Team:SCU-WestChina/Entrepreneurship
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Entrepreneurship
Idiopathic pulmonary fibrosis (idiopathic pulmonary fibrosis, IPF) is a chronic, progressive, fibrotic, and interstitial lung disease that is confined to the lungs. Lung function continues to decline irreversibly, seriously impairing the patient’s quality of life
There are many basic studies on IPF therapy, but there are problems such as incomplete evaluation of adverse reactions, incomplete safety evaluation, and unclear clinical trial results. Correspondingly, there is no breakthrough progress in the treatment of IPF, whether it is lung Non-drug therapies such as tissue transplantation and oxygen inhalation therapy or other drug treatments all have certain therapeutic limitations, and the therapeutic effects are generally not ideal. Therefore, innovative, safe and effective treatment methods are particularly important.
This year, iGEM SCU-WestChina aims to use synthetic biology technology to propose an innovative solution to solve the problems of IPF patients, and help them improve with a low-cost, effective treatment and minimal complications Quality of Life.
Fig1. The key advantages of our durg design
Business plan
Market analysis
IPF is the most common type of idiopathic interstitial pneumonia. It is characterized by progressive scarring of the lung parenchyma, leading to dyspnea and decreased lung function, eventually leading to respiratory failure. The survival period after diagnosis is only 3 to 5 years. In the 2000 international expert consensus, the expert group defined idiopathic pulmonary fibrosis as a type of fibrotic interstitial pneumonia of unknown cause and chronic progressive exacerbation; it is more common in the elderly, and the lesions are mainly limited to the lungs. Fibrosis is the irreversible pathological endpoint of many chronic diseases, including pulmonary fibrosis. Idiopathic pulmonary fibrosis is a progressive and often fatal disease with an increasing incidence. 5 million people worldwide suffer from pulmonary fibrosis. According to reports, the incidence and prevalence of pulmonary fibrosis have a wide range. The following rates are 1 in 100,000, and the ranges reflect the narrow and broad inclusion criteria.
Table1 IPF incidence
Based on these ratios, the prevalence of pulmonary fibrosis in the United States may exceed 29,000 to nearly 132,000 based on the population 18 years of age or older in 2000. Due to misdiagnosis, the actual number may increase significantly. Normally, patients have reached forty and fifty years of age at the time of diagnosis, and the incidence of idiopathic pulmonary fibrosis increases sharply after the age of fifty. However, loss of lung function is usually attributed to old age, heart disease or more common lung disease. A series of studies have shown that the incidence of lung cancer in patients with pulmonary fibrosis is higher than that in the general population. This trend also exists in diseases that affect the lung interstitium, such as systemic sclerosis, sarcoidosis, and occupational diseases. According to data from the Fibrosis Coalition (CPF), there are 40,000 deaths from IPF each year. Analysts predict that the annual sales of the IPF drug market will exceed $2 billion.
2.1.1 SWOT analysis
(1).Strengths-advantages
①The functional fusion protein wrapped in liposomes is directly delivered to the lungs by aerosol inhalation and targeted to the lesion, with good targeting and extremely low side effects;
②Compared with other pulmonary fibrosis treatment methods, the treatment cost is lower and it is suitable for patients with various degrees of lung function impairment, and the audience is wider.
(2).Weaknesses- disadvantage
① Limited management team and insufficient management experience in the initial stage of entrepreneurship;
②In the initial stage, the company was small in size, financing difficulties, insufficient initial funds, and slow progress in vertical technology research and development and horizontal product development;
③The products are currently limited to pulmonary fibrosis treatment systems based on liposomes. The business is single and volatile due to market influence.
(3).Opportunities-opportunities
①Idiopathic pulmonary fibrosis is a serious progressive lung disease. Nearly half of patients die within 2-3 years after diagnosis, and the 5-year survival rate can be less than 30%;
②At present, there is no recombinant protein drug that can effectively and gently carry out targeted treatment of pulmonary fibrosis. This project team has made the first breakthrough in this field;
③This product is highly plastic and highly research and development. It provides a new treatment idea for pulmonary fibrosis and even fibrosis of other organs and arteries. Different new products can be developed with good conditions for product horizontal development;
④Relying on the State Key Laboratory of Biotherapy and West China Hospital of Sichuan University to carry out project research, product research and development are fully guaranteed.
(4).Threats- threats
① OEM production, or other manufacturers imitating, there is a risk of technology leakage;
② The appearance of counterfeit and inferior products affects product sales and damages brand image;
③ The emergence of other similar products has increased the number of participating companies.
Fig2. SWOT analysis of Lung Knight
2.1.2 PEST macro environment analysis
(1).Policy Environment: China attaches great importance to medical reform and innovation, the policy level is geared towards chronic disease management, and China's idiopathic pulmonary fibrosis registration research is launched
Another important research in the field of respiratory in China, the first domestic idiopathic pulmonary fibrosis (IPF) epidemiological study "China Idiopathic Pulmonary Fibrosis Registration Study (PORTRAY)" was officially announced in Beijing. The PORTRAY study launched this time plans to enroll 800 Chinese patients in more than 5 years, covering no less than 15 IPF diagnosis and treatment centers in many provinces across the country, through the registration of newly diagnosed IPF patients in multiple centers, Establish a prospective cohort of idiopathic pulmonary fibrosis, build a standardized clinical database and biological specimen library, describe the demographic and clinical characteristics of IPF, natural course, complications, acute exacerbation risk, patient quality of life, prognosis and influencing factors , And disease burden, etc., to screen for relevant biological markers that predict the development and outcome of IPF. On this basis, establish a standardized management system and a multi-center collaboration network for IPF patients. Professor Dai Huaping said: "We hope that through this research, we can increase the awareness of respiratory doctors on IPF, improve the level of diagnosis, and further promote the improvement of IPF standard diagnosis and treatment."
(2). Economical Environment: The field of biomedical technology is a new market outlet and one of the ten emerging markets for global medical devices
The "2016-2022 China Medical Device Market Competitive Situation and Market Outlook Forecast Report" released by Zhiyan Consulting shows that with economic development, population growth, social aging, and people’s awareness of health care, the global medical device market demand With continuous growth, the medical device industry has become one of the fastest growing industries in the world today. China's medical device industry started late, but the domestic market demand is large and growing rapidly. The scale of medical device market sales has increased from 17.9 billion yuan in 2001 to 308 billion yuan in 2015. And the growth rate is stable
(3).Social Environment: It is imperative to improve IPF awareness. With the acceleration of medical growth, China's medical and health industry has ushered in a new starting point, and public health awareness has increased
IPF is a chronic and progressive fatal disease characterized by pulmonary fibrosis, which is a kind of interstitial lung disease. It will make lung tissue fibrosis and form permanent scars, leading to an irreversible decline in lung function. Due to decreased lung function, in addition to frequent asthma and cough, the quality of life of patients will also be severely affected, such as unable to climb stairs, unable to do housework, etc., and because the disease progression of IPF is unpredictable, acute exacerbations will significantly reduce the patient's chance of survival. According to data, the median survival time of IPF patients is only 2 to 3 years after diagnosis, and the 5-year survival rate is less than 30%, which is lower than the survival rate of most cancers. Therefore, IPF is often referred to as "cancer that is not cancer." . However, in the past 20 years, the incidence of idiopathic pulmonary fibrosis in China has gradually increased, and the mortality rate has remained high. According to market research reports, China's IPF is facing a low diagnosis rate, uneven diagnosis in hospitals, and a low proportion of anti-pulmonary fibrosis treatment drugs.
(4).Technological Environment: Pulmonary fibrosis is a fatal disease, and the current research progress is insufficient in clinical application
Although many drugs have failed in clinical trials, these failures have improved the understanding of the pathogenesis of IPF. Currently, two drugs are approved for IPF to slow the progression of the disease. However, the prognosis of IPF patients is still very poor, and drugs that inhibit the active pathogenic pathways in IPF are still being sought to further reduce or even stop the progression of the disease. Therefore, the development of a tissue material that can inhibit the simultaneous advancement of treatment with a long-term effect is essential for the treatment of idiopathic pulmonary fibrosis.
And pure synthetic materials: synthetic materials can be divided into non-absorbable/partially absorbing materials and absorbable materials. Non-absorbable/partially-absorbable material The non-absorbable part is always a foreign body to the recipient, which may cause chronic inflammation, infection, delayed bleeding, etc. In addition, different non-absorbable materials also have their own shortcomings. For example, thicker scars can be formed on the outside of polyester cloth and serious adhesion. Therefore, the use of synthetic biology methods to optimize the design of natural tissue materials has great application prospects.
To sum up, although the current research on repairing idiopathic pulmonary fibrosis has made great progress, there are generally deficiencies in clinical applications, and existing products are not conducive to large-scale production and clinical promotion. Therefore, it is very important to develop an optimized tissue material that can be completely absorbed, has good physical and chemical properties (flexibility, elasticity, etc.), and biological tissue compatibility, and promotes rapid repair of lung fibrosis.
2.2 Product overview
At present, there are few treatment methods and drugs for pulmonary fibrosis, and the small-molecule drugs in the traditional sense are entering clinical trials, which have poor targeting and large side effects. In response to this pain point, iGEM SCU-WestChina designs and synthesizes fusion proteins of cytokine receptors that degrade fibrotic proteins and inhibit the occurrence and progression of fibrosis, designs and builds liposome delivery systems, and uses engineered bacteria to produce products in large quantities. Our product uses aerosol inhalation to deliver liposome-encapsulated functional fusion protein-"EP3533-tTGF-βR recombinant protein" directly into the lungs and target fibrotic cells.
According to animal experiments, the product has good therapeutic effects, controllable side effects, good targeting, and has great development potential. It provides a new treatment idea for pulmonary fibrosis and even fibrosis of other organs and arteries.
iGEM SCU-WestChina has designed a recombinant protein EP3533-tTGF-βR and liposome targeted delivery system through in-depth understanding of the pathogenesis of fibrosis, molecular mechanism and signaling pathways, and pioneered the development of efficient and stable lung fibers in China Recombinant protein drugs have been developed and a targeted delivery system has been established to provide clinicians with efficient and convenient treatment options, and patients with pulmonary fibrosis provide more advantageous drug options.
2.2.1 Product advantages
Table2 Product advantages summary
2.2.2 Competitive product analysis
Table3 Competitive product analysis
Competitive product issues:
(1) The cost of treatment is high, and most patients cannot afford it
(2) Poor targeting and obvious side effects
(3) It is often only used for patients with specific conditions, and the symptoms of use are limited
(4) There is no effective treatment plan for pulmonary fibrosis, only lung transplantation or supportive therapy
2.3 Business model canvas
2.3.1 User positioning
Chronic progressive fibrotic interstitial pneumonia, the lesions are confined to the lungs, which are more common in middle-aged and elderly men, mainly manifested as progressively worsening dyspnea, accompanied by restrictive ventilatory dysfunction and gas exchange disorders, leading to hypoxemia , Even respiratory failure, poor prognosis. It is estimated that the disease will become one of the most important causes of severe lung disease in the next few decades. After 5 years, only 20-30% of patients are still alive. The median survival time is 2.5-3.5 years. Patients will eventually face the situation of lung transplantation. This product is based on mussel foot adhesion protein to reduce fibrosis and slow down the decline of lung function, delay the time of first deterioration, greatly improve the survival rate of patients, and extend the waiting time for lung transplantation for critically ill patients.
2.3.2 Customer positioning
(1) General hospitals
Through bidding and tendering, it has reached an in-depth cooperative relationship with hospitals, and sold products directly to China's domestic respiratory general hospitals and community hospitals. Use the reputation established by domestic hospitals in China to further explore the international market, establish customer relationships with general hospitals around the world, and gradually expand the market, bringing the gospel to patients with chronic pulmonary fibrosis worldwide and gaining reputation for hospitals.
(2) Chronic Disease Rehabilitation Center
Cooperate with health care institutions with relevant qualifications in the world to enrich patient treatment methods and make profits. Provide high-quality technical support for the rehabilitation center and the rehabilitation of patients with chronic respiratory diseases.
(3) Agent
We will rely on the good reputation of West China Hospital of Sichuan University and the 617 medical alliances in West China for product extrapolation, and establish stable cooperative relations with China's top domestic medical and pharmaceutical agents to promote and sell products through channels. Establishing a good cooperative relationship with agents in the world is one of the important ways for the company to expand sales channels. We will find agents worldwide to be more effective than traditional single chemotherapy and lung transplantation treatments. The advantages of products with lower cost, zero trauma and better therapeutic effect have won favor in the global market. Establish cooperative relations with hospitals and pulmonary fibrosis diagnosis and treatment training centers around the world to suppress the course of pulmonary fibrosis, while greatly reducing the treatment costs of patients and reducing the burden on patients' families.
2.3.3 Customer Relationship
(1) The main cooperation groups are government customers around the world, providing government customers with high-quality products and complete supporting service measures
(2) Looking for agents on a global scale, and establishing cooperative relationships with hospitals and private health care centers of Grade II and above on a global scale
2.3.4 Profit model
(1) Product profitability: By participating in the bidding of lung aerosol treatment equipment in the Department of Respiratory Medicine of West China Hospital, we can obtain the market of West China Hospital at a lower price and better utility. Because our products are lower in cost and do not need to be used together Anticoagulant can obtain greater profit margins than similar products, and it is initially estimated that it can increase profit by 12-15%.
(2) Brand profitability: In the process of product launch, create excellent product quality and product image, establish a good reputation among major domestic hospitals through utility and price advantages, and provide a market basis for the series of sub-products developed by the team in the later period. Consumer estimates, increase product profitability.
(3) Technological profitability: After the mature period, the company will use partial technology transfer to make profits. Because the company has a cooperative relationship with the West China National Heavy Industry Laboratory of Sichuan University, Gu can master the latest cutting-edge scientific research technology and use the latest technology to carry out products. Renewal, improve product performance, and achieve technological profitability.
Fig3. Profit model fiagram of Lung Knight
2.3.5 Cooperation Mode
(1) Science and technology research and development cooperation model: The technology part is supported by the State Key Laboratory of Biotherapy of Sichuan University, with technical support provided by laboratory researchers and laboratory undergraduates and doctoral students, and shares of the company with technology, and continuous progress Follow-up product research, design, development and building students are members of the scientific research team.
(2) OEM processing: OEM OEM model: the team’s products adopt the “manufacture and self-sale” model. The project team cooperates with professional medical drug manufacturers, the project team provides core production technology, and the production process is outsourced by the technology company Production, the project team pays production costs to it.
(3) Sales channels-medical fixed-point cooperation and consignment sales model: the company sells products to hospitals through medical sales agents, and at the same time directly conducts fixed-point cooperative direct sales with major top three hospitals across the country, as well as consignment channels such as the medical alliance product marketing.
(4) Community operation model: We will focus on the "community + question and answer" model to build a platform for exchanging experiences between consumers and hospitals. Patients can exchange their own experiences and experiences. At the same time, we will attract some doctors and experts on the platform to explain related issues. The knowledge, answers questions for patients, and improves consumer trust. Through sharing and Q&A to stimulate community activity, shorten the industry chain, and achieve value-added for the industry. Patients can make reservations for products through online platforms and go to offline docking pharmacies and hospitals to obtain products for treatment.
2.3.6 Cost structure
(1) Preliminary experiment cost materials: synthetic plasmid and liposome synthesis (2) Late animal experiment cost: animal feeding fee (2000 yuan); (3) Laboratory rental fee: the team cannot purchase experimental equipment in the early stage of the company’s establishment, and the laboratory is leased (4) Product additional accessories: handheld atomizer (95 yuan/piece);
Fig4. Cost structure diagram of Lung Knight
