Worth reading
59In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.Direction
Improvement
Direction inferred from the company’s description.Scale
50
Response rate (%)Wording
Conditional
How definitive the wording is.Decision and Details
Application for partial changes to the manufacturing and marketing approval of “Borofalan (10B),” a BNCT drug for angiosarcoma
Decision24 March 2026 (application date)
Implementation24 March 2026 (application submitted)
Going forwardApproval review by the Ministry of Health, Labour and Welfare. As the drug has been designated an orphan drug, it will undergo priority review, and the review is expected to proceed over a shorter period than for conventional pharmaceuticals
Quantity / scale10 cases, 3 partial responses, 2 complete responses, response rate of 50.0%, 90% confidence interval of 22.2%–77.8%, median progression-free survival of 6.3 months (95% confidence interval: 0.6–not estimable)
Reason
The domestic Phase II clinical trial produced favorable results and achieved its primary endpoint
Impact on Business Performance
The impact on results for the fiscal year ending March 2026 is immaterial.
| Item | Details |
|---|---|
| Matter Covered | Application for partial changes to the manufacturing and marketing approval of “Borofalan (10B),” a BNCT drug for angiosarcoma |
| Decision Date | 24 March 2026 (application date) |
| Implementation Date | 24 March 2026 (application submitted) |
| Quantity / scale | 10 cases, 3 partial responses, 2 complete responses, response rate of 50.0%, 90% confidence interval of 22.2%–77.8%, median progression-free survival of 6.3 months (95% confidence interval: 0.6–not estimable) |
| Impact on Business Performance | The impact on results for the fiscal year ending March 2026 is immaterial. |
| Reason | The domestic Phase II clinical trial produced favorable results and achieved its primary endpoint |
| Future plans | Approval review by the Ministry of Health, Labour and Welfare. As the drug has been designated an orphan drug, it will undergo priority review, and the review is expected to proceed over a shorter period than for conventional pharmaceuticals |
Items this document does not state (5)
Decision-Making BodyPeriod CoveredAmountGoverning RuleRelated previous disclosures
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.The domestic Phase II clinical trial conducted with 株式会社CICS produced favorable results, including a 50.0% response rate and a lower bound of the 90% confidence interval that met the prespecified target criterion.
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