Core Viewpoint - Danno Pharmaceutical (Suzhou) Co., Ltd. has submitted its 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 [4] - 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 for treating Helicobacter pylori infection; TNP-2092 injection, a potential first-in-class candidate for treating implant-related bacterial infections; and TNP-2092 oral formulation, the world's first multi-target candidate for treating gut microbiota-related metabolic diseases [4] Product Details - TNP-2198 is a stable conjugate drug constructed from rifamycin and nitroimidazole pharmacophores, aiming to overcome the global challenge of antibiotic resistance through a unique multi-target mechanism [5] - The drug has shown significant advantages in efficacy, safety, clinical application, and patient compliance compared to the current first-line treatment regimen [5] - Danno Pharmaceutical has completed a head-to-head Phase III clinical trial comparing TNP-2198 with the standard treatment, showing a higher eradication rate in multi-drug resistant populations (89.9% vs. 81.2%) [5][6] 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 [6] - TNP-2198 is expected to benefit from expedited review processes by the FDA due to its IND license and designations, potentially accelerating its market entry in the U.S. and other overseas markets [6] - Danno Pharmaceutical has signed an exclusive commercial collaboration agreement with a major life sciences company to support the successful launch of TNP-2198 in China [6] Financial Performance - For the fiscal years ending December 31, 2023, and 2024, the company reported operating losses of approximately RMB 122.4 million and RMB 77.8 million, respectively [7] - The financial data for the three months ending March 31, 2024, and 2025, shows operating losses of approximately RMB 11.6 million and RMB 17.1 million, respectively [8]
丹诺医药递表港交所 拥有利福特尼唑(TNP-2198)等三大核心产品
Zhi Tong Cai Jing·2025-07-30 22:56