Announced details
Boron neutron capture therapy (BNCT) for recurrent meningioma
Progression-free survival: 14.4 months in the investigational treatment group and 1.4 months in the comparator group. Response rate: 27.3% in the investigational treatment group and 0% in the comparator group. One-year survival rate: 100%; two-year survival rate: 90.9%.
The company has submitted an application for partial amendment approval of the manufacturing and marketing approval, which is scheduled to be deliberated by the subcommittee.
A subcommittee established within the Ministry of Health, Labour and Welfare's Pharmaceutical Affairs and Food Sanitation Council. Other information, including its location, representative and business activities, is not disclosed.
Orphan drug designation and evaluation for priority review
Ministry of Health, Labour and Welfare
The impact on earnings for the fiscal year ending March 2027 is expected to be immaterial.
The company does not address Contract Value / Offering price.
The Ministry of Health, Labour and Welfare's 2023 Patient Survey and the National Research and Development Agency Japan Agency for Medical Research and Development (AMED), among other sources
| Item | Details |
|---|---|
| Names of Products / Services Covered | SteboroninⓇ Intravenous Infusion Bag 9000mg/300mL |
| Counterparty | Second Subcommittee on Pharmaceuticals, Pharmaceutical Affairs and Food Sanitation Council, Ministry of Health, Labour and Welfare |
| Counterparty overview | A subcommittee established within the Ministry of Health, Labour and Welfare's Pharmaceutical Affairs and Food Sanitation Council. Other information, including its location, representative and business activities, is not disclosed. |
| Relationship with the Company | The company has submitted an application for partial amendment approval of the manufacturing and marketing approval, which is scheduled to be deliberated by the subcommittee. |
| Applicable area | Boron neutron capture therapy (BNCT) for recurrent meningioma |
| Award/certification name | Orphan drug designation and evaluation for priority review |
| Awarding / certifying body | Ministry of Health, Labour and Welfare |
| Quantitative Effects | Progression-free survival: 14.4 months in the investigational treatment group and 1.4 months in the comparator group. Response rate: 27.3% in the investigational treatment group and 0% in the comparator group. One-year survival rate: 100%; two-year survival rate: 90.9%. |
| Impact on Business Performance | The impact on earnings for the fiscal year ending March 2027 is expected to be immaterial. |
| Source | The Ministry of Health, Labour and Welfare's 2023 Patient Survey and the National Research and Development Agency Japan Agency for Medical Research and Development (AMED), among other sources |
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.Recurrent meningioma can recur even after surgery or radiation therapy, and treatment options in Japan are limited because no drug therapy has been approved domestically. New treatment options are therefore needed.