Komori
Other Disclosures190AChordia Therapeutics Inc.Pharmaceuticals

Notice regarding the review status of rogocekib, a CLK inhibitor, for orphan drug designation

The Pharmaceutical Affairs and Food Sanitation Council's Second Subcommittee on Pharmaceuticals has approved the designation of rogocekib as an orphan drug in Japan. The formal designation is now pending the Ministry of Health, Labour and Welfare's procedures and notification of the designation.

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Announced details

rogocekib (development code: CTX-712)
Applicable field (uses covered by this announcement)

Relapsed or refractory acute myeloid leukemia (AML)

Relationship between the counterparty and the company
Chordia Therapeutics Inc.190A
Relationship with the Company

The administrative authority and subcommittee reviewing rogocekib for orphan drug designation. Capital and personnel relationships are Not disclosed.

CounterpartyThe Pharmaceutical Affairs and Food Sanitation Council's Second Subcommittee on Pharmaceuticals, Ministry of Health, Labour and Welfare

The Pharmaceutical Affairs and Food Sanitation Council's Second Subcommittee on Pharmaceuticals is a subcommittee of the Pharmaceutical Affairs and Food Sanitation Council, which is established within the Ministry of Health, Labour and Welfare. Other information on its location, representative, capital and year of establishment is Not disclosed.

Award/certification name

Orphan drug designation (review toward designation in Japan)

Awarding / certifying body

Ministry of Health, Labour and Welfare

Impact on Business Performance

The transaction will have no impact on the Company's financial results.

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services Coveredrogocekib (development code: CTX-712)
CounterpartyThe Pharmaceutical Affairs and Food Sanitation Council's Second Subcommittee on Pharmaceuticals, Ministry of Health, Labour and Welfare
Counterparty overviewThe Pharmaceutical Affairs and Food Sanitation Council's Second Subcommittee on Pharmaceuticals is a subcommittee of the Pharmaceutical Affairs and Food Sanitation Council, which is established within the Ministry of Health, Labour and Welfare. Other information on its location, representative, capital and year of establishment is Not disclosed.
Relationship with the CompanyThe administrative authority and subcommittee reviewing rogocekib for orphan drug designation. Capital and personnel relationships are Not disclosed.
Applicable areaRelapsed or refractory acute myeloid leukemia (AML)
Award/certification nameOrphan drug designation (review toward designation in Japan)
Awarding / certifying bodyMinistry of Health, Labour and Welfare
Impact on Business PerformanceThe transaction will have no impact on the Company's financial results.
Items this document does not state (10)
Contract ValueOffering priceContract DateLaunch dateRegistration number and expiry dateLocationLocation scaleQuantitative EffectsUsage historySource

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 designation was approved by the Pharmaceutical Affairs and Food Sanitation Council's Second Subcommittee on Pharmaceuticals during its review toward orphan drug designation for relapsed or refractory acute myeloid leukemia (AML).

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Notice regarding the review status of rogocekib, a CLK inhibitor, for orphan drug designation | Chordia Therapeutics Inc. (190A) timely disclosure | Komori