OSAKA, Japan, November 11, 2026 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced today that it has entered into a license agreement (the “Agreement”) with Link Healthcare Singapore Pte Ltd (“Link”), headquartered in Singapore, for the development and market development of cefiderocol, a treatment for Gram-negative bacterial infections discovered by Shionogi, in Singapore and Malaysia.
In March 2025, Shionogi entered into a license agreement with Link Medical Products Pty Ltd, which, like Link, is part of Clinigen, for the development and market development of cefiderocol in Australia and New Zealand, and the companies have since been collaborating to make cefiderocol available in these markets1. Through this new Agreement, Shionogi is expanding its collaboration with Clinigen to Singapore and Malaysia, with the aim of making cefiderocol available to patients in both countries as a new treatment option, while promoting the appropriate use of antibiotics.
Under the terms of the Agreement, Link will obtain exclusive rights to develop and launch cefiderocol in Singapore and Malaysia. Link will be responsible for regulatory submissions, obtaining marketing approvals, and in-market activities in both countries. Under the terms of the Agreement, Shionogi will receive payments from Link in connection with the development and supply of cefiderocol.
Shionogi has identified “Protect People from the Threat of Infectious Diseases” as one of its material issues and is advancing initiatives toward the realization of total care for infectious diseases. Shionogi remains committed to addressing antimicrobial resistance (AMR), a global public health challenge, and to delivering the infectious disease treatments needed to protect people’s health to patients around the world.
About Cefiderocol
Cefiderocol is an antibiotic that effectively penetrates the outer membrane of Gram-negative bacteria, including multidrug-resistant strains, and exerts antibacterial activity. Cefiderocol is commercially available in multiple countries and regions, including Japan, the United States, Europe, Taiwan, and South Korea. Cefiderocol is included in the WHO Model List of Essential Medicines and plays an important role globally as a treatment option for infections caused by antimicrobial-resistant bacteria. In addition, multiple observational studies evaluating the effectiveness and safety of cefiderocol in real-world settings among critically ill patients with infections caused by antimicrobial-resistant bacteria have reported favorable outcomes2-5. Shionogi is also working to improve access to cefiderocol for patients in need in many low- and middle-income countries through a three-party collaboration agreement with the Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI)6.
About Antimicrobial Resistance (AMR)
Antimicrobial resistance (AMR) occurs when bacteria develop resistance to antibiotics, making these medicines less effective. Often referred to as a “silent pandemic,” AMR is one of the major global public health threats facing humanity and an urgent global challenge that requires immediate action7. In 2021, an estimated 1.14 million deaths worldwide were attributable to AMR8. Furthermore, without coordinated global action, AMR is projected to result in more than 39 million deaths by 20509.
For more information about Shionogi’s efforts to address AMR, please visit Address the problem of antimicrobial resistance (AMR).
About Link Healthcare Singapore Pte Ltd
For almost 30 years, LINK Healthcare, part of Clinigen, has been a trusted partner to healthcare professionals, hospitals, pharmaceutical and biotechnology companies across the APAC region. Providing specialised services across the product lifecycle, from clinical development through to launch and lifecycle management, LINK enables ethical and compliant access to registered and unregistered medicines.
About Clinigen
Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its mission is to accelerate access to medicines for patients in every corner of the globe. The Group supports pharmaceutical and biotech companies across the medical product lifecycle, from clinical through to commercial and operates from sites in North America, Europe, Africa and the Asia Pacific. Clinigen has more than 1,100 employees across five continents in 15 countries and provides access in more than 130 countries every year.
For more information on Clinigen, please visit http://www.clinigen.com.
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.
References:
1. Press release on April 2, 2025
2. Press release on April 19, 2024
3. Press release on October 16, 2024
4. Press release on October 20, 2025
5. Press release on October 21, 2026
6. Press release on June 15, 2022
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. https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance
For Further Information:
SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html