New stock news | Danuo pharmaceutical company submits an application to the Hong Kong Stock Exchange, owning three core products including Lefortinib (TNP-2198)

According to the disclosure by the Hong Kong Stock Exchange on July 30, Danno Medicine (Suzhou) Co., Ltd. (hereinafter referred to as Danno Medicine) has submitted an application for listing on the main board of the Hong Kong Stock Exchange, with CITIC SEC and Agricultural Bank International as joint sponsors. The prospectus shows that Danno Medicine was registered and established in 2013, and is a biotechnology company nearing commercialization stage, focusing on the discovery, development, and commercialization of innovative drug products for bacterial infections and related bacterial metabolism diseases with unmet clinical needs. With its independently developed multi-target conjugate molecule technology, the company is committed to providing the best treatment options for patients to overcome the limitations of traditional treatments and improve patient prognosis. As of the latest feasible date, the company has established a differentiated pipeline consisting of seven innovative assets, including three core products: Levofertinib (TNP-2198), the world's first and only new molecular entity (NME) candidate drug for the treatment of Helicobacter pylori infection; Levofloxacin (TNP-2092) injection, a potential first-in-class three-target therapy candidate drug for implant-related bacterial infections; and TNP-2092 oral formulation, the world's first multi-target candidate drug for the treatment of gastrointestinal microbiota metabolism related diseases. The core product, Levofertinib (TNP-2198), is a stable conjugate drug composed of the pharmacophores of levofloxacin and nitroimidazole. By inhibiting RNA polymerase and nitroreductase to activate the production of highly active substances for bactericidal action, it has a synergistic dual action mechanism on microaerophiles and anaerobes. With this unique multi-target mechanism, Levofertinib is expected to overcome antimicrobial resistance, a major and increasingly serious global challenge. As part of triple therapy, Levofertinib has significant advantages over the currently recommended first-line treatment regimen of bismuth quadruple therapy (BQT) in terms of efficacy, safety, clinical applicability, and patient potential compliance. Danno Medicine has completed a Phase III head-to-head clinical trial of Levofertinib triple therapy (RTT) compared to BQT in China, and plans to submit a new drug application (NDA) to the National Medical Products Administration (NMPA) by the end of August 2025. Clinical trial results show that RTT has advantages over BQT in eradication rate, safety, and tolerability. Notably, in the multidrug-resistant population, RTT demonstrated superior efficacy to BQT (89.9% vs. 81.2%; difference: 8.7%; non-inferiority test p <0.0001; superiority test p=0.023). The incidence of clinically relevant treatment-emergent adverse events (TEAE) in the RTT group was 37.3%, compared to 53.2% in the BQT group. Most TEAEs were mild to moderate in severity, and no treatment-related serious adverse events were reported. These results indicate that compared to BQT, RTT has better safety and tolerability. Additionally, RTT does not require pre-treatment susceptibility testing, highlighting its potential as a standard first-line therapy and seamless integration with the urea breath test (UBT). Furthermore, the more convenient dosing of RTT, combined with its superior safety and tolerability profile, is expected to significantly improve patient compliance. Danno Medicine is implementing a clear clinical development and commercialization strategy for Levofertinib. Through an exclusive commercial cooperation agreement with Far Eastern Life Sciences, the company will leverage its strong marketing capabilities and rich commercialization resources to support the successful market launch of Levofertinib for the treatment of Helicobacter pylori infection in China. With the IND license, fast track designation, and Qualified Infectious Disease Product (QIDP) designation granted by the US Food and Drug Administration (FDA), Levofertinib may benefit from an accelerated review process by the FDA, accelerating its market entry in the United States and other overseas markets. In addition to Helicobacter pylori infection, Levofertinib shows potential in a wider range of antimicrobial applications. With the IND approval obtained from the NMPA, the company plans to advance clinical development of Levofertinib for the treatment of bacterial vaginosis and difficult-to-treat Clostridium difficile infections. In terms of finances, for the years ended March 31, 2023, 2024, and the three months ended March 31, 2025, Danno Medicine reported operating losses of approximately RMB 122 million, RMB 77.998 million, RMB 11.561 million, and RMB 17.147 million respectively; and net losses of approximately RMB 192 million, RMB 146 million, RMB 27.873 million, and RMB 38.011 million respectively.