Receipt of a Complete Response Letter regarding the US approval application for SI-6603, a treatment for lumbar disc herniation
SEIKAGAKU CORPORATION
SI-6603, a treatment for lumbar disc herniation (generic name: condoliase), drug substance manufacturing facility, contract drug product manufacturing facility
In addition to the deficiencies identified during the inspection of the drug substance manufacturing facility not having been fully resolved, deficiencies were identified during the cGMP inspection of the contract drug product manufacturing facility, resulting in a determination that improvements are required
Related procedures
US FDA review of the approval application and issuance of a Complete Response Letter (CRL)
U.S. Food and Drug Administration (FDA)
The impact on the consolidated earnings forecast for the fiscal year ending March 2027 is currently under review. The Company will promptly disclose any matters requiring disclosure if they arise.
The Company will consider an early resubmission toward obtaining approval, in close coordination with the FDA and Ferring Pharmaceuticals, with which it has entered into a licensing agreement.
The Company will promptly disclose any matters requiring disclosure if they arise.
| Item | Details |
|---|---|
| Event name | Receipt of a Complete Response Letter regarding the US approval application for SI-6603, a treatment for lumbar disc herniation |
| Date of occurrence | 10 September 2026 (received on 9 September 2026, US time) |
| Date recognized / date notice received | 10 September 2026 (9 September, US time) |
| Subject Entity | SEIKAGAKU CORPORATION |
| Target Locations / Products | SI-6603, a treatment for lumbar disc herniation (generic name: condoliase), drug substance manufacturing facility, contract drug product manufacturing facility |
| Cause | In addition to the deficiencies identified during the inspection of the drug substance manufacturing facility not having been fully resolved, deficiencies were identified during the cGMP inspection of the contract drug product manufacturing facility, resulting in a determination that improvements are required |
| Impact on Earnings Forecast | The impact on the consolidated earnings forecast for the fiscal year ending March 2027 is currently under review. The Company will promptly disclose any matters requiring disclosure if they arise. |
| Type of litigation or proceeding | US FDA review of the approval application and issuance of a Complete Response Letter (CRL) |
| Court or authority | U.S. Food and Drug Administration (FDA) |
| Outlook | The Company will consider an early resubmission toward obtaining approval, in close coordination with the FDA and Ferring Pharmaceuticals, with which it has entered into a licensing agreement. |
| Planned follow-up disclosure | The Company will promptly disclose any matters requiring disclosure if they arise. |
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.The deficiencies identified during the inspection of the drug substance manufacturing facility have not been fully resolved, and deficiencies were also identified during a newly conducted cGMP inspection of the contract drug product manufacturing facility, resulting in a determination that improvements are required.