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pp-211

Cutaneous spray

Dossier type
CTD
Dossier status
Under development
Country of origin
China
GMP approvals
China
Unavailable markets
China
Comments
"Indication: Secondary wound infections in diabetic foot ulcers (Wagner Grade 2), burns, and traumatic wounds Clinical stage: Phase 3 completed — confirmatory Phase 3 results published (570 patients, 37 China hospitals) Modality: Biological (novel antimicrobial peptide — NBE) Mechanism / Target: Broad-spectrum antimicrobial peptide (AMP); disrupts bacterial cell membrane integrity via electrostatic membrane binding and pore formation; bactericidal against resistant gram-positive and gram-negative organisms (including MRSA, MDR-GN) in complex wounds Route / form: Topical spray Differentiation: Novel antimicrobial peptide with superior efficacy over traditional antibiotics for drug-resistant wound pathogens; Phase 3 confirmatory results published; addresses critical unmet need in diabetic foot/MDR wound infections;
Manufacturer #39348

National high-tech biopharmaceutical enterprise established in 2009, specializing in Rx peptide drugs and PROTAC-based targeted protein degrader development and manufacturing. Portfolio spans injectable and solid dosage form products for oncology and bacterial infections. Advances a targeted degrader and peptide pipeline with a global regulatory strategy.

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