ProteLight files for HKEX listing with world's first NDA-approved FIC gana-based drug

NewTimeSpace News: On 31 August 2026, ProteLight Pharmaceuticals (Jiangsu) Co., Ltd. filed its listing application with the Hong Kong Stock Exchange, with CITIC Securities acting as the sole sponsor. The Company is an antimicrobial peptide (AMP) biopharmaceutical company founded in April 2009, focusing on two core therapeutic areas of anti-infection and metabolic diseases.

PL-5 (Pelaiganan, brand name Puyike), the core product, is a topical spray for the treatment of secondary infections of first-degree or superficial second-degree burn wounds caused by Staphylococcus epidermidis, Staphylococcus haemolyticus or Acinetobacter baumannii, and diabetic foot infections (DFI). According to Frost & Sullivan, PL-5 is the world's first first-in-class (FIC) gana-based drug to have obtained approval of a new drug application (NDA), and it received NDA approval from the National Medical Products Administration in June 2026 for the treatment of secondary infections of burn wounds. Based on the "membrane discrimination mechanism" theory first jointly proposed by the founders in 2006, PL-5 represents a new mechanism of action in which the peptide's secondary structure folds to disrupt the integrity of microbial membranes, addressing the challenges associated with antibiotic resistance. The product has been consecutively selected for the National "Major New Drug Creation" science and technology major projects during the 12th and 13th Five-Year Plan periods.

The Company plans to seek additional indications for secondary infections of other types of wounds, such as DFI and infections of wounds caused by physical trauma, through further clinical trials in China. The pipeline also includes PL-3301, a thermosensitive peptide gel for the treatment of oropharyngeal candidiasis (OPC), and PL-18, an AMP drug for the treatment of vulvovaginal candidiasis (VVC) and potentially a range of gynaecological infections, and is being extended to therapeutic areas including metabolic diseases, oncology and autoimmune diseases. Among them, the preclinical asset PL-MD-333 is an oral FGF19/FGF21 inducer and lipid metabolism modulator; preclinical studies have shown that it reduces fat mass, increases lean muscle mass percentage, and exhibits synergistic effects when used in combination with GLP-1 receptor agonists such as semaglutide.

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.