China-based Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has revealed that a New Drug Application (NDA) for its sulbactam-durlobactam (SUL-DUR), a novel intravenous combination antibiotic used to treat patients with Acinetobacter infection (including multidrug-resistant and carbapenem-resistant strains), has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development and potential approval of this innovative antibiotic.
SUL-DUR: Drug Profile and Mechanism of Action
SUL-DUR consists of sulbactam, a broad-spectrum β-lactam drug against Acinetobacter baumannii, and durlobactam (formerly known as ETX2514), a new type of intravenously administered broad-spectrum A, C, and D β-lactamase inhibitor developed by Entasis. The drug targets infections caused by Acinetobacter baumannii calcium acetate complex (ABC), including multidrug-resistant and carbapenem-resistant strains. This combination offers a promising approach to treating challenging Acinetobacter infections.
Regulatory Milestones
The drug was awarded priority review status in the US, with a target finish date of May 29, 2023. In China, the drug was also awarded priority review status in January of this year, highlighting the urgent need for effective treatments against multidrug-resistant Acinetobacter infections.
Licensing Agreement and Market Expansion
Zai Lab struck a licensing deal with Entasis Therapeutics Holdings in April 2018, securing exclusive development and commercialization rights to the product in the Asia-Pacific region. This strategic move aims to accelerate the availability of SUL-DUR in the region, addressing significant unmet medical needs in the treatment of Acinetobacter infections.
Strategic Implications
The acceptance of the NDA for SUL-DUR by the NMPA is a strategic milestone for Zai Lab. It underscores the company’s commitment to advancing innovative treatments for infectious diseases and enhancing patient outcomes. By securing regulatory review in both the US and China, Zai Lab is well-positioned to bring this novel antibiotic to market, potentially improving the standard of care for patients with multidrug-resistant Acinetobacter infections.-Fineline Info & Tech
