SanBio Co. Ltd. announced that it was working to resolve the issue of production yield, to bring yield back to the level at the time of application filing toward obtaining marketing approval of SB623 to treat chronic traumatic brain injury (TBI) in Japan during the current fiscal year ending January 2024. The Company announced that whether the issue is resolved should be known by June 2023 and will be reported at the result briefing for the first quarter of the fiscal year ending January 2024.

The Company hereby provides a progress update, to ensure timely disclosure to concerned patients, their families, as well as shareholders and investors who await the approval of SB623. SB623 is under review in the Sakigake Designation System for approval as a treatment for chronic effects associated with TBI. Toward obtaining approval, the Company is currently focused on resolving the issue related to the production yield and responding to production-related review.

Although the company have yet to fully recover the production yield obtained at the time of application filing, additional data from the latest production run has led to measures that could resolve the yield-related issue. A production run with implemented measures is currently underway, and results are expected in August. Although the timing of approval is outside of the Company's control, by resolving the yield-related issue and responding to production-related review in a timely manner, presently the Company's goal remains to obtain approval during the current fiscal year.

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.

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 the estimated global prevalence of chronic impairment secondary to TBI was 55.5 million cases. 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, and it is estimated that 3.17 million people are living with long-term disabilities secondary to TBI.