Announced details
Treatment and prevention of infections caused by SARS-CoV-2. This additional approval covers the treatment of children aged 6 to under 12 years who weigh at least 20 kg.
117 children were enrolled. No new safety concerns were identified, and the plasma concentration profile in children was comparable to that in adults receiving the therapeutic dose.
Ensitrelvir fumaric acid was discovered through joint research by Hokkaido University and Shionogi & Co.,Ltd. The manufacturer and marketing authorization holder is Shionogi & Co.,Ltd.
jRCT2031230140 (identifier for the Clinical Research Submission and Publication System)
The 25 mg tablets are not listed in the National Health Insurance drug price standard. Other sales prices and pricing structures: Not disclosed
The impact on consolidated results for the fiscal year ending March 2027 will be minor.
The company does not address Contract Value.
Clinical Research Submission and Publication System (jRCT2031230140), World Health Organization, JAMA Network Open, and joint research by Hokkaido University and Shionogi & Co.,Ltd.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Xocova® tablets 125 mg, Xocova® tablets 25 mg, Ensitrelvir fumaric acid |
| Relationship with the Company | Ensitrelvir fumaric acid was discovered through joint research by Hokkaido University and Shionogi & Co.,Ltd. The manufacturer and marketing authorization holder is Shionogi & Co.,Ltd. |
| Offering price | The 25 mg tablets are not listed in the National Health Insurance drug price standard. Other sales prices and pricing structures: Not disclosed |
| Applicable area | Treatment and prevention of infections caused by SARS-CoV-2. This additional approval covers the treatment of children aged 6 to under 12 years who weigh at least 20 kg. |
| Registration number and expiry date | jRCT2031230140 (identifier for the Clinical Research Submission and Publication System) |
| Quantitative Effects | 117 children were enrolled. No new safety concerns were identified, and the plasma concentration profile in children was comparable to that in adults receiving the therapeutic dose. |
| Impact on Business Performance | The impact on consolidated results for the fiscal year ending March 2027 will be minor. |
| Source | Clinical Research Submission and Publication System (jRCT2031230140), World Health Organization, JAMA Network Open, and joint research by Hokkaido University and Shionogi & Co.,Ltd. |
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.No new safety concerns were identified in the Japan-based Phase 3 clinical trial, and a population pharmacokinetic analysis showed that the plasma concentration profile in children was comparable to that in adults receiving the therapeutic dose, supporting the appropriateness of the selected dose.