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Other Disclosures4544H.U. Group Holdings,Inc.Information and Communications, Services and Others

Obtaining manufacturing and marketing approval in Japan for a blood-based pTau217 test reagent to assist in assessing amyloid-β accumulation in the brain associated with Alzheimer’s disease

Fujirebio obtained manufacturing and marketing approval in Japan for a test reagent that measures plasma pTau217 to assist in assessing amyloid-β accumulation in the brain. The systems covered are the LUMIPULSE® G1200 and LUMIPULSE® G600II.

Worth reading
54Recurring
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Direction
Improvement
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Wording
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Announced details

LUMIPULSE Phosphorylated Tau 217 (Plasma)LUMIPULSE® G1200LUMIPULSE® G600II
Applicable field (uses covered by this announcement)

Assisting in the assessment of amyloid-β accumulation in the brain associated with Alzheimer’s disease (amyloid pathology); field of neurodegenerative diseases

Relationship between the counterparty and the company
H.U. Group Holdings,Inc.4544
Relationship with the Company

Fujirebio Inc., a subsidiary of Fujirebio Holdings Corporation, which is a consolidated subsidiary of H.U. Group Holdings, obtained the manufacturing and marketing approval. The Ministry of Health, Labour and Welfare is the approval authority.

CounterpartyMinistry of Health, Labour and Welfare
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.

Announced details
ItemDetails
Names of Products / Services CoveredLUMIPULSE Phosphorylated Tau 217 (Plasma), LUMIPULSE® G1200, LUMIPULSE® G600II
CounterpartyMinistry of Health, Labour and Welfare
Relationship with the CompanyFujirebio Inc., a subsidiary of Fujirebio Holdings Corporation, which is a consolidated subsidiary of H.U. Group Holdings, obtained the manufacturing and marketing approval. The Ministry of Health, Labour and Welfare is the approval authority.
Applicable areaAssisting in the assessment of amyloid-β accumulation in the brain associated with Alzheimer’s disease (amyloid pathology); field of neurodegenerative diseases
Awarding / certifying bodyMinistry of Health, Labour and Welfare
Items this document does not state (13)
Counterparty overviewContract ValueOffering priceContract DateLaunch dateAward/certification nameRegistration number and expiry dateLocationLocation scaleQuantitative EffectsUsage historyImpact on Business PerformanceSource

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The reasons the company gives

The company's own explanation, not something inferred from the numbers.

To provide further support for the diagnosis and treatment of Alzheimer’s disease. The Fujirebio Group stated that it will continue to expand its product lineup in the field of neurodegenerative diseases.

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Obtaining manufacturing and marketing approval in Japan for a blood-based pTau217 test reagent to assist in assessing amyloid-β accumulation in the brain associated with Alzheimer’s disease | H.U. Group Holdings,Inc. (4544) timely disclosure | Komori