SanBio Announces SB623 Regenerative Cell Therapy for Traumatic Brain Injury Has Received Ministry of Health, Labour and Welfare (MHLW) Sakigake Designation

TOKYO–(BUSINESS WIRE)–The SanBio Group (SanBio Co., Ltd. and SanBio, Inc.) (TOKYO:4592), a
scientific leader in regenerative medicine for neurological disorders,
announced today that SB623, a regenerative cell therapy that the Group
is developing globally for the treatment of chronic motor deficit
resulting from traumatic brain injury (TBI), has received the Sakigake
Designation for innovative medical products from the Ministry of Health,
Labour, and Welfare (MHLW) of Japan.

The Sakigake Designation System was unveiled in June 2014 as part of the
“Strategy of SAKIGAKE” by an MHLW project team to lead the world in the
practical application of innovative medical products. It is a scheme for
rapid authorization of innovative pharmaceutical products initially
developed in Japan for which exceptional effectiveness can be expected
based on preclinical results and early-stage clinical trials. The
Sakigake Designation System targets regenerative medicines that treat
serious diseases which urgently require innovative therapies.

SanBio’s proprietary regenerative cell medicine SB623, which has been
granted the Sakigake Designation, is made from modified and cultured
adult bone marrow-derived mesenchymal stem cells that undergo temporary
genetic modification. Implantation of SB623 cells into injured nerve
tissue in the brain is expected to trigger the brain’s natural
regenerative ability to recover lost motor functions.

The SanBio Group has been conducting a global Phase 2 clinical trial of
SB623 in Japan and the US by ourselves, targeting chronic motor deficit
resulting from TBI. Enrollment of 61 patients was completed in April
2018, and in November 2018, the Group received favorable results from
the trial; the primary endpoint was achieved, with the treatment group,
who were administered SB623 cells, demonstrating a statistically
significant improvement in motor function compared to the control group.
Based on these results, the Group is aiming to submit an application for
manufacturing and marketing approval for its TBI program in Japan during
the fiscal year ending January 31, 2020 (February 2019–January 2020),
using the conditional and term-limited authorization system for
regenerative medicine products under the Revised Pharmaceutical Affairs
Act of Japan.

Following the Sakigake Designation of SB623, SanBio will receive
priority consultation and review by the Pharmaceuticals and Medical
Devices Agency (PMDA) regarding manufacturing and marketing approval.
The SanBio Group will take advantage of the designation to apply for
approval in Japan.

SanBio Medical Director and Head of Development / Japan, Takehiko
Kaneko, commented: “We are delighted that the TBI program for SB623 has
received the Sakigake Designation. Conducting the clinical trials made
us realize how excited health professionals and patients in Japan are
about SB623. We are deeply grateful to everyone who helped us receive
the designation and reaffirm our commitment to delivering SB623 to
patients as soon as possible.”

For more information, please follow the link below:

MHLW release: Product Designation under the SAKIGAKE Designation System:
11 pharmaceutical products have been newly designated to accelerate
development of groundbreaking products in Japan
https://www.mhlw.go.jp/stf/newpage_04339.html
(Japanese)

About SanBio, Inc. (SanBio)

SanBio is a regenerative medicine company headquartered in Tokyo and
Mountain View, California, with cell-based products in various stages of
research, development and clinical trials. Its proprietary cell-based
product, SB623, is currently in a Phase 2b clinical trial for treatment
of chronic motor impairments resulting from stroke, and in a Phase 2
clinical trial for treatment of motor impairments resulting from
traumatic brain injury. More information about SanBio, Inc. is available
at http://sanbio.com.

Contacts

For more information, contact:
SanBio Co., Ltd.
Yoshihiro
Kakutani, Corporate Officer of Management Administration
[email protected]