Zai Lab and Pfizer to commercialise XACDURO in China

Zai Lab and Pfizer have entered a strategic collaboration to commercialise XACDURO (sulbactam-durlobactam), a new antibacterial drug, in mainland China.

The partnership will utilise Pfizer’s commercial infrastructure in the region to expedite patient access to the therapy. It will operate until November 2028 unless prematurely concluded or extended.

Pfizer’s affiliated companies have exclusive rights to undertake commercialisation activities for the drug.

XACDURO is the sole antimicrobial agent specifically developed to treat carbapenem-resistant Acinetobacter baumannii (CRAB).

The World Health Organization included CRAB in the critical group category of its list of bacterial priority pathogens in 2024.

Zai Lab chief operating officer and president Josh Smiley stated: “Drug resistance is becoming increasingly serious, with high clinical mortality rate and poor prognosis in critically ill patients, resulting in a serious disease burden.

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“Zai Lab was instrumental in the development of XACDURO, leading to its approval in China earlier this year. By joining forces with Pfizer, we seek to bring this innovative treatment to Chinese patients more quickly, saving the lives of those most at risk.”

XACDURO, developed by Entasis Therapeutics, combines sulbactam, a β-lactam antibiotic, with durlobactam, a β-lactamase inhibitor.

The drug received the US Food and Drug Administration (FDA) approval in 2023 and China’s National Medical Products Administration (NMPA) approval in 2024.

These approvals were intended for treating adults with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

Zai Lab holds an exclusive licence from Entasis Therapeutics for developing and commercialising XACDURO across a wide range of Asian territories, including Korea, Greater China, Vietnam and other Southeast Asian countries, Australia, New Zealand and Japan.

Pfizer China president Jean-Christophe Pointeau stated: “Pfizer has been deeply engaged in the anti-infective therapeutic area for many years. We have always been committed to addressing the challenges of multiple microbial infections, including bacterial, fungal as well as viral infections, and to reducing the burden of disease on patients.

“The collaboration with Zai Lab will help enable us to work together as we strive to address the growing problem of drug resistance in the treatment of Acinetobacter baumannii, and reflects the new quality productive forces in pharmaceutical companies, helping to achieve the goal of the Healthy China initiative.”