Medicine & Health

 

1.Introduction to Project

1.1Project Background

1.1.1Introduction to Product

Cytokines and growth factors are polypeptides or proteins in the cell growth process itself, and they regulate various activities and functions of cells through the signaling system, thus orderly stimulating cell growth, proliferation and differentiation. There are generally two methods to obtain them; one is the application of recombinant DNA genetic engineering technology to obtain single cell growth factors or cytokines; the other is special in vitro culture conditions for culturing cells, extracting from the cell culture medium to obtain these multiple naturally occurring cytokines and growth factors.

This project uses innovative tissue engineering cell to culture adult stem cells and skin fibroblasts technology, simulate three-dimensional in vivo growth state of normal skin cells. The cells under these conditions will grow closer to the physical health status, and the secretion naturally occurring cell growth factor and cytokines have large variety and high yield.

Cytokines and growth factors have four series of products:

 (1) Products for skin care, removing wrinkles and freckle, anti-aging skin products.

(2) Products in the clinical application of skin wounds and inflammation include skin wounds, burns; chronic skin ulcers caused by diabetes; chronic skin inflammation of psoriasis; skin eczema, chronic itching.

(3) Applied to high-end medical dressings.

(4) Regenerative medicine applications include the promotion of hair regrowth (cell growth factor ® formulation), treatment of periodontal tissue atrophy (cell growth factor ® + bioadhesive film), the treatment of degenerative osteoarthritis product (cell growth factor formula).

1.1.2 Market Prospects

(1) Market analysis of beauty and wrinkle-removing skin care products

In 2014, the market size of global skincare products is 60.82 billion euros,accounting for 35.3% of the total cosmetics market; cosmetics market in Asia Pacific in 2014 reached 59.79 billion euros, accounting for 34.7 % of the same period of the global total; the market size of Western Europe is 37.56 billion euros, accounting for 21.8%; the North American market size is 36.01 billion euros, accounting for 20.9%.

 

In 2014, Chinese cosmetics retail transaction size was 293.7 billion yuan (including personal care products), and is expected by 2019 to reach 423 billion yuan, with annual growth rate stabilizing at around 8 percent. Estimated according to 1.3 billion population, China's per capita consumption of cosmetics will increase from 27.81 dollars in 2011 to 35.04 dollars in 2014 gradually. According to statistics, Chinese skincare market sales grow at an average annual growth rate of 23.8%, and the highest rate amounts to 41 percent, thus the growth rate is much higher than the average growth rate of the national economy, and has considerable development potential.

For domestic cell growth factors skin care products, the cell growth factor is mainly obtained through purchase or genetically engineered recombinant DNA technology, including the Hong Kong Engelhard skin moisturizing cream (keratinocyte growth factor), Beijing Tieli cyan (epidermal cells growth Factor), Beijing Yum Andean (Sealy Bailu EGF epidermal growth factor brand lotion). But because the products have no originality, there is no famous brand, and market share is small.

The cell growth factors of foreign beauty and skin care products are extracted through cell culture naturally, such as the Swiss company NeoCutis Inc (TNS Essential Serum), US company SkinMedica (Bio-Restorative Day Cream) and Korean company RNLBIO (naturally derived protein). The sales of products of United States company SkinMedica cover 35 countries worldwide, and its flagship product is "TNS ESSENTIAL SERUM" ,28.4g / 1Oz priced at 260.00 dollars, accounting for most of the market share; while the Swiss company NeoCutis Inc is headquartered in Switzerland, and San Francisco Subsidiary is responsible for all sales, and its flagship product Neocutis BioGel 1.69oz is priced at 150.00 dollars. The main products are sold in the US, accounting for not much market share.

Since we have the advantages of advanced technology, large variety, high yield, strong efficacy, safety and reliability, no side effects, with physiological balance role and a variety of specific functions in cultivating and extracting growth factors and cytokines cell, our products are competitive at home and abroad. If funding permits, we plan to open up the domestic and international markets simultaneously. According to the current market distribution and market developments, we estimate our product can quickly account for 5% market share, and in two years, it will reach 10% -15% market share, increasing from 1.5 billion yuan per year to 3 billion yuan.

(2) Market Analysis of Products Treating Skin Wounds and Inflammation

China's number of patients suffering from gynecological diseases, oral diseases, chronic ulcers caused by diabetes and burns and trauma is as high as 83.99 million.

Obstetrics and Gynecology Market: Research data show that the incidence of cervical erosion of age women is up to 52.56%. Therefore, the potential number of consumers reaches 1.03 million.

Dentistry Market: aphthous oral ulcer is a common recurrent oral mucosal ulcerative damage of oral mucosa disease, and it is the highest incidence of the disease. Incidence age is 20-45 years, with the incidence of 18% -22%. Therefore, the number of potential consumption will reach 65 million.

Refractory Diabetic Ulcer Wounds Market: The 2005 - 2009 national sample survey shows that among people of more than 20 years old, the diabetes prevalence rate is 3.21%. The difficult to heal ulcer area of diabetes patients reaches 15-20%. This kind of ulcer can not heal in the long term, bringing great inconvenience to the life of patients.

Burns Market: In China, the burns incidence rate is 0.5% to 1%, of which 5% require to be hospitalized, and 95% can be treated in the outpatient department or home. Therefore, the potential number of consumers is 1.03 million.

Other aspects: radiation oncology, surgery, ENT etc. has huge market capacity.

The product’s range of applications includes the treatment of skin wounds, burns; chronic skin ulcers caused by diabetes, chronic skin inflammation of psoriasis, eczema, chronic itching; biological Band-Aid. Take biological band-aid for example. Most of the products on the domestic market are traditional anti-inflammatory and hemostatic, with prices at 100 pieces/20 yuan / box, including Guangzhou Fang Lin Nomad Band-Aid, Shanghai Hua Zhou, Qingdao Heino, Shanghai Johnson & Johnson Band-Aid and Dubai Band-Aid etc. Plastered growth factors, the main source of growth factor are natural extraction and genetic recombination, and on the market, there have not been formed products.

Thus, China has huge demand for trauma and wound ulcer medication. According to 8 million people using the biological active factor for treatment of disease, the market demand will be at least 40 million pieces. Calculated according to 100 yuan for one piece, it can generate 4 billion yuan economic value. It can be seen that the market prospects are broad.

(3) Analysis of High-end Medical Dressings Market

As the elderly closely related bedsores, ulcers and other chronic wound care has become an increasingly serious problem in recent years, in the global market of high-end medical dressings, Europe accounts for 41%, the United States accounts for 39%, and other countries and regions accounts for 20.5%. To gain share in this market, we must strive to enhance the technological innovation capability of the industry, which is the only option to achieve the transformation and upgrading of domestic medical dressing industry and sustainable development.

High moist dressing comprises hydrogel, hydrocolloid, alginate, foam dressings, transparent dressings, antimicrobial dressings, medical dressings, etc., but also includes wound treatment device, such as drainage, oxygen therapy, electrical stimulation therapy, low-intensity laser therapy, ultrasound therapy and maggot therapy. In general, new medical dressing has three characteristics, namely efficient materials, high-performance products and high efficiency of care, and the three characteristics are becoming the 3e design principles of medical dressings, and represent the direction of the development of medical dressings. According to the prediction of medmarkt, diligence, llc and other market research agencies, since the conventional medical dressing products can not meet the demand for treatment of chronic and complex wounds, in the future high-end dressing will be a major driver pushing dressing market. In the European market, high-end dressing accounts for 62.2% of the European total medical dressings market.

Dressings of cell growth factors and cytokines are high-end wound dressings within the medical field, and it has become a new bright spot in the field of development of medical dressings. It not only overcomes the drawback of single performance of traditional dressing, but also the addition of growth factors promotes wound healing and enhances the effectiveness of wound healing effect. In the first half of 2012, the sales revenue of China's medical dressing manufacturing reached 40 billion yuan, an increase of 65%. According to conservative estimates, after our products enter the market, it could quickly occupy 2-5% of the market share, realizing at least sales revenue of 1-2 billion yuan each year.

(4) Analysis of Regenerative Medicine Applications Market

Stem cells and regenerative medicine industry is one of the new bio-tech industries in China with the most potential. To accelerate the development of the industry has very important and realistic significance for improving the level of human life and creating benefit for human health.

In China, after clinical trials of the embryonic stem cells approved by FDA, the SFDA will gradually open restrictions on the use of human embryonic stem clinical trials cells, and therefore  it can be expected that China and the world will witness the birth of a huge market for stem cell research and industrialization. According to the Bio-Valley Institute statistics, in the next five years, the market scale of China's stem cell and regenerative medicine related fields will reach 86 billion yuan. Whether access standards of clinical research, or the R & D outsourcing of dry cell research, even organizations related with stem cells and regenerative medicine research services, it will occupy a huge market share in the industry chain. Now in the early stage of development, the early participation in stem cell research industry chain will be able to occupy the upper hand in the next round of stem cell industry outbreak.

This product includes hair regrowth promotion products, products for treatment of periodontal tissue atrophy, and degenerative osteoarthritis treatment products. Take the hair regrowth promotion products for example. On the market, there are hundreds of hair growth products, mostly concentrated in the kidney, follicular plugging, cortical hormone disorders, hair follicle regeneration etc. doctrines, but these methods have significant drawbacks. Grown hair is the most violent means, which is expensive and treatment process is painful, rejection response is great, and hair loss speed will be faster; endocrine regulation will only weaken female sexuality, with male breast enlargement; the specialty store is more time-consuming, with poor effects; follicle regeneration (DPFCF) uses human scalp hair DNA to clone healthy follicles cells to replace dead cells, and its shortcomings are becoming increasingly apparent. The hair regrowth products produced by the company uses cell growth factor and cytokine for the treatment of alopecia, which is safe, with non-toxic side effects, thus market prospects are broad. There are many products on the market, but given the specificity and non-paid role efficacy of our products, they will be favored and trusted by consumers. The estimated annual sales are 0.5-1 billion yuan.

(5) Demand Forecast

China has a large population. Each year, the number of patients suffering from gynecological diseases, oral disease, chronic ulcers caused by diabetes and burns is over 83.99 million. Thus the demand for treatment drugs is huge. According to 8 million people using biological active factor for the treatment of disease, per capita drug of 5 pieces, and the market demand is at least 40 million pieces. Calculated according to 100 yuan per piece, it can generate 4 billion yuan economic value. It can be seen that the market prospects are broad.

1.1.3 Technical Analysis

Apply unique and innovative skin cells cultured tissue engineering technology to extract various naturally occurring cell growth factors and cytokines from the cell culture medium. The desired skin cells are from embryonic stem cells or induced pluripotent stem cells differentiate to produce directional, umbilical cord mesenchymal stem cells induce differentiation or cell lines derived from embryonic skin and cell libraries. Application of the extracted natural physiological balance of a variety of cell growth factors and cytokine therapy: 1) acute or chronic skin wound healing; 2) skin diseases; 3) promote hair growth; 4) anti-aging skin care and beauty.

(1) Theoretical basis:

Ø  Cytokines and growth factors are polypeptides or proteins in the cell growth process itself, regulating the various activities and functions of cells by signaling system, orderly stimulate cell growth, proliferation and differentiation.

Ø Apply genetic engineering DNA recombinant technology to obtain single cell growth factors or cytokines.

Ø  In vitro culture special conditions, cultured cells, and cells naturally generate a variety of cell growth factors and cytokines, which can be obtained by extracting these cells in a variety of naturally occurring growth factors and cytokines.

(2) Experimental basis:

Domestic application of genetic engineering DNA recombinant technology to cell growth factor

A. Hong Kong Engelhard Pharmaceutical Group (beneficial skin Whitening Moisturizing Day Cream - keratinocyte growth factor)

B. Beijing Tieli Green Biotechnology Limited (epidermal growth factor)

C. Beijing Yum Andean Biological Engineering Co., Ltd. (Sealy Bailu EGF epidermal growth factor brand lotion)

Ø Naturally occurring cell growth factors and cytokines using cell culture abroad

A. Swiss company NeoCutis Inc (TNS Essential Serum)

B. American company SkinMedica (Bio-Restorative Day Cream)

C. Korean company RNLBIO (naturally derived protein)

(3) Technical method:

Conditioned medium preparation → tissue engineering three-dimensional cell culture → →  conditioned medium collecting → conditioned medium concentration and lyophilizing → collecting naturally occurring physiological balance of cell growth factors and cytokines → product formulations and terminal products.

(4) Contrast of technologies within the industry home and abroad

The project’s production schematic figure adopts three-dimensional culture for skin fibroblast cells and stem cells to obtain cytokines and growth factors for skin care.

Figure 3 Cell growth factor and cytokine production figure of foreign companies

US SKINMEDICA, Switzerland NeoCutis uses single skin fibroblasts to culture cell growth factors and cytokines for skin care.

Korea RNL Bio uses single fat stem cells to culture cell growth factors and cytokines for skin care.

1.1.4 Advantageous Conditions of Project Construction and Necessity

1.1.4.1 Advantageous Conditions of Project Construction

(1) Technical Advantage

The project’s technical barrier is firm, leading international technology, and it is difficult to track or imitate. It has applied for relevant patent, with independent intellectual property rights, and has applied for international and domestic patent protection.

Unique effects, safe and efficient. And there are not any similar products in China, and there are only three international competitors, thus our technology is more advanced, more competitive, with significant competitive advantage. Market potential is huge; market share occupation period is long. It has low cost and high profit margins. The project is mature, almost without risk.

(1) The drugs routinely used in the treatment of wounds, ulcers start from the sterilization and anti-wound infection, and achieve therapeutic effect by using the body’s re-birth ability; and biological cell activity factor grows and reproduces through the promotion of cell growth to actively repair wound. Normal wound healing generally requires 7-10 days, but after the use of biological cell activity factor, it needs 5-7 days, thus shortening healing time and reducing the risk of infection.

(2) Form different effects on scar. Conventional drug treatment of wounds and ulcers is an anti-infective passive repair process, which easily leaves scar and pigmentation; biological cell active factor can effectively reduce scarring and pigmentation due to active repair of wounds and ulcers and short healing time.

(3) Functional repair effects are different from conventional drug treatment of wounds and ulcers. Most of them are limited to the wound, and the functional recovery to skin ancillary functions, such as organ damage nerve endings, blood vessels, sweat glands etc. is not very effective; but biological cell active factor has protection and repair effect for neurons and blood vessels, and can promote their functional recovery. This is the only drug with such function for treatment of burns.

(2) 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.

(3) 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.

1.1.4.2 Necessity of Project Construction

Cell biological active factor has widespread clinical application prospects, and can be used for wound healing, cardiovascular diseases, skin care and so on. With China's large population, the number of patients suffering from gynecological diseases, oral disease, chronic ulcers caused by diabetes and burns is over 83.99 million. Thus the demand for treatment drugs is huge. According to 8 million people using biological active factor for the treatment of disease, per capita drug of 5 pieces, and the market demand is at least 40 million pieces. Calculated according to 100 yuan per piece, it can generate 4 billion yuan economic value. It can be seen that the market prospects are broad. The introduction of this project has important strategic significance for the development of China's pharmaceutical industry and improving people's health.

1.2 Construction Contents and Scale of Project

Annually produce wrinkle skin care products of 50,000 units, build 1000 square meters of production workshop.

Annually produce cellular active factor for treating dermatological disease of 200,000 pieces, build 2000 square meters of production workshop.

1.3   Total Investment of Project and Funds Raising

Table 4 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

8000

80

 

2

Interest Incurred in Construction Period

 

 

 

3

Working Capital

2000

20

 

 

Total Investment of Project

1+2+3

10000

100

Including technical transfer of 10 million yuan

1.4 Financial Analysis and Social Evaluation

1.4.1 Major Financial Indexes

Table 5 List of Major Indicators for Financial Benefits Forecast

Serial No.

Name

Unit

Indicator

Remarks

1

Sales Revenue

10,000 Yuan/a

15000

Excluding the small scale pilot period, normal year

2

Total Profits

10,000 Yuan/a

8200

Excluding the small scale pilot period, normal year

3

Financial Internal Rate of Return of All Investment

%

17

After income tax

4

Net Financial Present ValueIc=18%

10,000 Yuan

493

After income tax

operation period of 12 years

5

Payoff Period of All Investment (After Tax)

a

4.4

Excluding the small scale pilot period

6

Profit Margin of Investment

%

22

After income tax

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

1.4.2 Social Evaluation

The social benefits of this project are embodied in two main aspects: the ability to provide jobs, as the economic benefits of the project are gradually revealed, it will provide more jobs; cell bioactive factors are used clinically, and after the patients rehabilitate, they will contribute to the society with a healthy body and mind, thus creating new wealth for society.

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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