Komori
Other Disclosures4507Shionogi & Co.,Ltd.Pharmaceuticals

Obtaining partial approval for changes to the recombinant protein vaccine “Kobgoze intramuscular injection” in Japan

SHIONOGI & CO., LTD. has obtained approval in Japan to add a dosage and administration for the COVID-19 vaccine “KOBGOZE intramuscular injection” for use as a booster. However, the JN.1 vaccine covered by this approval will not be supplied because it differs from the designated strain for the 2026/2027 season.

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Announced details

KOBGOZE® intramuscular injection
Applicable field (uses covered by this announcement)

Prevention of COVID-19, booster immunization

Impact on Business Performance

The impact on consolidated results for the fiscal year ending March 2027 has already been incorporated into the earnings forecast

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services CoveredKOBGOZE® intramuscular injection
Applicable areaPrevention of COVID-19, booster immunization
Impact on Business PerformanceThe impact on consolidated results for the fiscal year ending March 2027 has already been incorporated into the earnings forecast
Items this document does not state (15)
CounterpartyCounterparty overviewRelationship with the CompanyContract ValueOffering priceContract DateLaunch 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.

To address the continuously evolving SARS-CoV-2 virus, the company is building a vaccine platform that can rapidly respond to the strains recommended for each season, based on approvals obtained for the original strain and the JN.1 strain. The company states that this approval has established the foundation for the platform.

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Obtaining partial approval for changes to the recombinant protein vaccine “Kobgoze intramuscular injection” in Japan | Shionogi & Co.,Ltd. (4507) timely disclosure | Komori