drug candidate produced in this project can inhibit and kill tumor cells, without toxic side effects on normal tissue cells. Technically, it mainly adopts molecular biology, virology and immunology, aims to explore the safety and efficacy problems in anti-tumor process. 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）Policy conditions

Changchun High-tech Zone is a famous high-level talents concentration area in China. Over ten famous universities and colleges, such as Jilin University, Changchun Institute of Light Machine, are located in the area. There are over 100,000 undergraduate students, and over 10,000 doctors and masters. Changchun Branch of Chinese Academy of Sciences, Changchun Institute of Light Machine, Changchun Applied Chemistry Institute etc. 39 national and ministerial level research institutions, 12 research institutions, 8 computing testing centers and 11 key open labs of the nation in Changchun are all concentrated in Changchun High-tech Zone. It owns 200,000 talents of every field, including professional technical talent of 50,000, and 6,000 senior talents participated in starting business, accounting for over one half of that in Changchun City. The percentage of scientific and technological talents is as high as 16.6%. The scientific research strength is concentrated, scientific instruments and equipments are concentrated, technological information and intelligence is concentrated, and hi-tech and scientific fruits are concentrated. It is the famous high-level talents concentration area and ideal place for developing hi-tech industry. Changchun has a long history in bio-pharmaceutical and traditional Chinese medicine industry, with a lot of industrial workers in this field. In addition, in order to ensure the sustainability of human resources, since 2011, with creating “Changbai Intelligence Valley” that takes gathering talents as the goal, Changchun High-tech Zone starts the construction of “talent special zone”, focuses on the four plans of “gathering of overseas high-end leading talent, introduction of high-level creative talents, enhancement of senior management personnel, and growth of highly skilled personnel”. Each year, it will allocate 100 million yuan to support innovation and entrepreneurship. A batch of industrial leading talent and senior management personnel has been gathered. It has obvious talent advantage.

（3）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.

（4）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.

（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）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. Thus the supporting infrastructure is excellent.

1.2 Content and Scale of Project Construction

1.2.1 Product Scheme and Scale

The project plans to newly purchase equipment of over 50 sets (units), with annual production of 2 million pieces.

1.2.2 Construction Content

The project covers an area of 20,000 square meters, including 14,000 square meters of construction area. The main buildings include R & D building, production workshop etc.

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 100 million yuan, including construction investment of 60 million yuan, interest incurred in construction period of 3.9 million yuan, and working capital of 36.1 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 27%, payback period (after tax) of all investment of 2.5 years, and profit rate of investment of 200%.

List of Major Indexes for Financial Benefits Forecast

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

1.4.2 Social Evaluation

Due to the changes of living environment and lifestyle, as well as population aging, increase of survival pressure etc. objective factors, the incidence rate of malignant tumors in China rises, and it has become the number one lethal disease endangering the health of people. According to related information, every year in the world, about 870,000 people are infected with tumor, and 6,900,000 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. The recombinant fowlpox virus anti-tumor drug candidate produced in this project only inhibits and kills tumor cells, without toxic side effects on normal tissue cells, and part of the live vector only causes necessary abortion infection (infection is not only proliferation) in inhibiting tumor. Thus it is highly safe. 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