New Stock Preview | Overcoming the challenge of antibiotic resistance, can Prolyse Pharmaceuticals' bid for a Hong Kong listing win a bet from the market?

Recently, Prolyse Pharmaceuticals submitted a listing application to the Main Board of the Hong Kong Stock Exchange, with CITIC SEC acting as the sole sponsor. This is the company's second filing, following its initial listing application submitted on February 13. Public information shows that since its establishment, the company has completed six rounds of financing from Pre-A to D+, raising a cumulative total of approximately RMB 787 million, with a post-investment valuation of RMB 2.505 billion. Participating institutions include PICC Science and Technology Innovation Fund and Yifeng Runjun, among others. It is understood that the company's core product, PL-5, is the world's first approved First-in-class (FIC) ganan-class anti-infective drug, having received marketing approval in June 2026. However, it has not yet generated commercialization revenue, and the company remains in a loss-making state. From a market prospect perspective, the problem of antibiotic misuse has long persisted, and as a rare polypeptide antibacterial drug globally, the commercialization prospects of the company's core product remain uncertain. Cumulative losses exceed RMB 300 million; core product not yet profitable Prolyse Pharmaceuticals was founded in April 2009 and is an antimicrobial peptide (AMP) therapeutic drug company focused on two core therapeutic areas: anti-infection and metabolic diseases. From a financial performance perspective, for the 2024 fiscal year, 2025 fiscal year, and the six months ended June 30, 2026, the company achieved revenue of approximately RMB 5.194 million, RMB 3.332 million, and RMB 2.192 million (RMB, same below), respectively, recorded gross profit of approximately RMB 2.174 million, RMB 1.308 million, and RMB 1.050 million, and incurred losses of approximately RMB 158 million, RMB 142 million, and RMB 85.240 million, respectively, for the periods. It is understood that all of the company's current revenue comes from daily care products. This daily care business is not the company's main business and serves only as a cash flow supplement during the R&D stage. Although the core innovative drug PL-5 has signed an exclusive cooperation agreement with Chia Tai Tianqing, it has not yet generated commercialization revenue. Although revenue in the first half of 2026 increased by 53.5% year-on-year, the overall scale of the daily care business remains relatively small, and its ability to support the company's overall operations is very limited. Changes in losses were affected by both R&D expenses and financing costs. The net loss in 2025 narrowed by 10.6% year-on-year, mainly because R&D expenses fell by 29.1% year-on-year after the core product PL-5 completed its NDA submission. The loss in the first half of 2026 expanded by 28.5% year-on-year, mainly due to a significant increase in financing costs caused by higher interest on equity repurchase liabilities, which eroded cash flow for the period. As of June 30, 2026, the company held only RMB 34.05 million in cash and cash equivalents, while net current liabilities had climbed to RMB 974 million. Both the current ratio and quick ratio were only 0.11, indicating insufficient short-term solvency. Net cash outflow from operating activities in the first half of 2026 was RMB 40.819 million. Based on the current burn rate, existing cash reserves can cover only about eight months of operations. Building a pipeline around antimicrobial peptides; antibiotic resistance poses a global challenge Prolyse Pharmaceuticals' R&D pipeline is built on the theory of a "membrane discrimination mechanism." Through novel peptide molecular design, antimicrobial peptides can precisely disrupt bacterial cell membranes without harming normal human cells. Compared with traditional antibiotics, antimicrobial peptides (AMPs) not only possess broad-spectrum antibacterial activity, but also retain killing efficacy against many bacterial strains that have developed resistance to conventional antibiotics. This characteristic addresses the most urgent clinical need in the current anti-infection field. With the widespread use of antibacterial drugs, the problem of pathogen resistance has become increasingly serious. Many pathogenic bacteria have developed multidrug resistance to traditional antibiotics, leading the World Health Organization to regard antimicrobial resistance as one of the top global public health threats of the 21st century. The WHO's "2025 Global Antimicrobial Resistance Surveillance Report" shows that in 2023, one in six laboratory-confirmed bacterial infections causing common infections worldwide was resistant to antibiotic treatment. Between 2018 and 2023, antibiotic resistance rose in more than 40% of monitored pathogen-antibiotic combinations, with an average annual increase of 5% to 15%. It is understood that Prolyse Pharmaceuticals' core product PL-5 (peilaiganan) is a product administered as a topical spray, used to treat secondary infections of first-degree or superficial second-degree burn and scald wounds (secondary burn wound infections) and diabetic foot infections (DFI) caused by Staphylococcus epidermidis, Staphylococcus haemolyticus, or Acinetobacter baumannii. It is the world's first First-in-class (FIC) ganan-class drug to receive New Drug Application (NDA) approval. Previously, PL-5 has demonstrated encouraging efficacy and safety, showing activity against multiple multidrug-resistant pathogens. Clinical data indicate that PL-5 can completely eradicate resistant bacteria in several cases, including Pseudomonas aeruginosa, Acinetobacter baumannii, methicillin-resistant Staphylococcus aureus, and multidrug-resistant Acinetobacter baumannii carrying the NDM-1 gene. According to WHO data, these are among the most clinically challenging resistant pathogens globally. The company has completed a Phase III clinical trial of PL-5 for secondary wound infections in China and obtained NDA approval in June 2026, making it a First-in-class ganan-class anti-infective drug. At the same time, the company is conducting a Phase II clinical trial in the United States, seeking to expand the indication to diabetic foot infections, which is expected to be completed by the third quarter of 2028. In terms of commercialization arrangements, PL-5 entered into an exclusive commercial cooperation agreement with Chia Tai Tianqing in December 2022. During the cooperation period, the company has granted Chia Tai Tianqing exclusive rights to promote PL-5 and conduct other commercialization activities in mainland China for all indications approved by the relevant authorities. The company will continue to be responsible for PL-5's R&D, global clinical trials, and regulatory strategy, and will retain commercialization rights outside mainland China during the cooperation period. In addition to the core product PL-5, Prolyse Pharmaceuticals has also laid out two other anti-infective candidate drugs, PL-3301 and PL-18, while extending its preclinical pipeline to therapeutic areas such as metabolic diseases. PL-3301 is a potential First-in-class thermosensitive peptide gel for the treatment of oropharyngeal candidiasis (OPC). This disease is common in immunocompromised populations, such as HIV patients, cancer patients after chemotherapy, and elderly people on long-term hormone therapy. Current treatments are mainly azole antifungals, but resistance problems also exist. The product is currently undergoing a Phase Ia clinical trial in China, received FDA approval in 2024 to conduct a Phase I clinical trial in the United States, and is expected to initiate Phase 2 in China in September 2026. In addition, the company is advancing preclinical development of PL-3301 for pulmonary infection indications and plans to submit an Investigational New Drug application for this indication in December 2027. Another major product, PL-18, is a potential First-in-class AMP drug for the treatment of vulvovaginal candidiasis (VVC) and may also be used to treat a range of gynecological infections, including bacterial vaginitis, fungal vaginitis, and mixed vaginitis. The product is currently undergoing a Phase II clinical trial in China and has received FDA approval to conduct a Phase II clinical trial in the United States. In addition to the aforementioned anti-infective drugs, Prolyse Pharmaceuticals is actively expanding its pipeline into therapeutic areas including metabolic diseases, oncology, and autoimmune diseases, with multiple assets currently in the preclinical stage. It is understood that the preclinical asset PL-MD-333 is an oral FGF19/FGF21 inducer and lipid metabolism regulator. Preclinical studies show that PL-MD-333 can reduce fat mass, increase the percentage of lean muscle mass, and demonstrate synergistic effects when used in combination with GLP-1 receptor agonists such as semaglutide, making it a potential candidate drug capable of changing the treatment paradigm for metabolic diseases. Overall, against the backdrop of increasingly severe global antibiotic resistance, antimicrobial peptides, as novel anti-infective drugs, have broad market prospects. As China's first innovative antimicrobial peptide drug, Prolyse Pharmaceuticals' core pipeline product PL-5 is in the first tier in terms of R&D progress, and its unique clinical value constitutes the company's most core competitive barrier. However, it is worth noting that PL-5 has been approved for only a short time and has not yet entered the commercialization stage. The subsequent medical insurance negotiations and hospital admission pace remain unclear, and the effectiveness of the promotional cooperation with Chia Tai Tianqing still needs time to be tested. At the same time, most of the follow-up pipeline is in the early stages of R&D, and it may be difficult for the company to achieve a turnaround and become profitable in the short term. During this period when commercial value has yet to be realized, the market may hold a relatively cautious attitude toward the company's valuation.