Zai Lab and Pfizer have entered into a strategic partnership focusing on the cutting-edge antibacterial medication Xacduro (sulbactam-durlobactam) for the market in mainland China. This initiative grants Pfizer’s partner entities exclusive rights to undertake various commercialization tasks for Xacduro within this region. By joining forces, Zai Lab will take advantage of the robust marketing infrastructure of Pfizer’s affiliates specializing in anti-infective solutions to expedite patient access to this crucial medication in mainland China. This collaboration is set for imports through November 2028, subject to potential early termination or extension.
Xacduro stands out as the sole antimicrobial product specifically formulated to combat carbapenem-resistant Acinetobacter baumannii (CRAB). It has gained approval in both the United States and mainland China for treating adult patients suffering from hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by strains of the Acinetobacter baumannii-calcoaceticus complex that are vulnerable to it. The Centers for Disease Control and Prevention (CDC) classifies carbapenem-resistant organisms as a critical threat. In 2019, Acinetobacter baumannii ranked among the top six pathogens linked to fatal antibiotic resistance, with CRAB categorized in the WHO’s Critical Group of bacterial priority pathogens as of their 2024 listing. Acinetobacter baumannii was pinpointed as a leading cause of antibiotic-resistance-related fatalities in China based on the 2019 global disease burden study, with around 300,000 isolates documented in mainland China in 2022. Historically, therapeutic options for CRAB-infected HABP/VABP were sparse, and before Xacduro’s approval, an ideal treatment for CRAB was absent.
“The escalating issue of drug resistance accompanies a high mortality rate and poor recovery outcomes in seriously ill patients,” noted Josh Smiley, Zai Lab’s president and COO. “Our efforts in developing Xacduro culminated in its recent approval in China. Partnering with Pfizer will allow us to deliver this groundbreaking treatment to Chinese patients with greater speed, thereby saving lives.”
Jean-Christophe Pointeau, president of Pfizer China, emphasized: “We have long been committed to overcoming the complex challenge posed by bacterial, fungal, and viral infections to alleviate disease burdens on patients. Teaming up with Zai Lab underscores our resolve to address the pressing issue of drug resistance in treating Acinetobacter baumannii, symbolizing burgeoning productive forces in the pharmaceutical landscape aligned with the ‘Healthy China’ initiative.”
Manufactured by Entasis Therapeutics Inc., part of Innoviva Specialty Therapeutics, Xacduro (sulbactam-durlobactam) involves a blend of the ß-lactam antibiotic sulbactam and the ß-lactamase inhibitor durlobactam. Xacduro’s approvals by both the US FDA in 2023 and China’s NMPA in 2024 pertain to treating HABP/VABP in adults infected by specific Acinetobacter baumannii-calcoaceticus strains.
The NMPA’s green light followed successful outcomes from the ATTACK trial (NCT03894046), a global, phase 3 registry trial that tested Xacduro against colistin in dealing with A. baumannii infections. Xacduro demonstrated non-inferiority to colistin concerning 28-day all-cause mortality in CRAB patients and recorded notable improvement in clinical cure rates, with favorable tolerance and safety throughout the study. Zai Lab’s involvement in the ATTACK study within China contributed local patient data, reinforcing global findings on mortality and clinical enhancements.
Zai Lab holds exclusive licensing for developing and distributing Xacduro across Greater China (comprising mainland China, Hong Kong, Taiwan, and Macau), as well as Korea, Vietnam, Thailand, Cambodia, Laos, Malaysia, Indonesia, the Philippines, Singapore, Australia, New Zealand, and Japan from Entasis Therapeutics.
Based out of China and the US, Zai Lab focuses on discovering and commercializing transformative solutions for medical conditions with significant unmet needs in oncology, immunology, neuroscience, and infections.