Suzhou-based Evopoint Biosciences Co., Ltd. has announced the submission of a Pre-NDA (New Drug Application) for its Category 1 product, a combination of funobactam, imipenem, and cilastatin, to the National Medical Products Administration (NMPA). This product, once approved, is poised to become the world’s first β-lactam/β-lactamase inhibitor (BL/BLI) with a broad-spectrum and potent antibacterial activity against three major carbapenem-resistant Gram-negative bacteria (CRO).
Clinical Study Results Support Pre-NDA Filing
The filing is supported by the results of the XNW4107-302 study, which assessed the efficacy, safety, and tolerability of the drug in patients with hospital-acquired pneumonia and ventilator-associated pneumonia caused by Gram-negative bacterial infections. The study used Merck’s Recarbrio (imipenem, cilastatin, and relebactam) as a control and enrolled a total of 449 subjects. The results demonstrated that funobactam, imipenem, and cilastatin achieved non-inferiority in terms of the primary endpoint of all-cause mortality at day 14.
Addressing the Global Challenge of Antibacterial Resistance
Bacterial resistance is a significant global challenge to public health. Data from the China Antimicrobial Surveillance Network (CHINET) indicates that the detection rate of carbapenem-resistant Gram-negative bacteria remains high in China. Evopoint Biosciences is committed to tackling the issue of bacterial resistance and boasts XNW4107, designed to address the ineffectiveness of β-lactamase inhibitors against Escherichia coli (CRE), Pseudomonas aeruginosa (PA), and carbapenem-resistant Acinetobacter baumannii (CRAB).-Fineline Info & Tech
