TREAT-GNB is an innovative trial to expedite the evaluation of various antibiotic choices and treatment strategies for severe multidrug-resistant Gram-negative bacterial infections, specifically bloodstream and lower respiratory tract infections. This approach combines platform trial elements with adaptive clinical designs to streamline the evaluation of various treatment options and optimise resource utilisation. The overall aim of the TREAT-GNB platform trial is to identify interventions that improve survival in patients with severe infections due to Gram-negative bacteria.
In the CR-GNB silo of TREAT-GNB, the primary objective is to quantify the effect on all-cause mortality at 28 days of a range of interventions in patients with bloodstream infections, ventilator-associated pneumonia, and hospital-acquired pneumonia caused by CR-GNB.

Start Date21 Apr 2025

Sponsor / Collaborator

National University of Singapore

[+1]

TCTR20240718005

/ Not yet recruitingPhase 2

A Multicenter, Single-arm, Open-label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Cefiderocol in Hospitalized Pediatric Patients from Birth to less than 3 Months of Age with Suspected or Confirmed Aerobic Gram-negative Bacterial Infections

Start Date01 Nov 2024

Sponsor / Collaborator

Shionogi, Inc.

NCT06547554

/ RecruitingPhase 1

A Phase 1, Randomized, Double-blind, Placebo-controlled, Drug-drug Interaction, Pharmacokinetic, and Safety Study of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants

A phase 1, randomized, double blind, placebo controlled drug-drug interaction, pharmacokinetics and safety study of cefiderocol in combination with xeruborbactam in healthy adult participants

Start Date04 Sep 2024

Sponsor / Collaborator

Qpex Biopharma, Inc.

[+2]

100 Clinical Results associated with Cefiderocol Sulfate Tosylate

100 Translational Medicine associated with Cefiderocol Sulfate Tosylate

100 Patents (Medical) associated with Cefiderocol Sulfate Tosylate

1,147

Literatures (Medical) associated with Cefiderocol Sulfate Tosylate

01 Dec 2025·MOLECULAR BIOLOGY REPORTS

Prevalence of New Delhi Metallo-β-lactamase (blaNDM) gene in a selected population of drug-resistant clinical isolates

Article

Author: Ahmed, Iftikhar ; Ahmad, Aftab ; Saeed, Muhammad ; Shafiq, Muhammad ; Latif, Kunza ; Hyder, Muhammad Zeeshan

OBJECTIVES:

Drug-resistant Enterobacterales carrying carbapenem-resistant genes cause severe infections in clinical settings worldwide. Among these, the New Dehli Metallo-β-lactamase (bla_NDM) gene is significantly prevalent and associated with high morbidity. This study was designed to investigate the susceptibility profiling of Carbapenem-Resistant-Enterobacterales (CRE), prevalence of bla_NDM and its variants, and associated risk factors.

METHODS:

CRE isolates from a tertiary care hospital, in Islamabad, Pakistan, were identified and the susceptibility testing was performed using disc diffusion method. MICs were determined for imipenem, tigecycline, and colistin through E-strips and microbroth dilution method respectively. For molecular characterization and typing of the bla_NDM gene, PCR products were sequenced, and the phylogenetic analysis was performed using MEGA ver 6.0 software.

RESULTS:

Among 5,134 clinical samples, 42.13% (n = 2,163) yielded pathogens including 42.58% (n = 921) Enterobacterales. On further screening, 39.52% (n = 364) of Enterobacterales were identified as CRE. The bla_NDM gene was detected in 75.27% (n = 274) in CRE isolates, comprising bla_NDM-1 (44%), bla_NDM-5 (53%), and bla_NDM-7 (3%) variants. Tigecycline (86.7%) and colistin (100%) were most effective antimicrobial agents with MICs ranging from 0.064 to 8 and 0.125-1 µg/ml respectively. bla_NDM-1-harboring bacteria exhibited high antimicrobial resistance compared to bla_NDM-5 and bla_NDM-7. Cefiderocol was 75.6% and ceftazidime/avibactam with aztreonam was 97.08% effective against bla_NDM-harboring bacteria. The phylogenetic analysis indicated that bla_NDM variants showed close genetic relationships and homology to the previously described sequences in GenBank databases having diverse connection with worldwide sequences.

CONCLUSION:

The high prevalence of bla_NDM in our study has of great concern for clinical practice and public health. Clinicians are left with few therapeutic options. However, ceftazidime/avibactam with aztreonam may show therapeutic success. Continuous surveillance is crucial to monitorgenetic variations of continuously evolving bla_NDM gene, which is essential for effective clinical management.

01 Aug 2025·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Rising threat of metallo-β-lactamase-producing Klebsiella oxytoca complex in Taiwan, 2013–2022

Article

Author: Bregente, Carl Jay Ballena ; Liao, Chun-Hsing ; Lee, Jia-Arng ; Lee, Tai-Fen ; Kao, Cheng-Yen ; Hsu, Wei-Yu ; Hsueh, Po-Ren ; Kuo, Yao-Wen ; Huang, Yu-Tsung

OBJECTIVES:

The emergence of metallo-beta-lactamases (MBLs) within the Klebsiella oxytoca complex (CRKO) poses a significant challenge in Taiwan, with so far incomplete characterization of species distribution and carbapenemase variants. This study aimed to elucidate the diversity, variants, and clinical presentations of CRKO isolates collected from 2013 to 2022.

METHODS:

We analyzed production of carbapenemases by the modified carbapenem inhibitory method (mCIM) and the NG test^TM CARBA-5. Confirmation of five common carbapenemases and multilocus sequence typing were determined by polymerase chain reaction and sequencing. Nanopore whole-genome sequencing was used for the species differentiation and plasmids analysis. We also evaluated the clinical characteristics of the CRKO-infected patients.

RESULTS:

Three species were identified: K. michiganensis (n = 102), K. pasteurii (n = 13), and K. oxytoca (n = 3). A majority of isolates (91.5%, n = 108) harbored at least one MBL gene, including bla_VIM-1 (n = 56), bla_IMP-8 (n = 26), and bla_NDM-1 (n = 19), with six isolates carrying dual carbapenemase genes. The bla_NDM-1 and bla_IMP-8 genes were located on IncFII(Yp) and IncA/C2 plasmids, respectively. Notably, 34.7% of isolates carried kleboxymycin gene clusters (KGC). Using CLSI and EUCAST criteria, 92.4% and 82.4% of isolates, respectively, were susceptible to cefiderocol. Among 92 infected patients, the 30-day mortality rate was 21.7%, associated with female gender, higher Charlson Comorbidity Index, higher Pitt bacteremia scores, presence of bacteremia, and inversely associated with KGC.

CONCLUSION:

The high prevalence of CRKO carrying MBLs and the recent surge of the ST27-bla_NDM-1 genotype, poses significant treatment challenges and underscores the urgent need for enhanced surveillance in Taiwan.

01 Aug 2025·THERAPEUTIC DRUG MONITORING

Risk of Underexposure and Lack of Efficacy of Cefiderocol by Reduced Dosing in Japanese Patients With Gram-Negative Bacterial Infections

Review

Author: Itoh, Naoya

Background::

Recently, a cost-saving, dose-reducing strategy for cefiderocol against gram-negative bacteria with low cefiderocol minimum inhibitory concentrations (MICs) was proposed as an alternative to the standard dosing (ie, 2 g every 8 hours, 3-hours infusion). The objectives of this article are to summarize the available evidence on the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of cefiderocol to support the rationale of the approved dosing and to assess any risk of underexposure with reduced doses (ie, 1 g every 8 hours or 12 hours) regarding higher cefiderocol MICs.

Methods::

Published data from phase 1–3 clinical, preclinical effectiveness, and surveillance studies were reviewed, and new population PK simulations were conducted.

Results::

Most carbapenem-resistant gram-negative isolates displayed cefiderocol MICs up to 4 mg/L. Single or multiple doses of cefiderocol, up to 4 g, were tested in phase 1 clinical studies, which confirmed a linear PK profile, low metabolism, renal clearance, and penetration into the lungs and soft tissues. Phase 2–3 randomized controlled clinical studies have demonstrated the efficacy and safety of cefiderocol at 2 g every 8 hours or renally adjusted doses versus comparators in patients with complicated urinary tract infections, nosocomial pneumonia, and bloodstream infection/sepsis caused by various carbapenem-susceptible or -resistant gram-negative pathogens. Population PK models incorporating clinical data predicted that the approved dosing regimen of cefiderocol, in contrast to reduced doses, would achieve high probability of target attainment against gram-negative isolates, with cefiderocol MICs of 2–4 mg/L across various infection types and patient populations.

Conclusions::

Administering low-dose cefiderocol to reduce treatment-related costs will lead to treatment failure and prolonged hospitalization and incur further expenses. Therefore, the approved cefiderocol dosing regimen is strongly recommended.

News (Medical) associated with Cefiderocol Sulfate Tosylate

18 Jul 2025

·www.shionogi.com

Submission of Letter of Intent and Concept Note to the Kenyan Ministry of Health to Accelerate Access to Cefiderocol

July 18, 2025 –Shionogi & Co., Ltd. (Head Office: Chuo-ku, Osaka, Japan; hereinafter, “Shionogi”), in collaboration with the Global Antibiotic Research & Development Partnership (Head Office: Geneva, Switzerland; hereinafter “GARDP”), has agreed to collaborate with the Ministry of Health of the Republic of Kenya (hereinafter, “Kenya”) on a project aiming to facilitate the introduction of cefiderocol, a treatment for serious Gram-negative bacterial infections in adults with limited treatment options, in the country. Shionogi and GARDP submitted to the Kenyan Ministry of Health a Letter of Intent and a project Concept Note, which were subsequently accepted. The project proposes to support the appropriate use of cefiderocol in select tertiary hospitals through a phased approach that aligns with the Kenyan Ministry of Health antimicrobial stewardship framework and national AMR priorities. This project will be a collaborative effort between Shionogi, GARDP, the Kenyan Ministry of Health, and other Kenyan stakeholders, and it will generate critical insights to inform broader access strategies for Kenya and beyond. One of Shionogi’s key material issues is to “Improve Access to Healthcare”. Shionogi is committed to strengthening collaborative initiatives with domestic and international partners, contributing to the development of a sustainable society.1,2 These efforts include improving access to antimicrobial treatments* and supporting maternal and child health programs in Africa.** As a global leader in infectious disease treatment, Shionogi continues to actively address a wide range of public health challenges, including some of the world’s major infectious diseases, such as AMR and COVID-19. *For more information on Shionogi’s initiatives on AMR, please click [here]. **For more information on Shionogi’s maternal and child health initiatives in Africa, please click [here]. About cefiderocol: In Europe, cefiderocol is commercially available under the brand name Fetcroja® for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.3 In the US, cefiderocol is commercially available under the brand name Fetroja® for the treatment of patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia and complicated urinary tract infections caused by certain susceptible Gram-negative microorganisms.4 In Japan, cefiderocol is commercially available under the brand name Fetroja® and received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for various infections caused by strains resistant to carbapenem antibiotics among sensitive strains of Escherichia coli, Citrobacter species, Klebsiella pneumoniae, Enterobacter species, Serratia marcescens, Proteus species, Morganella morganii, Pseudomonas aeruginosa, Burkholderia species, Stenotrophomonas maltophilia, and Acinetobacter species.5 About Antimicrobial Resistance: Antimicrobial resistance (AMR), the phenomenon where bacteria acquire resistance to antibiotics, is one of the most significant global public health threats facing humanity and requires urgent action. AMR has been referred to as a "silent pandemic,” and without countermeasures, it is projected to result in over 1.91 million deaths annually by 2050.6 Reference: 1. 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. 2. Shionogi, Nagasaki University, Saraya, and Connect Afya Enter into a Comprehensive Partnership Agreement to Support Antimicrobial Stewardship in Kenya｜ SHIONOGI 3. Fetcroja® Summary of Product Characteristics. Available at: Fetcroja, INN-cefiderocol 4. Fetroja® Prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209445s000lbl.pdf. 5. Press release on November 30, 2023. Regarding the Acquisition of Manufacturing and Marketing Approval for the New Siderophore Cephalosporin Antibiotic FetrojaⓇ(cefiderocol) Intravenous Infusion 1g vial in 6. 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. 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: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

License out/inDrug Approval

09 May 2025

·www.shionogi.com

Shionogi, Nagasaki University, Saraya, and Connect Afya Enter into a Comprehensive Partnership Agreement to Support Antimicrobial Stewardship in Kenya

OSAKA, Japan, May 9 , 2025 - Shionogi & Co., Ltd. (Head Office: Chuo-ku, Osaka; hereinafter, “Shionogi”) is pleased to announce that it has entered into a comprehensive partnership agreement (hereinafter, “the Agreement”) with Nagasaki University (Location: Nagasaki City, Nagasaki; hereinafter, “Nagasaki University”), Saraya Co., Ltd. (Location: Osaka City, Osaka; hereinafter, “Saraya”), and Connect Afya Inc. (Location: Tatsuno City, Hyogo; hereinafter, “Connect Afya”) to support antimicrobial stewardship (AMS) systems in healthcare institutions in the Republic of Kenya (hereinafter, “Kenya”) as of May 9. The four parties—Shionogi, Nagasaki University, Saraya, and Connect Afya—have each contributed to addressing antimicrobial resistance (AMR), one of the greatest global public health threats, through various roles such as academic research in infectious diseases, the development and supply of antimicrobials, infection control, and laboratory support. Sharing the common goal of strengthening AMR countermeasures in Kenya while also aiming to expand healthcare initiatives across other African countries and regions, the four parties have decided to formalize their collaboration through this Agreement. Based on this Agreement, the four parties will work together on the following initiatives: ・ Launch and implementation of joint research projects related to AMR in Kenya (Promotion of surveys and research related to AMR in Kenyan healthcare institutions) ・ International collaboration on AMR initiatives (Cooperation with the Kenyan government and healthcare institutions, as well as with Shionogi’s global partners such as the Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI)1 ) ・ Human resource development in infectious disease control (Training of future AMR leaders through education on infection control and appropriate antimicrobial use for Kenyan healthcare professionals) ・ Other collaborative activities supporting AMR measures Shionogi has identified “Improve access to healthcare” as one of its material issues (materiality), and is actively strengthening its collaborative efforts, including with its international partners1. The company contributes to a sustainable society by improving access to AMR treatment and supporting maternal and child health initiatives in Africa. As a leading company in infectious diseases, Shionogi remains committed to addressing major public health challenges, including the three major infectious diseases, AMR, and COVID-19. For more information on Shionogi’s initiatives on AMR, please click [here]. For more information on Shionogi’s maternal and child health initiatives in Africa, please click [here]. About Antimicrobial Resistance (AMR): Antimicrobial resistance (AMR), the phenomenon where bacteria acquire resistance to antibiotics, is one of the most significant global public health threats facing humanity and requires urgent action. AMR has been referred to as a "silent pandemic,” and without countermeasures, it is projected to result in over 10 million deaths annually by 20502-4.　 About Nagasaki University: With a legacy rooted in the introduction of Western medicine through Nagasaki during the Edo Period, Nagasaki University has been engaged in infectious disease research since 1942. Today, it becomes one of Japan’s leading centers for infectious disease research and education. The Department of Infectious Diseases and Infection Control Education Center at Nagasaki University Hospital, which plays a key role in this Agreement, owns and operates Japan’s designated isolation beds for patients with Class I infectious diseases such as viral hemorrhagic fever. This department and center actively contributes to infection control and care of the patients both within and beyond the hospital, including previous support in hospitals in Liberia, West Africa, where outbreak of Ebola diseases occurred. About Saraya Co., Ltd.: Saraya is committed to building a more prosperous and productive global society through its three core pillars of business: hygiene, the environment, and health. Since its founding in 1952, the company has been developing and providing a wide range of products and services, including various detergents, disinfectants, and food items, for both household and professional use. In Africa, Saraya began local production and sales of alcohol-based hand sanitizers in Uganda in 2014. In addition to supplying products to Kenya, South Sudan, the Democratic Republic of the Congo, and other countries, the company also contributes to the capacity building of infection control professionals in healthcare settings through collaborations with the Japan International Cooperation Agency (JICA) and local ministries of health. https://www.saraya.com/ About Connect Afya Inc.: Founded in 2018 and operating in Kenya as CA MEDLYNKS, Connect Afya Ltd. pursues one clear mandate—“Deliver Healthcare When and Where Necessary.” Its ISO 15189- and KENAS-accredited reference laboratory in Nairobi spans routine chemistry, hematology, and microbiology through next-generation sequencing on the latest Illumina systems and advanced immunohistochemistry for precision oncology. Building on this platform, the company aims to launch antimicrobial-resistance monitoring to support stewardship programs nationwide. Partnerships with a diverse group of Japanese healthcare and life-science firms have already transferred critical technologies and trained more than 100 Kenyan scientists, positioning Connect Afya to narrow Africa’s diagnostic gap. https://connectafya.com/ Reference: 1. 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. 2. Antimicrobial resistance (who.int) WHO. Antimicrobial resistance. Who.int. Published October 13, 2020. 3. Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet 2022; 399: 629–55 4. 160525_Final paper_with cover.pdf (amr-review.org)O’Neill J. ‘Tackling Drug-Resistant Infections Globally: Final Report and Recommendations’. Review on Antimicrobial Resistance. May 2016. 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: SHIONOGI Website Inquiry Form : https://www.shionogi.com/global/en/contact.html

07 May 2025

·www.shionogi.com

Announcement of Agreement on Company Split (Simplified Absorption-Type Split) of Japan Tobacco Inc.'s Pharmaceutical Business and Acquisition of Shares of Akros Pharma Inc. by Shionogi Inc. (Making it a Subsidiary)

OSAKA, Japan, May 7, 2025 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi" or the “Company”) today announced that at the Board of Directors meeting held on May 7, 2025, it resolved to succeed to the pharmaceutical business of Japan Tobacco Inc. (Headquarters: Minato-ku, Tokyo; President: Masamichi Terabatake; hereinafter referred to as "Japan Tobacco") (hereinafter referred to as "JT Pharmaceutical Business" or the "Business to be Split") through a company split (simplified absorption-type split) (hereinafter referred to as the "Absorption-Type Split") and to acquire all issued shares of Akros Pharma Inc. (a 100% sub-subsidiary of Japan Tobacco, headquartered in New Jersey, USA; hereinafter referred to as "Akros") by Shionogi Inc., a group company of Shionogi in the USA (hereinafter referred to as the "Share Acquisition"), and has entered into an agreement (hereinafter referred to as the "Agreement") regarding the same. In connection with the Agreement, the Company also resolved at the Board of Directors meeting held today to conduct a tender offer (hereinafter referred to as the "Tender Offer") for the common shares of Torii Pharmaceutical Co., Ltd. (hereinafter referred to as "Torii Pharmaceutical"), a consolidated subsidiary of Japan Tobacco, to make Torii Pharmaceutical a wholly-owned subsidiary of the Company (hereinafter referred to as the "Full Ownership"). For details on the Tender Offer, please refer to the "Notice of Commencement of Tender Offer for Shares of Torii Pharmaceutical Co., Ltd. (Securities Code: 4551)" released today. I. Purpose of the Absorption-Type Split and Share Acquisition (hereinafter referred to as the "Transaction") Shionogi's basic policy (SHIONOGI Group Heritage) is to always provide the best medicine (healthcare solutions) necessary to protect people's health. The Company engages in research and development, manufacturing, and sales activities of prescription drugs, over-the-counter drugs, and diagnostic agents. In 2020, the Company set forth the Vision (SHIONOGI Group Vision) that aims to achieve by 2030, "Creating the Future of Healthcare with a New Platform," and formulated the medium-term management plan Shionogi Transformation Strategy 2030 (STS2030) to realize this Vision. The Company is transforming into a Healthcare as a Service (HaaS) company that provides various healthcare services tailored to customer needs, not limited to the provision of prescription drugs, to comprehensively address the problems faced by patients and society worldwide. From fiscal 2020 to fiscal 2022, the Company aimed to contribute to the early end of the COVID-19 pandemic by providing not only therapeutic drugs but also total care solutions for COVID-19, including detection (epidemic prediction), prevention, diagnosis, and mitigation of severe cases. As a result, the Company obtained domestic approval for the COVID-19 therapeutic drug Xocova at an unprecedented speed, advancing its drug discovery capabilities. Additionally, the Company expanded its product and service offerings beyond prescription drugs, including its first vaccine and wastewater epidemiology survey service. Based on the achievements and lessons learned from these efforts, the path to realizing the SHIONOGI Group Vision became clearer, leading to the revision of STS2030 in 2023 and the start of STS2030 Revision. In STS2030 Revision, the three years from fiscal 2023 to fiscal 2025 are positioned as STS Phase 2, with the basic policy of global top-line growth centered on the infectious disease area and fostering growth drivers through aggressive investment, accelerating growth through transformation. In research and development, the Company focuses on high-impact infectious diseases and high-impact QOL diseases as priority areas. In infectious diseases, the Company has developed many innovative new drugs, such as the anti-HIV drugs (dolutegravir and cabotegravir), the for multidrug-resistant Gram-negative bacterial infections (cefiderocol), and the anti-influenza virus drug Xofluza, based on its strong foundation in small molecule drug discovery (creating drugs with molecular weights ranging from tens to hundreds). The Company aims to solve the problems faced by patients and society worldwide by further strengthening and expanding its strong foundation in small molecule drug discovery. On the other hand, JT Pharmaceutical Business has been engaged in research and development of prescription drugs since entering the business in 1987, aiming to create first-in-class small molecule drugs through stable research and development investment. Currently, under the business purpose of "valuing science, technology, and human resources and contributing to patients' health," Japan Tobacco conducts research and development, while Torii Pharmaceutical handles manufacturing, sales, and promotion activities, building an integrated value chain and maximizing synergies within the group. JT Pharmaceutical Business focuses on three priority research and development areas: cardiovascular, renal, and muscle, "immunology and inflammation, and central nervous system, with strengths in rapid clinical development through specialization on research and development in the small molecule drug discovery and collaboration between domestic and international research and development bases. To deliver new drugs created in-house to patients as early as possible, JT Pharmaceutical Business actively engages in out-licensing and partnerships with global mega-pharma companies, in addition to promoting in-house development. Shionogi has been considering collaboration with JT Pharmaceutical Business and Torii Pharmaceutical to realize the Vision of "Creating the Future of Healthcare with a New Platform" in STS2030 Revision. As a result of these considerations, the Company concluded that by adding the capabilities of JT Pharmaceutical Business, which has strengths in small molecule drug discovery and development , it would be possible to accelerate the advancement of promising pipeline projects and increase the responsiveness and efficiency of business operations through collaboration with the Company's pharmaceutical manufacturing functions. The Company proposed to Japan Tobacco the acquisition of JT Pharmaceutical Business and the full ownership of Torii Pharmaceutical, and after subsequent discussions, reached the Agreement. The Company believes that the Transaction will create a leading company that delivers innovative pharmaceuticals from Japan to the world, contributing to the health of patients and people worldwide, and contributing to the realization of a sustainable and healthy society. The Company also believes that the Transaction will provide opportunities for the employees of JT Pharmaceutical Business (including group companies) to continue to thrive with peace of mind. II. Overview of the Absorption-Type Split i. Summary of the Absorption-Type Split (1) Date (1) Date of Board Resolution for Agreement May 7, 2025 (2) Date of Agreement May 7, 2025 (3) Date of Board Resolution for Absorption-Type Split Agreement September, 2025 (planned) (4) Date of Absorption-Type Split Agreement September, 2025 (planned) (5) Effective Date of Absorption-Type Split December, 2025 (planned) (Note 1): The Absorption-Type Split falls under the simplified absorption-type split stipulated in Article 796, Paragraph 2 of the Companies Act for the Company, and Article 784, Paragraph 2 of the Companies Act for Japan Tobacco. Therefore, it will be carried out without the approval resolution of the shareholders' meeting. (Note 2): The schedule may be changed as necessary, considering the need for responses to approvals, registrations, notifications, etc., from relevant authorities, circumstances, and other various factors. (2) Method of Absorption-Type Split The Company will be the succeeding company, and Japan Tobacco will be the splitting company. (3) Allocation of Consideration The Company will pay 5,397 million yen to Japan Tobacco as consideration for the Absorption-Type Split. (4) Handling of Stock Acquisition Rights and Bonds with Stock Acquisition Rights Not applicable. (5) Increase or Decrease in Capital Due to Absorption-Type Split Not applicable. (6) Rights and Obligations to be Succeeded The Company will succeed to the assets, liabilities, and contractual rights and obligations related to the Absorption-Type Split, except for those separately specified in the Absorption-Type Split Agreement. (7) Prospects for Debt Performance The Company believes that there are no issues with performance of the debts that will become due after the effective date of the Absorption-Type Split. ii. Allocation of Consideration and Basis for the Absorption-Type Split (1) Basis and Reason for Allocation of Consideration The allocation of consideration was agreed upon after comprehensive discussions between both companies, taking into account the performance status and future prospects of the business to be split. (2) Matters Related to Calculation The Company has not obtained a valuation report from a valuation institution in connection with the Absorption-Type Split. (3) Prospect of Delisting and Its Reason Since the consideration involves the exchange of money, there is no prospect of delisting. (4) Measures to Ensure Fairness Not applicable. However, the Company has appointed Nishimura & Asahi Law Office as the legal advisor for the Absorption-Type Split and has received legal advice on various procedures, decision-making methods, and processes related to the Absorption-Type Split. Nishimura & Asahi Law Office does not have any significant interests that should be disclosed in relation to the Absorption-Type Split and is not a related party to the Company or Japan Tobacco. (5)Measures to Avoid Conflicts of Interest Not applicable. (Unit: million yen, unless otherwise specified.) i. Overview of JT Pharmaceutical Business (1) Content of JT Pharmaceutical Business Research and development of prescription drugs (2) Business Performance of JT Pharmaceutical Business Fiscal year ended December 2024 Net sales ¥44,942 million (3) Items and Amounts of Assets and Liabilities of the JT Pharmaceutical Business to be Succeeded (as of December 31, 2024) The assets (excluding shares of Torii Pharmaceutical and Akros) and liabilities, as well as other rights and obligations belonging to the JT pharmaceutical business, As stipulated in the absorption-type split agreement will be succeeded by our company. Assets Liabilities field book value field book value Current Assets ¥8,588 million Current Assets ¥5,448 million Fixed Liabilities ¥37,832 million Fixed Liabilities ¥9,875 million Total ¥46,420 million Total ¥15,323 million Note: The above amounts are calculated based on the balance sheet as of December 31, 2024, and the actual amounts to be succeeded will be adjusted for any increases or decreases up to the effective date. ii. Status After the Absorption-Type Split (1) Name of Company Shionogi & Co., Ltd. Japan Tobacco Inc. (2) Location 1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan 1-1, Toranomon 4-chome, Minato-ku, Tokyo (3) Representative Isao Teshirogi, Ph.D., Representative Director, President and CEO Masamichi Terabatake, President, Chief Executive Officer and Representative Director　 (4) Business Description Research, development, manufacturing and distribution of pharmaceuticals, diagnostic reagents and medical devices, etc. Manufacture, sale, import, etc., of manufactured tobacco (5) Paid-in Capital ¥21,279 million ¥100,000 million (6) Fiscal Year-End March 31 December 31 (7) Net Assets It is not confirmed at this time It is not confirmed at this time (8) Total Assets It is not confirmed at this time It is not confirmed at this time iii. Overview of Accounting Treatment For the accounting treatment related to the Absorption-Type Split, we plan to apply IFRS 3 'Business Combinations' and use the purchase method, with our Company as the acquiring entity. The amount of goodwill generated from this Absorption-Type Split is currently undecided, and we will inform you as soon as it is determined. iv. Future Outlook We are currently assessing the impact of this Absorption-Type Split on our consolidated performance, and will inform you as soon as it is determined. v. Other Noteworthy Matters The Agreement is contingent upon the absence of any factors hindering the execution of the stock acquisition, such as the issuance of a cease and desist order, based on the results of the Japan Fair Trade Commission's review of the notification under Article 10, Paragraph 2 of the Act on Prohibition of Private Monopolization and Maintenance of Fair Trade. II. Overview of this Stock Acquisition i. Overview of Our U.S. Subsidiary (Shionogi Inc.) Acquiring the Shares (1) Name of Company Shionogi Inc. (2) Location 400 Campus Drive, Florham Park, NJ 07932, USA (3) Representative President and Chief Executive Officer Nathan McCutcheon (4) Business Description Development, manufacturing, and sales of pharmaceuticals (5) Paid-in Capital 12 USD (as of March 31, 2024) (6) Date of Founding August 2008 (7) Major Shareholders and Shareholding Ratios Shionogi (100%) ii. Overview of the Subsidiary to be Acquired (1) Name of Company Akros Pharma Inc. (2) Location 302 Carnegie Center, Suite 300, Princeton, NJ 08540 (3) Job Title and Name of Representative President＆CEO Teppei Higuchi (4) Business Description Clinical development, joint research, and exploration of new technology projects overseas (5) Paid-in Capital 1,000 USD (as of December 31, 2024) (6) Date of Founding January 1999 (7) Net Assets 23,776 thousand USD (as of December 31, 2024) (8) Total Assets 32,986 thousand USD (as of December 31, 2024) (9) Major Shareholders and Shareholding Ratios JT AMERICA INC. (100%) ※ JT AMERICA INC. is a wholly owned subsidiary of Japan Tobacco Inc. (10) Relationship between Shionogi and said company Capital Relationship None. Personal Relationship None. Transactional Relationship None. Status as Related Party None. iii. Overview of the Counterparty in the Stock Acquisition (1) Name of Company JT AMERICA INC. (2) Location 112 W. 34th Street, 18th Floors, New York, NY 10120 (3) Job Title and Name of Representative President & CEO Toshimitsu Eguchi (4) Business Description Holding company functions in the U.S. for non-tobacco and non-food businesses (5) Paid-in Capital 51 thousand USD (as of December 31, 2024) (6) Date of Founding May 1988 (7) Net Assets 141,447 thousand USD (as of December 31, 2024) (8) Total Assets 142,125 thousand USD (as of December 31, 2024) (9) Major Shareholders and Ownership Ratios Japan Tobacco Inc.(100％) (10) Relationship between Shionogi and said company Capital Relationship None. Personal Relationship None. Business Relationship None. Related Party Relationship None. iv. Number of Shares to be Acquired, Acquisition Price, and the Status of Shareholding Before and After the Acquisition * The acquisition price has been converted at an exchange rate of 1 USD = 151.55 JPY (based on the average rate over the past six months). v. Date vi. Future Outlook We are currently assessing the impact of this stock acquisition on Shionogi’s consolidated financial results for the fiscal year ending March 2026. If it becomes necessary to revise the performance forecast, Shionogi will promptly disclose the information. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

AcquisitionLicense out/in

100 Deals associated with Cefiderocol Sulfate Tosylate

External Link

KEGG	Wiki	ATC	Drug Bank
D11013	Cefiderocol Sulfate Tosylate	J01D	DB14879

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Complicated urinary tract infection	South Korea	Jeil Pharmaceutical Co., Ltd.	18 Feb 2025
Infectious Diseases	Japan	Shionogi Pharma, Inc.	30 Nov 2023
Hospital-acquired pneumonia	United States	Shionogi, Inc.	25 Sep 2020
Klebsiella Infections	United States	Shionogi, Inc.	25 Sep 2020
Pneumonia, Ventilator-Associated	United States	Shionogi, Inc.	25 Sep 2020
Serratia Infections	United States	Shionogi, Inc.	25 Sep 2020
Gram-Negative Bacterial Infections	European Union	Qualicaps Netherlands BV	23 Apr 2020
Gram-Negative Bacterial Infections	Iceland	Qualicaps Netherlands BV	23 Apr 2020
Gram-Negative Bacterial Infections	Liechtenstein	Qualicaps Netherlands BV	23 Apr 2020
Gram-Negative Bacterial Infections	Norway	Qualicaps Netherlands BV	23 Apr 2020
Pyelonephritis	United States	Shionogi, Inc.	14 Nov 2019
Urinary Tract Infections	United States	Shionogi, Inc.	14 Nov 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hospital acquired bacterial pneumonia	Phase 3	United States	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Japan	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Belgium	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Canada	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Czechia	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Estonia	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	France	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Georgia	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Germany	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Hungary	Shionogi, Inc.	24 Oct 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05789199 (PERSEUS study, Pubmed \| Eur J Clin Microbiol Infect Dis)	Not Applicable	Gram-Negative Bacterial Infections	261	Cefiderocol	zklxfgrysj(ndkzrsgvcc) = bqytgdklui xjdpjvgedq (utjbxetggq ) View more	Positive	25 Mar 2025
NCT05789199 (PERSEUS study, Pubmed \| Eur J Clin Microbiol Infect Dis)	Not Applicable	Chronic Kidney Diseases Gram-negative bacteria	-	Cefiderocol (Stenotrophomonas maltophilia)	jztnxiiptg(vltbryvkmy) = uvjjyjkxml jjewkzfyqq (kpkkrujbjf )	Positive	24 Mar 2025
				Cefiderocol (Burkholderia cepacia complex)	jztnxiiptg(vltbryvkmy) = voujqxlnzc jjewkzfyqq (kpkkrujbjf )
NCT05395104 (CTgov)	Phase 1	-	14	Cefiderocol+Midazolam	bgwafgniwh(mujivhlmuc) = yioyoxmubm wqsalmnbop (fvxcaaeefo, 45.3) View more	-	14 Dec 2023
NCT03032380 (APEKS-NP, Pubmed) Manual	Phase 3	Healthcare-Associated Pneumonia	-	Linezolid+Cefiderocol	inmtzoxwut(vxcidtxmri) = hafmudmpbm mzhdaiidqh (svfykrcnjc ) View more	Non-inferior	13 Jan 2022
				Linezolid+meropenem	inmtzoxwut(vxcidtxmri) = vwqiukkowe mzhdaiidqh (svfykrcnjc ) View more
NCT02714595 (CREDIBLE-CR, Pubmed \| Lancet Infect Dis) Manual	Phase 3	Infectious Diseases	152	cefiderocol	rnzvbhausy(kswirjduxe) = nbsdbkafrm zijcatxtlt (rkhfddbzrh, 23.2 - 65.5) View more	Similar	01 Feb 2021
				best available therapy	rnzvbhausy(kswirjduxe) = jelemznove zijcatxtlt (rkhfddbzrh, 17.7 - 71.1) View more
NCT03032380 (APEKS-NP, CTgov)	Phase 3	Hospital acquired bacterial pneumonia \| Ventilator associated bacterial pneumonia	300	Cefiderocol+Linezolid (Cefiderocol)	vhgisymfjr = ujgcqwrjst hqlxhyukzg (uvuiwbsxsi, lfgbcgiqrb - rsivyzqhyl) View more	-	13 Nov 2020
				Meropenem+Linezolid (Meropenem)	vhgisymfjr = qtpmuzfuzp hqlxhyukzg (uvuiwbsxsi, zyyoxdveis - ujhpclsbpm) View more
NCT03862040 (CTgov)	Phase 1	Pneumonia, Bacterial	7	Standard of Care Antibiotic+Cefiderocol	dxklxhxgcs(spzxobenpr) = rjqkedlmzd awjpssoopl (jzyvonkcmr, tmfqxugvts - sszrczvdue) View more	-	05 Nov 2020
NCT02321800 (Pubmed) Manual	Phase 2	Urinary Tract Infections Gram-negative	452	Cefiderocol	nyagayeuls(waafgycuvx) = jpixtolhoy laobgralrn (uhjubecaau ) View more	Positive	01 Dec 2018
				imipenem-cilastatin	nyagayeuls(waafgycuvx) = dmvlcmhsaj laobgralrn (uhjubecaau ) View more

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