SanBio Co. Ltd. provided an update on the progress toward obtaining marketing approval of SB623 to treat chronic traumatic brain injury (TBI) in Japan, stating it aims to achieve approval by March 2024 and is actively engaged in the review process. Amidst this situation, the Ministry of Health, Labour and Welfare announced on January 22 that the Pharmaceutical Affairs and Food Sanitation Council's Subcommittee on Regenerative Medicine Products (the "Sub committee") would hold a meeting on February 5. However, developmental product SB623, which is undergoing approval review as a treatment for TBI under the framework of the Sakigake Designation System, was not included in the agenda for this meeting.
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Mar. 19 | SanBio Eyes Approval for Brain Injury Treatment Drug SB623 By March | MT |
Mar. 19 | Jefferies Adjusts SanBio’s Price Target to 270 Yen From 310 Yen, Keeps at Underperform | MT |
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- Sanbio Co., Ltd. Provides Update on Status of Manufacturing and Marketing Approval for Sb623 Chronic Traumatic Brain Injury Program in Japan