Extensive Expertise in Infectious Diseases
Strong Track Record for Development Achievements
Building on more than 100 years of experience and a strong track record in therapeutic development for infectious diseases, SHIONOGI has delivered therapeutics for a wide range of infectious diseases, including influenza, COVID-19, and antimicrobial resistance (AMR).
Major Commercialized Products (as of April 2026)
Product Name |
Key Features |
Approval / Launch Status |
Partnership |
XOFULUZA® |
Japan’s first single-dose oral treatment for influenza |
Japan: Approved in 2018 Currently marketed in more than 30 countries and regions, including Japan, Taiwan, and Europe |
Partnered with F. Hoffmann-La Roche Ltd. |
XOCOVA® |
Japan’s first domestically developed oral treatment for COVID-19 |
Japan: Emergency approval in November 2022 Regular approval in March 2024 |
ー |
Cefiderocol |
The world’s first siderophore cephalosporin antibiotic |
U.S.: Approved in November 2019 Europe：Approved in April 2020 Japan: Approved in November 2023 Currently marketed in more than 25 countries and regions worldwide, including Asia, Europe, and the U.S. |
ー |
COVGOZE® for Intramuscular Injection |
Monovalent preventive vaccine against the original strain of COVID-19 |
Japan: Approved for primary immunization in June 2024 |
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Addressing Emerging Threats from Infectious Disease
To address the remaining challenges in COVID-19, we are advancing development with the aim of delivering new healthcare solutions. We are also progressing multiple development programs in the infectious diseases field, including olorofim, a novel antifungal agent, and therapeutics for RS virus infections.
Our Commitment to Vaccine Development
SHIONOGI is developing a recombinant protein vaccine, a vaccine modality with a long history of use and an established safety profile, with the goal of ensuring a stable domestic supply in Japan.
In June 2024, we obtained approval for COVGOZE.
Collaboration with U.S. Public Institutions
For global development, we also collaborate with public institutions such as the Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH) in the United States. Through these partnerships, we are proactively working to address a broad range of needs for COVID-19 therapeutics and prepare for future threats.
Pharmaceutical Product |
Partner Institution |
Subject |
Antivirus S-892216 |
Supported by BARDA |
Advancement of global development for pre-exposure prophylaxis against COVID-19 using a Long-Acting injectable formulation |
Cefiderocol |
・Advancement of global development targeting pathogens that could pose national security threats, including Burkholderia pseudomallei and Yersinia pestis ・Expansion of indications for the treatment of pediatric hospital-acquired pneumonia and ventilator-associated pneumonia |
|
XOCOVA® |
Supported by NIH |
Advancement of global development for hospitalized patients with COVID-19 |