Receipt of an Application for Approval of a Partial Change to Add a Manufacturing Site to Rebuild the Stable Supply System for Steboronin®
STELLA PHARMA CORPORATION
Steboronin® (generic name: borofalan (10B)), a boron drug for BNCT, and the manufacturing site of the new domestic contract manufacturing partner
Quasi-bankruptcy of the primary contract manufacturing partner
Related procedures
Application for approval of a partial change to the approved information, and PMDA review and GMP compliance inspection
Pharmaceuticals and Medical Devices Agency (PMDA)
The Company aims to obtain approval following PMDA review, GMP compliance inspection and other procedures. Approval is currently expected around January 2027. After approval is obtained, the Company will establish a stable supply under the new manufacturing system.
| Item | Details |
|---|---|
| Event name | Receipt of an Application for Approval of a Partial Change to Add a Manufacturing Site to Rebuild the Stable Supply System for Steboronin® |
| Date of occurrence | 7 August 2026 (the date the application was received by the PMDA) |
| Date recognized / date notice received | 7 August 2026 (the date the Company became aware that the application had been submitted to and received by the PMDA) |
| Subject Entity | STELLA PHARMA CORPORATION |
| Target Locations / Products | Steboronin® (generic name: borofalan (10B)), a boron drug for BNCT, and the manufacturing site of the new domestic contract manufacturing partner |
| Cause | Quasi-bankruptcy of the primary contract manufacturing partner |
| Type of litigation or proceeding | Application for approval of a partial change to the approved information, and PMDA review and GMP compliance inspection |
| Court or authority | Pharmaceuticals and Medical Devices Agency (PMDA) |
| Date of filing / date of action | 7 August 2026 (application date) |
| Outlook | The Company aims to obtain approval following PMDA review, GMP compliance inspection and other procedures. Approval is currently expected around January 2027. After approval is obtained, the Company will establish a stable supply under the new manufacturing system. |
| Planned follow-up disclosure | Approval is currently expected around January 2027. |
Items this document does not state (14)
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.To rebuild the stable supply system for Steboronin® following the quasi-bankruptcy of the primary contract manufacturing partner, and to prepare for future increases in demand and expansion of indications.