March 26, 2024
Company name: SanBio Co., Ltd.
Representative:

Keita Mori, Representative
Director and President(TSE Growth Code: 4592)
Contact:

Yoshihiro Kakutani,Corporate Officer ofManagement Administration(TEL. +81-3-6264-3481)

Further Update on Status of Manufacturing and Marketing Approval for
SB623 Chronic Traumatic Brain Injury (TBI) Program in Japan

SanBio Co., Ltd. hereby provides an update on this matter as per the attached document.

March 26, 2024
SanBio Co., Ltd.

Further Update on Status of Manufacturing and Marketing Approval for
SB623 Chronic Traumatic Brain Injury (TBI) Program in JapanOn March 25, our regenerative medicine product, “AKUUGO suspension for intracranial
implantation,” developed as SB623, was deliberated by the Pharmaceutical Affairs and Food
Sanitation

Council'sSubcommittee

onRegenerative

Medicine

Products(the“Subcommittee”). The Subcommittee concluded to continue the deliberation at a later date.
Following the Subcommittee meeting, the Ministry of Health, Labour, and Welfare publisheda summary of the deliberations, as detailed below. We regret that SB623 did not receive
acceptance for approval during the meeting, thus missing our goal of regulatory approval
within March. The Subcommittee recognized the clinical significance of making SB623
available for medical use; therefore, we understand that the remaining focus for approval
centers on quality-related issues. We plan to engage in further consultations with theregulatory authorities and to submit additional information such as additional data addressingquality.
Below is a reprint from the Ministry of Health, Labour, and Welfare website, titled “Summaryof Deliberations on AKUUGO Suspension for Intracranial Implantation at the Pharmaceutical
Affairs and Food Sanitation Council's Subcommittee on Regenerative Medicine Products”:
1. Main discussions and deliberation results
The Subcommittee acknowledged the progress made to date and the future direction.
(1) On clinical issues
Provided that comparability between the investigational product and this product forcommercial use is confirmed, the product is expected to demonstrate some degreeof efficacy. Considering the benefits, its safety is considered acceptable. Despite thecurrent limited data on efficacy and safety, it is deemed significant to make thisproduct available to clinical sites.
(2) On quality issues
With the current data, it is not possible to confirm comparability between theinvestigational product and this product for commercial use.
2. Future plans

If additional information such as additional data are submitted by the company, thePMDA will conduct a review of such data, and the Pharmaceutical Affairs and Food
Sanitation Council will deliberate again on the approval or disapproval of the product.

About SB623
SB623 (INN: vandefitemcel) is a human (allogeneic) bone marrow-derived modified
mesenchymal stem cell that is produced by modifying and culturing mesenchymal stem cells
derived from the bone marrow aspirate of healthy adults. Implantation of SB623 cells into
injured nerve tissues in the brain is expected to trigger the brain’s natural regenerative ability
to restore lost functions. SB623 is currently being investigated for the treatment of several
conditions including chronic neurological motor deficit resulting from traumatic brain injury
and ischemic stroke.
About Traumatic Brain Injury
Traumatic brain injury (TBI) 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 theestimated global prevalence of chronic impairment secondary to TBI was 55.5 million cases.1
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. In the United States, approximately 43% of surviving hospitalized persons with
TBI experience long-term disabilities,2 and it is estimated that 3.17 million people are livingwith long-term disabilities secondary to TBI.3
About SanBio Group (SanBio Co., Ltd. and SanBio, Inc.)
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 thetreatment of several conditions including chronic neurological motor deficit resulting fromtraumatic brain injury and stroke. The Company is headquartered in Tokyo, Japan andOakland, California, and additional information about SanBio Group is available athttps://sanbio.com/en/<References>
1 James 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.
2 Selassie AW, et al. “Incidence of long-term disability following traumatic brain injury hospitalization,U.S.”, 2003. J Head Trauma Rehabil 2008;23:123-31

3 Zaloshnja 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 NovDec;23(6):394-400.

For more information, contact:
SanBio Co., Ltd.
Management Administration
Email: info@sanbio.com