Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a China-based biopharmaceutical company, in collaboration with US partner Innoviva Specialty Therapeutics, has announced the marketing approval of Sulbactam-Durlobactam (SUL-DUR) by China’s National Medical Products Administration (NMPA). The novel intravenous combination antibiotic is now approved for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by sensitive strains of Baumann calcium acetate Acinetobacter complex in patients aged 18 and above.
The approval follows the positive results from the global Phase III ATTACK study, which demonstrated that SUL-DUR showed statistical non-inferiority compared to polymyxin E in the 28-day all-cause mortality rate among patients with carbapenem-resistant Acinetobacter infection, the primary endpoint of the study. Additionally, the product showed a significant improvement in clinical cure rates and exhibited good tolerability and safety.
Zai Lab had entered into a licensing agreement with Entasis Therapeutics Holdings, an affiliate of Innoviva, in April 2018, securing exclusive development and commercialization rights for the product in the Asia-Pacific region. Prior to this, SUL-DUR received marketing approval in the US in May 2023 for the treatment of HABP/VABP caused by sensitive isolates of Baumann calcium acetate Acinetobacter complex in patients aged 18 years and above.- Flcube.com
