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Other Disclosures4582SymBio Pharmaceuticals LimitedPharmaceuticals

Beginning application of the Humanitarian Assistance Program (CUP) for brincidofovir

The company has decided to begin providing the unapproved drug brincidofovir (BCV) under a compassionate use program (CUP) today to patients with adenovirus infections following hematopoietic stem cell transplantation. The program will allow the investigational drug to be provided under certain criteria to patients who are in life-threatening condition, have no alternative treatment and are not eligible for clinical trials.

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Announced details

Brincidofovir (BCV)
Applicable field (uses covered by this announcement)

Adenovirus infection following hematopoietic stem cell transplantation. Intended for patients who do not meet the eligibility criteria for clinical trials, have no alternative treatment and are in life-threatening condition

Launch date8 October 2026 (starts today; CUP begins)
Impact on Business Performance

No impact on consolidated results for the fiscal year ending December 2026

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services CoveredBrincidofovir (BCV)
Launch date8 October 2026 (starts today; CUP begins)
Applicable areaAdenovirus infection following hematopoietic stem cell transplantation. Intended for patients who do not meet the eligibility criteria for clinical trials, have no alternative treatment and are in life-threatening condition
Impact on Business PerformanceNo impact on consolidated results for the fiscal year ending December 2026
Items this document does not state (14)
CounterpartyCounterparty overviewRelationship with the CompanyContract ValueOffering priceContract DateAward/certification nameAwarding / certifying bodyRegistration 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.

Requests had been received from patients and their families seeking access to BCV because the patients did not meet the eligibility criteria for clinical trials and were in life-threatening condition without alternative treatment. On humanitarian grounds, the company will provide the unapproved drug under strict eligibility criteria.

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Beginning application of the Humanitarian Assistance Program (CUP) for brincidofovir | SymBio Pharmaceuticals Limited (4582) timely disclosure | Komori