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Entrepreneurship

Who Are We?

An innovative pharmaceutical company that uses the NanoDisguiser to treat various viral infectious diseases.

Our Targets——Current pain points

For infectious diseases caused by enveloped viruses, there are many unmet needs with existing therapies.

  • Drug resistance: Viruses may develop resistance to existing antiviral drugs, which limits their long-term effectiveness.

  • Side effects: Most antiviral drugs cause serious side effects, affecting patients' quality of life and treatment compliance.

  • Easy to lose effect: The rapid mutation of viruses leads to the failure of existing drugs, requiring continuous development of new drugs to cope.

Our Solution--Product Analysis

Synopsis

Our company is committed to making different types of the NanoDisguisers, which vary in size and contain different types of membrane proteins. They can bind with different enveloped viruses, causing the virus to detach and release genetic material, thereby exerting antiviral effects.

Advantages

As an innovative drug, the Naonodisguiser has advantages such as broad-spectrum, reduced drug resistance, better targeting ability, nice biocompatibility, stable structure, and the ability to pass through the biological barrier. You can see the details by flipping through the following cards.

Broad Spectrum

NanoDisguiser can combine with multiple mutant strains formed by the same virus mutation based on the conservative stages of the virus lifecycle (namely the fusion process between the virus and human cell membrane proteins during invasion).

Reducing Drug Resistance

Due to the short lifecycle of the virus and its susceptibility to mutation, it is easy to form mutant strains and therefore develop drug resistance. But by targeting the conserved membrane fusion process, NanoDisguiser can effectively solve this issue.

Better Targeting Ability

When designing NanoDisguisers, specific receptors are selected. Unlike small molecule drugs, the assembled NanoDisguiser will not cause damage to normal cells, and the specific receptors can provide targeted binding to viruses.

Nice Biocompatibility

Due to the truly similar structure to human cells, NanoDisguiser has good biocompatibility and safety, reducing their immunogenicity as foreign molecules. They will not produce immune reactions when entering the patient's body, providing a better medication experience for patients.

Stable structure

NanoDisguiser has clearer structures, longer cycles, higher stability and better uniformity. It creates a highly stable environment for the membrane proteins to maintain their biological activity, thereby better exerting their binding to viral surface receptors.

Crossing Biological Barriers

The blood-brain barrier is a barrier that is difficult for most antiviral drugs to cross. However, cells in the blood-brain barrier have LDL and LRP receptors which can combine with the NanoDisguiser, so it can pass through the blood-brain barrier.

Product Comparison between NanoDisguiser and other drugs

We have carefully compared with other existing drugs, accurately analyzed their respective strengths and weaknesses, and evaluated their potential in terms of therapeutic efficacy. Actually, current treatments usually adopt a complementary strategy of "cocktail therapy" combination therapy, but NanoDisguiser can comprehensively cover the advantages of each of these therapies. It likely can be regarded as the first in class.

(Product Comparison Analysis Chart)

Our Recipe--Technology roadmap

NanoDisguiser is an original laboratory creation of ours. We have absolute control over our technology. Below is our detailed technical roadmap for manufacturing and functional verification of NanoDisguiser. For NanoDisguiser fabrication, our main experimental design focuses on membrane proteins and MSP, and we use SEND system to verify the function of NanoDisguiser.

(NanoDisguiser technology roadmap)

Our Plan--Research and Development Progress

“Dripping water through stones is not a one-day effort.”

Although we are still in the initial stage of constructing and validating the effect of NanoDisguiser in laboratory, we have gained a detailed understanding of the future development and market launch process of innovative drugs, and have listed possible timelines for our product.

(NanoDisguiser Development Timeline)

Discovery&Development(2024)

At this stage, we pioneered a way to manufacture NanoDisguisers by changing the length of MSP proteins to produce NanoDisguisers of different sizes, and by inserting different types of membrane proteins to produce NanoDisguisers which can target different viruses.

At the same time, modeling is used to simulate the changes in the function of NanoDisguiser under different conditions, in order to find the optimal conditions for its antiviral function.

Lead Optimization(2025)

At this stage, we validated the in vitro efficacy of the NanoDisguiser using the improved SEND system. We co-transfected three plasmids into HEK239FT cells to collect exosomes mimicking the virus. If HEK293T cells are infected with these exosomes, GFP mRNA will be injected into the cells and green fluorescence can be observed.

But when NanoDisguiser is added simultaneously with exosomes, a decrease or disappearance of fluorescence signal will be detected, thus verifying the effectiveness of NanoDisguiser in blocking viral infection.

Pre-clinical Test(2026)

In order to determine whether NanoDisguiser can exert antiviral effects in vivo and whether there are differences in the antiviral effects of NanoDisguiser against different viruses, we conduct animal experiments to investigate drug toxicity, efficacy, and drug delivery in vivo.

PhaseI, PhaseIIa, PhaseIIb, PhaseIII(2029)

Through clinical trials, we comprehensively evaluate the human tolerance, pharmacokinetics, and pharmacodynamics of NanoDisguiser, explore its therapeutic effects, and confirm its efficacy. Furthermore, key indicators such as the starting dose, maximum tolerated dose, and number of doses of NanoDisguiser will be further confirmed, laying the foundation for NanoDisguiser to obtain FDA approval.

File for Appoval(2030)

Good job!

PhaseIV+Launch(2031)

For the clinical research of NanoDisguiser after its launch, we comprehensively consider the efficacy and benefit/risk ratio of the drug in large-scale infection patients, explore possible combination therapy combinations, and adjust the pricing model of the drug appropriately.

Then we will comprehensively launch NanoDisguiser innovative drugs that are safe, effective, and reasonably priced.

Our Market--Market Analysis

Market Model Based on Current Situation

For the current market of NanoDisguiser, we use a market analysis model to divide our market into potential available market (PAM), target available market (TAM), served addressable market (SAM), and serviceable and obtainable market (SOM) to represent different levels of market size.

(Market Analysis)

PAM: The global antiviral drug market is huge, with a market size of 37.494 billion US dollars in 2023 and expected to grow to 48.148 billion US dollars by 2028.

TAM: We will specifically consider HIV and influenza viruses, two highly prevalent and widespread infectious diseases that occur annually, to analyze our target market size.

(Infection count statistics of Influenza virus and HIV)

Type Global number of infections
Influenza virus 3 to 5 million cases of serious illnesses annually
HIV The average annual increase of HIV patients is about 1.3 million

SAM: We consider the market segments that our company can actually serve, including its sales network, distribution capabilities, and the competitiveness of its products in the target market. Due to the lack of drug resistance, extremely low side effects, and good therapeutic effects of our drugs, it is expected that all patients in our service area will purchase our drugs. It is estimated that about 4 million patients will receive NanoDisguiser drug treatment every year.

SOM: Considering the actual market share that our company can obtain, NanoDisguiser has significant advantages compared to ordinary antiviral drugs, such as low research and development costs, broad-spectrum, non drug resistance, and no side effects. We are suggested to adjust marketing strategies in a timely manner based on these advantages.

Our company will conduct market research to understand patient needs, optimize product portfolio, develop effective market entry and penetration strategies, and is expected to provide services to 3 million patients.

SWOT Analysis

(SWOT Analysis Chart)

PEST Analysis

(PEST Analysis Chart)

Our Stakeholders——Product Chain

From manufacturing to deployment of NanoDisguiser, who are our potential stakeholders? We have divided the industrial chain into three stages: R&D Process, Operation Process and Channel Process. We have carefully considered the position and role of each stakeholder in the product chain, and analyzed the possible connections between us and them.

(Product chain of NanoDisguiser)

Our Finance--Financial Analysis

We have comprehensively considered the entire process of NanoDisguiser from production, manufacturing to deployment, and divided the expenses into four parts: raw material cost, experimental equipment cost, labor cost and delivery cost. We have calculated the expenses of each part in detail, and the results are as follows.

(Cost Breakdown Table)

Type Items Amount Price (¥)
Raw Material Cost Cells and BL21 Star (DE3) super competent cells 10*100μl 388
plasmids Plasmid expressing MSP 19563.92
Proteins LDLR Protein, Human, Recombinant (His& Avi) 100μg 2960
nker+> 6xHis + SGFP 1120.2
Consuming reagents DOPC 0.12g 0.12
DOPS 0.36mg 4.41
Tris-HCl 31.08ml 10.44
β-mercaptoethanol 9ml 12.54
IPTG 0.09ml 2.79
Imidazole 3.6g 0.92
Glycerol 5.4ml 0.12
SDS-PAGE assay kit 1 304
Ni NTA Beads 6FF 36ml 576
Experimental Equipment Cost 4ml Ultrafiltration tube 3 171
EP tube 100 130
Microporous filter membrane 1 128.8
Tissue culture dish 10 160
Labor Cost Manufacturing Time 60h 2520
Delivery Cost 22
Sum 28075.26

Explanations:

1. According to the literature, when the concentration of NanoDisguiser is 96nM, it can significantly inhibit the growth of the virus. Therefore, we use 96nM as the concentration at which NanoDisguiser can exert antiviral function, and calculate the raw material cost for producing the 96nM NanoDisguiser.

2. Chassis bacteria and plasmids targeting one specific virus can be permanently reused after a single purchase.

3. The cost of membrane proteins is exemplified by purchasing the VSV receptor LDL-R directly. Due to NanoDisguiser's ability to resist different viruses by changing the type of membrane protein, this cost will vary depending on the targeted virus. However, it is also worth noting that a mature company does not need to purchase membrane proteins, but can conduct experiments on its own to express them.

4. According to data from the National Bureau of Statistics, in China, the average hourly wage for non private employees in urban areas across the country was 42 RMB in 2023. Therefore, we use this value to calculate labor costs.

5. We use SF Express to transport NanoDisguiser to the destination. The chain transportation fee of this courier company is RMB per kilogram. As the mass of NanoDisguiser is much less than 1kg, we use this value to calculate the transportation cost.

Our Business Canvas--Business Model

So let's take a glimpse at our bussiness canvas now! We illustrate it with three business models.

In our "Christmas Tree" Value Model, you can get a direct understanding of our key partners and core product chain, and identify our company's key stakeholders.

In our "3 HOW" Trading Model, you can learn about our pricing strategy, the price advantage over other drugs and the potential profit of our innovative drugs when launched.

In our "Step Up" Resource Model, you can understand where our company is in the industry chain, the core technology NanoDisguiser relies on to go from raw materials to a mature product.

(Business Canvas)

Our preparations--Patent application and financing plans

Patent application

For our innovative drug, we have carefully considered the issues related to NanoDisguiser's application, and obtained answers by reading relevant documents and visiting the National Patent Office.

Patent Protection: A patent could provide strong legal protection, offering exclusive rights to our specific designs and production methods. However, given the customizable nature of our nanodiscs, a single patent might not cover the full scope of our technology. Each variation in size, membrane composition, or application could require separate patents, which could be costly and complex to manage. Additionally, the public disclosure required in patent applications could reveal critical aspects of our technology, enabling competitors to develop similar systems that fall just outside the scope of our patent claims.

Trade Secret: On the other hand, trade secrets offer a more flexible and potentially more effective form of protection. By keeping our nanodisc production methods and customization processes confidential, we can maintain a competitive edge without the need to disclose sensitive information. This strategy allows us to protect the full range of our technology, including any future innovations, without the limitations of patent claims. However, trade secrets require robust internal controls and legal frameworks to prevent unauthorized disclosure, which can be challenging in a rapidly growing company.

Strategic Considerations: Given the nature of our technology, a hybrid approach might be the most advantageous. We could pursue patents for certain core components or unique aspects of our technology that are critical to our business, while keeping other elements as trade secrets. For example, the specific method of modifying the size of the nanodiscs could be patented, while the exact formulations of membrane proteins used for different viruses could be kept as trade secrets. This approach would give us legal protection while also preserving the flexibility to innovate and adapt to new challenges.

Financing plans

During and after the establishment of the company, we discussed our project with investors from different backgrounds and received guidance and advice on financing.

(Investors we have consulted)

Our Ambition--Future prospects

Nanodisc technology not only shows significant potential in the treatment of infectious diseases but also promises to become a core platform for delivery across various applications in the future. Its unique structure allows it to overcome many limitations of traditional drug delivery systems, particularly in more complex therapeutic areas.

One of the primary advantages of nanodiscs is their ability to adjust size and incorporate specific membrane proteins, making them suitable for delivering small molecule drugs or antibodies. Because nanodiscs mimic the phospholipid bilayer of cell membranes, they can effectively encapsulate and deliver a wide range of drugs. This versatility positions nanodiscs as a promising tool in personalized medicine and for treating complex diseases.

A key future application lies in the ability of nanodiscs to cross the blood-brain barrier. While traditional drugs struggle to penetrate this barrier and reach the central nervous system, nanodiscs can transport drugs across it. This opens up new possibilities for treating neurological disorder, such as Alzheimer's and Parkinson's disease, providing a new avenue for drug delivery where traditional methods have struggled.

Additionally, nanodiscs hold great potential in cancer therapy. By enabling targeted delivery of anti-cancer drugs, nanodiscs can concentrate the medication in tumor regions, reducing damage to healthy tissue. This targeted approach not only improves the effectiveness of treatment but also minimizes side effects.

Looking ahead, nanodiscs could also be employed in gene therapy, vaccine delivery, and immunotherapy, enhancing the immune response by carrying specific antigens or genetic material. This technology could accelerate the development of novel therapies and push the boundaries of personalized treatment.

In summary, the potential of nanodisc technology extends far beyond antiviral drug development. It is poised to play a significant role in treating neurological diseases, cancer, and advancing gene therapies, offering vast possibilities for the future of medicine.

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