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Other Disclosures4593HEALIOS K.K.Pharmaceuticals

Notice Regarding the Acquisition of a Marketing Authorization for Regenerative Medical Products

The Company received a license certificate for the manufacture and marketing of regenerative medicine products from the Governor of Hyogo Prefecture. This establishes a structure enabling the Company to manufacture and market regenerative medicine products if its development products obtain marketing approval in the future.

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53Recurring
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Improvement
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Announced details

License to market regenerative medical productsHLCM051
Applicable field (uses covered by this announcement)
Acute Respiratory Distress Syndrome (ARDS)Acute phase of cerebral infarctionTrauma-induced acute kidney injury (AKI)Cancer immunotherapyOphthalmologyLiver disease
Launch date24 August 2026 (license certificate issued)
Relationship between the counterparty and the company
HEALIOS K.K.4593
CounterpartyGovernor of Hyogo Prefecture
Award/certification name

License Certificate to Manufacture and Market Regenerative Medicine Products

Awarding / certifying body

Governor of Hyogo Prefecture

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

Announced details
ItemDetails
Names of Products / Services CoveredLicense to market regenerative medical products, HLCM051
CounterpartyGovernor of Hyogo Prefecture
Launch date24 August 2026 (license certificate issued)
Applicable areaAcute Respiratory Distress Syndrome (ARDS), Acute phase of cerebral infarction, Trauma-induced acute kidney injury (AKI), Cancer immunotherapy, Ophthalmology, Liver disease
Award/certification nameLicense Certificate to Manufacture and Market Regenerative Medicine Products
Awarding / certifying bodyGovernor of Hyogo Prefecture
Items this document does not state (12)
Counterparty overviewRelationship with the CompanyContract ValueOffering priceContract DateRegistration number and expiry dateLocationLocation scaleQuantitative EffectsUsage historyImpact on Business PerformanceSource

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 Company re-obtained the license, which it first obtained in April 2022, following a review of its product development plans.

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.
Weight is not a verdictIt measures how much this changes what the company had already told the market. It is not a view on the shares.
Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.
Notice Regarding the Acquisition of a Marketing Authorization for Regenerative Medical Products | HEALIOS K.K. (4593) timely disclosure | Komori