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Other Disclosures4888STELLA PHARMA CORPORATIONPharmaceuticals

Progress on the technology transfer and manufacturing site change involved in transferring production of our products to a new contract manufacturer

To transfer production of Steboronin® (pharmaceutical product) to a new contract manufacturer, we have completed pilot manufacturing and evaluation at the commercial plant and have now begun process validation using production equipment. We plan to file an application to change the manufacturing site around August 2026, obtain approval around January 2027, and begin commercial production thereafter.

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Announced details

Steboronin®
Applicable field (uses covered by this announcement)

Pharmaceutical manufacturing and product supply to the market

Launch dateFull-scale production at the new contract manufacturer is scheduled to begin after approval is obtained, expected around January 2027. Shipments to Hainan Island, China, are scheduled to begin around March 2027.
Relationship between the counterparty and the company
STELLA PHARMA CORPORATION4888
Relationship with the Company

Production is being transferred to a new contract manufacturer

Impact on Business Performance

All costs associated with this matter have been incorporated into the earnings forecast for the fiscal year ending March 2027

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

Consultations with the Ministry of Health, Labour and Welfare and PMDA

Announced details
ItemDetails
Names of Products / Services CoveredSteboronin®
Relationship with the CompanyProduction is being transferred to a new contract manufacturer
Launch dateFull-scale production at the new contract manufacturer is scheduled to begin after approval is obtained, expected around January 2027. Shipments to Hainan Island, China, are scheduled to begin around March 2027.
Applicable areaPharmaceutical manufacturing and product supply to the market
Impact on Business PerformanceAll costs associated with this matter have been incorporated into the earnings forecast for the fiscal year ending March 2027
SourceConsultations with the Ministry of Health, Labour and Welfare and PMDA
Items this document does not state (12)
CounterpartyCounterparty overviewContract ValueOffering priceContract DateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleQuantitative EffectsUsage history

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 ensure a stable supply to the market and avoid disruption to product supplies. The process is being carried out based on consultations with the Ministry of Health, Labour and Welfare and PMDA (Japan's Pharmaceuticals and Medical Devices Agency).

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Progress on the technology transfer and manufacturing site change involved in transferring production of our products to a new contract manufacturer | STELLA PHARMA CORPORATION (4888) timely disclosure | Komori