pp-081 Injection

Indication: Severe infections caused by multidrug-resistant Gram-negative pathogens, including carbapenem-resistant Acinetobacter baumannii, Pseudomonas aeruginosa, Klebsiella pneumoniae, and other carbapenem-resistant Enterobacterales. Clinical stage: U.S. Phase 1 completed (2022); China Phase 1 completed (2024). Modality: Small-molecule antibacterial (novel polymyxin class). Mechanism / Target: Disruption of Gram-negative bacterial outer-membrane integrity through interaction with lipopolysaccharides, consistent with polymyxin-class activity while engineered for improved therapeutic index. Route / form: Intravenous formulation. Differentiation: Designed to overcome toxicity and efficacy limitations of legacy polymyxins; optimized to retain activity against highly drug-resistant Gram-negative organisms; backed by a national strategic new-drug development initiative;