Zai Lab and Pfizer to market XACDURO in China

Zai Lab and Pfizer have formed a strategic alliance to distribute the new antibacterial drug XACDURO (sulbactam-durlobactam) in mainland China. This collaboration aims to leverage Pfizer's extensive commercial network in the region, with the goal of enhancing patient access to this vital therapy. The agreement is set to run until November 2028, unless terminated or extended.

Under this partnership, Pfizer's affiliated companies will have exclusive rights to carry out commercialization activities for XACDURO. Notably, XACDURO is the only antimicrobial agent specifically designed to treat carbapenem-resistant Acinetobacter baumannii (CRAB), a bacteria included in the World Health Organization's critical group of priority pathogens list in 2024.

Josh Smiley, Zai Lab's chief operating officer and president, emphasized the gravity of drug resistance, highlighting its associated high clinical mortality rates and poor outcomes for critically ill patients. He noted that Zai Lab played a crucial role in the development of XACDURO, leading to its approval in China earlier this year. By partnering with Pfizer, they aim to expedite the availability of this innovative treatment to Chinese patients, potentially saving many lives.

XACDURO, developed by Entasis Therapeutics, is a combination of sulbactam, a β-lactam antibiotic, and durlobactam, a β-lactamase inhibitor. The U.S. Food and Drug Administration (FDA) approved the drug in 2023, followed by China's National Medical Products Administration (NMPA) approval in 2024. These approvals cover the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

Zai Lab possesses exclusive rights from Entasis Therapeutics to develop and commercialize XACDURO in a wide array of Asian territories, including Korea, Greater China, Vietnam, and other Southeast Asian countries, as well as Australia, New Zealand, and Japan.

Jean-Christophe Pointeau, president of Pfizer China, stated that Pfizer has been actively involved in the anti-infective therapeutic area for many years. The company has a longstanding commitment to tackling the challenges posed by various microbial infections, including bacterial, fungal, and viral infections, aiming to alleviate the disease burden on patients. Pointeau highlighted that the partnership with Zai Lab will enable the two companies to address the escalating problem of drug resistance in treating Acinetobacter baumannii. This collaboration is a testament to the evolving productive capacities within pharmaceutical companies, contributing to the goals of the Healthy China initiative.

In summary, the collaboration between Zai Lab and Pfizer represents a significant step forward in the fight against drug-resistant infections in China. By combining their strengths, the two companies aim to make XACDURO more accessible to patients in need, ultimately improving health outcomes and reducing the impact of CRAB-related infections.