Decision and Details
Withdrawal of PureLift's regulatory approval
Domestic supply was discontinued following the termination of the manufacturing agreement with the domestic manufacturer. As there were fewer candidates than expected for a new manufacturing site, establishing a manufacturing system became difficult amid changes in Japan's business environment and cost pressures.
This matter will have no impact on full-year results or business revenue under the current medium-term management plan. Shipments in Japan were limited to premarketing purposes, and the Company believes there will be no impact on the market.
| Item | Details |
|---|---|
| Matter Covered | Withdrawal of PureLift's regulatory approval |
| Decision Date | 26 June 2026 (date the notification to withdraw the approval was submitted) |
| Implementation Date | 26 June 2026 (submitted). As a result, the regulatory approval for this product will expire. |
| Impact on Business Performance | This matter will have no impact on full-year results or business revenue under the current medium-term management plan. Shipments in Japan were limited to premarketing purposes, and the Company believes there will be no impact on the market. |
| Reason | Domestic supply was discontinued following the termination of the manufacturing agreement with the domestic manufacturer. As there were fewer candidates than expected for a new manufacturing site, establishing a manufacturing system became difficult amid changes in Japan's business environment and cost pressures. |
| Future plans | The Company will advance development of a prefilled syringe product for the U.S. market. For the Japanese market, it will consider the direction of its future business development based on the progress of product development and the status of regulatory approvals obtained overseas, among other factors. |
Items this document does not state (6)
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 the termination of the manufacturing agreement with the domestic manufacturer, there were few candidates for a new manufacturing site, and establishing a manufacturing system required considerable time. In light of changes in Japan's business environment and cost pressures, the Company received a response that starting production would be difficult under the current circumstances. The Company believes that the product has strong commercial potential in the U.S. market and that demand for a prefilled syringe product is also high.