Challenge the world of regenerative medicine research with the aim of further dramatic growth
First of all, please tell us about your business.
Kids Well-Bio Benibayashi: Our company is a bioventure from Hokkaido University, which was born in Sapporo, Hokkaido with the aim of developing biopharmaceuticals. The original company name was "GEN Techno Sciences Co., Ltd." and changed its name to the current company name two years ago. Later, we reviewed the business policy and entered the biosimilar field. This business is growing steadily, and three products are on the market at the moment. The fourth product is scheduled to be launched by the end of this year. After that, he also entered the field of regenerative medicine. Currently, we are developing the biosimilar business and the regenerative medicine business as the two pillars of our business.
Kids Well Bio Mitani: We are not a pharmaceutical company, but our fabless business does not have our own factory. Specifically, we will pass the drug candidate developed by our company to CDMO (Manufacturing and Development Contractor) to the partner pharmaceutical company to proceed with clinical development, and the pharmaceutical company will also be in charge of manufacturing and marketing applications. We are developing our business based on a business model of providing raw materials to pharmaceutical companies.
Could you tell us a little more about your regenerative medicine business?
Kids Well-Bio Benibayashi: Among our core businesses, the biosimilar business has been performing well since its entry. However, what we expect from bio ventures like our company should be explosive growth rather than stable business performance. Therefore, we acquired Cell Technology Co., Ltd., which had a proprietary technology to extract SHED from milk teeth, and made it a wholly owned subsidiary, and entered the regenerative medicine field in earnest. Actually, I was originally enrolled in that company, and with the sale of the company, I transferred to Kidswell.
Kids Well Bio Mitani: We are currently conducting research and development of regenerative medicine for serious diseases using the spinal stem cell isolation and culture technology originally owned by Cell Technology Corporation. SHED is characterized by its young age and high cell proliferation power. Toothing teeth naturally, there is no physical burden. In our company, in cooperation with an NPO, we will contact the family who has agreed, collect milk teeth of a child donor who is nearly changing at a designated medical institution, and use this as a raw material. The manufacturing and development contracting company has established a series of processes of manufacturing SHED master cellbank under GMP. It is named "S-Quatre®" and is positioned as our core business.
Currently, we aim to commercialize both free and insurance medical treatment.
Have you ever had a hard time developing?
Kids Well-Bio Benibayashi: It was difficult to launch the SHED Master Cell Bank business, and it took a lot of time than originally expected. When I was at Cell Technology, I didn't even have any guidance for donating organizations for commercial purposes. The Ministry of Economy, Trade and Industry (METI) announced guidance, so the business has made significant progress. It took about three years to establish the infrastructure and establish the SHED master cell bank after approval by the ethics review committee of the university of the tooth extraction collaborating facility.
Kids Well Bio Mitani: As far as we know, there are no companies that have already progressed to the clinical trial stage for regenerative medicine using SHED, especially in Japan, the United States and Europe. Therefore, at the moment, we believe that we are the first runner in this area.
Using milk teeth is an interesting technology. Could you tell us about your future plans?
Kids Well Bio Mitani: Currently, we are prioritizing clinical research based on the Act on Assurance of Regenerative Medicine, we aim to obtain approval as a repaid therapeutic drug (products for regenerative medicine, etc.). However, in some cases, treatment through free medical treatment may be more suitable for some diseases, so we will continue to promote research and development in both free and insurance medical treatment. Preparations for the clinical trial are underway, and we plan to apply for a clinical trial as soon as we are ready.
Is the use of cell bank a regenerative medicine product using the same type of cell?
Kids Well-Bio Benibayashi: That's right. Our current business policy is to develop products such as regenerative medicine using the same type of cell using the SHED master cell bank. However, in regenerative therapy for diseases with a very small number of patients, we believe that there are situations where treatment using autologous cells under an assurance method is more suitable for treatment using autologous cells under an assurance method.
I would like to proceed with regenerative medicine research into the next step at Mitsui Link Lab Shinkiba 2
Please tell us why you moved into Mitsui Link Lab Shinkiba 2.
Kids Well-Bio Benibayashi: In order to further develop our regenerative medicine business in the future, we thought that it was urgently necessary to secure more research staff, so we thought that we should open a research base in Tokyo separately from the research bases on the Hokkaido University campus. Therefore, we examined multiple candidate sites, and finally selected Mitsui Link Lab Shinkiba 2, taking into account the viewpoint of securing human resources, the location relationship where communication with the head office is easy to communicate with the head office, and the fact that there is a common equipment room. did.
Kids Well Bio Mitani: Regarding the position of the research institute, the research institute in Sapporo will continue to be in charge of research and development toward the practical application of naive stem cell technology, which is equivalent to the first generation of regenerative medicine. On the other hand, Shinkiba Lab will be in charge of the development of next-generation stem cell technology while introducing new ideas. At the same time, we will take on the challenge of maximizing the value of our cell technology, for example, by carrying genes and viruses.
What kind of impression did you have when you actually worked in the link lab?
Kids Well Bio Mitani: Thanks to you, we were able to achieve all the objectives up to the time of moving in. We were able to secure excellent staff, and the location was as expected. The facilities are also sophisticated, the corridors and laboratories are bright, and in a good sense, there is no lab-likeness. I think it's a very good design. With good traffic access and easy access to the Shinkiba Lab from our head office in Kayabacho (Chuo-ku), our head office staff often visit Shinkiba Lab and hold meetings with research staff.
Kids Well-Bio Benibayashi: Although there is a smooth communication between the research base on the Hokkaido University campus and the head office in Tokyo, if we were to set up a new laboratory in Tokyo, I didn't want to create a physical distance between the head office as possible. If you're in Shinkiba, you can take the Hibiya Line and Keiyo Line immediately from Kayabacho, where your head office is located. By minimizing physical distances as much as possible, we have taken care to ensure that the head office staff and newly hired research staff can work smoothly.
Also, please tell us about the roles you expect from Mitsui Link Lab and LINK-J.
Kids Well-Bio Benibayashi: Our business is not limited to Japan, but we hope to expand overseas markets such as the United States. For this purpose, networking with overseas biotechs, pharmaceutical companies, and VCs is also essential. We look forward to your continued support in such a situation as well. Of course, we would like to participate in various events and expand our network further.