Announced details
Inhibition of the progression of ataxia in spinocerebellar ataxia (SCA3 and SCA6)
The Company applied to Kanagawa Prefecture for a license to manufacture and market regenerative medical products and obtained the license. For Stemchymal®, the Company holds an exclusive commercialization license in Japan.
License to market regenerative medical products
Kanagawa Prefecture
The impact on the current fiscal year's results is expected to be minor at this time.
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Stemchymal® (Stemchymal) |
| Counterparty | Kanagawa Prefecture |
| Relationship with the Company | The Company applied to Kanagawa Prefecture for a license to manufacture and market regenerative medical products and obtained the license. For Stemchymal®, the Company holds an exclusive commercialization license in Japan. |
| Launch date | Domestic supply is scheduled to begin after approval. Specific date: Not disclosed |
| Applicable area | Inhibition of the progression of ataxia in spinocerebellar ataxia (SCA3 and SCA6) |
| Award/certification name | License to market regenerative medical products |
| Awarding / certifying body | Kanagawa Prefecture |
| Impact on Business Performance | The impact on the current fiscal year's results is expected to be minor at this time. |
Items this document does not state (10)
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.Following approval for the manufacture and marketing of Stemchymal®, the Company will handle domestic supply as the marketing authorization holder and assume responsibility for quality control and post-marketing safety management.