Announced details
BNCT for recurrent meningioma, particularly recurrent high-grade meningioma
Progression-free survival was 14.4 months in the trial treatment group and 1.4 months in the control group. The response rate was 27.3% in the trial treatment group, while there were no responses in the control group. The 1-year survival rate was 100%, and the 2-year survival rate was 90.9%.
Osaka Medical and Pharmaceutical University conducted an investigator-initiated clinical trial for recurrent high-grade meningioma. Our company took over the clinical trial data and used it in the application for approval. The Second Committee on Drugs of the Pharmaceutical Affairs and Food Sanitation Council reviewed this application.
Osaka Medical and Pharmaceutical University conducted the investigator-initiated clinical trial. The Second Committee on Drugs of the Pharmaceutical Affairs and Food Sanitation Council is the body that conducts pharmaceutical regulatory reviews. Other information on location, representative, capital, and year of establishment is Not disclosed.
Orphan drug designation and priority review status
The impact on financial results for the fiscal year ending March 2027 is expected to be minor. Over the medium to long term, the product is expected to contribute to the growth of the BNCT business.
The company does not address Contract Value / Offering price.
Investigator-initiated clinical trial conducted at Osaka Medical and Pharmaceutical University with support from AMED (the Japan Agency for Medical Research and Development)
| Item | Details |
|---|---|
| Names of Products / Services Covered | Steboronin® (BNCT drug) |
| Counterparty | Second Committee on Drugs of the Pharmaceutical Affairs and Food Sanitation Council, Osaka Medical and Pharmaceutical University |
| Counterparty overview | Osaka Medical and Pharmaceutical University conducted the investigator-initiated clinical trial. The Second Committee on Drugs of the Pharmaceutical Affairs and Food Sanitation Council is the body that conducts pharmaceutical regulatory reviews. Other information on location, representative, capital, and year of establishment is Not disclosed. |
| Relationship with the Company | Osaka Medical and Pharmaceutical University conducted an investigator-initiated clinical trial for recurrent high-grade meningioma. Our company took over the clinical trial data and used it in the application for approval. The Second Committee on Drugs of the Pharmaceutical Affairs and Food Sanitation Council reviewed this application. |
| Launch date | The timing of the product launch following formal approval is Not disclosed. |
| Applicable area | BNCT for recurrent meningioma, particularly recurrent high-grade meningioma |
| Award/certification name | Orphan drug designation and priority review status |
| Quantitative Effects | Progression-free survival was 14.4 months in the trial treatment group and 1.4 months in the control group. The response rate was 27.3% in the trial treatment group, while there were no responses in the control group. The 1-year survival rate was 100%, and the 2-year survival rate was 90.9%. |
| Impact on Business Performance | The impact on financial results for the fiscal year ending March 2027 is expected to be minor. Over the medium to long term, the product is expected to contribute to the growth of the BNCT business. |
| Source | Investigator-initiated clinical trial conducted at Osaka Medical and Pharmaceutical University with support from AMED (the Japan Agency for Medical Research and Development) |
Items this document does not state (8)
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 options for recurrent meningioma are limited, and there are no approved drug therapies for the condition in Japan. New treatment options are therefore needed.