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New Biologics Business

What is Bio Medicine?

Bio medicine is a generic term of medicines produced using advanced biotechnology such as genetic recombination and cell fusion.

What is Bio Medicine?What is Bio Medicine?

Many conventional medicines are created by chemical synthesis. Bio medicines are produced by culturing them in cells or microorganisms. Typical examples are antibody medicines that use immune functions to eliminate foreign substances.

What is the Benefit?What is the Benefit?

  • Gentle for body as it is created using the proteins (hormones, enzymes, antibodies, etc.) originally found in the human body.
  • Antibiotics, a type of bio medicines, have fewer side effects as they use the immune function of humans and act directly on the wrong parts of the body.
  • The therapeutic effect can be expected against intractable diseases such as cancer

Developing new biologics targeting unmet medical needs

（What is “Unmet medical needs”?）

This term refers to diseases and other disorders where there is a strong need of treatments from patients and health care professionals but still no progress with developing effective drugs.

Responding to the thought of people 's wish to have a good medicine

Development of molecular targeted medicine

Development of molecular targeted medicine

Since the 1980s, molecular biology has evolved dramatically, and attempts have been continuted to resolve differences between normal and diseased bodies and between cancer cells and normal cells at gene level and molecular levels.
Molecular targeting treatment is to determine the molecular target that causes the disease and apply that to the design of new drug or therapeutic treatment. In particular, Kidswell Bio Corporation is focusing on the development of "antibody drugs" among the molecular targeted medicine to improve the QOL of patients.

Antibody drugs (an example of a molecular targeted medicine)

Antibody drugs (an example of a molecular targeted medicine)

The immune system works by eliminating pathogens in our bodies and preventing from becoming disease.
Antibodies are substances that play a part in the function of the immune system and proteins with the functionality to combine with pathogens invading the body and detoxify them.
"Antibody drugs" are the treament method applying those mechanism, and produced to target a molecule causing a disease, and used for treatments. Antibody drugs have the advantage of being able to achieve the desired drug efficacy by targeting a specific molecule, and the use of the protein inside the body is unlikely to cause unexpected side effects.

Development of improved bio medicines by a protein engineering.

Development of improved bio medicines by a protein engineering.

Protein engineering is a method of artificially creating new proteins that add new functions to natural proteins such as enzymes and antibodies that play an important role in our body or improve the function of the protein itself. Using this methodology, Kidswell Bio Corporation is working on the research and development of improved bio medicines that have higher therapeutic efficacy, more sustainability, and safer than conventional ones. Our bio medicine products are produced by introducing genetic information of pharmaceuticals into Escherichia coli or mammalian cells, creating transgenic cells, and mass-culturing these cells. In the construction of cell lines, biotechnology is widely used. It is spread throughout the world to further improve those biotechnologies and attempt to create new type of bio medicines.

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Biosimilars Business

What is Biosimilars?

It is called as a biosimilar that has the same efficacy and safety with new bio medicine guaranteed by the authority.

  • Bio

  • Similar

Characteristics of biosimilar

Similar but not the same.

Unlike the generic medicines, bio medicines can not be produced exactly same as their predecessors.

Similar but not the same.

The main raw materials used for developing bio medicines are those in which organisms produced such as from Escherichia coli or cultured cells. Like a human being which has many differences between individuals, cells produced from the same organism are not exactly the same. It is impossible to create a biosimilar product with exactly the same structure as the new bio medicines.

Same efficacy and safety as the new bio medicines

In order to be approved as a biosimilar, it is required to prove that the efficacy and safety of the drug are the same as those of new bio medicines.
Compared to genetic medicines, bio medicines have a huge and complex molecular structure, which results in a huge development period and cost.
Also, as described above, it is not possible to produce a product with exactly the same structure, therefore the same level of clinical trial is required as new medicines.

About the approval of biosimilar products

A generic medicine does not require a clinical trial if it has the same structure as that of the originals, but a biosimilar requires same level of clinical trial with a new medicine.
As a result, it is possible to prove the efficacy and safety.

  • New Drugs

    New Drugs

    In the application form for new drugs, seven kinds of materials for manufacturing methods, quality, and clinical trials must be submitted.

  • Generic Medicine

    Generic Medicine

    In the case of generic medicine, approx. submissions are completed only with about three kinds of materials.

  • Biosimilars

    Biosimilars

    In the application form of biosimilars, it is required to submit almost the same level of materials as the new medicine.

Social significance of biosimilars

  • Present status

    Present status

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    • Use of biologics produces high medical costs.
    • Even as generics are adopted, the use of expensive biologics also increases, and society as a whole does not see a large reduction in medical costs.

  • Ideal

    Ideal

    〇
    • Lower medical costs
    • Lower medical costs mean that more patients can receive advanced care.
    • Reduces the strain of healthcare financing on the Japanese government

Developing biosimilars to supply medicine with high quality to many patients as possible

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New biotech business (Cell therapy)

What is Regenerative Medicine (Cell therapy)?

Treatments to recover or regenerate the lost tisses and functionalities of organs by applying cultured and processed cells extracted from parients themselves or others

Process

Process

Types of Stem Cells

Types of Stem Cells

KWB promotes a cell therapy business maximising the capability of stem cells from human exfoliated deciduous teeth (SHED)

What are SHEDs ?

  • One type of dental pulp stem cells that extracts from a dental pulp cavity. Possible to extract from the decidous teeth, which has many sampling timings, and less burden on the donor.
  • It is derived from neural crest cells, and it is easy to differentiate into bone, cartilage, and nerve cells.
  • Stem cells extracted from exfoliated deciduous teeth are particularly active and have higher repair and regeneration ability.

歯髄幹細胞

Stem cells from exfoliated deciduous teeth Other Mesenchymal
stem cells
Age of Donor 5~12 years old Not only child but also adult included
Timing of Extraction
 Maximum 20 times /donor Relatively limited time of extraction
Burden on Donor Easy to extract of deciduous teeth Including invasive methodology
Ethical Issues No issues because usually treated as medical waste depends

Regenerative medicine and cell therapy using the characteristics of stem cells that differentiate into various cells have a potential to apply for various treatment methods. It is attracting attention as one of the most effective treatment for intractable diseases and the like.

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