Core Viewpoint - Danno Pharmaceutical (Suzhou) Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with CITIC Securities and Agricultural Bank of China International as joint sponsors [1] Company Overview - Founded in 2013, Danno Pharmaceutical is a biotechnology company nearing commercialization, focusing on the discovery, development, and commercialization of differentiated innovative drug products to address unmet clinical needs in bacterial infections and related metabolic diseases [3] - The company has established a pipeline of seven innovative assets, including three core products: TNP-2198, the world's first and only new molecular entity candidate drug for treating Helicobacter pylori infection; TNP-2092 injection, a potential first-in-class candidate drug for treating implant-related bacterial infections; and TNP-2092 oral formulation, the world's first multi-target candidate drug for treating gut microbiota-related metabolic diseases [3] Product Details - TNP-2198 is a stable conjugate drug constructed from rifamycin and nitroimidazole pharmacophores, designed to combat antibiotic resistance through a dual mechanism of action against microaerophilic and anaerobic bacteria [4] - The drug has shown significant advantages in efficacy, safety, clinical application, and patient compliance compared to the current first-line treatment regimen [4] - Danno Pharmaceutical has completed a head-to-head Phase III clinical trial comparing TNP-2198 with the standard treatment, demonstrating superior eradication rates and safety profiles [5] Clinical Development and Commercialization Strategy - The company plans to submit a New Drug Application (NDA) to the National Medical Products Administration by the end of August 2025 [4] - TNP-2198 has received IND approval from the FDA, along with Fast Track and Qualified Infectious Disease Product designations, which may expedite its review process in the U.S. and other markets [5] - Danno Pharmaceutical has signed an exclusive commercial partnership with a major life sciences company to support the successful launch of TNP-2198 in China [5] Financial Performance - For the fiscal year 2023, the company reported an operating loss of approximately 122.4 million RMB, with projected losses of 77.8 million RMB for 2024 and 17.1 million RMB for the first quarter of 2025 [6][7] - Research and development expenses are expected to decrease from 108.4 million RMB in 2023 to 69.8 million RMB in 2024, while administrative expenses are also projected to decline [7]