SBP GROUP (01177): Peilaijian Spray Approved for Market Launch

SBP GROUP (01177) announced that its subsidiary, Zhen Dai Tian Qing Pharmaceutical Group Co., Ltd. ("Zhen Dai Tian Qing"), has received approval from the China National Medical Products Administration (NMPA) to market the Class 1 innovative drug Pei Lai Jia Nan Spray (trade name: Pu Ye Ke) for the treatment of I-degree or superficial II-degree burn secondary wound infections caused by Staphylococcus epidermidis, hemolytic Staphylococcus, and Acinetobacter baumannii. Pei Lai Jia Nan is the world's first nanobiotic antimicrobial drug, a peptide-based broad-spectrum antibiotic that acts by disrupting the barrier function of bacterial biofilm systems. It applies the "cell membrane compartmentalization mechanism" theory and has a unique bactericidal mechanism, providing strong bactericidal advantages against various drug-resistant bacteria including MRSA (Methicillin-resistant Staphylococcus aureus) and multidrug-resistant Acinetobacter baumannii containing the NDM-1 gene. It has received major special project support for "Major New Drug Development" in the 12th and 13th "Five-Year Plans" of the country and is the first nanobiotic antimicrobial drug named by the World Health Organization (WHO) in China. The approval of Pei Lai Jia Nan by the NMPA for marketing is mainly based on several key clinical research results. A phase IIIa clinical study showed that for patients with secondary wound infections such as burns, physical injuries, and diabetic foot infections, the clinical efficacy rates on the first day after the end of treatment were 90.4% vs. 78.7% (p=0.0006) for the experimental group (2% Pei Lai Jia Nan spray) compared to the positive control group (1% silver sulfadiazine cream). A phase IIIb clinical study showed that for patients with secondary wound infections from burns, the complete healing rates on the first day after the end of treatment were 64.3% vs. 43.1% (p=0.0002) for the experimental group compared to the control group, showing significantly better efficacy in the experimental group. In addition, Pei Lai Jia Nan can maintain high and long-lasting antibacterial activity locally, unaffected by microcirculation disorders or vascular occlusions in the wound, and can deeply eliminate drug-resistant bacteria in the wound. Studies on multiple strains have confirmed that Pei Lai Jia Nan has a broad-spectrum antibacterial effect, with similar minimum inhibitory concentration (MIC) levels for susceptible and resistant strains. As a non-antibiotic drug, the risk of antibiotic resistance induction is extremely low, and it has no cytotoxicity to new granulation tissue, demonstrating good safety. The spray form can achieve uniform coverage of various irregular and complex wounds, with the advantages of painless operation, precise dosage, and effective avoidance of mechanical damage and cross-contamination risks caused by repeated application. In January 2023, Zhen Dai Tian Qing reached a strategic cooperation agreement with Pray Pharmaceuticals to obtain exclusive commercialization rights for Pei Lai Jia Nan in China. Leveraging Zhen Dai Tian Qing's mature nationwide channel layout and professional academic promotion capabilities in the anti-infective field, the two parties will work together to quickly bring this innovative therapy to patients with secondary wound infections and improve its clinical accessibility.