Shionogi has been awarded a major US government contract to scale domestic manufacturing and expand the use of its antibiotic cefiderocol to combat antimicrobial resistance and high-priority biothreat pathogens.
Shionogi & Co., has secured a federal contract aimed at strengthening the United States’ preparedness against antimicrobial resistance and biological threats. Through its US subsidiary, Shionogi Inc., the company was awarded funding under Project BioShield, managed by the Biomedical Advanced Research and Development Authority. The agreement is initially valued at $119 million, with the potential to reach up to $482 million over multiple years. The funding will support a range of initiatives designed to enhance national health security, including establishing U.S.-based manufacturing for the antibiotic, cefiderocol (Fetroja), increasing procurement, and advancing its use against dangerous Gram-negative bacterial infections.
“This contract complements our existing work with the US government and enables us to advance our ongoing expansion efforts in the US at greater pace and scale,” Shionogi President and CEO Nathan McCutcheon said in a statement.
A key component of the contract is the development of domestic pharmaceutical production capacity. By building a US manufacturing site for cefiderocol, the initiative aims to reduce reliance on international supply chains and ensure rapid access to critical treatments during public health emergencies. The contract also supports efforts to expand cefiderocol’s clinical applications, including its potential use against high-priority biothreat pathogens such as Burkholderia pseudomallei, which causes melioidosis, and Yersinia pestis, the bacterium responsible for plague.
The U.S. government is investing up to $482 million to strengthen antibiotic supply chains and biothreat readiness through Shionogi.
Domestic manufacturing of Fetroja will enhance rapid response capabilities and reduce dependence on foreign production.
The contract expands efforts to combat antimicrobial resistance and develop treatments for high-risk pathogens, including those linked to potential bioterror threats.
In addition, Shionogi plans to pursue regulatory expansion for pediatric use of cefiderocol in treating hospital-acquired and ventilator-associated bacterial pneumonia. This effort will involve submitting a supplemental New Drug Application to the FDA, reflecting a broader push to address unmet needs in vulnerable patient populations.
The contract aligns with ongoing federal strategies to combat antimicrobial resistance, a growing global health threat. Programs like Project BioShield are designed to accelerate the development and availability of medical countermeasures against chemical, biological, radiological, and nuclear threats, underscoring the importance of partnerships between government agencies and pharmaceutical companies.
Shionogi’s continued investment in antimicrobial innovation, including previous acquisitions and research expansions, highlights its long-term commitment to addressing drug-resistant infections. With cefidercocol already approved in the US for serious infections such as hospital-acquired bacterial pneumonia and complicated urinary tract infections, this new contract further positions the company as a key player in global infectious disease preparedness.
