We participated in the 2024 Synthetic Biology Open Conference held by Hubei University.At this conference, experts from different professional fields gathered in a circle to communicate and guide the participating teams, and answered their questions. During the conference, our team members actively sought advice from experts, communicated and exchanged ideas with other teams, and looked forward to future cooperation.
Our Mission
WHY?
Legume based insulin P37 (also called Vglycin) has a remarkable blood-glucose-lowing effect on Type 2 Diabetes (T2D) patients. However, extracting P37 directly from soybeans is not conducive to large-scale production due to several disadvantages, such as low yield, lengthy cycles and complex processes.
HOW?
Producing P37 in microorganisms by synthetic biology technique.
WHAT?
Expression and purification of hypoglycemic peptide P37 from Pichia pastoris.
Summary
At present, diabetes poses a significant health challenge globally. After conducting market research, we found that the currently popular drugs in the market have unpleasant drawbacks that cannot be ignored. Therefore, we began to consider how to make our products effective, affordable and without side effects. We have known that the new bioactive P37 is the first natural polypeptide in the world to be taken to prevent and treat diabetes. We expressed and purified the polypeptide from Pichia pastoris, and proposed to use it as an effective solution to control the blood sugar, offering it as an effective solution for blood sugar control to combat the rising number of diabetes patients.
Unmet Needs
Problem Statement
Since 2015, diabetes has become the sixth leading cause of disability, exerting substantial economic pressure on patients and society, causing over a trillion dollars in losses to the global health economy. From the 1980s to the beginning of this century, the incidence and prevalence of T2D have quadrupled due to global obesity, sedentary lifestyles, and an aging population.
At present, there are two major types of blood sugar control products on the market: drugs and meal replacements or sugar substitutes. Oral small molecule chemotherapy drugs, such as sulfonylureas, which have obvious side effects, are prone to developing drug resistance, and are toxic to the liver and kidneys. Injectable protein drugs are expensive and have poor patient compliance. What’s more, meal replacements and sugar substitutes have no therapeutic effects, and most of them are high in oil and sodium, leading to nutrient imbalances and potential hypoglycemia. Therefore, diabetes patients and society urgently need an ideal hypoglycemic product, which should have both drug like hypoglycemic effect and food like safety.
Delve into the following pop-ups in order to find more about our clients, their unmet needs and the existing solutions which back up our product opportunity to enter the market.
Type 2 diabetes patients
As mentioned above, diabetes patients are the main customers of our products. According to our human practice activities, we have known the probability of disease among people of different ages, and the medication treatment of diabetes patients. At present, type 2 diabetes is in an outbreak period in China, increasing at the rate of at least 3000 people per day, with an average annual increase of 1.2 million people. By 2022, the number of diabetes patients in China has exceeded 100 million. Such people (including diabetes type 1 and type II) will benefit from the hypoglycemic food developed by P37 peptide.
To present these situations more intuitively, please refer to the following images.
Figure 1. Age distribution of respondents.
Figure 2. The blood sugar status of the subjects.
Figure 3. The blood glucose distribution of the subjects before meals.
Figure 4. Post-meal blood glucose distribution of the subjects.
Understanding their pains and unmet needs
Although diabetes will bring many adverse effects to the body, many patients with diabetes still have poor treatment compliance, and some patients who have begun to use treatment products have experienced adverse reactions, some patients' blood sugar levels did not significantly decrease after taking medication, and some cannot afford high treatment costs. Understanding their unmet needs is crucial for the successful development and implementation of Vglycin.
Patients with diabetes want a product with significant hypoglycemic effect, no side effects, and low price. Vglycin needs to be experimentally analyzed and compared to prove that Vglycin is superior to other treatment methods.
First Potential Customers
Hyperglycemic group: This group is characterized by high blood sugar, and other symptoms are in the pre-potential development stage, so it is a high-risk person for diabetes.
Personnel with diabetes family inheritance history: For potential patients with diabetes family inheritance, Vglycin can effectively prevent the occurrence of diabetes.
Existing solutions
Figure 5. Benchmarking：Analyzing Vglycin’ competition(“+” indicates that it does have this effect, the number of “+” indicates the degree, “-” indicates that it does not have this effect.)
There are currently two main types of sugar control products on the market, namely drugs and meal replacement foods. Oral small molecule chemotherapy drugs, such as sulfonylureas, have obvious side effects and can lead to drug resistance in patients, causing toxic effects on their liver and kidneys. However, injectable protein drugs are expensive and have poor treatment compliance. But, meal replacement and sugar replacement foods have no therapeutic effect, and most of them are high in oil and sodium. Patients have an unbalanced intake of nutrients, and long-term consumption can lead to hypoglycemia. Therefore, diabetes patients and society urgently need an ideal hypoglycemic product, which should have both drug like hypoglycemic effect and food like safety.
Market Analysis: SOM, SAM & TAM
Analyzing the Serviceable Obtainable Market (SOM), Serviceable Available Market (SAM), and Total Addressable Market (TAM) is crucial for understanding the market opportunity for Vglycin. These concepts are essential in market research and planning for Vglycin’ success. We have started conducting market research and analysis on Vglycin, with our main goal of verifying the existence of the market and its potential profitability. We have taken the following steps to identify our market.
⚫ SOM: This represents the market segment we can access in the short to medium term. We plan to expand into the Wuhan market in Hubei province, with sales revenue exceeding 5 million CNY and net profit reaching 1.8 million CNY within 2 years. Our profitability is good and we are at a mid to high level in the industry.
⚫ SAM: In order to expand our market, we will establish ourselves in Wuhan and deepen our presence in the Hubei market. Within three years, the main business revenue will reach 10 million CNY, the net profit will exceed 3 million CNY, and the annual profit growth rate will remain stable at around 30%.
⚫ TAM: Realizing the development of business depth and horizontal expansion, vglyicn firmly occupies a leading position in the field of hypoglycemic products. We will realize omnichannel marketing and expand the product sales market to the national or even global level and comprehensively achieve economic, social, and ecological benefits.
Despite uncertainties, the potential for our venture in the market is encouraging, aligning with sustainability trends and growth opportunities.
Solution
Vglycin is set to become a groundbreaking treatment that revolutionizes, completely, diabetes treatment. Through our human practice, society and diabetes patients urgently need a hypoglycemic product that can significantly lower blood sugar level, has no side effects and is cheap.
As shown below, we've meticulously outlined a mockup that serves as our Minimum Viable Product (MVP).
Figure 6. Product samples.
To learn more about the technology behind, click below.
Vglycin Technology
If you are interested in learning more about the technicalities of Vglycin, delve into the project description section.
Figure 7. Core technology process diagram.
Vglycin' Label
In accordance to the Measures for the Supervision and Administration of Food Labels, which are the technical regulations that have to be followed in order for a product to successfully reach the registration and commercialization stage, we followed the stipulated in the Pharmacopoeia of the People's Republic of China.
Figure 8. Label schematic diagram.
Scalability
Scaling up a lab experiment offers significant potential for refining the production process before committing to larger-scale implementation.
To learn more about our process scaling-up, click below to download.
Inventiveness
Although there are several treatment methods and solutions for diabetes, Vglycin stands out with its innovative methods. Through our research and interaction with customers, we have found a gap in the market-there is no cost-effective method to treat diabetes without side effects. The numerous advantages of our product have generated considerable demand among the population affected by this issue, highlighting its unique creativity.
Development Plans
We understand the problem we are addressing and have a clear vision of what we aim to achieve. Now, let's delve into the 'how' and explore the entire developmental process. In this section, you will find a comprehensive overview of the tools and development plans we have put in place to transform our project into a startup and take it through to the commercialization phase. It's worth noting that everything described here has been meticulously crafted and planned with the guidance and expertise of a diverse group of professionals in the field of entrepreneurship, ranging from experienced entrepreneurs to technical and business mentors from incubation programs, investors, and industry professionals.
SWOT Analysis
Business Model
Drafting a Business Model Canvas is crucial as it provides a structured framework to analyze, plan, and refine a startup's strategy. We've used this powerful tool to clearly define how we create, deliver, and capture value in our innovative approach to tackling diabetes.
Based on our industry and actual situation, our team will make profits through two channels: B2B and B2C. Firstly, we extract a new type of hypoglycemic peptide, which is then processed by distributors for food production. Then, our team sells it online and distributors distribute it offline. Secondly, we establish pharmaceutical factories to independently produce drugs and directly supply them to pharmaceutical companies and pharmacies.
To learn more about each step of our Business Model, click below.
Channels
In crafting our path to reach our Customer Segments and deliver our compelling value proposition, our company recognizes the pivotal role of our stakeholders and the significance of personalized distribution. Our approach to reaching our market is multifaceted, designed to cater to the diverse needs and preferences of our customers.
Online channels: primarily focused on community marketing
Since 2023, the COVID-19 has changed people's consumption habits, new sales channels such as community group buying and direct sales from production areas have experienced explosive growth. The new sales channels are in line with the consumption habits of "stay at home" consumers, and the company will also use new forms such as online community marketing to deliver Vglycin products to consumers' homes.
Offline channels - mainly distributors
The company adopts a sales model mainly based on distributors. The company will establish corresponding sales teams to connect with various cities near Wuhan, and select intermediaries with corresponding capabilities based on the city's trade capacity and estimated demand size (intermediary capabilities focus on suitability and cost-effectiveness, initially starting from medium capacity intermediaries or retail terminals) to promote sales.
Online channel maintenance:
For the company's business on the Internet platform, the company will set up special departments to manage e-commerce work, mainly responsible for store maintenance, logistics contacts, customer after purchase services, etc. At the same time, the company will also establish a customer information database to track information and promptly handle after-sales issues, provide timely feedback and solve customer opinions and suggestions, continuously improve service quality to maintain customer relationships, and establish a good corporate image. In addition, in the early stages of development, it is necessary to keep online channels in the hands of the company to ensure coordination between online and offline channels and avoid malicious competition between them; In the later stage of development, online channel exclusive products can be customized for online channels to avoid conflicts between online and offline channels.
Offline channel management:
As the company develops steadily in the later stage, it will radiate the market to the whole of China, and there will inevitably be some differences in the specific channel setting and management methods of each regional branch. Therefore, small changes and adjustments should be made to the specific channel setting and management methods of each regional branch according to the actual situation, and relevant sales activities should be carried out using the model that best matches the local market form.
⚫ Firstly, supply management: Ensure timely supply, and on this basis, assist dealers in establishing and streamlining sales subnets, dispersing sales and inventory pressures, and accelerating the circulation speed of goods.
⚫ Secondly, order management: Strengthen the management of order processing for distributors to reduce delivery delays caused by errors in the order processing process.
⚫ Thirdly, support management: strengthen support for dealer advertising and promotion, and reduce resistance to product circulation; Timely help dealers eliminate concerns, guide and support dealers to shift towards a direction conducive to product marketing.
⚫ Fourth, other management: including training for distributors to enhance their recognition of the company's philosophy and values, as well as their understanding of product knowledge.
Strategy
Research and Development Strategy
The support and emphasis of the state on scientific and technological research and patent protection, as well as the important role played by technological strength in market competition, all tell us that the core of future enterprise competition will inevitably be technological content and service quality. Adopting research and development strategies, strengthening technological research and development, and product innovation are the paths that enterprises must choose to achieve long-term development./P>
The company has reached strategic cooperation with State Key Laboratory in technology research and development, actively carried out horizontal subject cooperation, applied for invention patents, and promoted technological innovation; In the sales process, the company independently develops an e-commerce platform and strengthens the construction of sales channels; In the future development process, the company will achieve digital transformation and promote the development of informatization and intelligence; Intensify product and technology research and development efforts to inject a continuous stream of innovative vitality into the development of enterprises.
Marketing Strategy
The company adopts an organic combination of offline and online marketing methods for marketing. Offline channels adopt classified pricing and installment payment methods to provide satisfactory pricing to customers, and through customer follow-up, respect customer opinions, strengthen relationship building with customers, play a role in stabilizing basic customers and ensuring market share; Through online channels, the company will strengthen cooperation with various e-commerce platforms and continuously develop and improve its independently built e-commerce platform. With the continuous increase of product types and the popularization of consumer groups in the later stage of the company's development, the company will strengthen data analysis and market research work, formulate different marketing strategies according to different segmented markets, and achieve the best return on investment with the most suitable marketing costs.
Brand Strategy
The name should be concise, easy to remember, and representative. Consider using names that contain vocabulary such as' blood sugar ',' regulation ',' health ',' biology ', etc. For example: Healthy Sugar Biotechnology, Blood Glucose Regulation Technology, Glycosyl Biotechnology, etc. The brand logo should be concise, exquisite, and easily recognizable. You can consider using graphics that contain elements such as "regulation", "health", "biology", etc. The colors should be gentle and fresh.
The brand slogan should be concise and easy to understand. For example: regulating blood sugar and promoting a healthy lifestyle; Biotechnology, nurturing health; Sugar is limited, health is infinite, etc.
Brand Communication Strategy:
⚫ Establish a complete brand image and standards, unify the brand image, and enhance brand awareness.
⚫ Utilize social media, search engines, and other online channels to carry out online promotional activities.
⚫ Collaborate with health consulting agencies, medical institutions, etc. to carry out offline promotion activities and increase product exposure.
⚫ By providing after-sales service and conducting user surveys, build consumer relationships and promote brand loyalty.
⚫ Strengthen cooperation with industry associations, authoritative media, etc., to enhance brand reputation and influence.
Exit Strategy
We are well aware of the importance of developing exit strategies when starting a business. Having such strategies not only provides security for business growth, but also makes the enterprise more attractive to investors. Based on this insight, in addition to developing a business model for Vglycin, exit strategies were also considered. To make this strategy effective, it is crucial to emphasize the importance of patent registration, which is a key component in protecting our inventions and establishing different business models: patent licensing. After obtaining the patent, if we are unable to manage production and manufacturing due to economic constraints, we will seek an exit strategy by acquiring a laboratory company in China. The acquiring company must possess the knowledge and mechanisms necessary for our project development. Therefore, we explored the legal aspects and the best ways to reach fair agreements with any potential partners.
Milestones & Next Steps
Highlighting Vglycin' milestones to date and laying out our future steps through a timeline is pivotal because it not only showcases our journey of progress but also serves as a roadmap for our stakeholders, guiding us towards our shared vision of revolutionizing diabetes treatment.
We went to Suzhou to attend the 11th China iGEMer Exchange Conference.During this conference, we listened to many excellent teams' wonderful presentations and had in-depth exchanges with some of them. In the process of communicating with them, we saw, heard, and learned many valuable suggestions. Their presentations provided us with many new ideas for promoting our iGEM project. On the last day of our communication, we also reported our project. After the report, the judge pointed out the problems in the overall direction of our team and had a detailed discussion with us. The guidance of the judge made us suddenly enlightened and also gave us a new understanding of iGEM.
We went to Shenzhen to participate in the Synthetic Biology Innovation Competition.I witnessed the combination of synthetic biology and art at the competition venue. Art can make synthetic biology more well-known to the public, and other forms of expression can play a significant role in promoting synthetic biology. Through communication with other participating teams, we have learned about many cutting-edge synthetic biology technologies. For example, some teams have adopted new gene editing tools to improve the efficiency and accuracy of genetic modification; Some teams have innovated in protein engineering. The exchange and collision of these technologies, although our project is relatively traditional, have provided new ideas and methods for our project through excellent presentations from other schools. After the defense, the judges from Beijing University of Chemical Technology suggested us to consider to add molecular chaperones to maintain disulfide bonds, which provided us with direction and inspiration for our future research.
Financial projection
In order to delve into financial projections and understand why they are pivotal for our growth and sustainability, check out our section 8 on our business plan.
Intellectual Property
To discover the intellectual property landscape of Vglycin and grasp its significance in safeguarding our innovation and market position, click below.
Business documents
Every startup requires a solid foundation for its scalable and secure growth. In pursuit of this, we have prepared a series of documents that will drive the development of Vglycin.
Legal Considerations
Last but certainly not least, it is crucial to meticulously address all regulatory and legal aspects to ensure the proper establishment, development, and commercialization of Vglycin. Below, you will find our legal plan.
Skills、capabilities & stakeholder
Outlining the required skills, capabilities, and stakeholders is of prime importance for Vglycin’ success. This project is based on the School of Life Sciences and Health Engineering at Hubei University of Technology, and has research platforms such as the Key Laboratory of Fermentation Engineering of the Ministry of Education, the Hubei Provincial Key Laboratory of Industrial Microbiology, and the Institute of Biomedical Research at Hubei University of Technology. In addition to basic molecular and cell biology experimental instruments and animal rooms, the supporting unit also has various advanced instruments necessary for protein/peptide purification and identification, such as analytical/preparative HPLC, quantitative PCR instrument, LC-MS/MS instrument, laser confocal microscope, etc.
The laboratory has gathered multiple high-level talents at the national and provincial levels, forming a high-level innovative research team with a reasonable academic background, age structure, and professional title structure. The laboratory has formed a scientific research system from basic research to applied basic research, product development and promotion, and has achieved a number of achievements including the National Science and Technology Progress Second Prize, Hubei Province Science and Technology Progress First Prize, and the Ministry of Education Natural Science First Prize; Published multiple high-level research papers in renowned academic journals in the field of fermentation engineering, such as MetabEng, ApplEnvironMicrobiol, BioresourceTechnol, etc; Obtained multiple US and Chinese invention patent authorizations; Actively promoting the application and transformation of scientific and technological achievements has promoted the development of the fermentation industry in Hubei Province and even the whole country, achieving good economic and social benefits.
Wuhan Gexin Biotechnology Co., Ltd
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Dezhou Lanli Biotechnology Co., Ltd.
It is a high-tech innovative enterprise specializing in the production and research and development of bioactive peptide series. At the same time, it is the largest collagen peptide manufacturer in China. The company mainly produces and operates fish collagen peptide, cow collagen peptide, soybean peptide and other animal and plant, as well as marine biological series of bioactive peptide products.
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Wuhan Lanzhi Biotechnology Co., Ltd
Wuhan Lanzhi Biotechnology Co., Ltd. has diversified business development in the field of biotechnology. The business of the company involves biochemical product technology research and development, chemical product sales (excluding licensed chemical products), food Internet sales (only selling prepackaged food), food sales (only selling prepackaged food), cosmetics wholesale, cosmetics retail, health food (prepackaged) sales, daily necessities wholesale, electronic product sales, electronic measuring instrument sales, technical services, technology development, technical consultation, technical exchange, technology transfer, technology promotion, goods import and export, technology import and export and other fields.
Long-term impacts
Visualizing the long-term positive and negative impacts of Vglycin is crucial because it allows informed decision-making, responsible product management, and the creation of a more resilient and successful market presence for Vglycin. To facilitate your understanding of these long-term impacts, we invite you to engage with the diagram below.
++ Significant hypoglycemic effect
It has the same or even better hypoglycemic effect as traditional hypoglycemic drugs.
++ Non-toxic side effects
Our team once commissioned the Institute of Preventive Medicine of Hubei Provincial Center for Disease Control and Prevention to complete the acute toxicity test of P37 peptide on Balb/c mice. The results showed that the extremely high dose of P37 peptide did not damage the main tissues and organs of the test animals (including heart, liver, spleen, lungs, kidneys, and pancreas), and there were no significant abnormalities in body weight and serum routine biochemical indicators.
++ Low cost
P37 hypoglycemic peptide is extracted from Pichia pastoris, a naturally occurring fungus with a wide range of raw material sources and low cost.
-- Production
If SOP is not followed during the production process, it may pose a threat to human health. We aim to counter this impact by taking biosafety courses and following good practices within the laboratory.
-- Emission
The production of Vglycin require scold storage, leading to increased energy consumption and operational costs. Emissions can also be produced by the transportation and disposal of the product. Promote the concept of green manufacturing, optimize the energy consumption structure, increase the proportion of new energy use, and reduce the environmental impact during production and transportation processes.