Zai Lab and Pfizer have entered a partnership to commercialize XACDURO (sulbactam-durlobactam) in mainland China, addressing the rising threat of drug-resistant infections caused by carbapenem-resistant Acinetobacter baumannii (CRAB). With Pfizer’s robust infrastructure and Zai Lab’s innovative drug development, this collaboration aims to expedite access to this life-saving therapy, especially for critically ill patients.

The collaboration grants Pfizer’s affiliated companies exclusive rights to commercialize XACDURO in mainland China through November 2028. The drug has been approved by the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) for treating adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by CRAB.

Critical need for CRAB-targeted treatment

CRAB is a top-tier health concern globally, recognized by the World Health Organization as part of its Critical Group category for bacterial priority pathogens. In China, it represents the leading cause of deaths related to antimicrobial resistance, with nearly 300,000 reported isolates in 2022. These infections are notoriously difficult to treat due to limited therapeutic options and high resistance levels.

Zai Lab’s Chief Operating Officer, Josh Smiley, highlighted the urgency of addressing CRAB infections, citing alarming resistance rates of approximately 74% to carbapenem antibiotics in China. He emphasized that the collaboration with Pfizer will accelerate access to XACDURO, potentially reducing mortality rates among critically ill patients.

What makes XACDURO innovative?

Developed by Entasis Therapeutics, an affiliate of Innoviva Specialty Therapeutics, XACDURO is a combination of sulbactam, a β-lactam antibiotic, and durlobactam, a β-lactamase inhibitor (BLI). This unique pairing directly targets carbapenem-resistant Acinetobacter baumannii, offering a much-needed alternative to outdated therapies like colistin.

The drug’s approval in China was supported by data from the global ATTACK trial, a Phase 3 registrational study comparing XACDURO to colistin. Results showed that XACDURO was non-inferior in reducing 28-day all-cause mortality but significantly outperformed colistin in clinical cure rates. It also demonstrated a favourable safety profile, addressing critical gaps in treatment standards for CRAB.

Pfizer’s expertise in anti-infectives

Pfizer China’s President, Jean-Christophe Pointeau, underscored the company’s long-standing commitment to combating microbial infections. He noted that the partnership with Zai Lab aligns with Pfizer’s mission to reduce the global disease burden and supports China’s “Healthy China” initiative.

Global collaboration with local impact

Zai Lab’s role extends beyond China, holding exclusive development and commercialization rights for XACDURO across Greater China, Southeast Asia, and other Asia-Pacific regions, including Australia and New Zealand. This positions the drug as a potential cornerstone in the global fight against CRAB infections.

The collaboration not only strengthens Pfizer’s portfolio in anti-infectives but also exemplifies how pharmaceutical partnerships can address public health crises. With its targeted approach to a critical bacterial threat, XACDURO is poised to significantly impact the treatment landscape for drug-resistant infections.

  Acinetobacter baumannii, China, CRAB, Pfizer, XACDURO, Zai Lab