Challenge the world of regenerative medicine research with the aim of further growth
First of all, please tell us about your business.
Mr. Kids Well Bio Benibayashi: Our company is a bio venture from Hokkaido University that was born in Sapporo, Hokkaido with the aim of developing biopharmaceuticals. The original company name was "Jin Techno Science Co., Ltd.", which was changed to the current company name two years ago. Later, we revised some of our business policies and entered the biosimilar field. This business is growing steadily, and we have launched three products at the moment. The fourth product is also scheduled to be launched by the end of the year. Since then, it has also entered the field of regenerative medicine. Currently, we are developing our biosimilar business and regenerative medicine business as two pillars.
Mr. Kids Well BioMitani: We are not a pharmaceutical company, but a fabless business that does not have our own factory. Specifically, we will pass on drug candidates that we have commissioned and developed to CDMOs (manufacturing and development contracting companies) to our partner pharmaceutical companies to proceed with clinical development, and the pharmaceutical companies will also be responsible for applying for manufacturing and sales. Our business is primarily based on the business model of providing crude drugs to pharmaceutical companies.
Please tell us a little more about your regenerative medicine business.
Mr. Kids Well Bio Benibayashi: Among our core businesses, the biosimilar business has been performing well since entering the market. However, what is originally expected of bio-ventures like us should be explosive growth rather than stable performance. Therefore, we acquired and made a wholly owned subsidiary of Cell Technology Co., Ltd., which possessed proprietary technology for extracting SHED from milk teeth, and entered the field of regenerative medicine in earnest. Actually, I was originally enrolled in your company and transferred to Kids Well with the sale of the company.
Mr. Kids Well BioMitani: We are currently conducting research and development of regenerative medicine for serious diseases using the isolation and culture technology of tooth cerebrospinal stem cells originally owned by Cell Technology. SHED is characterized by its young and high cell growth potential. As teeth come out naturally, there is no physical burden. In our company, in cooperation with an NPO, we contact the family who supported us, collect milk teeth of a child donor who is about to grow at a designated medical institution, and use this as a raw material A one-stop service has established a series of flows of manufacturing SHED master cell banks under GMP at a manufacturing development contract company that partners. It is named "S-Quatre®" and is positioned in our core business.
Currently, we aim to commercialize both free medical care and insurance medical care.
Have you ever struggled with development?
Mr. Kids Well Bio Benibayashi: The launch of the SHED master cell bank business was difficult, and it took a lot of time than originally expected. When I was in Cell Technology, I didn't even have any guidance to donate an organization for commercial purposes. Later, the Ministry of Economy, Trade and Industry announced guidance, and the business has made significant progress since there. It took about three years to launch the infrastructure with the approval of the university's Ethics Review Committee of the dental extraction cooperative facility and establish the SHED Master Cellbank.
Mr. Kids Well BioMitani: As far as we know, there are no companies that have already advanced to the clinical trial stage in regenerative medicine research 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.
It's an interesting technique to use milk teeth. Please tell us your future plans.
Mr. Kids Well BioMitani: Currently, we are prioritizing the implementation of clinical research based on the Act on Safety of Regenerative Medicine, etc., but ultimately we aim to obtain approval as a reimbursable therapeutic agent (regenerative medicine products). However, in some cases, free medical treatment may be more suitable for diseases, so we will continue to promote research and development in both free and insurance medical treatment. Preparations for clinical trials are also underway, and we plan to apply for clinical trials as soon as they are ready.
Is the use of cell banks a regenerative medicine product using similar cells?
Mr. Kids Well Bio Benibayashi: That's right. Our current business policy is to develop products such as regenerative medicine using the SHED master cell bank. However, in regenerative treatment for diseases with a very small number of patients, we believe that there are situations where treatment using self-cells under the safe method is more suitable due to the difficulty of development under the Pharmaceutical Machinery method.
I would like to proceed with regenerative medicine research to the next step at Mitsui Link Lab Shinkiba 2.
Please tell us why you moved into Mitsui Link Lab Shinkiba 2.
Mr. Kids Well Bio Benibayashi: In order to further develop our regenerative medicine business in the future, we believe it is urgently necessary to secure more research staff, and we believe that we should establish a research base in Tokyo separately from the research base on the Hokkaido University campus. Therefore, we examined multiple candidate sites and finally selected Mitsui Link Lab Shinkiba 2 in consideration of the viewpoint of securing human resources, the positional relationship that facilitates communication with the head office, and the presence of a common equipment room.
Mr. Kids Well BioMitani: Regarding the position of the research institute, the research institute in Sapporo will continue to be in charge of research and development for the practical application of naive-type stem cell technology, which is equivalent to the first generation of regenerative medicine research. On the other hand, Shinkiba Lab will be responsible for the development of next-generation stem cell technology while introducing new ideas. At the same time, we will also take on the challenge of maximizing the value of our cell technology, such as carrying genes and viruses, as a platform technology for the development of new drugs.
What kind of impression did you have when you actually worked at Link Lab?
Mr. Kids Well BioMitani: Thanks to you, I was able to achieve all the objectives up to the time of moving in. We were able to secure excellent staff, and the location is as expected. The facilities are also refined, 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 access to transportation and easy access to Shinkiba Lab from our headquarters in Kayabacho (Chuo-ku), head office staff often visits Shinkiba Labs to meet with research staff.
Mr. Kids Well Bio Benibayashi: We have been able to communicate smoothly between the research base on the Hokkaido University campus and the head office in Tokyo, but if we were to set up a new research institute in Tokyo, we did not want to create a physical distance between the head office as much as possible. If you are in Shinkiba, you can transfer the Hibiya Line and Keiyo Line from Kayabacho, where the head office is located. By avoiding physical distances as much as possible, we have taken care to ensure that the head office staff and newly hired research staff can work together smoothly.
In addition, please tell us about the expected roles of Mitsui Link Lab and LINK-J.
Mr. Kids Well Bio Benibayashi: Our business is not limited to Japan, but we hope to expand overseas, such as the United States. To do so, networking with overseas biotech, pharmaceutical companies, and VCs is also essential. We look forward to your continued support in such situations. Of course, we would like to participate in various events and further expand our network.