Shionogi to Present New Data from Anti-Infective Portfolio at IDWeek

Scientific Contributions at Congress Include Real-World Evidence on More Than 1,000 Cefiderocol Patients

Findings from Antimicrobial Surveillance Program Will be Featured in Oral and Poster Presentations

New Research on Antibiotic Asset Advancing Through Shionogi Qpex Laboratory to be Presented

Florham Park, NJ, September 3, 2025 - Shionogi Inc., a United States subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.), will share 17 scientific presentations from across its anti-infective programs at IDWeek 2025 (October 19-22, 2025) in Atlanta, Georgia.

Presentations at IDWeek will feature new real-world evidence from three separate analyses from PROVE (Retrospective Cefiderocol Chart Review), the largest observational study to evaluate the use of Fetroja^® (cefiderocol). Shionogi and its research partners will present analyses from PROVE, which assessed outcomes from more than 1,000 hospitalized patients with infections caused by serious Gram-negative bacteria, the majority of which were resistant to carbapenem antibiotics.

Presentations from the SENTRY Antimicrobial Surveillance Program (2020-2024) examining cefiderocol’s in vitro* activity against more than 60,000 high-priority Gram-negative clinical isolates collected in the U.S. and Europe will also be featured during the congress.

“Shionogi is continually working to help physicians improve outcomes for seriously ill patients by investing in real-world studies and surveillance programs that evaluate cefiderocol’s activity and efficacy against established and emerging difficult-to-treat pathogens,” said Nathan McCutcheon, MBA, President and CEO, Shionogi Inc. “While we continue working toward better outcomes for patients today, we also recognize that infectious diseases are always changing. As pathogens and viruses constantly evolve, the future of healthcare depends on investing in research and advancing agents through the drug discovery process.”

Shionogi’s scientific contributions at IDWeek will also include two poster presentations from its COVID-19 program. Shionogi recently announced the FDA acceptance of its New Drug Application for its investigational oral antiviral ensitrelvir for the prevention of COVID-19 following exposure to an infected individual.

At IDWeek, Shionogi will also present preclinical research on the combination of cefiderocol with xeruborbactam, an investigational beta-lactamase inhibitor, discovered by Qpex Biopharma, Inc., a Shionogi Group Company.

As part of Shionogi’s ongoing efforts to address current and emerging health threats, the company recently opened its first drug discovery laboratory in the U.S. with Qpex. Through the new laboratory, Shionogi is focusing on advancing a robust portfolio of potential best-in-class, clinical-stage antimicrobial compounds. Learn more about the new lab and hear perspectives from leading academic researchers and clinicians here.

IDWeek attendees can visit Booth #121 to learn more about Shionogi’s ongoing research and innovation in infectious disease. At the booth, Shionogi will also bring back its AMR (antimicrobial resistance) Warrior experience with new interactive features.

Summary of IDWeek Presentations

Cefiderocol data presentations:

Oral #627: β-lactam-β-lactamase Inhibitor Combinations Show a High Degree of Cross Resistance in Gram-Negative Bacteria but Not to Cefiderocol; Results from the SENTRY Antimicrobial Surveillance Program (2020-2024)
Poster #P-1353: Earlier Cefiderocol Use was Associated with Better Outcomes for Challenging Gram-Negative Bacterial Infections: U.S. Results from the Global Observational PROVE Study
Poster #P-1352: Clinical Outcomes of Cefiderocol for Treatment of Bloodstream Infections Caused by Gram-Negative Bacteria: Subgroup Analysis of the PROVE Study
Poster #P-1354: Outcomes of Patients Treated with Cefiderocol for Infections Caused by β-Lactam–β-Lactamase Inhibitor Non-Susceptible Bacteria: Subgroup Analysis of the PROVE Study
Poster #P-1222: Population PK/PD Analysis of Cefiderocol in Chinese Patients with Complicated Urinary Tract Infections
Poster #P-1279: Five-year Trend Analysis of Carbapenem-resistant Enterobacterales, including Isolates Carrying Metallo-β-lactamase Genes in United States, Europe and Adjacent Regions during 2020–2024
Poster #P-1278: Activity of Cefiderocol and Comparator Agents Against Carbapenem-resistant Enterobacterales, including Molecularly Characterized Isolates Recovered from United States Hospitals in 2020–2024
Poster #P-1287: In Vitro Activity of Cefiderocol Against Resistant Subsets of Pseudomonas aeruginosa collected from United States Hospitals during 2020–2024
Poster #P-1286: In Vitro Activity of Cefiderocol against Carbapenem-nonsusceptible Acinetobacter baumannii-calcoaceticus Complex, Including Molecularly Characterized Clinical Isolates, Causing Infections in United States Hospitals (2020–2024)
Poster #P-1310: Cefiderocol Remains Active Against U.S. Clinical Isolates of Stenotrophomonas maltophilia Non-susceptible to Comparator Agents: Results from the SENTRY Antimicrobial Surveillance Program (2020–2024)
Poster #P-1220: Analyzing Trends of Cefiderocol Susceptibility Across Five Years of the SENTRY Surveillance Program
Poster #P-1300: Activity of Cefiderocol and Comparator Agents Against Metallo-β-Lactamase Carrying Acinetobacter baumannii-calcoaceticus Complex Isolates Collected in the SENTRY Antimicrobial Surveillance Program
Poster #P-1198: Inner Zones of Inhibition in Disk Diffusion Testing of Cefiderocol Best Reflect Activity Against Acinetobacter baumannii
Poster #P-1221: In Vitro Activity of Cefiderocol Against Clinical Strains Collected from China in 2023

Xeruborbactam data presentation:

Poster #P-1186: Pharmacodynamic Assessment of Combination of Cefiderocol with Xeruborbactam in Murine Thigh Infection Model

Ensitrelvir data presentations:

Poster #P-1666: Ensitrelvir (ESV) Population Pharmacokinetics (PK) in Nonhospitalized Adults with COVID-19
Poster #P-1606: Clearance of Infectious Virus in COVID-19 Patients Treated with Ensitrelvir Across Vaccination Status, Age, and Risk Subgroups: Exploratory Analyses from the SCORPIO-HR Study

For full Prescribing Information for Fetroja^® (cefiderocol), including approved indications and Safety Information, please visit https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf.

*In vitro activity does not necessarily correlate with clinical efficacy.

About Shionogi in Infectious Disease

Since 1953, Shionogi has been a leader in infectious disease discovery and commercialization. Our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Today, our global pipeline includes investigational agents developed to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus.

As part of our commitment to addressing unmet medical needs, Shionogi is partnering with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi has a landmark license and technology transfer agreement for cefiderocol with Global Antibiotic Research and Development Partnership (GARDP) and a collaboration agreement with the Clinton Health Access Initiative (CHAI) to transform the landscape of access to antibiotics in many low-income countries, most lower middle- and upper middle-income countries, and select high-income countries.

About Shionogi & Co. Ltd.

Shionogi & Co., Ltd. is a 146-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders, cardiovascular diseases and gastroenterology. Shionogi’s research and development currently target two therapeutic areas: infectious diseases and pain/CNS disorders. For more information on Shionogi & Co., Ltd., please visit https://www.shionogi.com/global/en.

Forward-Looking Statements

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

For Further Information, Contact:

U.S. Media: ShionogiCommunications@shionogi.com

SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

EU Media: Shionogi Europe Press Office: pressoffice@shionogi.eu