Core Viewpoint - The China Securities Regulatory Commission has issued a notice regarding the overseas issuance and listing of Danuo Pharmaceutical (Suzhou) Co., Ltd., allowing the company to issue up to 12,498,400 overseas listed ordinary shares and convert 43,472,926 domestic unlisted shares into overseas listed shares for trading on the Hong Kong Stock Exchange [1]. Company Overview - Danuo Pharmaceutical was established in 2013 and 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 developed a differentiated pipeline consisting 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 [4]. Product Details - The core product TNP-2198 is a stable conjugate drug constructed from the pharmacophore of rifamycin and nitroimidazole, which exerts its bactericidal effect by inhibiting RNA polymerase and activating nitroreductase to produce highly active substances, demonstrating a dual mechanism of action against microaerophilic and anaerobic bacteria [5]. - TNP-2198 is expected to overcome the significant and increasingly serious global challenge of antibiotic resistance, showing significant advantages in efficacy, safety, clinical application, and potential patient compliance compared to the currently recommended first-line treatment regimen, the bismuth quadruple therapy [5].

Core Insights - The article highlights the emergence of Danno Pharmaceuticals as a key player in the biotechnology sector, focusing on innovative drug products targeting bacterial infections and related diseases, particularly with its lead product, Rifoternizole, which aims to be the first new molecular entity for Helicobacter pylori infection since its discovery [1][7]. Group 1: Technology Platform and Product Pipeline - Danno Pharmaceuticals has established a dual barrier through its proprietary multi-target conjugate molecule technology, which is pivotal for drug development in bacterial infections and related diseases [2]. - The company boasts a globally leading multi-target conjugate molecule technology platform that integrates the entire drug design, synthesis, and evaluation process, significantly reducing development risks associated with safety and efficacy [3]. - As of January 24, 2026, Danno holds 42 authorized patents and 87 patent applications, providing robust intellectual property protection for its core products [3]. Group 2: Differentiated Product Pipeline - Danno's product pipeline consists of seven innovative assets targeting major unmet clinical needs, including Helicobacter pylori infection and other bacterial-related conditions, with all products intended as first-line or initial treatment options [4]. - The pipeline includes one product nearing commercialization (Rifoternizole), two in late-stage clinical development (Rifoketone injection and TNP-2092 oral formulation), one with IND approval, and three in preclinical stages [4]. Group 3: Global Development Strategy - Danno Pharmaceuticals has initiated or is conducting a total of 16 clinical trials in China and the U.S. for its pipeline products, with core products positioned for global development [6]. - Rifoternizole and Rifoketone have received multiple FDA designations, including QIDP, orphan drug, and fast track status, laying the groundwork for international commercial expansion [6]. Group 4: Core Product - Rifoternizole - Rifoternizole (TNP-2198) is the first new molecular entity for treating Helicobacter pylori infection since 1982, showcasing a unique multi-target synergistic mechanism that effectively targets both microaerophilic and anaerobic bacteria [7]. - Clinical trials in China demonstrated that Rifoternizole's three-drug regimen achieved non-inferiority compared to the bismuth quadruple therapy, with a success rate of 92.0% versus 87.9% [7]. - The early clinical results of Rifoternizole have been published in The Lancet Infectious Diseases, and the product has garnered significant media attention, reflecting its clinical value and societal significance [8]. Group 5: Commercialization Pathway - Danno Pharmaceuticals submitted a new drug application for Rifoternizole to the National Medical Products Administration in August 2025, with expectations for approval by the end of 2026 [12]. - The company has signed an exclusive commercialization agreement with Yuan Da Life Sciences for Rifoternizole in Greater China, ensuring rapid market penetration post-approval [12]. - The market potential for Rifoternizole is substantial, with an estimated 621.1 million people infected with Helicobacter pylori in China and 4.081 billion globally, highlighting the significant unmet medical need [12]. Group 6: Other Key Products - Rifoketone (TNP-2092 injection) is positioned as the first clinical candidate effective against biofilm infections, with a multi-target mechanism that enhances its efficacy against traditional antibiotic resistance [13]. - TNP-2092 oral formulation shows promise in treating metabolic-related diseases, with a low spontaneous resistance rate and superior activity against gut bacteria compared to existing treatments [14]. - The global market for artificial joint infections is projected to grow significantly, indicating a vast potential for Danno's products in addressing these critical health issues [14].

香港聯合交易所有限公司與證券及期貨事務監察委員會對本申請版本的內容概不負責，對其準確性或完整 性亦不發表任何意見，並明確表示概不就因本申請版本全部或任何部分內容而產生或因倚賴該等內容而引 致的任何損失承擔任何責任。 TenNor Therapeutics (Suzhou) Limited 丹諾醫藥（蘇州）股份有限公司 （於中華人民共和國註冊成立的股份有限公司） 本公司招股章程根據香港法例第32章《公司（清盤及雜項條文）條例》送呈香港公司註冊處處長登記 前，本公司不會向香港公眾人士提出要約或邀請。倘於適當時候向香港公眾人士提出要約或邀請， 有意投資者務請僅依據送呈香港公司註冊處處長登記的本公司招股章程作出投資決定；有關文本將 於發售期內向公眾刊發。 (a) 本文件僅為向香港公眾人士提供有關本公司的資料，概無任何其他目的；投資者不應根據本 文件中的資料作出任何投資決定； (b) 在聯交所網站登載本文件或其補充、修訂或更換附頁，並不引起本公司、其保薦人、整體協 調人、顧問或包銷團成員在香港或任何其他司法權區必須進行發售活動的責任。本公司最終 會否進行發售仍屬未知之數； (c) 本文件或其任何補充、修訂或更換附頁的內 ...

Group 1: Company Overview - Danuo Pharmaceutical is a biotechnology company focused on discovering, developing, and commercializing differentiated innovative drugs to address unmet clinical needs in bacterial infections and related diseases [1] - The company has developed a rich pipeline consisting of seven innovative assets, with three core products having global first-in-class potential [1] - Danuo Pharmaceutical aims to overcome the limitations of traditional treatments and improve patient outcomes, positioning itself as a leader in the biopharmaceutical sector [1] Group 2: Market Opportunity - Helicobacter pylori infection is a major cause of gastric cancer, with an infection rate of 44% in China and a projected market size of RMB 5.5 billion (approximately USD 690 million) for treatment in 2024 [2] - There has been a lack of innovative drugs specifically targeting Helicobacter pylori since its discovery in 1982, with traditional therapies facing high resistance rates and poor patient compliance [2] - The resistance rate to at least one recommended antibiotic for Helicobacter pylori is 85%, with a multi-drug resistance rate of 46%, increasing the risk of treatment failure [2] Group 3: Product Development - Danuo Pharmaceutical's TNP-2198 capsule is the world's first new molecular entity candidate specifically targeting Helicobacter pylori infection, utilizing a dual mechanism to inhibit RNA polymerase and activate damaged DNA [2] - The drug maintains high activity against resistant strains, with a spontaneous resistance rate of less than 10%, significantly reducing the risk of resistance [2] - A Phase III clinical trial involving 700 participants across 40 centers in China showed that the eradication rate of TNP-2198 in treatment-naive patients reached 92% in mITT analysis and 94% in PP analysis, exceeding the 90% international threshold [2] Group 4: Clinical Trial Results - In a population with multiple drug resistance, the eradication rate of TNP-2198 reached 90%, outperforming traditional therapies [2] - The incidence of adverse events in the TNP-2198 group was 37%, lower than the 53% in the traditional therapy group, with no serious adverse events reported, indicating better tolerability [2] - The simplified dosing regimen of TNP-2198 is expected to enhance patient compliance [2] Group 5: Future Prospects - The successful development of TNP-2198 validates the clinical value of the multi-target conjugate molecule technology and provides new insights for innovative drug development [3] - Danuo Pharmaceutical plans to invest RMB 57.3 million (approximately USD 8.1 million) in core pipeline research and development in 2024, representing 82% of its total R&D expenditure [3] - The commercialization of TNP-2198 is anticipated to fill a global gap in innovative treatments for Helicobacter pylori, potentially transforming the current treatment landscape dominated by traditional therapies [3]

Core Viewpoint - Danuo Pharmaceutical (Suzhou) Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, focusing on innovative drug development to address unmet clinical needs in bacterial infections and related diseases [1][2]. Company Overview - Founded in 2013, Danuo Pharmaceutical is a biotechnology company nearing commercialization, specializing in the discovery and development of differentiated innovative drug products [1]. - The company has established a pipeline consisting of seven innovative assets, with three core products: TNP-2198 (Rifoterin), TNP-2092 injection, and TNP-2092 oral formulation [1]. Product Details - Rifoterin (TNP-2198) is a stable conjugate drug designed to combat bacterial resistance through a dual mechanism of action against microaerophilic and anaerobic bacteria [1]. - The company has completed a head-to-head Phase III clinical trial in China, showing that the Rifoterin triple therapy (RTT) outperforms the bismuth quadruple therapy (BQT) in eradication rates, safety, and tolerability, especially in multi-drug resistant populations [2]. - The company plans to submit a new drug application for Rifoterin to the National Medical Products Administration by the end of August [2]. Market Position and Challenges - Danuo Pharmaceutical relies entirely on contract development and manufacturing organizations (CDMO) for production, lacking its own manufacturing base [2]. - The company has signed an exclusive agreement with Yuan Da Life Sciences for the commercialization of Rifoterin in China, but the partner's experience in infectious disease promotion is yet to be validated [2]. - The company has not yet achieved profitability, with projected net losses of 191.8 million yuan and 145.9 million yuan for 2023 and 2024, respectively, and R&D expenses accounting for 90.7% and 82.0% of total expenses [2]. Financial Overview - As of March 2025, the company's net current liabilities rose to 932 million yuan, primarily due to redemption liability pressure [2]. - Although the company plans to alleviate some financial pressure through E-round financing in 2024, it will still need external capital support for pipeline advancement [2].

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]