China's National Medical Products Administration (NMPA) accepted a new drug application (NDA) on 8 July for Evopoint Biosciences's imipenem + cilastatin + funobactam (XNW4107), the first β-lactam/β-lactamase inhibitor combination active against all three World Health Organization (WHO)-critical carbapenem-resistant organisms: Acinetobacter baumannii (CRAB), Enterobacteriaceae (CRE) and Pseudomonas aeruginosa (CRPA). The submission is based on positive Phase III results (n=450), where XNW4107 demonstrated superior 14-day survival rates and microbial eradication versus imipenem in hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP).

XNW4107's broad-spectrum activity addresses a critical gap in antimicrobial resistance, as carbapenem-resistant infections cause over 1 million deaths annually. Evopoint's candidate showed favourable safety in the clinic and has the potential to become the only therapy covering all three WHO-priority pathogens in HABP/VABP. The drug was developed under China's Major New Drug Innovation program.