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Notice of joint research agreement with ABI CO., LTD.

Rege Nephro Co., Ltd. (Headquarters: Sakyo-ku, Kyoto, Representative Director: Toshihiro Ishikiriyama, hereinafter “Rege Nephro”) has signed a joint research agreement with ABI Co., Ltd. (Headquarters: Nagareyama City, Chiba Prefecture, President: Norio Owada, hereinafter “ABI”) .

The purpose of this joint research agreement is to develop a manufacturing process for non- clinical and clinical trial samples for cell therapy using renal progenitor cells, and ABI will promote development of cryopreservation process.

Rege Nephro is a venture company established in September 2019 based on the research results of Professor Kenji Osafune of the Dept. of Cell Growth and Differentiation, Center for iPS Cell Research and Application (CiRA), Kyoto University. Professor Osafune has succeeded in establishing a technology for highly efficient production of renal progenitor cells from iPS cells, starting with the discovery of the existence of renal progenitor cells for the first time in the world.

The number of patients suffering from chronic kidney disease (CKD) is increasing with the aging of society, and the number of CKD patients is 13% of the adult population in Japan, reaching about 13 million. There are few effective medicines and treatment techniques for treating CKD at this time, except for kidney transplantation, which has a serious donor shortage problem, and symptomatic treatment is the only option. If CKD worsens, dialysis will be required, but the number of dialysis patients is increasing year by year, and the annual medical expenses exceed 1.5 trillion yen. The development of technology to improve the symptoms of CKD and reduce its introduction to dialysis is a social urgency.

The iPS cell-derived renal progenitor cells invented by Professor Osafune have shown the effect of improving renal damage in animal experiments. In the future, Rege Nephro will work on the practical application of cell medicine containing iPS cell-derived renal progenitor cells as an active ingredient, aiming to obtain approval for CKD as an indication.

ABI has developed the “CAS (Cells Alive System) engine” as the world’s first “device that saves cells” that was originally developed, and is actively jointly developing it with companies, universities, research institutes, etc. In particular, the development in the medical field is remarkable, and various results have been achieved such as practical application of periodontal ligament to transplantation medicine, establishment of cryopreservation technology for human iPS cell-derived neural progenitor cells, and establishment of transplantation regeneration therapy alternative to living-donor liver transplantation. Furthermore, by applying this technology to the food field and attaching the CAS engine to an existing quick freezer, we have succeeded in developing technology that restores the state to “the same as raw materials.”

By concluding a joint research agreement with ABI, Rege Nephro will promote the development speed by proceeding with the development of manufacturing processes for differentiation induction, expansion culture, and cryopreservation in parallel, and is eventually aiming for leading to integrated production. Rege Nephro will promote its business under the mission of improving the quality of life (QOL) of patients suffering from kidney disease and contributing to society.

<Overview of Rege Nephro>

Rege Nephro Co., Ltd.
Representative Director: Toshihiro Ishikiriyama
Address: MIC bldg. Graduate School of Medicine, Kyoto University
53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
Business: R & D, production and sales of therapeutic agents for renal diseases
Established: September 2019
URL: https://regenephro.co.jp

<Overview of ABI>

ABI Co., Ltd.
President and CEO: Norio Owada
Address: 1-12-1 Otakanomorihigashi, Nagareyama , Chiba 270-1038 Japan
Business: Development / manufacturing / sales of CAS engine, development / manufacturing / sales of quick freezer, development / manufacturing / sales of harmonic vibration storage
Established: February 1, 1989
URL: https://www.abi-net.co.jp

<Inquiries regarding this matter>

Katsuhisa Yamaguchi (CFO & General Manager, Finance & Administration Division)
TEL: 075-708-3275
E-mail: info@regenephro.co.jp