June 12 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.

June 12, 2024
SanBio Co., Ltd.

Further Update on Status of Manufacturing and Marketing Approval for
SB623 Chronic Traumatic Brain Injury (TBI) Program in JapanOn March 26, 2024, SanBio Co., Ltd. (the “Company”) provided an update on the progress
toward obtaining marketing approval of SB623 to treat chronic traumatic brain injury (TBI) inJapan, stating it was concluded to continue the deliberation at a later date by thePharmaceutical Affairs and Food Sanitation Council's Subcommittee on Regenerative
Medicine Products (the “Subcommittee”) and we planned to engage in further consultations
with the regulatory authorities and to submit additional information such as additional data
addressing quality.
Today, the Ministry of Health, Labour and Welfare announced that the Pharmaceutical Affairs
and the Subcommittee will hold a meeting on June 19, and we learned that the Subcommittee
will deliberate, among others, on whether to grant marketing approval for the regenerative
medicine “AKUUGO suspension for intracranial implantation”, whether to stipulate conditions
and a time limit for the approval, and whether to designate a reexamination period.
Accordingly, the Subcommittee will determine whether to grant the Company’s development
product SB623 marketing approval in the meeting.
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 InjuryTraumatic 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’spropriety 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