Zai Lab Limited announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for sulbactam-durlobactam (SUL-DUR) for the treatment of infections caused by Acinetobacter baumannii, including multidrug-resistant and carbapenem-resistant (CRAB) strains. Priority review was established in China to encourage innovative drug development with significant clinical value and urgent clinical need. It is implemented under the Drug Registration Rules (Bureau Order 27) and the Working Procedure for Priority Review and Approval of Drug Marketing Authorization (Tentative, NMPA 2020 No.

82) effective on July 1, 2020 and July 7, 2020, respectively. According to these guidelines, the regulatory authority will prioritize the evaluation resources for applications under priority review to help reduce review and approval timelines. SUL-DUR is an intravenous, or IV, investigational drug developed by Entasis Therapeutics that is a combination of sulbactam, an IV ß-lactam antibiotic, and durlobactam, a rationally designed broad-spectrum IV ß-lactamase inhibitor, or BLI, being developed for the treatment of infections caused by ABC, including multidrug and carbapenem-resistant strains.

SUL-DUR has been designated a Qualified Infectious Disease Product by the FDA, a designation that aims to spur development of new antibiotics for difficult-to-treat infections. The FDA has accepted the SUL-DUR NDA for priority review with an action date of May 29, 2023. Zai Lab has an exclusive license to develop and commercialize SUL-DUR in Greater China (mainland China, Hong Kong, Taiwan and Macau), Korea, Vietnam, Thailand, Cambodia, Laos, Malaysia, Indonesia, the Philippines, Singapore, Australia, New Zealand and Japan.