On June 22, the official website of the National Medical Products Administration (NMPA) showed that the world's first-in-class (FIC) Ganan-class anti-infective drug, Peceleganan Spray (Puyike^®), has been approved for marketing in China for the treatment of secondary wound infections in first-degree or superficial second-degree burns caused by Staphylococcus epidermidis, Staphylococcus haemolyticus, and Acinetobacter baumannii. Sino Biopharm's (1177.HK) core enterprise, Chia Tai Tianqing, reached a collaboration agreement with ProteLight Pharmaceuticals in 2023, obtaining exclusive commercialization rights for it in China. 

New Mechanism Ganan-Class Peptide, an Innovative Non-Antibiotic Therapy

Secondary wound infection refers to open wound infections caused by various bacteria, including diabetic foot, pressure ulcers, and burns. With the use of traditional antibiotics, the proportion of drug-resistant bacteria is increasing, which has become a serious clinical concern. The continuous evolution of antibiotic drug resistance requires systemic antibacterial treatment, especially local antibacterial treatment for the site of infection. 

Peceleganan is a broad-spectrum peptide antibacterial drug that exerts its effect by disrupting the barrier function of the bacterial biofilm system. Applying the "cell membrane differentiation mechanism" theory, it has a unique bactericidal mechanism and shows strong bactericidal advantages against various drug-resistant bacteria, including the superbug methicillin-resistant Staphylococcus aureus (MRSA) and NDM-1 gene-containing multidrug-resistant Acinetobacter baumannii. It has received support from the national "12th Five-Year" and "13th Five-Year" "Major New Drug Creation" science and technology major projects and is the first Ganan-class anti-infective drug in China to be named by the World Health Organization (WHO). 

Comprehensive Superiority in Clinical Data, Convenient Operation with Spray Formulation

The current approval of Peceleganan for the treatment of secondary wound infections in burns is based on the results of multiple pivotal clinical studies. A Phase IIIa clinical study showed that for patients with secondary wound infections such as burns, physical injuries, and diabetic foot infections (DFI), the clinical response rates on Day 1 after the last dose were 90.4% for the investigational group (2‰ Peceleganan spray) vs 78.7% for the positive control group (1% sulfadiazine silver cream) (p=0.0006). A Phase IIIb clinical study showed that for patients with secondary wound infections in burns, the complete wound healing rates on Day 1 after the last dose were 64.3% for the investigational group vs 43.1% for the control group (p=0.0002), with the efficacy of the investigational group being significantly superior to the control group ^[1,2]. 

In addition, Peceleganan can maintain a high local concentration for a sustained effect, unaffected by wound microcirculation disorders or vascular embolism, and can deeply clear drug-resistant bacteria from the wound. Multiple strain experiments have confirmed that Peceleganan has a broad-spectrum antibacterial effect, with comparable minimum inhibitory concentrations (MIC) for both sensitive and drug-resistant strains. As a non-antibiotic drug, it has a very low risk of inducing antibiotic resistance, shows no cytotoxicity to newly formed granulation tissue, and has a favorable safety profile. Meanwhile, the spray formulation can evenly cover various irregular and complex wounds, is painless to operate, provides precise dosage, and avoids mechanical injury and cross-pollution from repeated application and contact with the wound. 

In January 2023, Chia Tai Tianqing and ProteLight Pharmaceuticals reached a strategic cooperation, obtaining exclusive commercialization rights for Peceleganan in China. Chia Tai Tianqing will leverage its mature national commercialization channels, professional academic promotion team, and strong brand influence in the anti-infective field to provide this innovative therapy to patients with secondary wound infections as soon as possible, accelerating the accessibility of the innovative Peceleganan therapy. 

References:

[1] Wei Y, Wu J, Chen Y, et al.Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections: A Phase IIb Randomized Clinical Trial.Annals of Surgery 2023, 277, 43-49 .

[2] Wei Y, Li Y, et al.Peceleganan Spray for the Treatment of Skin Wound Infections: A Randomized Clinical Trial.JAMA Network Open.2024,7(6),e2415310.

Declaration:

1. This press release is intended to facilitate the communication and exchange of medical information and is for reference by healthcare professionals only. It is not for advertising purposes. 

2. The company does not recommend any drugs and/or indications. 

3. The information contained in this press release is for reference only and cannot replace professional medical guidance in any way, nor should it be considered as a diagnosis or treatment recommendation. If you wish to understand specific disease diagnosis and treatment information, please follow the advice or guidance of a physician or other healthcare professional. 

Forward-Looking Statements:

This press release contains certain forward-looking statements, including statements regarding the clinical development plan, expectations of clinical benefits and advantages, commercialization outlook, the likelihood of clinical benefit for patients, and potential commercial opportunities for [Peceleganan Spray]. Words such as "expect", "believe", "continue", "may", "estimate", "hope", "intend", "plan", "potential", "predict", "project", "should", "will", "propose", and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words. These forward-looking statements are predictions or expectations made by the company based on currently available data and information, and actual results may differ materially from these forward-looking statements due to uncertainties or risks such as policy, R&D, market, and regulatory factors. Current or potential investors are advised to carefully consider the potential risks and should not place undue reliance on the forward-looking statements in this press release, which contain information only as of the date of this press release. Unless required by law, the company undertakes no obligation to update or revise any forward-looking statements in this press release as a result of new information, future events, or other circumstances. 

Source: ProteLight Official WeChat Account