SanBio Joins the Newly Formed National TBI Registry Coalition (NTRC) as a Founding Member Organization

Rhea-AI Summary

SanBio Group (OTC-PINK:SNBOY) has joined the National TBI Registry Coalition (NTRC) as a founding member. Launched on December 6, 2021, the NTRC aims to create a national registry for individuals with traumatic brain injury (TBI), enhancing surveillance and awareness. SanBio is preparing to file a Biologics License Application in Japan for its lead product, SB623, which targets chronic motor deficits from TBI. TBI affects millions globally, with significant long-term disabilities reported, highlighting the need for effective treatment and support.

Positive

• SanBio is a founding member of the National TBI Registry Coalition, which could enhance its visibility and partnerships.
• The company is preparing to file a Biologics License Application for SB623 in Japan, indicating progress in regulatory approval for its key product.

Negative

• None.

TOKYO & MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- The SanBio Group (SanBio Co., Ltd. of Tokyo, Japan, SanBio, Inc. of Mountain View, California, US, and SanBio Asia Pte. Ltd. of Singapore) (TSE:4592), today announced it is one of the founding member organizations of the National TBI Registry Coalition (NTRC) in the United States.

The NTRC announced its official launch on December 6, 2021 and was formed to align several leading nonprofit and corporate organizations dedicated to working with the U.S. government to create a national registry for individuals living with a traumatic brain injury (TBI). Once created, the registry will assist individuals and families with surveillance and prevention opportunities as well as provide easily accessible information about new therapies and services to address TBI. Additionally, NTRC member organizations are working together to promote public awareness about individuals and caregivers impacted by TBI. The NTRC website can be accessed at www.nationaltbiregistry.org.

“We believe a national TBI registry is critically important to improve surveillance, increase awareness, and provide support to individuals living with a traumatic brain injury, and we are proud to be one of the founding members of the NTRC,” said Keita Mori, Chairman of SanBio and Secretary of the NTRC Steering Committee. “Joining this coalition with like-minded organizations is another step towards potentially improving the lives of individuals suffering from complications resulting from a traumatic brain injury. In addition, we continue to publish important research relevant to the field, and we are currently preparing to file a Biologics License Application for potential approval in Japan for our lead asset, SB623, for the treatment of chronic motor deficits resulting from TBI.”

About Traumatic Brain Injury

Traumatic brain injury (TBI) is defined by the U.S. Centers for Disease Control and Prevention as any bump or blow to the head, or penetrating injury, that results in the disruption of normal brain function, and is one of the leading causes of death and disability worldwide. The estimated global incidence of acute TBI during 2016 was 27 million cases, and the estimated global prevalence of chronic impairment secondary to TBI was 55.5 million cases.¹ In the United States, approximately 43% of surviving hospitalized persons with TBI experience long-term disabilities², and it is estimated that 3.17 million people are living with long-term disabilities secondary to TBI.³ Overall, TBI and long-term motor deficits secondary to TBI significantly impair a person’s self-care, employability, and quality of life, and are major burdens on healthcare systems worldwide.

About SB623

SB623 is a proprietary, cell-based investigational product made from allogeneic modified and cultured adult bone marrow-derived mesenchymal stem cells (MSCs) 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. SanBio is preparing to file a Biologics License Application with the Pharmaceuticals and Medical Devices Agency in Japan for SB623 for the treatment of chronic motor deficits resulting from TBI.

About SanBio Group (SanBio Co., Ltd., SanBio, Inc. and SanBio Asia Pte. Ltd.)

SanBio Group is engaged in the regenerative cell medicine business, spanning research, development, manufacture, and sales of regenerative cell medicines. The Company’s propriety regenerative cell medicine product, SB623, is currently being investigated for the treatment of several conditions including chronic neurological motor deficit resulting from traumatic brain injury and stroke. The Company is headquartered in Tokyo, Japan, Mountain View, California, US, and SanBio Asia Pte. Ltd. of Singapore), and additional information about SanBio Group is available at https://sanbio.com/en/

Sources:

1James SL, et al. “Global, regional, and national burden of traumatic brain injury and spinal cord injury, 1990-2016 : a systematic analysis for the Global Burden of Disease Study 2016.” Lancet Neurol 2019;18:56-87.

2Selassie AW, et al. “Incidence of long-term disability following traumatic brain injury hospitalization, U.S.”, 2003. J Head Trauma Rehabil 2008;23:123-31

3Zaloshnja E, Miller T, Langlois JA, Selassie AW. Prevalence of long-term disability from traumatic brain injury in the civilian population of the United States, 2005. J Head Trauma Rehabil. 2008 Nov-Dec;23(6):394-400.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20211214005648/en/

For more information, contact:

SanBio Co., Ltd.

Management Administration

Yoshihiro Kakutani

info@sanbio.jp

Source: Sanbio Company Limited

FAQ

What is the significance of SanBio joining the National TBI Registry Coalition?

SanBio's membership could improve its collaboration opportunities and increase awareness about TBI treatments.

What is SB623 and its relevance to SanBio's business?

SB623 is a cell-based investigational product aimed at treating chronic motor deficits resulting from TBI, crucial for SanBio's growth.

When was the National TBI Registry Coalition launched?

The NTRC was officially launched on December 6, 2021.

How many people suffer from TBI globally?

The estimated global incidence of acute TBI was 27 million cases in 2016.

What does the NTRC aim to achieve?

The NTRC aims to create a national registry to support individuals with TBI through better surveillance, awareness, and access to therapies.