Medicine & Health

 

1.Introduction to Project

1.1 Project Background

1.1.1Introduction to Product

Adalimumab (Humira) is humanized monoclonal antibody of anti-human tumor necrosis factor (TNF), and it is the disulfide-bonded dimmer of human monoclonal D2E7 heavy chain and light chain. It is used for the relief of anti-rheumatic drugs (DMARD) therapy of structural damage in moderate to severe rheumatoid arthritis (RA) in adult patients.

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 of Adalimumab

The clinical features of rheumatoid arthritis manifestations: synovitis and articular cartilage damage due to joint swelling and pain, and recurrent synovitis. Rheumatoid arthritis is one of the main causes of loss of labor force and disability of population, and its danger lies in: pain; disability; long treatment process; life-threatening.

In view of the above factors, the relevant national laws and regulations pay much attention to the treatment of these diseases, and adalimumab is monoclonal antibody drug mainly used in moderate to severe rheumatoid arthritis patients. Its widely application to the Chinese market will cause great reduction of patients with rheumatoid arthritis, thus protecting young workers needed for national economic construction and providing necessary guarantees for the economic development of the country.

Adalimumab was approved in 2010. Currently, there is one import company applying for production (Abbott Laboratories), and there is no domestic production clinical use. Introduction of adalimumab by enterprises will fill the gap, and the market is optimistic, with good prospects for market development.

During 2011-2012, domestic sales are 7 million yuan. Adalimumab antibody, as the top ten best-selling drugs in 2009, realized sales of 5.6 billion dollars. It has been predicted that its sales in 2016 will be more than ten billion US dollars. In 2012, EU approves Adalimumab for treating ulcerative colitis, which makes the EU approved use of the drug reach as many as seven. Because Adalimumab is entirely imported from abroad, there is no domestic manufacturer for its production, the price is very expensive, and therefore it has huge market prospect. Due to cost reduction, sales gap in the market; it will bring huge profits to the enterprise.

Data show that in 2011, global biopharmaceutical monoclonal antibody drugs accounted for 34.4% of market share, while in China, this indicator is only 1.7%, far below the global average. This product has not been nationalized now. Because of the high-tech content of this product, the number of domestic manufacturers is not large, and in the domestic market, there is huge space for growth. Foreign institutions predict that over the next three years, rheumatoid arthritis drug etanercept will still possess the leading position. Afterwards, the adalimumab will replace is to become the number one. Sales will reach a peak in 2016, reaching more than ten billion US dollars.

(2) Analysis of market demand

The incidence of rheumatoid arthritis in different populations is between 0.01% and 0.05%, and the prevalence rate is 0.18% -1.07%. Its incidence has certain ethnic differences, with Indian higher than Caucasians, Caucasians higher than the yellow race in Asia. The rheumatoid arthritis can occur in all ages, with incidence peak at 30-50 years old. Generally, incidence of women is higher than men, and the incidence ratio of male to female is 1: 3. The two-year disability rate is 55%, and three-year disability rate is 75%.

In rheumatoid arthritis drug, monoclonal antibody drugs will become the future mainstream. Although in these markets, etanercept is the first, its 2009 sales had reached 8.2 billion dollars, but many varieties of monoclonal antibody drugs of such drugs already on the market has gradually grown up, including Johnson & Johnson and Merck infliximab single anti-Abbott adalimumab, Centocor's golimumab, UCB's pegylated plug trastuzumab and the like; and several varieties already in clinical stage will be launched soon.

The reason why the industry is optimistic about adalimumab is that as biological monoclonal antibody, it is difficult to challenge in terms of efficacy and technical barriers; in addition, more and more doctors prefer subcutaneous administration in the treatment of rheumatoid, with no need for injection process and costs, and in this aspect, adalimumab will have a huge advantage. Although comparative clinical trials with etanercept have not been announced, it is generally considered that adalimumab has better efficacy.

Foreign institutions predict that over the next three years, the rheumatoid arthritis drug will be led by etanercept. Afterwards, the adalimumab will replace is to become the number one. Sales will reach a peak in 2016, reaching more than ten billion US dollars.

The domestic price of adalimumab is 7000-8000 yuan / box, 2 weeks / box, half year as a course, then each patient needs about 84,000—96,000 yuan. The number of rheumatoid arthritis patients in China is about 5 million. As rheumatoid arthritis has the recurrent features, according to this calculation, the total market demand will be about 60 billion yuan (priced according to 1000 yuan / box).

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 reporting requirements for monoclonal antibody drugs.

The production process of monoclonal class biopharmaceutical includes upstream cell culture, downstream purification, culture media and buffer preparation, quality control, and liquid cryopreservation and other steps. Namely: after removing seeding cells from the liquid nitrogen tank, after recovery, transferred into shake flask for culturing. Cells are obtained by culturing, harvesting, sterile filtering, concentrated by ultrafiltration, purification, packaging system.

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.

(7) Technical Advantage

This product adopts the gene recombinant method, using mammalian cell expression systems, with significant specificity effect and few side effects. Adalimumab is subcutaneous dosage forms, without the need for injection process and cost, which gives adalimumab huge advantage. Although the comparative clinical trials of etanercept have not been announced, it is generally considered that adalimumab has better efficacy.

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 200L, with an annual output of 20 batches, designed annual production capacity is 110,000 pieces.

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

16676

78

 

2

Interest Incurred in Construction Period

 

 

 

3

Working Capital

4832.36

22

 

 

 Total Investment of Project

1+2+3

21508.36

100

Including technical transfer of 30 million yuan, and financial expenses of 46.3236 million yuan.

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

22000

Excluding the average in small scale pilot period

2

Total Profits

10,000 Yuan/a

15815

Excluding the average in small scale pilot period

3

Financial Internal Rate of Return of All Investment

%

73

After income tax

4

Net Financial Present ValueIc=18%

10,000 Yuan

1237.48

After income tax

operation period of 12 years

5

Payoff Period of All Investment (After Tax)

a

4.36

Excluding the small scale pilot period

6

Profit Margin of Investment

%

73

After income tax

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

1.4.2 Social Evaluation

The monoclonal antibody adalimumab industrial project has good economic and social benefits. Implementation of this project will provide good-quality and reasonable-priced bio-pharmaceutical products for the cancer patients, reliable autoimmune diseases patients (such as rheumatoid arthritis) etc. in China. It will improve people's health. Investment risk is small, with significant economic benefits.

For the development of enterprise, the monoclonal antibody research and development project is suitable for the development of enterprises. It can fully utilize the experience of the company in industrial construction of large-scale modernization of biopharmaceutical field, effectively improve drug development and industrialization speed, and gain competitive advantage in its competition with other domestic manufacturers.

The project is fully feasible, and it has important strategic importance for the enterprise to quickly enter the field of monoclonal antibody drugs and get advantage.

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-mail

29221198@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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