SanBio Company Limited provided an update on the progress toward obtaining marketing approval of SB623 to treat chronic traumatic brain injury (TBI) in Japan, stating that the Company was focused on resolving the issue related to the production yield and responding to production-related review by regulatory authorities, with the goal of obtaining approval by the end of the current fiscal year. The Company hereby provides another progress update, to ensure timely disclosure to concerned patients and their families, as well as shareholders and investors who await the approval of SB623. SB623 is undergoing approval review under the framework of the Sakigake Designation System as a treatment for chronic effects associated with TBI.

The production yield-related issue has been resolved, and the review process is proceeding to a conclusion. However, given the status of the review process, it will take some more time until approval is granted, and for this reason, the Company now expects to obtain approval in March 2024. Although the timing of approval is outside of the Company's control, SanBio will continue to work as one and do utmost to obtain approval.