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Other Disclosures4588Oncolys BioPharma Inc.Pharmaceuticals

Notice Regarding the Obtaining of Manufacturing and Marketing Approval (Regular Approval) for Telomelysin Injection, an Oncolytic Virus

Standard approval has been obtained in Japan for the oncolytic virus Telomelysin Injection for esophageal cancer. Fujifilm Toyama Chemical will handle sales after National Health Insurance price listing, with sales scheduled to begin in the fiscal year ending December 2026.

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Announced details

Oncolytic virus Telomelysin Injection (generic name: suratadenoturev; development code: OBP-301)
Applicable field (uses covered by this announcement)

Esophageal cancer for which curative resection and chemoradiotherapy are not indicated

Launch dateSales scheduled to begin in the fiscal year ending December 2026 (after National Health Insurance price listing; planned)
Contract DateFebruary 2024 (sales partnership agreement)
What the company reported numerically
Quantitative Effects

A pivotal clinical trial was conducted at 17 facilities in Japan

Relationship between the counterparty and the company
Oncolys BioPharma Inc.4588
Relationship with the Company

The Company entered into a sales partnership agreement in February 2024. Fujifilm Toyama Chemical will handle sales after National Health Insurance price listing. The Company will receive milestone revenue and an advance payment for the product purchase price from Fujifilm Toyama Chemical.

CounterpartyFUJIFILM Toyama Chemical Co., Ltd.
Awarding / certifying body

Ministry of Health, Labour and Welfare (manufacturing and marketing approval)

Registration number and expiry date

Standard approval. This is not a conditional and time-limited approval. Approval date: 8 June 2026. Registration number: Not disclosed

Impact on Business Performance

Milestone revenue is expected to be recorded in net sales for the fiscal year ending December 2026. The remaining advance payment for the product purchase price is expected to be received during the current fiscal year and recorded in net sales sequentially after sales begin. The impact of this matter on current-year results is under review. The amount is not disclosed.

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services CoveredOncolytic virus Telomelysin Injection (generic name: suratadenoturev; development code: OBP-301)
CounterpartyFUJIFILM Toyama Chemical Co., Ltd.
Relationship with the CompanyThe Company entered into a sales partnership agreement in February 2024. Fujifilm Toyama Chemical will handle sales after National Health Insurance price listing. The Company will receive milestone revenue and an advance payment for the product purchase price from Fujifilm Toyama Chemical.
Contract DateFebruary 2024 (sales partnership agreement)
Launch dateSales scheduled to begin in the fiscal year ending December 2026 (after National Health Insurance price listing; planned)
Applicable areaEsophageal cancer for which curative resection and chemoradiotherapy are not indicated
Awarding / certifying bodyMinistry of Health, Labour and Welfare (manufacturing and marketing approval)
Registration number and expiry dateStandard approval. This is not a conditional and time-limited approval. Approval date: 8 June 2026. Registration number: Not disclosed
Quantitative EffectsA pivotal clinical trial was conducted at 17 facilities in Japan
Impact on Business PerformanceMilestone revenue is expected to be recorded in net sales for the fiscal year ending December 2026. The remaining advance payment for the product purchase price is expected to be received during the current fiscal year and recorded in net sales sequentially after sales begin. The impact of this matter on current-year results is under review. The amount is not disclosed.
Items this document does not state (8)
Counterparty overviewContract ValueOffering priceAward/certification nameLocationLocation scaleUsage 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.

Manufacturing and marketing approval in Japan was obtained from the Ministry of Health, Labour and Welfare. The Company aims to provide a new treatment option in clinical practice for esophageal cancer and contribute to its treatment through the acquisition of this approval.

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Notice Regarding the Obtaining of Manufacturing and Marketing Approval (Regular Approval) for Telomelysin Injection, an Oncolytic Virus | Oncolys BioPharma Inc. (4588) timely disclosure | Komori