新股前瞻｜全球首款幽门螺杆菌新药临近上市，丹诺医药能否成为行业黑马？

Core Viewpoint - Helicobacter pylori (H. pylori) infection is a significant public health issue globally, with an infection rate exceeding 50%, and is closely linked to gastric cancer, classified as a Group I carcinogen by the World Health Organization [1][2] Industry Overview - H. pylori is associated with various gastric diseases, including gastric ulcers and chronic gastritis, with approximately 80% of gastric cancer cases related to this pathogen [2] - In China, H. pylori infection rates are notably high, with an overall infection rate exceeding 70%, leading to an estimated 340,000 new gastric cancer cases annually, accounting for 42% of global cases related to H. pylori [2] - The global market for H. pylori treatment drugs was valued at $5.3 billion in 2019 and is projected to grow at a compound annual growth rate (CAGR) of 6.0%, reaching $6.9 billion by 2024 and $10 billion by 2029 [3][4] Company Overview - Dano Pharmaceutical (Suzhou) Co., Ltd. is a biotechnology company focused on developing innovative drugs for bacterial infections, with its core product, Rifoternizole (TNP-2198), being the only innovative antibacterial drug in development for H. pylori infection [8][11] - The company has established a differentiated pipeline with seven innovative assets, including TNP-2198, which aims to overcome antibiotic resistance and improve treatment outcomes [9][10] - Dano Pharmaceutical plans to submit a New Drug Application (NDA) for TNP-2198 by the end of August 2025, following successful Phase III clinical trials demonstrating its advantages over existing treatments [10][11] Market Potential - The Chinese market for H. pylori treatment drugs is expected to grow from 5.6 billion RMB in 2019 to 6.8 billion RMB by 2029, with a CAGR of 4.3% [4] - The introduction of TNP-2198 is anticipated to significantly impact the H. pylori treatment market, especially given the rising antibiotic resistance and the shift towards more effective treatment regimens [7][11] Financial Considerations - Dano Pharmaceutical has reported operating losses of approximately 122 million RMB, 77.8 million RMB, and 17.1 million RMB for the years 2023, 2024, and the first three months of 2025, respectively [12] - The company is actively seeking to raise funds through an IPO to support its ongoing research and development efforts, which require substantial financial resources [12][13]