Clinigen and Shionogi CEOs meet for signing ceremony to reaffirm new strategic relationship and reinforce commitment to accelerating ethical patient access to antibiotic addressing antimicrobial resistance in Australia and New Zealand
LONDON, UK, 29 May 2025: Clinigen, the global specialty pharmaceutical services group, today highlights a key collaborative milestone with Shionogi, an impact-driven pharmaceutical company, marking the launch of their new strategic relationship. Clinigen CEO Jerome Charton met last week with Shionogi President and CEO Dr Isao Teshirogi at the Shionogi global headquarters in Osaka, Japan, for a ceremonial signing event to mark the progress following the exclusive licensing agreement for cefiderocol announced by Shionogi in April.
The agreement grants Clinigen's Australian subsidiary, Link Medical Products Pty Ltd, the exclusive rights for the development and commercialisation of cefiderocol in Australia and New Zealand. Cefiderocol is not yet approved for use in Australia and New Zealand. The Therapeutic Goods Administration (TGA) regulatory authority in Australia accepted the market authorisation application for cefiderocol in December 2024 and the application is under evaluation [1].
Under the terms of the agreement, Clinigen will in-license cefiderocol from Shionogi and obtain exclusive rights for its development and commercialisation in Australia and New Zealand. Shionogi will receive an upfront payment, milestone payments based on development progress, and royalties from Clinigen.
The signing ceremony celebrated this new strategic relationship between the two companies and their shared commitment to expanding potential access to cefiderocol in Australia and New Zealand.
Jerome Charton, CEO of Clinigen, says: “Establishing a new strategic relationship with a respected innovator in impactful medicines like Shionogi is a pivotal moment for Clinigen. Our work together to potentially bring cefiderocol to Australia and New Zealand in the future enables us to support the broader response to growing antimicrobial resistance, while simultaneously building a valuable presence in the growing Asia Pacific market.”
Dr Isao Teshirogi, Shionogi President and CEO, comments: “Shionogi is committed to the research and development of innovative treatments for infectious diseases for the benefit of patients around the world, addressing urgent global health challenges such as antimicrobial resistance. We are pleased to initiate this new collaboration with Clinigen for cefiderocol in Australia and New Zealand to expand the access to cefiderocol for patients who can benefit from it. Clinigen’s established market presence makes them an ideal partner.”
This press release contains information about medicines that may not be approved in all territories. The intent of this press release is to share pertinent information with the investment community about this collaboration between Clinigen and Shionogi and does not constitute promotion of any medicines.
For media enquiries, please contact:
Fight or Flight on behalf of Clinigen
Email: clinigen@fightorflight.com
Notes for Editors:
About Cefiderocol
Cefiderocol is not yet approved for use in Australia and New Zealand.
The Therapeutic Goods Administration (TGA) regulatory authority in Australia accepted the market authorisation application for cefiderocol in December 2024 and the application is under evaluation [1]. Cefiderocol is listed on the World Health Organization's Essential Medicines List [2], and preparations are underway through a collaborative agreement with The Global Antibiotic Research and Development Partnership (GARDP) and Clinton Health Access Initiative (CHAI) to improve access to this antibacterial agent for patients in low- and middle-income countries [3].
About Shionogi
Headquartered in Osaka, Japan, Shionogi is a pharmaceutical company with a 147-year history of innovation and a strong commitment to public health. The company has identified “Protect people from the threat of infectious diseases” as one of its key material issues and is dedicated to researching and developing innovative treatments for infectious diseases. Shionogi aims to benefit patients worldwide and contribute to addressing urgent global health challenges, including antimicrobial resistance (AMR).
For more information on Shionogi, please visit Shionogi & Co., Ltd.
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
About Link Medical Products Pty Ltd
For almost 30 years, Link Healthcare, part of the Clinigen Group, has played a vital role in the Australasian healthcare landscape as a trusted partner providing ethical and compliant pathways to both registered and unregistered medicines. With a team of 58 employees, Link Healthcare offers specialised pharmaceutical services across the product lifecycle, from clinical through to commercial, supporting pharmaceutical and biotech companies and healthcare professionals to address unmet patient needs.
For more information on Link Healthcare, a Clinigen Company visit: https://www.linkhealthcare.com.au
[1] Shionogi Press release on December 3, 2024. Acceptance of a New Drug Application for the Gram-Negative Bacterial Infection Treatment, Cefiderocol, in Australia.
[2] WHO Model List of Essential Medicines - 23rd list, 2023. WHO Model List of Essential Medicines - 23rd list, 2023 Accessed: May 2025
[3] Shionogi Press release on June 15, 2022 Shionogi, GARDP and CHAI announce landmark license and collaboration agreements to treat bacterial infections by expanding access to cefiderocol in 135 countries.