Komori
Other Disclosures4507Shionogi & Co.,Ltd.Pharmaceuticals

Approval in Japan of an additional indication for Xocova, an anti-SARS-CoV-2 drug, for the prevention of COVID-19

Xocova has received approval for an additional indication so that it can also be used in Japan for post-exposure prophylaxis against COVID-19. Prevention has been added to its indications alongside the existing treatment indication.

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Announced details

Xocova Tablets 125 mg (generic name: ensitrelvir fumaric acid)
Applicable field (uses covered by this announcement)

Treatment and prevention of infections caused by SARS-CoV-2, including post-exposure prophylaxis against COVID-19.

Relationship between the counterparty and the company
Shionogi & Co.,Ltd.4507
Relationship with the Company

Created through joint research with Hokkaido University. Manufactured and marketed by Shionogi & Co.,Ltd.

Offering price

Xocova Tablets 125 mg: ¥7,090 per tablet

Impact on Business Performance

The impact on consolidated results for the fiscal year ending March 2026 will be minor.

The company does not address Contract Value.

Source (materials cited by the company)

SCORPIO-PEP study, CROI 2025, JAMA Network Open, the Vaccine Committee and COVID-19 Vaccine Task Force of the Japanese Association for Infectious Diseases, and others

Announced details
ItemDetails
Names of Products / Services CoveredXocova Tablets 125 mg (generic name: ensitrelvir fumaric acid)
Relationship with the CompanyCreated through joint research with Hokkaido University. Manufactured and marketed by Shionogi & Co.,Ltd.
Offering priceXocova Tablets 125 mg: ¥7,090 per tablet
Applicable areaTreatment and prevention of infections caused by SARS-CoV-2, including post-exposure prophylaxis against COVID-19.
Impact on Business PerformanceThe impact on consolidated results for the fiscal year ending March 2026 will be minor.
SourceSCORPIO-PEP study, CROI 2025, JAMA Network Open, the Vaccine Committee and COVID-19 Vaccine Task Force of the Japanese Association for Infectious Diseases, and others
Items this document does not state (12)
CounterpartyCounterparty overviewContract ValueContract DateLaunch 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.

Approval was obtained based on favorable results from the global Phase 3 post-exposure prophylaxis study (SCORPIO-PEP).

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.
Approval in Japan of an additional indication for Xocova, an anti-SARS-CoV-2 drug, for the prevention of COVID-19 | Shionogi & Co.,Ltd. (4507) timely disclosure | Komori