SanBio: Supplementary Information to the Notice Regarding an Equity & Bus. Alliance Between Five Companies for Joint Research...
September 21 2018 - 4:10AM
Business Wire
SanBio Co., Ltd. (representative: Keita Mori, headquarters:
Chuo-ku, Tokyo; hereinafter SanBio) has agreed to enter into an
equity and business alliance with CareNet, Inc. (representative:
Katsuhiro Fujii, headquarters: Chiyoda-ku, Tokyo; hereinafter
CareNet), Medical Incubator Japan K.K. (representative: Jun
Katsura, headquarters: Minato-ku, Tokyo; hereinafter Medical
Incubator), Vital KSK Holdings, Inc. (representative: Taisuke
Murai, headquarters: Setagaya-ku, Tokyo; hereinafter Vital KSK
Holdings), and Astem Inc. (representative: Tsuguo Yoshimura,
headquarters: Oita, Oita Prefecture; hereinafter Astem) regarding
the appropriate use, adoption, and stable distribution of
regenerative cell medicine SB623 as announced in the “Notice
regarding an equity and business alliance between five companies
for joint research on the appropriate use, adoption, and stable
distribution of regenerative cell medicine SB623” on the same day
as this supplementary information.
The following outlines the details of the agreement.
Since its founding as a biotechnology startup in 2001, SanBio
has worked to develop its propriety regenerative cell medicine
SB623 targeting central nervous system disorders and made steady
progress. In the SB623 development program targeting chronic motor
deficit from ischemic stroke in the US, phase 2b clinical trials
are currently underway. Enrollment of 163 patients have already
been completed, and SanBio plans to announce the results of the
clinical trial in the first half of the fiscal year ending January
31, 2020 (February 2019 to July 2019) after a 12-month follow-up
period. In Japan, SanBio is currently preparing for the development
of SB623 with an aim of launching the product targeting chronic
motor deficit from ischemic stroke in Japan ahead of anywhere else
in the world. Further, in the program targeting chronic motor
deficit from traumatic brain injury (TBI) in Japan and the US,
phase 2 clinical trials are currently underway. Enrollment of 61
patients have been completed, and the results of the clinical
trials are scheduled to be announced during the fiscal year ending
January 31, 2019 (February 2018 to January 2019) after a six-month
follow-up period. For the program targeting chronic motor deficit
from TBI in Japan, SanBio aims to apply for manufacture and
marketing approval by utilizing the conditional and time-limited
authorization system for regenerative medicine products under the
Revised Pharmaceutical Affairs Act of Japan, in the fiscal year
ending January 31, 2020 (February 2019 to January 2020).
While SanBio is making steady progress in the R&D of SB623
as outlined above, it is preparing to establish a system for
manufacture, distribution, and sales of SB623, which will be
necessary after its launch. As part of preparatory measures for
establishing a manufacturing system, SanBio Group has entered into
a business alliance agreement with Hitachi Chemical Group regarding
manufacture of SB623 on March 13, 2018. SanBio decided to form an
equity and business alliance with the four companies stated above
to ensure the appropriate use, adoption, and stable distribution of
SB623 after launch in Japan as part of its effort to prepare for
building a distribution and sales system. Based on the alliance
agreement, with SB623 as the research target, SanBio will conduct
joint research on the appropriate use and adoption of the product
with CareNet and Medical Incubator, and on distribution with Vital
KSK Holdings and Astem. By utilizing CareNet and Medical
Incubator’s extensive track records in providing pharmaceutical
information and educational content for physicians and pharmacists
and Vital KSK Holdings and Astem’s experience and knowledge in
pharmaceutical distribution, SanBio believes it can enrich the
content and quality of the joint research.
Since its founding, CareNet has been dedicated to educating
physicians and providing support to pharmaceutical companies.
CareNet’s business assets include over 140,000 member physicians,
proven track records in providing sales support for pharmaceutical
companies, and a network of physicians built through its
educational content business for physicians. Based on such, SanBio
has judged that it can accelerate the promotion of appropriate use
and adoption of regenerative cell medicine SB623—a new type of drug
many in the pharmaceutical and healthcare industry are not familiar
with—by collaborating with CareNet, and hence decided to invest in
CareNet.
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version on businesswire.com: https://www.businesswire.com/news/home/20180921005101/en/
For more information, contact:SanBio Co., Ltd.Masahito Kumagae,
+81-3-6264-3481Management Administration