ProteLight：Peceleganan was approved
On June 22, the NMPA official website showed that the Category 1 new drug Peceleganan , filed by Protelight Pharma, was approved for marketing in China. The approved indication is for the treatment of superficial secondary wound infections, including those caused by burn and physical trauma, due to susceptible pathogens such as Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Staphylococcus haemolyticus, and Acinetobacter baumannii .
Peceleganan Spray (PL-5) is a First-in-class (FIC) Ganan-class anti-infective drug independently developed by Protelight Pharma with global intellectual property rights . As a non-antibiotic antimicrobial, it features a novel mechanism of action based on the “cell membrane differentiation theory,” making it the first Ganan-class anti-infective drug to receive a WHO international nonproprietary name (INN) .
The drug has a broad antibacterial spectrum, with potent activity against multidrug-resistant organisms, including MRSA and NDM-1-producing A. baumannii . It received support from China’s National Science and Technology Major Projects for “Major New Drug Development” during the 12th and 13th Five-Year Plan periods . Its clinical development was bolstered by a strategic partnership with Chia Tai Tianqing, which secured Greater China commercialization rights in January 2023 .
The approval is supported by two Phase III trials. Results published in JAMA Network Open showed the 2‰ Peceleganan spray achieved a clinical efficacy rate of 90.4% compared to 78.7% for the control group (p<0.001) . A separate Phase IIIb trial demonstrated a complete wound healing rate of 64.3% versus 43.1% for the control group (p=0.0002) .
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