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Other Disclosures4521KAKEN PHARMACEUTICAL CO.,LTD.Pharmaceuticals

Submission of an application for marketing approval of "KP-001," a treatment for vascular malformations

Kaken Pharmaceutical submitted an application for marketing approval in Japan for “KP-001,” a treatment for vascular malformations. The product is at the stage of entering the approval review process, not at the stage of beginning sales after approval has been obtained.

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Announced details

Vascular Malformation Treatment “KP-001” (generic name: ceraverisib phosphate hydrate)
Applicable field (uses covered by this announcement)

Refractory vascular malformations

Relationship between the counterparty and the company
KAKEN PHARMACEUTICAL CO.,LTD.4521
Relationship with the Company

The product has been designated by the Ministry of Health, Labour and Welfare as an orphan drug. The ministry was not identified as the institution to which the application for marketing approval was submitted.

CounterpartyMinistry of Health, Labour and Welfare
Award/certification name

Orphan drug designation

Awarding / certifying body

Ministry of Health, Labour and Welfare

In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.

Source (materials cited by the company)

Information website of the Research Group for Pharmacotherapy of Intractable Hemangiomas and Vascular Malformations

Announced details
ItemDetails
Names of Products / Services CoveredVascular Malformation Treatment “KP-001” (generic name: ceraverisib phosphate hydrate)
CounterpartyMinistry of Health, Labour and Welfare
Relationship with the CompanyThe product has been designated by the Ministry of Health, Labour and Welfare as an orphan drug. The ministry was not identified as the institution to which the application for marketing approval was submitted.
Applicable areaRefractory vascular malformations
Award/certification nameOrphan drug designation
Awarding / certifying bodyMinistry of Health, Labour and Welfare
SourceInformation website of the Research Group for Pharmacotherapy of Intractable Hemangiomas and Vascular Malformations
Items this document does not state (11)
Counterparty overviewContract ValueOffering priceContract DateLaunch dateRegistration number and expiry dateLocationLocation scaleQuantitative EffectsUsage historyImpact on Business Performance

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 refractory vascular malformations are extremely limited, resulting in a substantial unmet medical need among patients. The company aims to provide a new treatment option to patients who need it and contribute to their treatment through this product.

How to read this page

This is not the documentKomori reads the disclosure the company filed and writes this summary. Figures are as stated by the company and are not audited.
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Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.
Submission of an application for marketing approval of "KP-001," a treatment for vascular malformations | KAKEN PHARMACEUTICAL CO.,LTD. (4521) timely disclosure | Komori