IMMUNEONCO(01541)
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宜明昂科(01541) - 截至2026年1月31日止股份发行人的证券变动月报表
2026-02-05 03:02
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 致:香港交易及結算所有限公司 公司名稱: 宜明昂科生物醫藥技術(上海)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) 呈交日期: 2026年2月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01541 | 說明 | H股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 420,477,305 | RMB | | 1 RMB | | 420,477,305 | | 增加 / 減少 (-) | | | 0 | | | RMB | | | | 本月底結存 | | | 420,477,305 | RMB | | 1 RMB | | 420,477,305 | | 2. 股份分類 | 普通股 | 股份類別 | 其他 ...
港股宜明昂科-B(01541.HK)涨超5%
Mei Ri Jing Ji Xin Wen· 2026-01-22 07:06
每经AI快讯,宜明昂科-B(01541.HK)涨超5%,截至发稿,涨5.11%,报4.94港元,成交额834.81万港 元。 (文章来源:每日经济新闻) ...
宜明昂科-B涨超5% 核心产品IMM01预期年底递交preBLA申请
Zhi Tong Cai Jing· 2026-01-22 07:00
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]
港股异动 | 宜明昂科-B(01541)涨超5% 核心产品IMM01预期年底递交preBLA申请
智通财经网· 2026-01-22 06:56
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]
宜明昂科-B:业务营运及临床开发维持正常
Zhi Tong Cai Jing· 2026-01-21 12:17
Group 1 - The company successfully 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 needed for interim analysis by the end of March 2026 [1] - The board confirmed that the company's business operations and clinical development remain 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, designed to activate macrophages through a dual mechanism [2] - The product has received orphan drug designation from the U.S. Food and Drug Administration for first-line treatment of CMML in combination with Azacitidine 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]
宜明昂科-B(01541.HK):完成核心产品IMM01的CMML一线治疗III期临床招募
Ge Long Hui· 2026-01-21 11:14
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]
宜明昂科(01541) - 自愿公告 - 有关IMM01(替达派西普)临床试验的最新消息
2026-01-21 11:05
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。 ImmuneOnco Biopharmaceuticals (Shanghai) Inc. 宜明昂科生物醫藥技術(上海)股份有限公司 關於IMM01(替達派西普) (於中華人民共和國註冊成立的股份有限公司) (股份代號:1541) 自願公告 有關IMM01(替達派西普)臨床試驗的最新消息 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「本集團」)自願作出,以告知本公司股東及潛在投資者有關本集團的 最新業務發展情況。 本公司董事(「董事」)會(「董事會」)欣然宣佈,本公司於2025年12月31日成功完 成IMM01(替達派西普)用於慢性粒-單核細胞白血病(CMML)一線治療的III期臨 床試驗的104例患者招募,並預期將於2026年3月底前完成中期分析所需的132 例患者招募。截至本公告日期,董事會確認本集團的業務營運及臨床開發維持 正常,且本集團的業務營運及財務狀況並無 ...
15个月的蹉跎,宜明昂科如何用一个“迟到”的资产敲开MNC大门?
Xin Lang Cai Jing· 2026-01-15 14:14
Core Viewpoint - The termination of the collaboration between 宜明昂科-B (1541.HK) and AxionBio highlights the challenges faced by Chinese innovative drug companies in the global market, emphasizing that the choice of partners may be more critical than the technical advantages of the products themselves [5][21][25]. Group 1: Collaboration Details - In August 2024, 宜明昂科-B signed a potential licensing agreement with AxionBio worth over $2 billion, which was seen as a significant step for the company's international expansion [2][18]. - By January 2026, 宜明昂科-B announced the recovery of global rights for its dual-antibody drug IMM2510 and CTLA-4 antibody IMM27M, marking the end of the collaboration [4][21]. - The company retained the $35 million upfront and milestone payments received from AxionBio, indicating a strategic decision rather than a forced exit [5][21]. Group 2: Clinical Development Challenges - The clinical trial progress for IMM2510 was notably slow, with only three patients enrolled in the Phase I trial in the U.S. before the collaboration ended [7][23]. - The FDA approved the clinical trial application for IMM2510 in July 2025, but AxionBio did not administer the first patient until October 2025, resulting in a 15-month delay from the agreement to actual clinical operations [7][23]. Group 3: Market Competition - The PD-(L)1/VEGF dual-antibody market is highly competitive, with 17 drugs currently in clinical trials, all associated with Chinese innovative drug companies [10][27]. - Major players like 康方生物 and 三生制药 have advanced their products to Phase III clinical trials in collaboration with multinational giants, creating a challenging environment for 宜明昂科-B [10][27]. Group 4: Strategic Implications - The decision to regain rights to the assets allows 宜明昂科-B to explore new partnerships and strategies without being constrained by previous agreements, although it also means assuming all associated risks and costs [15][33]. - The company plans to target multinational corporations for future business development while also considering partnerships with mid-sized companies [29][33]. Group 5: Financial Considerations - Despite receiving $35 million from the previous collaboration, the funds are insufficient to cover the long-term costs of global clinical development for the two drugs [30][31]. - 宜明昂科-B has reported continuous losses from 2023 to 2025, with increasing R&D expenditures, indicating significant financial pressure moving forward [30][31].
宜明昂科-B午前涨超9% 机构指公司价值严重低估建议积极关注
Xin Lang Cai Jing· 2026-01-13 03:43
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].
宜明昂科-B(01541.HK)早盘涨超10%
Mei Ri Jing Ji Xin Wen· 2026-01-13 03:27
Group 1 - The stock of Yiming Anke-B (01541.HK) rose over 10% in early trading, currently up 8.63% at HKD 6.67 [1] - The trading volume reached HKD 11.1965 million [1]