Risk of unexpected adverse effects and quality issues
First written in FY2024. 1 of 2 entries say "Mitigated", first in FY2025. Latest entry: FY2025.
The whole theme swung hardest in 2026: 6 of 20 companies on the "Worse" side.
8 other companies' latest entry also says "Mitigated".
- FY2025MitigatedAnnual report
「With respect to the safety management required in pharmaceutical development, we have established a quality assurance department directly under the president with independent authority over clinical development and the suspension or discontinuation of sales, creating a structure capable of responding to unforeseen events.」
The Company has established measures to address unexpected quality issues and adverse effects, including outsourcing manufacturing to a CDMO, establishing a quality assurance department and planning to obtain insurance. It also reported that no serious safety events were observed in the LAPiS trial. - FY2024First statedAnnual report
「Products, including the regenerative medicine products under development by the Company, may be subject to unexpected quality issues or adverse effects during clinical trials and after commercialization.」
The Company identifies the possibility of recalls, sales suspensions, additional trials and liability arising from quality issues or adverse effects.