China-based biopharmaceutical company Zai Lab has teamed up with US drugmaker Pfizer for the commercialisation of its antibacterial drug Xacduro in mainland China.
Xacduro (sulbactam-durlobactam) is an intravenous drug developed by Entasis Therapeutics, an affiliate of Innoviva Specialty Therapeutics.
Zai Lab obtained an exclusive license to develop and commercialise Xacduro in Greater China, including mainland China, Hong Kong, Taiwan and Macau.
The licence from Entasis Therapeutic also includes Korea, Vietnam, Thailand, Cambodia, Laos, Malaysia, Indonesia, the Philippines, Singapore, Australia, New Zealand and Japan.
Under the strategic collaboration, Pfizer’s affiliates will get exclusive rights to undertake certain commercialisation activities for Xacduro in mainland China.
The partnership is valid until November 2028, with the potential for early termination or extension.
It will allow Zai Lab to leverage Pfizer’s commercialisation infrastructure in the anti-infective therapeutic area to enhance access to Xacduro in mainland China.
Zai Lab president and chief operating officer Josh Smiley said: “Drug resistance is becoming increasingly serious, with high clinical mortality rate and poor prognosis in critically ill patients, resulting in a serious disease burden.
“According to recent surveillance data from China8, resistance of Acinetobacter baumannii to the carbapenem class of antibiotics has reached approximately 74%.
“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.”
According to Zai Lab, Xacduro is the only antimicrobial agent specifically developed for the treatment of carbapenem-resistant Acinetobacter baumannii (CRAB).
The drug was approved by the US Food and Drug Administration (FDA) last year, and China’s National Medical Products Administration (NMPA) this year.
It is indicated for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Acinetobacter baumannii-calcoaceticus complex.
The NMPA approval is based on positive results from the Phase 3 ATTACK registrational trial evaluating the safety and efficacy of Xacduro compared to colistin.
In the study, Xacduro showed statistical non-inferiority in 28-day all-cause mortality compared to colistin, and a statistically significant improvement in clinical cure rates.
Xacduro was well tolerated in the study and showed a favourable safety profile.
Pfizer China president Jean-Christophe Pointeau said: “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 reduce 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.”
