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The Developing Paradigm Shift for Drugs

The Transition of Cellular Medicine Products and Our Future with Regenerative Medicine Products

Everyone wants to stay healthy. Humans have put great effort into researching and developing better medicines and treatment methods in order to promote and maintain their health.

To develop more effective and safer drugs, in recent years pharmaceutical development has been shifting toward the discovery of biodrugs (generated in the human body and possessing effective functions) and away from finding compound drugs among candidate molecules synthesized from chemical compounds. A representative example of biodrugs is one that uses antibodies (proteins), which provide an immunological function.

The iPSC regenerative medicine products that Healios is developing use cells which are the smallest unit of life, to develop biodrugs. We expect such biodrugs to serve as breakthrough drugs for chronic diseases caused by aging or hereditary conditions that result in cell degeneration.

Healios believes such products will be part of a major paradigm shift in the life science arena that will lead the biorevolution of the 21st century.

The Transition of Cellular Medicine Products and Our Future with Regenerative Medicine Products

The Developing Paradigm Shift for Drugs

The pharmaceutical industry began with the development of low molecular weight compounds, then moved to antibody drugs. It is now moving to cell therapy drugs and regenerative medicine products.

Japan’s regenerative medicine technologies are among the best in the world, and the levels of research in academia, industry and at research institutes are highly advanced.

In particular, iPS cells, which are now drawing worldwide attention, are likely to bring about a paradigm shift in medicine. iPS cells were established by Dr. Shinya Yamanaka at Kyoto University, and he was awarded the 2012 Nobel Prize in Medicine or Physiology just six years after his work was published. Because iPS cells have the ability to differentiate into various organs and cells and are capable of proliferating indefinitely, they have the potential to provide effective treatment for any diseases in human tissue. iPS cells have a large advantage over embryonic stem (ES) cells from the perspective of bioethics because they are not derived from human embryos.

Transitions in Cellular Medicine

  Somatic cells (autologous)1 Mesenchymal stem cells (allogenic)2 ES cell
(allogenic)2
iPS Cells
(allogenic)2
Invented 1970 1991 1964 2007
Differentiation potency3 None Weak Pluripotent Pluripotent
Proliferative capacity4 Low
=Lots changed each time
Medium
= Frequent lot changes
High
=1 lot
= Easy to standardize
High
=1 lot
= Easy to standardize
Method of creation From a human sample Obtained from
a human sample
Obtained from
a human embryo
Obtained from
a human sample
Mechanism of action5 Functional
substitution
Nutritional
supplementation
Functional
substitution
Functional
substitution

 

  1. In the above table, autologous (cell) refers to the use of a person’s own cells to make a medical product.
  2. Allogenic (cells): Another person’s cells are used to make a medical product.
  3. Differentiation potency: The ability of a cell to change (differentiate) from one type of cell to another.
  4. Proliferative capacity: The ability of a cell to divide and proliferate.
  5. Mechanism of action: How each of the cell types in the above table functions in the human body.

As can be seen from the above table, iPSC regenerative medicine products are particularly superior among cellular medicine products in terms of pluripotency and proliferative capacity. It also has the advantage of having few bioethical issues, so it is expected that they will provide breakthrough treatments in the future for chronic diseases.

With respect to the safety of regenerative medicine using iPS cells, the risk of tumor formation has been pointed out due to the proliferative capacity of the cells. However, significant safety improvements have been achieved through advances in manufacturing methods(see Note below).

Note:

  1. It is thought that there are two main reasons for tumorigenesis with iPS cells; 1) tumors caused by reprogramming factors introduced during the creation of the iPS cells and 2) a portion of the iPS cells transferred to the patient that fail to differentiate into the target cell remain and causes tumor formation. However, ongoing research has brought about the development of alternative reprogramming factors with a low tumorigenesis risk, improved methods for selecting iPS cells with high differentiation potency, and more reliable methods for iPS cells differentiation.

How We Envision the Future Pharmaceuticals Market

revolution_1_e

Healios will, in addition to the compound drug field, position ourselves as a core company in the field of regenerative medicine products that utilize iPS cell technologies. We will build cooperative relationships with leading research institutes, universities and businesses around the world for the research and development of drugs and regenerative medicine products.