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Other Disclosures4596Kubota Pharmaceutical Holdings Co.,Ltd.Pharmaceuticals

Notice Regarding the Commencement by a Consolidated Subsidiary of GMP-Compliant Manufacturing of the Drug Substance for Emixustat Hydrochloride, a Candidate Treatment for Stargardt Disease

The consolidated subsidiary has transferred the manufacturing process for emixustat hydrochloride to a new manufacturing site and is scheduled to begin manufacturing the active pharmaceutical ingredient in compliance with GMP for clinical use in April 2026.

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Announced details

Emixustat hydrochloride
Applicable field (uses covered by this announcement)

Stargardt disease; France's compassionate-use program

Launch dateApril 2026 (scheduled)
Contract DateSupply and license agreement announced on 2 March 2026 (the contract date is not specified)
Relationship between the counterparty and the company
Kubota Pharmaceutical Holdings Co.,Ltd.4596
Relationship with the Company

Kubota Vision has entered into a supply and license agreement with KÔL. Kubota Vision is responsible for procuring raw materials, manufacturing the active pharmaceutical ingredient and finished products, and handling regulatory matters, while KÔL is responsible for storage and distribution in France, liaison with ANSM, and certain medical affairs activities.

CounterpartyLaboratoires KÔL
Location (as indicated in this announcement)

New manufacturing site (location Not disclosed)

Impact on Business Performance

The impact on the Company's results is expected to be immaterial.

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services CoveredEmixustat hydrochloride
CounterpartyLaboratoires KÔL
Relationship with the CompanyKubota Vision has entered into a supply and license agreement with KÔL. Kubota Vision is responsible for procuring raw materials, manufacturing the active pharmaceutical ingredient and finished products, and handling regulatory matters, while KÔL is responsible for storage and distribution in France, liaison with ANSM, and certain medical affairs activities.
Contract DateSupply and license agreement announced on 2 March 2026 (the contract date is not specified)
Launch dateApril 2026 (scheduled)
Applicable areaStargardt disease; France's compassionate-use program
LocationNew manufacturing site (location Not disclosed)
Impact on Business PerformanceThe impact on the Company's results is expected to be immaterial.
Items this document does not state (10)
Counterparty overviewContract ValueOffering priceAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocation 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.

To establish a supply system for France's compassionate-use program.

How to read this page

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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.
Notice Regarding the Commencement by a Consolidated Subsidiary of GMP-Compliant Manufacturing of the Drug Substance for Emixustat Hydrochloride, a Candidate Treatment for Stargardt Disease | Kubota Pharmaceutical Holdings Co.,Ltd. (4596) timely disclosure | Komori