Sino Biopharmaceutical Limited (SBP GROUP; HKEX: 01177) announced that its core subsidiary, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), has obtained marketing approval from China’s National Medical Products Administration (NMPA) for Peceleganan Spray (trade name: 普亦克®). The product is indicated for treating wound infections secondary to first-degree or superficial second-degree burns and scalds caused by Staphylococcus epidermidis, Staphylococcus haemolyticus and Acinetobacter baumannii.
Peceleganan is the world’s first Ganan-class anti-infective agent and China’s first of its class to be recognised by the World Health Organisation (WHO). Developed as a broad-spectrum antimicrobial peptide, the drug disrupts bacterial biofilms and demonstrates potent activity against drug-resistant pathogens, including MRSA and NDM-1-positive Acinetobacter baumannii. Its novel “Membrane Discrimination Mechanism” underpins its bactericidal action while minimising the risk of inducing antibiotic resistance.
Regulatory approval was chiefly supported by two pivotal late-stage trials: • Phase IIIa (secondary wound infections, including burns, scalds, injuries and diabetic foot): clinical response rate of 90.40% for 2‰ Peceleganan Spray versus 78.70% for 1% silver sulfadiazine cream (p = 0.0006). • Phase IIIb (burn and scald infections): complete healing rate of 64.30% for Peceleganan versus 43.10% for the control group (p = 0.0002).
Pharmacological assessments showed sustained local drug concentration and prolonged antibacterial activity independent of microcirculatory status, with MIC values against resistant and susceptible strains remaining comparable. The spray formulation enables uniform, painless application across irregular wounds, reducing mechanical trauma and cross-contamination risks.
In January 2023, CTTQ entered a strategic partnership with ProteLight Pharmaceuticals, acquiring exclusive commercialisation rights for Peceleganan within China. Leveraging CTTQ’s nationwide distribution and academic promotion capabilities in anti-infectives, both parties aim to expedite patient access to the newly approved therapy.
The product’s development received consecutive designations under China’s 12th and 13th Five-Year Plan National Major Scientific and Technological Special Project for “Significant New Drugs Development,” underscoring its strategic importance in addressing antimicrobial resistance and unmet clinical needs in wound care.