Medicine & Health

 

1. Introduction to Project

1.1Project Background

1.1.1Introduction to Product

Therapy cetuximab (trade name "Erbitux") is a monoclonal antibody drug. Used alone or in combination with irinotecan (irinotecan) for linking to irinotecan-based chemotherapy drug for metastatic colorectal cancer. Cetuximab monoclonal antibody (Cetuximab) for the EGF receptor IgG1 monoclonal antibody that specifically binds two by binding to the EGF receptor tyrosine kinase (TK) inhibition, blocking intracellular signal transduction pathway, thereby inhibiting cancer cell proliferation and induce apoptosis of cancer cells, reducing matrix metalloproteinase and vascular endothelial growth factor production.

Antibody technology, as an important part of the biotechnology industry and new medicine, is the major scientific achievement of the twentieth century and the current important medical technology frontier. The " Twelfth Five-Year Plan for National Economic and Social Development of the People's Republic of China " and the “National Strategic Emerging Industry Development Plan for the ‘Twelfth Five-Year’” list antibody drug as one of seven strategic emerging industries; local governments have also introduced the relevant support policies and measures, and biopharmaceutical has become a new growth point in the pharmaceutical industry.

The achievements by the research team of Hopkins Institute of Medicine after years of research and research has broken large-scale fermentation and quality control and other technical problems, and mature technology platform technology has been established. At present, the project is in the pilot study stage, pilot scale is up to 200 L-500 L, and antibody expression amount is up to 1.5-2 g / L.

1.1.2 Market Prospects

(1) Analysis of Current Situation

Colorectal cancer is a common malignancy of neutrality, and the incidence rate is second only to lung cancer and stomach cancer, ranking the third. The incidence rate in urban areas grows with the rate of 4.5% per year. In recent years, in Shanghai, Beijing and other big cities, the incidence of colorectal cancer has far exceeded the growth rate in Western countries. The age of onset of colorectal cancer in China is more than 40-60 years, the peak is at about 50 years old, and colorectal cancer patients under age 30 are not uncommon. The median incidence age of colorectal cancer in China is earlier than in Europe for about 10 years, and it is more common in young patients than in Europe. According to the literature department of the authority, to 2015, China's urban male incidence of colorectal cancer is 33.92 / 100,000 (125,000 cases), urban women is 27.13 / 100,000 (93,000 cases), rural male is 13.61 / 100,000 (48,000 cases), rural women is 13.68 / 100,000 (45,000 cases), and the total number is about 311,000 cases, which will grow with an annual rate of 4%.

Increase of colorectal cancer incidence rate and improvement of the level of health of China contribute to the rapid expansion of the therapeutic areas of drug markets. According to the latest research of Decision Resources, a consulting and research company specializing in the pharmaceutical and healthcare industry, the market value of colorectal cancer drugs in China will grow from 118 million US dollars in 2007 to 261 million in 2011, and to 2016, it will increase to 404 million dollars. In 2009, the global sales of cetuximab were 2.57 billion dollars, which will grow to 3.2 billion dollars in 2010, an increase of 24.5%. It ranks the sixth among the top ten monoclonal antibody species. In 2011, the global sales of it were 3.79 billion dollars.

Cetuximab is the first targeting monoclonal antibody approved for marketing, used for the treatment of metastatic colorectal cancer, colorectal cancer biological targeted therapy drugs. Compared with traditional chemotherapy drugs, cetuximab, a monoclonal antibody targeted therapy is like precision-guided biological missiles that can accurately hit the tumor cells and normal cells rarely hurt; on the mechanism of action of monoclonal antibody, cetuximab is also different from the traditional chemotherapy drugs, which not only has no serious side effects of traditional chemotherapy drugs, and compared with traditional chemotherapy drugs, irinotecan in patients with advanced metastatic colorectal cancer resistant Kang, cetuximab, a monoclonal antibody can achieve satisfactory results and even reverse some patients resistant case. In the first-line treatment of metastatic colorectal cancer, the monoclonal antibody cetuximab in combination with FOLFOX reached the highest reported response rate (81%) so far. Monoclonal antibody cetuximab injection in December 2005 obtained SF-DA and was approved to enter the Chinese market. According to the data provided by Minei Net within the SFDA Southern Medicine Economic Institute, in 2010, the national sales of sample hospitals monoclonal antibody cetuximab injection have exceeded 141 million yuan, an increase of 100%.

In recent years, sales of targeting anti-cancer drugs grow year after year, and now this product has not been nationalized. Because of the high-technology content, the number of domestic manufacturers for competition is not large. With short period of market launch, the amount of cetuximab in the domestic key sample cities in 2012 is 139 million yuan, and the domestic market has huge space for growth.

(2) Analysis of Competing Products

Currently, the main drugs of colorectal cancer in national clinical use of China includes: injection of chemotherapy drugs oxaliplatin, capecitabine tablets, biological agents bevacizumab and panitumumab.

Oxaliplatin: the approved indications for oxaliplatin with 5-fluorouracil and leucovorin combined with first-line treatment of metastatic colorectal cancer applications. There was a slight slowdown in China’s 16 major cities in the sample hospitals oxaliplatin treatment in recent years, but in 2011, it has reached 521 million yuan. Among them, in the oxaliplatin market competition, the imported products possess a leading position. The Eloxatin in Belgium LaboratoiresThissen Pharmaceutical (Hangzhou Sanofi - Aventis livelihood equipment) began to be imported and sold since 2000, occupying 44% market share. The domestic oxaliplatin have been approved consecutively sincee 2009, in which Jiangsu Hengrui Medicine Co., Ltd. Ai Hang occupies 36% market share, followed by imported products.

Capecitabine: Capecitabine is another single-agent chemotherapy first-line treatment of metastatic colorectal cancer, but the drug's approved indications also include docetaxel chemotherapy for the treatment of anthracycline failure metastatic breast cancer. Roche's Xeloda (capecitabine tablets) began to be imported since 2000, but there are many domestic enterprises beginning to imitate, and it is awaiting the approval of the SFDA. The used amount of capecitabine in the sample hospitals of China’s 16 major cities slightly slowed down during 2010—2011, but the growth rate still reached 22% and 16% respectively. In 2011, the capecitabine amount in the sample hospitals of 16 domestic major cities reached 436 million yuan. With the relatively low price of domestically listed capecitabine, capecitabine market growth is likely to continue to slow down or decline slightly.

Monoclonal antibody Avastin: Avastin (bevacizumab injection) Roche in 2010 approved by the SFDA of colorectal cancer antibody drugs. Bevacizumab injection approved for metastatic colorectal cancer, bevacizumab combined with 5-fluorouracil to apply based chemotherapy in patients with metastatic colorectal cancer treatment.

Panitumumab: In 2006, Amgen's panitumumab treatment of colon cancer (Panitumumab) was also launched, and it is approved for the treatment of colon cancer in the world in the first strains of transgenic mice produce fully human monoclonal antibodies. In 2009, sales of panitumumab reached 592 million yuan, an increase of 15%. According to the 2012 drug approval database, Amgen panitumumab has been carried out in our country to apply for import.

In the case of domestic research imitation: in July 2007, Shanghai Zhangjiang Biological Technology Co., Ltd. developed "recombinant chimeric monoclonal anti-EGFR antibody injection" to obtain clinical approval.

(3) Forecast of Market Demand

Cetuximab is targeting epidermal growth factor receptor (EGFR) monoclonal antibody of IgG1 that is first approved for marketing in several countries around the world, which has brought a new choice for the treatment of colorectal cancer patients. Because cetuximab are entirely imported from abroad, there is no domestic manufacturers to produce, thus it is expensive, and therefore has a huge market space. Due to cost reduction and sales gap in the market, it will bring huge profits to the enterprise. This product is small volume injection, and the required raw materials and packaging material supply is guaranteed. Enterprises adopt clinical model, re-establish clinical sales force, increase sales of the product market promotion efforts, and strive to achieve sales of 400 million yuan within three years. According to the production scale of the company's existing plant, saturation capacity is up to 399 ,000 pieces/ year, with sales of 560 million yuan, which can meet production needs, and ensure sustainable development of the product.

Domestic price of Cetuximab is about 4620 yuan / box, 2 weeks / box, according to the general course of six months, each patient needs about 55,000 yuan. After our products are launched to market, due to lower costs, the retail price is tentatively scheduled for 1850 yuan / box, then the cost of treatment per patient will be reduced to 22,200 yuan. The number of patients with colorectal cancer in our country is about 300,000. If it only occupies 5% market share, the future market will have 3.33 billion yuan market share.

1.1.3 Technical Analysis

The project’s technical staff members are talents returning from abroad, with abundant project technical maturity, the rich experience of core staff development and industrialization, thus it enjoys a high academic status in the field of monoclonal antibody drug research, with product development and industrialization capabilities. For enhancing the level of domestic research and development level of domestic antibody drug, it plays a role in promoting this product.

Hopkins Institute of Medicine has established a mature antibody drug research and development technology platform, breaking the two technical barriers of large scale expression and purification in the antibody drug development process, with the establishment of a complete quality analysis system. In the aspect of large-scale mammalian cells expression, we have rich experience in technology research and amplification, and pilot train could reach 500L (reached the stage of the domestic scale antibody production); in the aspect of purification, through the three-step purification, the protein after total recovery is more than 60 percent, and each purification indicator will meet or exceed the national application requirements for monoclonal antibody drugs.

1.1.4 Advantageous Conditions of Project Construction and Necessity

1.1.4.1 Advantageous Conditions of Project Construction

(1) Policy Advantage

The monoclonal antibody drug is the new star after recombinant protein in the biopharmaceutical field. Chinese mAb industry is being gradually optimized in the industrial environment, talent and technology accumulation, and more and more products enter the provincial local health insurance directory. Meanwhile, it is more rational for the drug approval rhythm vital for the healthy development of domestic industry and policy support. On the occasion of the global monoclonal antibody product patent expirations peak and transfer of production capacity tide approaching, China’s mAb industry is expected to get a blowout development opportunity. Antibody drugs is a major development strategy need in China, due to government efforts to increase support, it provides a good policy environment for China to aim at a large variety of biological drugs for the international development of biosimilars.

(2) Jilin Province has the advantage of antibody drug development

Of the 25 kinds of products of genetic engineering techniques products approved by the country, our province can produce 11 of them: of the 35 kinds of vaccine products, 26 kinds of products have been produced in Changchun, and Changchun has become Asia's largest production base of genetically engineered drugs and vaccines. In our province, the biopharmaceutical products are mainly vaccines, genetic engineering drugs and blood products as the main three categories, accounting for 63% of the current production of varieties. In recent years, the emergence of a number of prominent features of bio-pharmaceutical products, such as recombinant human insulin by Tonghua Dongbao Group, recombinant human growth hormone researched and developed by Changchun Kinsey Pharmaceutical, and the recombinant human granulocyte colony stimulating factor. Following the automotive, chemical and agro-processing, similar to the total amount of the province's two other industry - building materials industry and the pharmaceutical industry, the location, industrial base, talent base, technical resources, policy support make the pharmaceutical industry have more obvious advantages. With huge space for development, it will become the fourth largest pillar industry in our province.

(3) Technical strength of project research unit

Hopkins Institute of Medicine was established in February 2012 and currently employs 27 people, including eight doctors, 12 masters and seven undergraduates. Currently, it has 236 technical projects, 86 overseas high-end talent teams, 81 projects that can be transformed, and it has applied for 34 patents, with four offices in domestic first-tier cities, and five branches in North America and Europe. With registered capital of 10 million yuan, it is a scientific and technological innovation-oriented enterprise integrating biomedical technology, natural medicine, Chinese medicine, chemicals, medical equipment, medical dressing product development, production, sales. It owns a well-known research team engaged in domestic and foreign enterprises for years, with rich experience in antibody drug development and industrialization, and can finish the whole process from cells structuring, clinical research to the workshop production. It reduces the risk and shortens the development process for enterprises. It adheres to the strategy of sustainable development in the mAb projects, and strives to form talent advantage, technical superiority and competitive advantage in this area worldwide.

(4) Advantage of raw materials supply

Of the main raw materials, some depend on imports, although the price is expensive but it is reliable and suppliers are many, with adequate supply; other raw materials and other auxiliary materials required in production can be purchased from the domestic market, with numerous suppliers and adequate supply. The company can choose high-quality manufacturers to establish long-term cooperative relations to ensure high reliability and economy. Regularly informed of the supplier's production status, carry out supplier qualification examination; conduct real-time monitoring of transport links; do well emergency plan before the accident; master the operation right of the supply chain; establish safety stock reserves. Whether raw materials are from domestic or foreign sources, there are adequate source and there is no dependency.

(5) Talent Advantage

Changchun has a number of biotechnology products production management, quality management, research and development, engineering personnel, who are familiar with relevant laws and regulations. The introduction of this project will make full use of corporate experience in the field of large-scale modernization of the biopharmaceutical industry in construction, and effectively improve drug development and industrialization rate, and gain advantage in competition with other domestic manufacturers. We have a professional production and marketing team, which is able to adapt to development, production and sales of new products quickly and quickly enter working conditions.

(6) Competitive Advantage

Breakthrough monoclonal antibody localization and industrialization of the biggest technical bottleneck, increasing the yield, greatly reduce production costs, and drug prices will witness a significant decline on the basis of the current market price, with strong competitive advantage.

Currently there is no domestic product, and the application of the domestic pharmaceutical clinical is completely dependent on imports. The market demand falls short of supply, with high price, therefore the competition of the market in domestic market is relatively small.

1.1.4.2 Necessity of Project Construction

Monoclonal antibodies will bring good prospects for the development of enterprises, enhance their market competitiveness, bring huge profits for the enterprise, and promote the development of the biotechnology industry. The project’s introduction will fully improve innovation capability and economic benefits of enterprises, seize more market share, but also enhance the technical level of the entire industry. It is a high technology project, is in line with new national industrial policy. The project’s construction has great necessity and feasibility.

1.2 Construction Contents and Scale of Project

Each batch cultures 1000L, with an annual output of 20 batches, designed annual production capacity is 180,000 pieces.

1.3 Total Investment of Project

The total investment of project is 231.0662 milion yuan, of which: the project transfer is 30 million yuan; R & D investment is 81 million yuan; plant is 15 million yuan; instruments and equipment is 52.56 million yuan; unforeseen costs are 5 million yuan, and financial expenses are 47.5062 million yuan.

1.3   Total Investment of Project and Funds Raising

Table 2 Summary Table of Total Investment of Project      Unit: 10,000 Yuan

Serial No.

Name of Expense

Investment Amount

Percentage to Total Investment (%)

Remarks

1

Construction Investment

17856

77.3

 

2

Interest Incurred in Construction Period

 

 

 

3

Working Capital

5250.62

22.7

 

 

 Total Investment of Project1+2+3

23106.62

100

 

1.4 Financial Analysis and Social Evaluation

1.4.1 Major Financial Indexes

Table 3 List of Major Indicators for Financial Benefits Forecast

Serial No.

Name

Unit

Indicator

Remarks

1

Sales Revenue

10,000 Yuan/a

25200

Excluding the average in small scale pilot period

2

Total Profits

10,000 Yuan/a

18500

Excluding the average in small scale pilot period

3

Financial Internal Rate of Return of All Investment

%

80

After income tax

4

Net Financial Present ValueIc=18%

10,000 Yuan

1870

After income tax

(operation period of 12 years)

5

Payoff Period of All Investment (After Tax)

a

4.25

Excluding the R & D period

6

Profit Margin of Investment

%

80

After income tax

Notethe “ten thousand yuan” in the table refers to RMB.

1.5 Cooperative Ways of Project

Joint venture.

1.6 What-To-Be-Invested by Foreign Party

Transfer fee or technical investment.

1.7 Construction Site of the Project

Changchun Hi-tech Development Zone

1.8 The On-going Condition of Project

Project proposal has been finished.

2.  Introduction to Partner

2.1 Basic Conditions

NameJilin Hopkins Drug Research Institute Co., Ltd.

Address 881 Zhuoyue Avenue, Changchun Hi-Tech Zone

2.2 Overview

Jilin Institute of Johns Hopkins Medicine is jointly established by returned overseas students studying abroad and domestic bio-medical experts. It is a scientific and technological innovation-oriented enterprise integrating biomedical and biotechnology products research, development, production, sales. The Institute has established cooperative research and joint development with the Harvard Medical School, Columbia University School of Medicine, University of Maryland School of Medicine, University of Texas, MD Anderson Medical Center, University of California Medical Center; University of Calgary Medical Center; biopharmaceutical company Genzyme, and Abbott etc. the world's leading pharmaceutical companies, medical research institutions and pharmaceutical enterprises. The Research Institute also maintains extensive and close contact and interaction with American Chinese Association of Pharmaceutical Scientists, American Chinese Association of Chinese Biomedical Sciences etc. The Institute carries out collaborative research with a number of domestic pharmaceutical companies and research institutions, has applied for a number of invention patents, and has won many national, provincial, municipal and district awards for high-end overseas leading talents, and undertakes national scientific and technological innovation projects. It is appraised as the “top 100 most entrepreneurial potential businesses in Pioneer Park for Chinese Overseas Students” by the Ministry of Science, and the Central Organization Department. The Institute, with "innovation, development, cooperation and win-win" as the philosophy, when developing biomedical products with independent intellectual property rights, it also sets up cooperation platform for overseas biomedical expert (and overseas students) and domestic pharmaceutical enterprises for technology exchange, project cooperation, the application innovation, fruits transformation, and interest sharing. At present, 78 overseas biomedical expert teams have already joined the platform. It carries out scientific and technological innovation and cooperation with institutes, which enhances the scientific and technological achievements transformation capability, and accelerates the international process of China’s bio-medical technology products.

2.3 Contact Methods

Contact Person of Project UnitZhang Lingling

Tel13504419082

Fax0431-81958807

E-mail29221198@qq.com

 

Contact Methods of Project City (Prefecture)

Contact Unit Changchun Economic and Technological Cooperation Bureau

Contact Person: Bo Zhanlin

Tel: 0431-82763933  82765252

Fax: 0431-82763933

E-mail: cc82763933@163.com

Website of City (Prefecture): http://www.ccmbc.com/

 

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