Medical Incubator Japan K.K. (Representative: Jun Katsura; Head Office: Minato City, Tokyo) (hereinafter referred to as “MIJ”) has agreed to establish a capital and business agreement with SanBio Co, Ltd. (Representative: Keita Mori; Head Office: Chuo City, Tokyo) (hereinafter referred to as SanBio) with the aim of establishing proper use/distribution of SanBio’s regenerative cell medicine SB623.

In addition to acquiring SanBio shares through the CareNet Innovation Investment Limited Partnership (hereinafter referred to as “CNI”), in which MIJ is a general partner, we will strongly support the acceleration of proper use and distribution of the new drug candidate before and after their launch onto the market through collaboration with the SSI Consortium (a consortium providing support for commercialization of pharmaceutical products and medical devices), which was established in May of this year.

What is SB623?

SB623 is a regenerative cell medicine currently being developed for the purpose of treating central nervous system diseases/conditions—such as chronic phase cerebral infarction and traumatic brain injury—by SanBio, a drug discovery venture business that was launched in 2001. Under the SB623 Chronic Phase Cerebral Infarction Program, Phase 2b clinical trials are being conducted in the United States, while under the SB623 Traumatic Brain Injury Program, Phase 2 clinical trials are in progress in Japan and the United States. Utilizing Japan’s Early Approval System, the Japanese SB623 Traumatic Brain Injury Program is aiming to submit an application for drug approval in the period ending January 2020 (February 2019 – January 2020), with high expectations held for SB623 as a new drug candidate.

Purpose of the capital and business agreement

MIJ was established in May of this year with the purpose of providing financial support through investment for pharmaceutical, medical device, digital health, and other venture businesses in the healthcare field that have “innovative” technologies, as well as providing support for accelerating programs through activities supporting development and marketing. In carrying out our business activities, MIJ has become a general partner in CNI—which has investments in enterprises such as healthcare information venture business CareNet, Inc., hands-on start-up fund TARO Ventures, and genome-editing venture business EdiGENE—begun operating funds, and laid the groundwork for investment activities. Furthermore, in collaboration with CareNet, Inc., ASKLEP Inc., Pharma Information Network Inc., Golden Child Co., Ltd., Macromill, Inc., MIJ has established the SSI Consortium, which can provide one-stop support services for various processes ranging from the development of pharmaceuticals and medical devices through to sales, thereby creating a total support platform for enterprises developing promising new products. The capital and business agreement with SanBio is MIJ’s first full-scale incubation project following this groundwork preparation.

Future outlook

In collaboration with the SSI Consortium, MIJ will commence our incubation activities by first of all providing support for the development of SanBio’s regenerative cell medicine SB623. Having simultaneously established capital and business agreements with both CareNet, Inc.—an SSI Consortium member—and SanBio, MIJ will utilize to the maximum business assets that include CareNet’s network comprising more than 140,000 physicians as well as its educational content provision capabilities through our especially close cooperative relationship with CareNet in order to develop and provide solutions for new product development, proper usage, and marketing.

MIJ is currently constructing highly specialized networks for discovering investment projects both in Japan and overseas. Looking ahead to next year, we also intend to create a new investment fund with the aim of establishing second and third SanBio projects.

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