经济观察网 基于截至2026年2月的最新公开信息，宜明昂科-B（股票代码：01541.HK）有以下值得关注 的事件进展，主要涉及核心产品研发、监管申请及合作动态。以下内容均来自公司公告及媒体报道，按 时间顺序和重要性梳理。 产品研发进展 III期临床试验中期分析：公司核心产品IMM01（替达派西普）用于慢性粒-单核细胞白血病（CMML） 一线治疗的III期临床试验，已于2025年12月31日完成104例患者招募，预计在2026年3月底前完成中期分 析所需的132例患者招募。中期分析数据将用于评估完全缓解率（CR率），为后续申请奠定基础。 合作调整与资产回收：2026年1月，公司终止与Instil Bio子公司Axion Bio的许可协议，收回IMM2510 （PD-L1xVEGF双抗）和IMM27M（CTLA-4抗体）的全球权利，并保留已收到的3500万美元付款。创 始人田文志表示，公司正与多家跨国药企接触，计划在2026年寻求新的合作伙伴以推进全球化开发。 公司状况 公司治理事件：2026年2月10日，公司向创始人田文志提供了一笔本金为1372.47万元人民币的贷款，公 告称此举基于公司财务状况良好，且不会 ...

Core Viewpoint - The company, 宜明昂科-B, has seen a stock increase of over 5% following the announcement of successful patient recruitment for a Phase III clinical trial of IMM01 for chronic myelomonocytic leukemia (CMML) treatment, indicating positive momentum in its clinical development and potential future partnerships [1] Group 1: Clinical Development - The company announced the successful recruitment of 104 patients for the Phase III clinical trial of IMM01, aimed at treating CMML, with expectations to complete recruitment of 132 patients by the end of March 2026 [1] - The company plans to submit a pre-BLA application by the end of 2026 and is advancing its research in atherosclerosis to the concept validation stage [1] Group 2: Business Operations - As of the announcement date, the board confirmed that the company's business operations and clinical development remain normal, with no significant adverse changes in the financial status [1] Group 3: Industry Engagement - The company participated in the 44th J.P. Morgan Healthcare Conference, where its founder and CEO, Dr. Tian Wenzhi, presented the company's development status and key project progress [1] - During the conference, the executive team engaged with over ten multinational pharmaceutical and biotechnology companies, establishing deep communication with several potential partners, which is expected to lead to substantial progress in 2026 [1]

Core Viewpoint - The company, Immune-Onc Therapeutics, has successfully completed the recruitment of 104 patients for its Phase III clinical trial of IMM01 for the first-line treatment of chronic myelomonocytic leukemia (CMML), with expectations to complete the recruitment of 132 patients by the end of March 2026 [1][1][1] Group 1 - The company's stock price increased by over 5%, reaching HKD 4.94, with a trading volume of HKD 8.3481 million [1][1][1] - The board confirmed that the company's business operations and clinical development remain normal, with no significant adverse changes in its financial status [1][1][1] - The company plans to submit a pre-BLA application by the end of 2026 and is advancing its research in atherosclerosis to the concept validation stage [1][1][1] Group 2 - The company participated in the 44th J.P. Morgan Healthcare Conference, where its founder and CEO, Dr. Tian Wenzhi, presented the company's development status and key project progress [1][1][1] - During the conference, the management team engaged with over ten multinational pharmaceutical and biotechnology companies, establishing deep communication with several potential partners, with positive feedback received [1][1][1] - The company anticipates substantial progress in 2026, which could inject new momentum into its global pipeline [1][1][1]

Group 1 - The company completed the recruitment of 104 patients for the Phase III clinical trial of IMM01 (Tadapaximab) for first-line treatment of Chronic Myelomonocytic Leukemia (CMML) by December 31, 2025, and expects to complete the recruitment of 132 patients for interim analysis by the end of March 2026 [1] - The board confirmed that the company's business operations and clinical development are normal, with no significant adverse changes in the business operations and financial status [1] Group 2 - IMM01 (Tadapaximab) is an innovative targeted CD47 molecule and the first SIRPα-Fc fusion protein to enter clinical stages in China [2] - The product activates macrophages through a dual mechanism by blocking the "don't eat me" signal and delivering the "eat me" signal, demonstrating good safety and macrophage activation capabilities [2] - IMM01 (Tadapaximab) received orphan drug designation from the U.S. Food and Drug Administration for first-line treatment of CMML in November 2023 [2] - The company holds global intellectual property and commercialization rights for IMM01 (Tadapaximab), with a patent family that includes granted patents in China, the United States, Japan, and the European Union [2]

Core Viewpoint - Yiming Anke-B (01541) has received approval from the National Medical Products Administration of China for clinical trials of IMM01 (Tadapaxip) for the treatment of atherosclerosis, which has positively impacted its stock price [1][4]. Group 1: Company Developments - Yiming Anke's stock price increased by 9.28% to HKD 6.71, with a trading volume of HKD 12.32 million [1][4]. - The company holds global intellectual property and commercialization rights for IMM01 (Tadapaxip), with a patent family that includes authorized patents in China, the United States, Japan, and the European Union [1][4]. Group 2: Research and Development Insights - Guoyuan International reported that the company has regained global rights for IMM2510 and IMM27M, which will accelerate its overseas clinical research and development pace [1][4]. - Clinical data for IMM2510 is reported to be excellent, with good safety and significant differentiation advantages [1][4]. - The company has a rich R&D pipeline, enhancing its risk resistance, with promising clinical efficacy data for the CD47CD20 dual antibody (IMM0306), which is expected to become a key drug in the autoimmune field [1][4]. - The company is recognized as a global innovator in CD47 fusion proteins, with broad application prospects in oncology, autoimmune diseases, and cardiovascular fields [1][4]. - The current market capitalization is only HKD 2.7 billion, indicating a significant undervaluation, and it is recommended to pay close attention to the company [1][4].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示概不就因本公告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。 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1541） ImmuneOnco Biopharmaceuticals (Shanghai) Inc. 宜明昂科生物醫藥技術（上海）股份有限公司 – 1 – 本集團擁有IMM01（替達派西普）的全球知識產權及商業化權利。截至本公告日 期，就IMM01（替達派西普）而言，本集團擁有一個專利家族，其中包括在中國、 美國、日本及歐盟的已授權專利。 根據香港聯合交易所有限公司證券上市規則第18A.05條的警示聲明：本公司無 法保證能夠成功開發或最終上市銷售IMM01（替達派西普）。本公司股東及潛在 投資者在買賣本公司股份時應謹慎行事。 承董事會命 宜明昂科生物醫藥技術（上海）股份有限公司 自願公告 IMM01（替達派西普）獲國家藥監局批准進行 動脈粥樣硬化治療的臨床試驗 本公告由宜明昂科生物醫藥技術（上海）股份有限公司（「本公司」，連同其附屬 公司統稱「本集 ...