智通财经APP获悉，2月6日，中国证监会国际合作司发布《关于丹诺医药(苏州)股份有限公司境外发行上市及境内未上市股份"全流通"备案通知书》。公司 拟发行不超过12,498,400股境外上市普通股并在香港联合交易所上市。公司49名股东拟将所持合计43,472,926股境内未上市股份转为境外上市股份，并在香港 联合交易所上市流通。 | 索 引 号 | bm56000001/2026-00001529 ਦੇ | | 类 | 结果公 | | --- | --- | --- | --- | --- | | 发布机构 | | 发文日期 | | 2026£ | | 名 称 | 关于丹诺医药（苏州）股份有限公司境外发行上市及境内未上市股份"全流通"备案通知书 | | | | | 文 특 | 国合函〔2026〕299 号 | 主题词 | | | 招股书显示，丹诺医药于2013年注册成立，是一家临近商业化阶段的生物科技公司，专注于发现、开发及商业化差异化的创新药产品，以解决细菌感染及细 菌代谢相关疾病领域的未被满足临床需求。凭借自主开发的多靶点偶联分子技术，公司致力于为患者提供最佳治疗方案，以克服传统治疗的局限性并改善患 者预后 ...

在此基础上，丹诺医药形成了坚实的技术护城河。截至2026年1月24日，公司拥有42项已授权专利及87项专利申请， 为核心产品提供了有效的知识产权保护。 在全球抗菌药物耐药性（AMR）危机日趋严峻、肠道菌群代谢与疾病关系日益明确的背景下，丹诺医药迈入资本视 野。 作为一家临近商业化阶段的生物科技公司，丹诺医药专注于发现、开发及商业化针对细菌感染及细菌代谢相关疾病的 差异化创新药产品。其核心产品利福特尼唑有望成为自幽门螺杆菌发现以来全球首款针对幽门螺杆菌感染的新分子实 体药物，并在尚处蓝海的核心适应症中抢占先发优势。 一、构筑技术平台与产品管线的双重壁垒 丹诺医药依托以自主开发的多靶点偶联分子技术进行新药研发，聚焦细菌感染和细菌代谢相关疾病领域。 1、全球领先的多靶点偶联分子技术平台 丹诺医药的核心竞争力源于其全球领先的多靶点偶联分子技术平台以及由此构建的差异化产品管线。 该技术平台是全面整合的研发引擎，涵盖药物设计、合成及评估全流程，战略聚焦于细菌感染及细菌代谢相关疾病领 域。通过该平台，公司根据适应症选择合适的靶点进行偶联分子的设计与合成，并利用其独特的评价体系进行偶联分 子的优化。 这一技术显著降低与安全性 ...

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 ...

丹诺医药是一家临近商业化阶段的生物科技企业，始终专注于发现、开发及商业化差异化的创新药，旨 在解决细菌感染及细菌代谢相关疾病领域的未被满足临床需求。依托自主研发的多靶点偶联分子技术平 台，公司构建了由七项创新资产组成的丰富管线，其中三项核心产品均具备全球首创潜力。自成立以 来，丹诺医药始终以"为患者提供最佳治疗方案"为使命，致力于克服传统治疗的局限性，改善患者预 后，逐步成长为生物医药领域细分赛道的领军企业。 幽门螺杆菌感染是导致胃癌的主要因素。在中国，感染率高达44%，2024年治疗幽门螺杆菌感染药物的 中国市场规模为人民币55亿元，全球市场规模为69亿美元。自1982年发现以来，一直缺乏专门这对幽门 螺杆菌感染的创新药物，传统铋剂四联疗法(BQT)面临耐药率飙升、不良反应多、依从性低等问题。数 据显示，幽门螺杆菌对至少一种指南推荐抗生素的耐药率达85%，多重耐药率达46%，治疗失败风险加 剧。丹诺医药推出的利福特尼唑(TNP-2198)胶囊是全球首个针对幽门螺杆菌感染的新分子实体候选药 物。通过抑制RNA聚合酶和硝基还原酶激活损伤DNA的双重机制协同杀菌。这一设计突破单靶点局 限，对耐药菌株保持高活性，自 ...

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]