NMPA (China) approval for Xacduro (sulbactam-durlobactam) (or SUL-DUR) for hospital-acquired and ventilator-associated pneumonia caused by acinetobacter baumannii-calcoaceticus complex in China

The World Health Organization considers Acinetobacter a top-priority pathogen worldwide that needs novel antibiotics.

The NMPA approval of Xacduro in China is based on positive results from the ATTACK trial (NCT03894046), a global, Phase III registrational trial evaluating the safety and efficacy of Xacduro versus colistin in patients with infections caused by A. baumannii. In the pivotal study, Xacduro demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a statistically significant improvement in clinical cure rates. Xacduro was well tolerated and exhibited a favorable safety profile across the clinical program. Zai Lab participated in the global ATTACK study by enrolling patients in China. The Chinese patient cohort data confirm the findings of the global study regarding mortality and clinical response improvement.

In May 2023, Innoviva Specialty Therapeutics announced that the FDA approved Xacduro for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex – the first such FDA-approved pathogen-targeted therapy.