The novel drug Peilaijianan Spray, developed through an exclusive collaboration by the group's subsidiary, Zhengda Tianqing Pharmaceutical Group Co., Ltd., has received marketing approval from China's National Medical Products Administration (NMPA).
Designated for treating secondary wound infections from first-degree or superficial second-degree burns and scalds caused by Staphylococcus epidermidis, Staphylococcus haemolyticus, and Acinetobacter baumannii, Peilaijianan is a globally pioneering antimicrobial agent from the Jianan class.
This broad-spectrum polypeptide drug combats bacteria by disrupting the barrier function of bacterial biofilm systems, utilizing a "cell membrane differentiation mechanism" for its unique bactericidal action. It demonstrates potent efficacy against various drug-resistant bacteria, including MRSA (Methicillin-resistant Staphylococcus aureus) and NDM-1 gene-containing multidrug-resistant Acinetobacter baumannii.
The drug received support from China's national "Major New Drug Innovation" science and technology projects during the 12th and 13th Five-Year Plan periods and is the first drug of the Jianan class to receive a name from the World Health Organization (WHO).
The NMPA approval is primarily based on results from several pivotal clinical studies. A Phase IIIa study showed that for patients with secondary wound infections from burns, physical injuries, or diabetic foot infections (DFI), the clinical effective rate one day after the final dose was 90.4% in the test group (2‰ Peilaijianan Spray) versus 78.7% in the positive control group (1% silver sulfadiazine cream).
A Phase IIIb study focusing on secondary wound infections from burns and scalds reported a complete wound healing rate one day post-final dose of 64.3% in the test group compared to 43.1% in the control group, indicating significantly superior efficacy for the test group.
Furthermore, Peilaijianan maintains a high, sustained local antibacterial concentration unaffected by impaired wound microcirculation or vascular embolism, enabling deep clearance of drug-resistant bacteria in wounds. Multiple strain studies confirm its broad-spectrum antibacterial activity, with comparable Minimum Inhibitory Concentration (MIC) levels against both sensitive and resistant strains.
As a non-antibiotic agent, it carries an extremely low risk of inducing antibiotic-like resistance and exhibits no cytotoxicity to new granulation tissue, demonstrating a favorable safety profile. The spray formulation allows for uniform coverage of various irregular, complex wounds, offering advantages such as pain-free application, precise dosing, and effective avoidance of mechanical damage and cross-contamination risks associated with repeated topical applications.
In January 2023, Zhengda Tianqing entered a strategic collaboration with Puli Pharmaceutical, securing exclusive commercial rights for Peilaijianan in China. Leveraging Zhengda Tianqing's established nationwide distribution network and professional academic promotion capabilities in the anti-infective field, the partners aim to expedite patient access to this innovative treatment for secondary wound infections.