User Group Analysis

1.Group background checks

The pace of modern life continues to accelerate, poor lifestyle affects human health. Among them, constipation has become an embarrassing problem for many people. According to incomplete statistics, there are about 745 million people in the world suffering from constipation, of which only in China there are about 17 million people suffering from constipation.

Medical experts say that many people have misconceptions about constipation, thinking that it is a minor problem that does not matter. In fact, constipation is also a disease, need to be treated as soon as possible to ensure that the intestinal tract as soon as possible to restore health. China's adult chronic constipation prevalence rate of up to 4% -6%, and with age and increase. In our population, the prevalence of constipation in young and middle-aged people is about 5 per cent, while the prevalence in the elderly is about 30 per cent, and the prevalence in the long-term bed-ridden elderly is up to more than 80 per cent ^[1]. Due to lack of knowledge of preventive measures, 4 out of 10 people worldwide suffer from constipation, making it a highly prevalent and recurring disease.

2.Group fact-finding

Constipation is a common and easy-to-occur disease, which has various causes. Elderly people have a higher incidence of constipation due to decreased secretion of digestive juices in the gastrointestinal tract, weakened peristalsis, and low activity level. In addition to the elderly, the number of young and middle-aged patients with constipation is also increasing due to poor lifestyle habits and excessive mental stress. At the same time, intestinal lesions, abuse of laxatives and other factors can also cause constipation, making the number of constipation patients continue to grow, seriously affecting the quality of human life.

Long-term constipation people suffer from constipation, more likely to feel nervous, anxiety, and even lead to insomnia and forgetfulness, suffering from neuropsychiatric disorders; constipation in the defecation of people in the hard to use force, the blood pressure will suddenly rise 30-50 mm Hg, which aggravates the cardio-cerebral vascular load, so that patients with constipation angina pectoris, myocardial infarction, cerebral haemorrhage, stroke and sudden death rate of significantly higher; when prolonged constipation in the digestive tract for a long time to produce a large number of harmful substances will be partially diffused into the central nervous system, resulting in memory loss, intellectual decline, slow thinking. Significantly higher; when a long time constipation, metabolites placed in the digestive tract for a long time, the production of a large number of harmful substances will be part of the diffusion into the central nervous system, resulting in patients with memory loss, intellectual decline, slow thinking.

3.User pain point analysis

The number of chronic constipation patients in China is huge, but the consultation rate is not high. Most patients do not consider constipation as a disease and take over-the-counter medicines for treatment on their own, which to a certain extent promotes the development of laxative products in the retail market.

However, most of the traditional constipation medications are laxatives, mainly osmotic laxatives and stimulant laxatives, which are very effective for short-term improvement of symptoms. However, long-term use of laxatives, especially stimulant laxatives, can cause damage to the intestinal mucosal nerves and reduce intestinal muscle tone, which in turn leads to more severe constipation. Half of the patients with constipated irritable bowel syndrome (IBS-C) suffer from abdominal pain and bloating. Although traditional osmotic or stimulant laxatives (e.g., polyethylene glycol, bisacodyl, lactulose, sulfate, etc.) have fewer adverse effects, are clinically proven, and are inexpensive, traditional osmotic or stimulant laxatives fail to reduce the symptoms of abdominal pain and bloating, and can even aggravate the symptoms of the patients.

Industry Market Analysis

1.Market Development Analysis

China has a large patient population with an increasing incidence. With the aggravation of aging, chronic idiopathic constipation of the elderly will be a major problem plaguing the elderly; with the gradual increase in life pressure, the incidence of irritable bowel syndrome is also increasing; with the reduction of exercise, sedentary time increases, constipation of office workers will also be a problem that can not be ignored. At this stage, the incidence of constipation in China to project the number of constipation patients in China has reached more than 100 million people.^[1]

As people's health awareness improves and attention to intestinal health grows, people are increasingly inclined to take active ways to alleviate constipation, and constipation medication, as one of the convenient choices, is gradually being recognised and accepted by the market. ^[2]In addition, the huge demand for diagnostic tests and the growing concern for early diagnosis and treatment of gastrointestinal diseases will further expand the demand for constipation treatment drugs, and the constipation drugs market has huge space.

2.Market size analysis

From 2012 to 2018, the market size of China's constipation medication market grew from 1.54 billion yuan to 3.78 billion yuan, with a CAGR of 16.3%. In China's constipation medication market, the market share of chemical drugs is higher than that of proprietary Chinese medicines, and the growth rate is faster, and the share ratio continues to rise. 2012-2018, the chemical drug market size of China's constipation medication grew from 1.06 billion yuan to 2.82 billion yuan, with a compound annual growth rate of 17.8%; and the market share ratio increased from 69% to 75%. China's constipation medication market as a whole maintains rapid growth^[3] . China's constipation medication market sales revenue reached 3.725 billion yuan in 2022, and is expected to reach to 7.313 billion yuan in 2029, with a compound annual growth rate (CAGR) of 9.85% over the period 2023-2029. In the future, the retail pharmacy market size is expected to rise at a growth rate of 9.92%, while the market growth rate of online retail is as high as 14.27%.

3.Market Landscape Analysis

According to the IMS report, the global market for constipation medications is approximately $3 billion, and despite the proliferation of generic anti-constipation medications, there is still a $570 million global market for polyethylene glycol, which is too old to be used, and bisacodyl, which sells for $260 million to Boehringer Ingelheim alone^[4] (Pharmacovigilance database). In terms of branded drugs, the market size for the above constipation drugs is US$2 billion when searched in the PDNA database. Traditional constipation medicines have been discouraged by many manufacturers due to their low price and low profit margins, but still have a market share of around 50% of the overall constipation medicine market .^[5]

The new generation of anti-constipation drugs, unlike traditional laxatives, are less irritating to the intestinal tract, and many of the products can also reduce the hypersensitivity of the intestinal nerves and reduce abdominal pain, which is particularly advantageous for constipated irritable bowel syndrome^[5]. As medical technology continues to advance, new types of constipation medications continue to emerge as new favourites on the market. These drugs relieve constipation by changing the intestinal flora and promoting intestinal peristalsis, which is more effective and promotes the development of the constipation drugs market.^[3]

4.Market Environment Analysis

The camp of biological drugs is very large and developing rapidly. At present, half of the world's pharmaceutical products have been biosynthesised, especially when synthesising drugs with complex molecular structures, which is not only simpler than the chemical synthesis method, but also has higher economic benefits. Over the past half century, a series of breakthrough applications of microbial transformation in drug development have created enormous medical value and economic benefits for the pharmaceutical industry.

From the political and legal environment: biopharmaceuticals are highly technical and therefore the technology is highly proprietary, so biopharmaceuticals have high legal barriers and are more difficult to enter.

From the economic environment:With the rapid development of human society, the economic development is unprecedented, people can have more financial ability to invest in medical and health care, while science and technology is changing rapidly, the technology of biopharmaceuticals will gradually mature and updated, so from the general trend, biopharmaceuticals will have a broad market demand.

From the social and cultural point of view:With the improvement of people's living standards, people pay more attention to their own health problems, so biopharmaceuticals can be very good to meet this demand, and there is no substitute.

From the technical analysis:Biopharmaceuticals are technologically demanding, not only to prevent new competitors from joining the industry, but also to lead technologically to pre-empt the existing competitive conditions in the industry.^[6]

Products

1.Product name

Gut-Sweeper: an engineered E. coli that integrates prevention, monitoring and treatment of constipation

2.Product Profile

Using synthetic biology, our team used E. coli EcN as a chassis to design an engineered bacterium that integrates prevention, monitoring, and treatment to help improve constipation in patients with functional constipation, and we plan to modify it to be able to be added to yoghurt, so that the patient can intervene in constipation subconsciously in their daily diet. Our engineered bacteria include sensing, metabolism, and safety modules that express 5-HT based on the level of butyrate in the gut of constipated patients, which promotes peristalsis and secretion to treat intestinal problems. Meanwhile, the engineered bacterium has a safety module that is adapted to low-temperature preservation and transport, and drug-controllable, which provides a guarantee for the safety of the engineered bacterium.

3.Module Introduction

We validate the wet experiments for each module, and also fit the results of the wet experiments by modelling the dry experiments. The specific modules are described below.

Sensory module:consists of pchA and CI proteins that can sense butyrate concentration and express the corresponding amount of CI proteins, Cl proteins are inhibitory and inhibit metabolic modules in normal humans.

Metabolic Module: It consists of TPH and TDC and is placed downstream of the plam promoter. TPH and TDC are two enzymes that catalyse the production of 5-HT, which binds to 5-HT receptors on the intestinal wall and promotes intestinal peristalsis and secretion to improve constipation.

Safety Module: Two circuits to ensure the temperature and drug control of the engineered bacteria. part1 drug control: use bistable switch to achieve drug control when the engineered bacteria are in the human body, if there is a low dose of tetracycline and its analogue TET in the environment, the plac promoter and its downstream tetR will be inhibited, the bacteria will express MazF, which will lead to the death of the bacteria. part2 temperature control: use the toxin-antitoxin system so that the engineered bacteria have different survival states in different environments. When the engineered bacteria are in the intestine, i.e. at 37 degrees, MazF is not expressed, MazE is expressed and the bacteria survive. As we plan to add the engineered bacteria into yoghurt at a later stage, we need a low temperature preservation environment, so when it is lower than 37 degrees Celsius and the yoghurt contains rhamnose, MazF and MazE are expressed at the same time, which is neutralised by each other, and the bacteria survive. However, when it is lower than 37 degrees and the environment does not contain rhamnose, i.e., after the engineered bacteria are expelled from the body, the expression of MazE decreases and cannot neutralise MazF, and the bacteria are induced to die, which ensures that our engineered bacteria will not pollute the environment after they are expelled from the body.

4.core competence

Product Advantage:Compared with traditional constipation pills, which are effective but have side effects and are not friendly enough for the elderly, the NMU-China team visited the elderly and investigated their special needs, and designed this synthetic biology engineered bacterial product with both therapeutic and preventive functions. By regulating the intestinal microflora, the product is gentler and has fewer side effects than traditional laxatives, which reduces the pain of taking medication for the elderly who are already physically weak. At the same time, when the engineered bacterial colony is colonised in the intestinal tract, it can spontaneously maintain the bacterial colony's number and the therapeutic effect, reducing the frequency and dosage of medication when constipation recurs and alleviating the patient's financial burden. In addition, the preventive function makes the product forward-looking, which can feel the precursor of constipation occurrence for self-regulation, and effectively control the condition before it starts or further deteriorates.

safety:Regarding the pharmacological treatment of functional constipation, traditional osmotic and stimulating laxatives have therapeutic effects, but long-term use will aggravate the loss of water and nutrients in the body, further damage to the patient's stomach and intestines, and there is also a high risk of triggering other underlying diseases and causing adverse reactions. Microecological preparations containing probiotics can improve the intestinal environment by regulating intestinal flora and treating constipation with less irritation to the intestinal tract, which has the advantages of less side effects and higher safety, and can effectively improve the health index of patients. Meanwhile, GUT-Sweeper products are designed with safety modules adapted to low-temperature preservation and transport, drug-controllable, and the engineered bacteria will be induced to die when it is removed from the human environment, so that it will not pollute the environment. The team validated wet experiments for each module and established models to fit the results of wet experiments through dry experiments to provide assurance of the safety of the engineered bacteria as well as a reference for subsequent experiments.

customer care:The NMU-China team has a deeper understanding of the constipation population and their needs and preferences through resource integration and field research, and has a clearer targeting of customers.The NMU-China team's project has received strong support from the Naval Medical University, and with the support of the Department of Anorectal and Intestinal Surgery of the Changhai Hospital affiliated with the University, the NMU-China team has a more comprehensive and detailed understanding of the lifestyles of constipation patients. With the support of the Department of Anorectal Surgery of Changhai Hospital, the NMU-China team gained a more comprehensive and detailed understanding of the lifestyles, conditions, and demands of constipation patients, and the NMU-China R&D team had the advantage of being in close proximity to the hospitals and the frontline patients that other teams do not have. This information has enabled us to add more humanistic factors to our product design and improve more details to provide a better service experience. Meanwhile, the NMU-China team has carried out several constipation awareness and education campaigns in cooperation with neighbourhood committees, and will continue to do so in the future to spread the public's correct understanding of the basic conditions and dangers of constipation.

5.development potential

Future applicability: The GUT-Sweeper product will be tested in the future for feasibility in a real clinical setting. This will include results in patients of different ages and comparisons with existing treatments. The team will focus on and work to further explore and expand the product's advantages over traditional approaches, such as better results, faster treatment or fewer side effects. As well as experimenting with potential future areas of research, such as the possibility of personalised treatments or combination therapies for specific populations.

Increased market demand: China has entered the stage of aging, the elderly population continues to increase, with the aging of the population, constipation may become more common, the aging process will become the main factor of increased market demand. In addition, the increasing pressure of work and life, the influence of bad living habits caused by the incidence of constipation in China continues to increase, as well as people's attention to intestinal health will also further expand the market demand for constipation-related products.

Policies and development pattern: the State promulgated the "14th Five-Year Plan" for the development of pharmaceutical industry, the construction of Healthy China has been comprehensively promoted, and the cause of health care has been transformed from treating illnesses to focusing on people's health; the domestic pharmaceutical market has entered a stage of high-quality development; the new round of technological change and cross-border integration has been accelerated, and transformative new drug creation technologies and innovative therapies have been emerging. innovative therapies, and new types of drugs continue to emerge. With the construction of the pharmaceutical industry pattern, the upstream and downstream industry chains are more complete, and the effective integration of resources will further reduce the cost of products and support the production and sales of products. Product competitiveness will be further enhanced through economies of scale, supply chain optimisation or technological improvements. In addition, the stability and increase in social resources will help ensure a continuous supply of products.

business model

1.operating model

Overview: To provide products and related consultancy and after-sales service to hospitals and other medical institutions and to the demand and direct users of constipation-related products.

Team:Based on the core R&D team, develop a specialised team, mainly including sales staff, drug experts, lawyers, managers, information gatherers, etc., focusing on division of labour and coordination.

Division of labour: the R&D department should focus on developing new technologies to produce products that satisfy consumers and meet their needs; the sales staff is responsible for building sales channels, including negotiating with hospitals and other medical institutions for cooperation, establishing good contacts with retailers, strengthening product promotion and establishing product image among potential user groups, and realizing the distribution and resale of products. At the same time in hospitals and residential areas to set up special consulting and after-sales service agencies, the establishment of a two-way contact between service personnel and consumers to strengthen communication and mutual supervision of the harmonious atmosphere. Consulting agencies are mainly responsible for answering the hospital doctors and patients and residents of the residential areas of drug-related information, while playing a role in promoting new products and collecting information on their higher needs, so as to facilitate the company's development of new drugs, promote new drugs and further expand the product market; after-sales service agencies are mainly responsible for the collection of the effect of the use of medicines, feedback to the R & D department, and at the same time to deal with some of the after-sales problems of the analysis and investigation and minimise the adverse effects. Pharmaceutical experts provide professional advice, relevant policies and industry knowledge, and a team of lawyers provides legal services.

2.Profit Model

As a startup, NMU-China has a spontaneous profit model, which is consciously adjusted and designed by the team through the summary of the profit practice. The smaller team size enables the team to have better flexibility, the core team members have clarity and focus, and the team can better adapt to the market environment and adopt more advantageous pricing strategies. In summary, there are two main types of team profitability models.

Product sales: The buyer and user base of Gut-Sweeper products and services is one of the main sources of profitability, and the improved quality of Gut-Sweeper products in relation to the needs and preferences of the target users will help to consolidate loyalty and increase the repurchase rate, while the unique value that the products can offer will appeal to a larger group of users. Through cooperation with suppliers and technological upgrades, the team will be optimised to reduce costs, and publicity will be used to expand sales and gain more market share.

Patent Revenue: Gut-Sweeper products have fully exclusive intellectual property rights, and the synthetic biological routes designed and developed independently have certain technical barriers. In the future, the NMU-China team will apply for patent protection, and gain revenues by licensing and permitting patents. These proceeds will be used for scale-up and continuous R&D and improvement of the products, or for co-operation with other companies to improve innovation and expand product advantages.

Competitive Analysis

1."Whole Bowel Sang" (Bacillus licheniformis Live Bacteria Capsules)

Manufacturer: Northeast Pharmaceutical Group Shenyang First Pharmaceutical Co.

Approval Number: S10950019

The product is used for acute and chronic enteritis and diarrhoea caused by bacteria or fungi. It can also be used for the prevention and control of intestinal flora imbalance caused by other reasons. After entering the intestinal tract with live bacteria, this product has antagonistic effect on pathogenic bacteria such as staphylococcus and yeast-like bacteria, while it has growth-promoting effect on bifidobacteria, lactobacillus, anaplastic bacillus, and digestive streptococcus, so that it can adjust the dysfunction of the intestinal flora to achieve the therapeutic purpose. This product can induce the body to produce antibacterial active substances, killing pathogenic bacteria. In addition, it can make the intestinal tract hypoxic through oxygen-capturing biological effect, which is conducive to the growth of a large number of anaerobic bacteria. However, it can only alleviate short-term discomfort, but not from the root cause to play a therapeutic effect.

2.G-NiiB Probiotic Red Stripe

Manufacturer: Jingjin Microbiology Technology Co.

For Probiotics brand, a nutraceutical, not a drug, and does not have a therapeutic effect in the standard sense.

This product is made with Bifidobacterium youthfulum, a dominant bacterium commonly found in the intestines of young individuals, which can help to rejuvenate the intestines. Bifidobacterium youthfulum can decrease in number as we age and cannot be consumed in the usual three meals a day, so it needs to be replenished through probiotics. Adopted from Italy Microencapsulation G-NiiB Blue Strips are suitable for daily use to maintain the balance of intestinal flora and improve intestinal problems such as constipation, flatulence, indigestion, etc. It is suitable for those who want to take care of their daily health care and have occasional difficulty in defecation, while G-NiiB Red Strips are the enhanced version of G-NiiB Blue Strips, with 5 times more probiotics than the blue version. G-NiiB Red Strips is the enhanced version of G-NiiB Blue Strips, with 5 times more probiotics than Blue Strips, which helps to fight against intestinal problems and strengthen the intestinal flora. It is more suitable for people who have just undergone surgery, or elderly people with low immunity.

interested party

1.Upstream

The upstream chain of biopharmaceuticals includes the laboratory research and development stage and the industrial production stage.

The R&D phase of the laboratory is divided into molecular development phase and cell line development phase. It mainly involves scientific research reagents (general reagents and high-end reagents), laboratory consumables and laboratory analytical instruments.

The industrialised production stage is divided into an upstream production stage and a downstream production stage. The upstream production stage mainly refers to cell culture, while the downstream production stage mainly involves purification and filling. It involves reagent raw materials (antigen/antibody, enzyme), consumables (cell culture medium, chromatography packing/chromatography medium, filtration products), production equipment (bioreactor, post-packaging equipment), etc.^[7]

2.Midstream

State Food and Drug Administration (SFDA) Drug Administration (SFDA) Bureau is State Council It is an organisation directly under the State Council responsible for the comprehensive supervision and supervision of medicines, and is responsible for the administrative and technical supervision of the research, production, circulation and use of medicines (including traditional Chinese medicines and ethnomedicines). Its core is risk supervision and preventive supervision to ensure the safety, effectiveness and reliable quality of medicines. Its duties include formulating supervision and management policies and plans, organising the drafting of laws and regulations, formulating departmental rules and supervising their implementation. Researching and formulating policies for the management and service of new technologies and products that encourage medicines^[8] . Therefore, it is of great significance for the development of pharmaceutical enterprises to comply with the supervision policies of the drug regulatory authorities and to understand the relevant encouragement policies of the drug regulatory authorities.

3.Downstream

Downstream customers mainly include pharmaceutical distribution companies such as drug distributors and sales terminals (pharmacies and medical service institutions, etc.). The former is mainly responsible for the distribution of drugs, while the latter is mainly responsible for the final sale of drugs. The sales volume of pharmaceutical products to downstream customers directly affects the performance of the pharmaceutical manufacturing industry.

Terminals also include purchasers of medicines from medical institutions, prescribing decision makers, i.e. prescribing doctors, and purchasers of products, i.e. patient users. For purchasers of medicines in medical institutions, it is possible to negotiate co-operation to increase the distribution of the product. For the prescribing decision makers, i.e. prescribing doctors, we can gain their trust through publicity and product introduction, training and guidance on application and suitable population. For buyers, the team believes that it is necessary to educate the public about constipation, such as the gut and microbiology. On the one hand, it can draw the public's attention to constipation and help them pay more attention to intestinal health; on the other hand, it can also raise the public's awareness that constipation is a disease and enhance their willingness to seek reasonable medical treatment.

4.Industry and intellectual property experts

Prior to entering the industry, the team needs to actively seek advice from industry and IP experts for advice on the commercialisation process and transfer of relevant knowledge such as technology. This pre-analysis phase is critical as it helps the team better understand the market environment and IP challenges. We have already had initial collaborations with a number of industry authorities who have provided valuable insights to help us optimise our product development and commercialisation strategy. This collaboration helps us ensure that we enter the market with sufficient knowledge and strategy to improve our chances of success. For example, we can apply for invention or utility model patents to protect our intellectual property. As well as learning more about the experience and requirements related to the clinical, registration, approval and marketing of drugs, this will help the team achieve its goals faster.

5.Policy and Law

Drug listing laws and regulations include: Drug Administration Law of the People's Republic of China, Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, and Food Safety Law.

Laws and regulations on business operation include: Administrative Licensing Law of the People's Republic of China, Company Law of the People's Republic of China, Work Safety Law of the People's Republic of China, Patent Law of the People's Republic of China, and Law of the People's Republic of China Against Unfair Competition.

About Gut-Sweeper products: The China Food Industry Association (CFIA) led the release of the group standard "Probiotic Foods", which regulates the technical requirements for probiotic foods accordingly. Regular probiotic products use Probiotic strains The probiotic strains used in regular probiotic products must comply with the "List of probiotic strains that can be used in health food" and its announcement issued by the state, or comply with the list of strains approved and registered by the state for use in health food. Probiotics need to be edible strains that have been approved for use after national safety assessment. Among them, the strain used should also carry a strain number, which means that the probiotic strain has undergone a large number of clinical trials and its safety and efficacy have been confirmed.

Project Team

1.Core staff:

The NMU-China team is a diversified group of professionals, with different personnel in the HP group, wet lab group, modelling group and art group, enabling them to complete the basic research, development and promotion of the Gut-Sweeper product, and to complete the transformation of the identity of a start-up team. The team also has a good reserve of personnel for further marketing, product design and iteration, and publicity and sales. The team has strong expertise and a separate molecular and cellular laboratory. The team members are enthusiastic and collaborative, brainstorming and sharing ideas, planning the project process together step by step, putting it into practice and turning the vision into reality.

2.Academic resources, technical support

The NMU-China2023 team was strongly supported by NMU and received long-term guidance from the Biophysics Department of the university. Strong support was received from the Department of Anorectal Surgery, Changhai Hospital, the First Affiliated Hospital of the University.

development project

1.Current Operations:

Product Iteration: During the current period, we will continue to iterate on our products to continually improve the performance and functionality of our existing products. This includes making improvements based on user feedback and market demand to ensure products remain competitive.

2.Growth Strategies:

Team Recruitment: We will be actively recruiting people with multi-disciplinary expertise to strengthen our team. This includes people in research and development, marketing, sales and operations to ensure we can fully support the growth of our business.

Marketing Promotion: We have developed a diverse marketing strategy that includes digital marketing, social media outreach and partnerships with health professionals. We also plan to expand into additional markets and increase brand awareness.

External Cooperation: We will actively seek strategic cooperation with other companies and organisations in order to jointly advance product development and market expansion. This could include research collaborations, distribution partnerships or technical co-operation.

3.The ultimate goal:

Product Line Expansion: One of our ultimate goals is to build a diversified product line that encompasses more health and lifestyle related categories. This could include the development of ancillary products related to constipation treatment or further exploration of other areas of health to meet the needs of different customer segments and increase the Company's revenue streams.

New Market Entry: We plan to enter new markets to increase our market share. This requires an understanding of the culture and regulations of different markets in order to develop an adaptable entry strategy.

Creating an ecosystem: Our long-term goal is to build an ecosystem that encompasses several health-related areas. This will help to increase the company's impact and foster continued growth and innovation.

Sources of funding, allocation of funds and risk assessment

1.Sources of funding:

Pre-phase: In the pre-phase, we will actively seek support from academic programmes and research funding. This will help us carry out initial research and development to validate the potential and feasibility of the product. We plan to partner with universities, research institutes and research grants to secure the necessary funding and resources to advance the early stages of the project. Long-term partnerships with suppliers and sponsors are also sought to obtain equipment and resources and to reduce production costs. This can be achieved by negotiating contracts, negotiating prices and co-developing projects.

Mid-phase: participation in investor roadshows and startup competitions to showcase the GUT-Sweeper product and business potential. These could include industry seminars, startup incubator demo days and venture investor conferences. We may also actively participate in competitions organised by government healthcare sponsors for prizes and financial support. These competitions often provide support for projects with innovative and market potential.

Post-phase: actively seek corporate investment to support further development and commercialisation of the product. We will develop a detailed financing plan, specifying the use of funds required and expected returns. We will also actively seek networking opportunities with potential investors, including through social media, industry events and common business contacts, which will help build trust and exchange business opportunities. When presenting investment opportunities to potential investors, we will provide detailed profitability analyses highlighting the market potential of the product and expected returns. We will emphasise the competence and experience of our team and our expertise in the field. We will demonstrate our unique selling points and competitive advantages in the market, making it clear why investors should choose to invest in our project over other competitors.

2.Allocation of funds

Iterative product development (60 per cent):

We plan to invest a portion of our capital in market research to gain a deeper understanding of customer needs, the competitive environment and market trends. This will help guide the direction of product iterations and ensure that products meet market needs. We also invest a portion of our capital in product research and development, including ongoing technology updates and upgrades to improve performance and safety, to ensure that our products remain competitive, and to improve the functionality of our products to meet the changing needs of our customers.

Marketing (30 per cent):

We will invest capital to establish effective marketing channels, including online advertising, social media, and content marketing to increase brand awareness and attract more potential customers. We will also conduct targeted promotional activities, including product launches, promotional events and participation in industry trade shows to increase sales.

Business development (10 per cent):

We will use a portion of the funds to recruit highly qualified team members, including research and development personnel, sales and marketing specialists, and managers. A portion of the funds will be used for effective team management. In addition, we plan to engage professional product consulting services to obtain valuable professional advice on product design, user experience and market positioning.

3.Sub-insurance assessment

Upstream: Upstream suppliers of the microbiological preparation manufacturing industry mainly include including raw materials, consumables and instruments/equipment. If the upstream enterprises do not comply with national environmental protection standards and policy requirements in the production process, or if the prices of raw materials and other raw materials of the upstream enterprises increase, this may lead to a decrease in the supply capacity of the upstream or an increase in the supply price of raw materials, which may affect the cost of the products.

Midstream: the market share of the constipation medicine industry has been seized and divided. At present, constipation drugs mainly include chemical drugs and proprietary Chinese medicines, with lactulose, polyethylene glycol and Keserol as the main chemical drugs; proprietary Chinese medicines are mainly composed of rhubarb, hemp kernel, aloe vera and other main ingredients. In different areas, there are many market enterprises and fierce competition.

Downstream: The pharmaceutical sales segment is greatly affected by national policies, and if significant adjustments occur in the national drug procurement policy, health insurance payment policy, etc., it may lead to changes in the downstream industrial pattern or business model, thus affecting the team's business model and sales scale.