Purpose & Our product

Our pioneering product, a-kb, presents a cutting-edge solution for hair regeneration, catering to individuals of all backgrounds grappling with hair loss, particularly those afflicted with allergies or those unable to utilize Minoxidil. Our primary focus lies in addressing telogen effluvium, a subset of hair loss that receives comparatively less attention. Simultaneously, a-kb stands out as a cost-effective alternative to pricier hair regrowth methods like hair transplants, rendering it accessible to almost everyone. To instill public trust, we have positioned a-kb as an over-the-counter medication, ensuring that it will be readily available through hospitals, pharmacies, and various distributors upon its launch.

Unlike Minoxidil, a-kb brings forth a myriad of additional advantages. It is water-soluble and ，being a food additive, making it a safer and milder option in comparison. Furthermore, a-kb can be incorporated into diverse product forms such as hair products and dietary supplements, enhancing its versatility before it hits the market as an over-the-counter drug. As a product of synthetic biology, a-kb embraces an innovative approach, boasting shorter production cycles and greater energy efficiency when compared to traditional industrial methods. By leveraging synthetic biology in the treatment of hair loss, we introduce a fresh perspective to the market, effectively tackling the issue of product oversaturation.
Value proposition

The market of allopecia is huge in the whole world. Our product aims to remedy the shortcomings of the market of Minoxidil and provide those individuals who could not use Minoxidil a suitable product.

In our region, China, hair loss has become one of the most important health problems in 2020, with about 27% of respondents suffering from hair loss. In 2020, the number of people with hair loss reached 250 million, accounting for 18% of the total population, including 163 million men and 87 million women (See Fig.2.1). What is worse, the number of people with hair loss continues to grow. Moreover, the phenomenon of hair loss shows a younger trend (See Fig.2.2). From 2017 to 2021, the proportion of post-90s hair loss increased from 36.1% to 39.3%, which has become the largest proportion of hair loss group.

Fig 2.1 left：source from Dr.Dingxiang’s 2020 National Health Insight Report; right: source from National Health Commission data

Fig 2.2 source from Mob Research Institute
Minoxidil is the most popular hair treatment drugs in recent market. Shown on the Fig.2.3, 1.21 USD billion was earned by Minoxidil in 2021 and 1.28 USD billion in 2022. It is predicted that in the future decade, sales will continuously soar. All this evidence reveals that the demand for the allopecia market is huge and there is substantial potential in our project.

While Minoxidil could solve many hair problems, there are still a portion of people who can not use Minoxidil. Many side effects are present in this drug which are shown in the Fig.2.4. As a result, Minoxidil is not tender enough to meet everyone's needs. A new product needs to be manufactured to fit those people's demands.

Fig2.3 Global minoxidil market, By product, 2021-2023(USD Billion). Source from By Region, Pricing Analysis & Global Forecast, 2023-2032

Fig.2.4 Side effects of minoxidil. Bars represent the percentage of patiens who reported the given side effect. Source from Compliance to Topical Minoxidil and Reasons for Discontinuation among Patiens with Androgenetic Alopecia.Dermatol Ther(Heidelb) 13,1157-1169(2023).
Target customers

Just like Minoxidil, our product "a-KB" is designed for hair growth. It caters to individuals who suffer from abnormal hair loss, specifically targeting two groups that could be our ideal customers. The first group of people is those who can not be covered by Minoxidil, or are allergic to it. The second group includes patients suffering from telogen effluvium, a condition caused by factors like chronic stress, rapid weight loss, and postpartum hormonal changes. With the increasing prevalence of hair loss among younger individuals due to societal pressure, there is a huge market demand. We aim to target these young patients, as well as those experiencing postpartum hair loss. Currently, there is no suitable drug for postpartum hair loss, and doctors typically prescribe placebos instead of Minoxidil due to its lack of tenderness. In the future, we hope that doctors can offer our trustworthy product, a-KB, as a viable solution when patients seek help for postpartum hair loss.

Human practices
After identifying potential early adopters, our next step is to conduct interviews with real-life users of Minoxidil and patients with telogen effluvium to gain insights into their experiences with hair loss, their current treatments, and their specific needs. We reached out to volunteers among our friends and online, and were able to connect with two individuals who had used Minoxidil and four who is suffering from telogen effluvium.

During the interviews with Minoxidil users, we found common themes among the participants. All of them started using Minoxidil based on positive reviews and their own observation of hair loss. However, both Minoxidil users experienced varying degrees of allergic reactions that forced them to stop using the product. The first respondent (refer to Fig.3.1) described an unpleasant experience with Minoxidil, reporting an oily and uncomfortable sensation, rough hair, and allergic reactions on her face, including redness, itching, and swelling. The second respondent (refer to Fig.3.2) also experienced significant allergies, including itching at the application site and ears, severe peeling, and increased hair loss at the application site.

We also asked the Minoxidil users about their ideal hair growth product. Both of them emphasized the importance of a mild and non-irritating product. Additionally, the second user mentioned a preference for oral medication over topical. When it came to synthetic drugs, both users expressed willingness to consider them after seeing positive feedback from other consumers. Therefore, we see a need for educational activities to promote synthetic biology (refer to the Human Practice page for more details).

During interviews with telogen effluvium patients, we found that they all have a deep sense of anxiety and self-esteem issues related to their hair loss. They feel less confident in dating and job-seeking due to their hair deficiencies. Interestingly, two interviewees even expressed a willingness to become samples for testing the effectiveness of a-KB, highlighting how hair problems are becoming significant concerns across various aspects of their lives. Furthermore, while most doctors advise telogen effluvium patients not to worry as the condition usually resolves on its own, these patients face various challenges during the recovery stage. Therefore, there is a clear demand for a new drug specifically targeting telogen effluvium, as expressed by all the patients we interviewed.

During interviews with telogen effluvium patients, we found that they all have a deep sense of anxiety and self-esteem issues related to their hair loss.They feel less confidentin dating and job-seeking due to their hairdeficiencies. Interestingly, two interviewees even expressed a willingness to become samples for testing the effectiveness of a-KB, highlighting how hair problems are becoming significant concerns across various aspects of their lives. Furthermore, while most doctors advise telogen effluvium patients not to worry as the condition usually resolves on its own, these patients face various challenges during the recovery stage. Therefore, there is a clear demand for a new drug specifically targeting telogen effluvium, as expressed by all the patients we interviewed.

Based on the findings from our interviews, we believe that a-KB offers distinct advantages over Minoxidil as a mild hair growth product that can be taken orally or applied topically. The needs expressed by both groups are genuine, and they are eager for a new approach to address their hair loss concerns.
Based on the findings from our interviews, we believe that a-KB offers distinct advantages over Minoxidil as a mild hair growth product that can be taken orally or applied topically. The needs expressed by both groups are genuine, and they are eager for a new approach to address their hair loss concerns.

SWOT analysis

SWOT

strength: ● A cheaper choice than physical hair transplant. ● Short production cycle，energy saving and environmental protection compared with industrial production. ●Milder and safer (soluble in water, not allergic). ●Various in the product forms (diet, hair care essential oil, etc.).	weakness: ● Produced by synthetic biology (some people may refuse to use the product). ● Production techniques need to be optimized. ● Synthetic biology acceptance.
opportunities: ● The market of hair loss is large and still growing. ● The drugs in nowadays’s is too single, Minoxidil negative reputation. ● Government support.	threats: ● No clinical data. ● No certificate of approval for over-the-counter drugs. ● The appearance of other effective constituents.

Potential problems

In the future, we eventually want to appear in the public in the form of over-the-counter drugs. In the Human practice meetings with doctors（check hp pages for more details）, we learned that new drugs development is a project with high investment and long cycle. At present, a-KB has only been reported to have a hair-generating effect on mice, and there is no human clinical trials data at present. The biggest problem we face in the future is the funding of new drug research and development, followed by the needs to continue optimizing the production of a-KB and expand the scale of production. We believe that our business can continue to develop as long as we ensure sufficient capital and deep cultivation of technology. For the scaling up of a-KB production, we interviewed with Links-Spider conpany, a synthetic biology company founded in 2019, to find out about the cost and resources required.

We developed a full timeline for both issues to ensure the success of the business plan. Business Development: Our plan is to first generate profits through non-pharmaceutical means, such as essential oils, cleansing, and other skincare products, in order to support the later development of pharmaceuticals. In the first two years, we do not expect to make any profits. Instead, we aim to apply for cosmetics usage qualifications and establish contacts with business companies to seek investment and collaboration. Once we obtain the cosmetics usage qualifications, we will use a-KB as a raw material molecule and cooperate with well-known skincare brands to accumulate funds. At the same time, we will start the pharmaceutical research phase of a-KB. We anticipate completing preclinical studies for a-KB within five years, including pharmacology, pharmacokinetics, and safety evaluations in animal models. We will then seek approval from the national drug regulatory authority, which is a prerequisite for conducting clinical trials in our region. Subsequently, we plan to apply for patent protection and continue with clinical experiments. Within eight years, we expect to complete Phase I-III clinical trials. If everything progresses smoothly, a-KB is projected to be launched as an over-the-counter drug in ten years.

Fig.4.1 A-KB's listing flow chart

Technology and scale: During the first two years, we will continue to genetically modify our biological and produce them in stable small fermenters in the laboratory. At that time, the yield of a-KB is 250 millimetre every time. Between the two years and five years, our AIS strain in the lab to maximize yield and stabilize the laboratory fermentation, and we intend to supply the production required for the initial commercial collaboration at a lab-scale production rate (6L/ run, with yield calculated at 1.8g/L). Subsequently, we will further expand the fermentation scale and yield. For this, we plan to ask technical support and external work to explore the conditions of stable fermentation，aimed to expand to 60 litre per run. In the fifth-eighth year, we will look for stable factories to achieve stable large-scale fermentation. In ten years, we begin to prepare for constructing our own factories. The profits are substantial and increasing every year. The yield will become 100 litre per run in ten years plan.

	2-year plan	5-year plan	8-year plan	10-year plan
Business Development	·Apply for cosmetics usage qualifications	·Anticipate completing preclinical studies for a-KB ·Establish contacts with business companies to seek investment and collaboration	·Seek approval from the national drug regulatory authority ·Plan to apply for patent protection and continue with clinical experiments ·Complete Phase I-III clinical trials.	·a-KB is projected to be launched as an over-the-counter drug
Technology and Scale	·Continue to genetically modify our biological AIS strain in the lab ·Conical flask（250ml）to Stable fermentation in mini fermenter （6L）	·Ask technical support and external work to explore the conditions of stable fermentation for 60L.	· Look for stable factories for stable fermentation.	·Build our own factory

Table 4.2 Our ten years plan of Business Development and Technology and Scale

Revenue model and financing

Product price prediction

It is difficult for us to determine the actual price of our product a-kb, so we searched and compared the price of other competitive companies. Shown in the table 5.1, the average price of related commodities like Minoxidil and some types of hair tonic could be used to decide the approximate price of a-kb (0.33$/ml). Altering the price a bit, which slightly below that of Minoxidil to compete for market position, the price we set is 0.23 dollar per milliliter eventually.

Name of the Product	Ingredients	USD $/ml	CNY ¥/ml
Minoxidil	-Ethanol -Polypropylene glycol	0.32	2.4
Hair Tonic (e.g. Lukefy hair conditioner)	-Ginseng root -ginger root -rhizome root -Radix polygonatum -Platycypress leaf -Diaminopyrimidine oxide	0.50	3.66
Shampoo (e.g. Ficcecode ginger shampoo)	-Lemon bar extract zinc lactate -Zingiber Officinale -Allantoin	0.05	0.33
Average	/	0.29	2.13
alpha-KB predicted	/	0.23	1.7

Table 5.1 Similar Products Price Estimation List

Concentration of a-kb: 1.8 gram per litre
Labour force: 8 employees in two-five years plan and 30 employees in eight-ten years plan.

	Two years plan	Five years plan	Eight years plan	Ten years plan
Revenues/$	None	Sales of a-KB per year: 132,480.00 Angel investment: 685,320.00 Total in three years: 1,082,720.00	Sales of a-KB per year: 1,324,800.00 Financing: First round: 1370640.00 Second round: 6853200.00 Third round: 13706400.00 Total in three years: 22,327,440.00	Sales of a-KB per year: 2,208,000.00 Financing: First round: 68,532,000.00 Second round: 137,064,000.00 Total in two years: 210,012,000
Costs/$	Payment to Links-Spider company: 1,027.64 per month Apply for qualification: 4,110.57 Employees expense: 1,095.67 per month per person Total in two years: 239,142.57	Factory expense：68,509.50 per year Employees expense (e.g. Salaries): 1,095.67 per month per person Advertisement: 684.80 per year Raw materials: 1,369.59 per year Packaging: 684.80 per year Preclinical trial cost: 137,019.00 Total in five years：905,460.60	Factory expense：13,706.40 per year Employees expense (e.g. Salaries): 13,669.14 per month per person Advertisement: 1,369.60 per year Raw materials: 136,959.00 per year Packaging: 1,369.60 per year Clinical trial cost: 1370640.00 Total in three years: 16,593,525.00	Factory expense：13,706.40 per year Employees expense (e.g. Salaries): 13,669.14 per month per person Advertisement: 1,369.60 per year Raw materials: 136,959.00 per year Packaging: 1,369.60 per year Total in two years: 10,148,590
Profits/$	-239,142.57	177,259.40	5,733,915.00	199,863,410

Table 5.2 Our ten years plan of Revenues and Costs

*Links-Spider company would support us for the laboratory requirement, hence we need not consider the lab cost.

Purpose & Our product

Value proposition

Target customers

SWOT analysis

Revenue model and financing