Hua Xia Shi Bao·2025-08-06 17:45Core Viewpoint - Danuo Pharmaceutical is seeking to go public on the Hong Kong Stock Exchange, aiming to raise funds primarily for research, development, registration, and commercialization of its core products, as well as for the development of other candidates and operational expenses [1][3]. Financial Performance - Danuo Pharmaceutical has accumulated losses of 376 million RMB, with R&D expenses exceeding 80% of total expenditures [3]. - The company reported net losses of 192 million RMB, 146 million RMB, and 38 million RMB for the years 2023 to Q1 2025, respectively [3]. - As of March 2025, the company had only 146 million RMB in cash, while current liabilities reached 932 million RMB, indicating significant financial pressure [3][4]. R&D Investment - The R&D expenditure for core products accounted for 90.7%, 82%, and 65.3% of total R&D expenses from 2023 to Q1 2025, respectively [3]. - R&D costs are a critical driver for innovation but also pose substantial financial strain on the company [3][6]. Product Pipeline - Danuo Pharmaceutical has three core products in its pipeline, including TNP-2198 for Helicobacter pylori infection and TNP-2092 for multi-target treatment of bacterial infections [6][8]. - The company plans to submit a New Drug Application (NDA) for TNP-2198 by August 2025, with an expected approval by the end of 2026 [8]. Commercialization Challenges - The commercialization of TNP-2198 faces risks, including the potential for the agreement with Yuan Da Life Sciences to be terminated if the product does not receive market approval by the end of 2026 [7][8]. - Even if the product is approved, challenges such as price negotiations and competition may hinder revenue generation [8]. Supply Chain Dependency - Danuo Pharmaceutical relies heavily on WuXi AppTec, which is both a major supplier and a shareholder, raising concerns about independence and fair pricing [9][12]. - The company’s procurement from its top five suppliers increased significantly, with WuXi AppTec accounting for 53.5% of total procurement in Q1 2025 [9][12]. Regulatory and Market Concerns - The dual role of WuXi AppTec as a supplier and shareholder may attract regulatory scrutiny regarding the independence and fairness of transactions [15]. - The ongoing losses, the timeline for core product commercialization, and the reliance on external manufacturing partners will be focal points for regulatory inquiries and market attention [15].