Shionogi & Co., Ltd.
Additional Approval in Japan for the COVID-19 Antiviral Drug Xocova® for Prevention of COVID-19 Infection
Shionogi & Co., Ltd.'s anti-SARS-CoV-2 drug Xocova® obtained additional approval in Japan for post-exposure prevention of COVID-19. Impact on FY ending March 2026 earnings is minimal.
Key Figures
- Drug Price: Xocova® tablet 125mg, 1 tablet 7,090 yen
- Dosage and Administration: For patients aged 12 and older, 375mg on Day 1, then 125mg once daily orally from Day 2 to Day 5
- Impact on Consolidated Earnings for FY Ending March 2026: Minimal
AI要約
Regarding Additional Approval of Product Indications
Shionogi & Co., Ltd.'s anti-SARS-CoV-2 drug Xocova® (Ensitrelvir Fumarate) has received additional approval in Japan for the indication of post-exposure prevention of COVID-19 based on favorable results from the global Phase 3 post-exposure prophylaxis trial (SCORPIO-PEP). Xocova is the world's first and only oral antiviral drug that can be used to prevent infection development after exposure. The dosage is 375mg orally once on Day 1, followed by 125mg once daily orally from Day 2 to Day 5 for children aged 12 and over and adults.
Future Outlook and Global Expansion
Shionogi positions liberation from the threat of infectious diseases as a key issue and is advancing research and development toward comprehensive infectious disease care. Internationally, a new drug application was submitted to the U.S. FDA in 2025 and is under review (PDUFA date: June 16, 2026), with reviews ongoing in Europe and Taiwan as well. Additionally, a licensing agreement with Medicines Patent Pool has been concluded to expand global access in low- and middle-income countries. The impact on consolidated earnings for the fiscal year ending March 2026 is expected to be minimal.
