Announced details
Improvement of chronic motor paralysis associated with traumatic brain injury
First post-marketing case (as of 2 October 2026)
Medical institution where Aqogo® was administered. Capital and personnel relationships are Not disclosed.
Hokkaido University Hospital. Other details, including location, representative and business activities, are Not disclosed.
Product designated under the Sakigake designation system, RMAT designation, ATMP designation
Ministry of Health, Labour and Welfare; U.S. Food and Drug Administration (FDA); European Medicines Agency (EMA)
Approval for manufacture and marketing subject to conditions and a time limit was obtained on 31 July 2024. The approval number and other details are Not disclosed.
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
Lancet Neurology 2019; Journal of Head Trauma Rehabilitation 2008 (2 publications)
| Item | Details |
|---|---|
| Names of Products / Services Covered | Akugo® Intracerebral Implant Injection (generic name: vandefitemcel) |
| Counterparty | Hokkaido University Hospital |
| Counterparty overview | Hokkaido University Hospital. Other details, including location, representative and business activities, are Not disclosed. |
| Relationship with the Company | Medical institution where Aqogo® was administered. Capital and personnel relationships are Not disclosed. |
| Launch date | 2 October 2026 (administration date, actual) |
| Applicable area | Improvement of chronic motor paralysis associated with traumatic brain injury |
| Award/certification name | Product designated under the Sakigake designation system, RMAT designation, ATMP designation |
| Awarding / certifying body | Ministry of Health, Labour and Welfare; U.S. Food and Drug Administration (FDA); European Medicines Agency (EMA) |
| Registration number and expiry date | Approval for manufacture and marketing subject to conditions and a time limit was obtained on 31 July 2024. The approval number and other details are Not disclosed. |
| Usage history | First post-marketing case (as of 2 October 2026) |
| Source | Lancet Neurology 2019; Journal of Head Trauma Rehabilitation 2008 (2 publications) |
Items this document does not state (7)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Treatment has begun in actual clinical practice following approval for manufacture and marketing in July 2024 and the start of sales in May 2026.