Cefiderocol Sulfate Tosylate

OSAKA, Japan, April 1, 2025 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereinafter, "Shionogi") today announced that its group-wide efforts to combat antimicrobial resistance (AMR) have been highly rated in the Antimicrobial Resistance Benchmark 2026 (the “Report”),¹ published by the Netherlands-based non-profit organization, Access to Medicine Foundation. Shionogi was ranked second among leading global research-based pharmaceutical companies. The Report is an international research initiative that evaluates pharmaceutical companies’ company’s contributions to addressing AMR across three key areas: Research & Development, Responsible Manufacturing, and Appropriate Access & Stewardship. Since its launch in 2018, Shionogi has been included among the companies assessed. Shionogi’s key achievements highlighted in the Report include: 1. Research & Development Shionogi was rated as having the second-largest and most innovative pipeline among global research-based pharmaceutical companies in the field of antibacterial drugs and vaccines targeting pathogens categorized as “Critical” or “High” priority in the World Health Organization (WHO) Bacterial Priority Pathogens List (BPPL). This pipeline comprises six antibacterial agents, one antifungal agent, and one antibacterial vaccine. In particular, all seven antibacterial agents currently under development target pathogens designated as high-priority by WHO, and four of these meet WHO’s criteria for innovation, which was highly commended. In addition, in April 2025, the Company established a drug discovery laboratory in the United States to support antibacterial R&D and further strengthen its drug discovery capabilities2. 2. Responsible Manufacturing Shionogi manages the discharge of antibiotic active pharmaceutical ingredients (APIs) into the environment—recognized as one of the drivers of AMR—in accordance with international standards. At the Company’s manufacturing sites, APIs in wastewater are controlled to levels below concentrations that may impact the environment. Notably, both the API manufacturing and formulation processes for cefiderocol at the Kanegasaki Plant have obtained the international certification “BSI Kitemark™ for Minimized Risk of AMR” for antibacterial manufacturing3. Furthermore, the Company requires relevant suppliers to implement similar measures through on-site audits, while also confirming and supporting their initiatives. An overview of these efforts is disclosed on the Company’s website4. These initiatives to mitigate AMR risks, together with a high level of transparency in disclosure, were highly evaluated, resulting in the Company receiving the highest rating in this category among global research-based pharmaceutical companies. 3. Appropriate Access & Stewardship Shionogi continues its efforts to promote appropriate use of antibacterial agents by decoupling sales volume from compensation. The Company was recognized for advancing initiatives to promote appropriate use and access to antibacterial agents through partnerships. These include supporting technology transfer to Orchid Pharma in collaboration with the Global Antibiotic Research & Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI)⁵, as well as promoting antimicrobial stewardship (AMS) in the Republic of Kenya through a comprehensive partnership with Nagasaki University, Saraya Co., Ltd., and Connect Afya Co., Ltd.⁶. In addition, its efforts to establish systems for stable supply based on demand forecasting, as well as its participation in or implementation of three antimicrobial susceptibility surveillance programs conducted both in Japan and internationally, were also positively evaluated. Protecting people from the threat of infectious diseases is a key area of focus for Shionogi. The Company will continue to fulfill its objectives to address total care for infectious diseases —research and development, manufacturing, supply, and appropriate use—to address the global challenge of AMR. For more information on Shionogi’s AMR initiatives, please visit our website. Address the problem of antimicrobial resistance (AMR) About Antimicrobial Resistance (AMR) AMR refers to the phenomenon whereby bacteria become resistant to antimicrobial agents, rendering treatments less effective or ineffective, primarily due to the inappropriate use of antibiotics. Often described as a “silent pandemic,” AMR is recognized as one of the most significant global public health threats, requiring urgent action.7 In 2021, AMR was estimated to have caused 1.14 million deaths worldwide.8 Without coordinated global action, it is projected to result in more than 39 million deaths over the next 25 years.9 Despite this growing threat, available treatment options remain limited, making AMR an area with significant unmet medical needs. About the Access to Medicine Foundation The Access to Medicine Foundation is an independent, Netherlands-based non-profit organization dedicated to transforming the healthcare ecosystem and advancing global health equity. For over 20 years, the Foundation has tracked and evaluated the efforts of leading pharmaceutical companies, providing independent, evidence-based insights into how the industry impacts access to essential medicines worldwide. For more information, please visit the Access to Medicine website. References 1. AMR benchmark 2026(Access to Medicine Foundation) ・2026 Antimicrobial Resistance Benchmark | Access to Medicine ・Shionogi & Co, Ltd_Report 2. Press Release (June 4, 2024) Shionogi Expands Global Infectious Disease and Antimicrobial Research Operations to U.S. to Address Current and Emerging Health Threats 3. Press Release (June 4, 2024) Shionogi Pharma’s Kanegasaki Plant Receives “BSI Kitemark™ for Minimized Risk of AMR” Certification for Antimicrobial Manufacturing 4. Website: AMR | Environment | Shionogi & Co., Ltd. 5. Press Release (June 4, 2024) Shionogi, GARDP and CHAI announce landmark license and collaboration agreements to treat bacterial infections by expanding access to cefiderocol in 135 countries｜News｜Shionogi Co., Ltd. 6. Press Release (June 4, 2024) Shionogi, Nagasaki University, Saraya, and Connect Afya Enter into a Comprehensive Partnership Agreement to Support Antimicrobial Stewardship in Kenya｜ SHIONOGI 7. Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet 2022; 399: 629–55. 8. GBD 2021 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance 1990-2021: a systematic analysis with forecasts to 2050. Lancet. 2024 Sep 28;404(10459):1199-1226. doi: 10.1016/S0140-6736(24)01867-1. Epub 2024 Sep 16. PMID: 39299261. 9. Antimicrobial resistance (who.int) WHO. Antimicrobial resistance. Who.int. Published October 13, 2020. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html 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.