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宜明昂科-B(01541):提交IMM2510的III期临床试验申请
智通财经网· 2025-10-02 00:49
Core Viewpoint - The company has submitted an application for a Phase III clinical trial of IMM2510 for the treatment of immune therapy-resistant non-small cell lung cancer (NSCLC) to the National Medical Products Administration of China [1] Group 1: Clinical Trial Developments - The company has recently submitted two Phase III registration clinical trials for different types of lung cancer [1] - The I phase study data presented at the 2025 World Lung Cancer Conference showed an objective response rate (ORR) of 35.3% and a disease control rate (DCR) of 76.5% among 17 evaluable patients with advanced squamous NSCLC who had previously received immune therapy [1] - The median duration of response (DoR) was reported as 7.59 months, and the median progression-free survival (PFS) was 9.4 months [1] Group 2: Future Plans - Based on the promising results from the I phase study, the company plans to further validate the efficacy and safety of IMM2510 through the Phase III clinical trials [1] - The aim is to provide more effective treatment options for lung cancer patients [1]
宜明昂科-B:提交IMM2510的III期临床试验申请
Zhi Tong Cai Jing· 2025-10-02 00:45
Core Viewpoint - The company has submitted an application to the National Medical Products Administration of China for a Phase III clinical trial of IMM2510, aimed at treating immune therapy-resistant non-small cell lung cancer (NSCLC) [1] Group 1: Clinical Trial Developments - The company has recently submitted two Phase III registration clinical trials for different types of lung cancer [1] - The I phase study data presented at the 2025 World Lung Cancer Conference showed an objective response rate (ORR) of 35.3% and a disease control rate (DCR) of 76.5% among 17 evaluable patients with advanced squamous NSCLC who had previously received immune therapy [1] - The median duration of response (DoR) was reported as 7.59 months, and the median progression-free survival (PFS) was 9.4 months [1] Group 2: Future Plans - Based on the promising results from the I phase study, the company plans to further validate the efficacy and safety of IMM2510 through the Phase III clinical trials [1] - The goal is to provide more effective treatment options for lung cancer patients [1]
宜明昂科-B(01541.HK):提交IMM2510的III期临床试验申请
Ge Long Hui A P P· 2025-10-02 00:29
Core Viewpoint - The company has submitted an application for a Phase III clinical trial of IMM2510 for the treatment of immune therapy-resistant non-small cell lung cancer (NSCLC) to the National Medical Products Administration [1] Group 1: Clinical Trials and Research - The company has recently submitted two additional Phase III registration clinical trial applications for different types of lung cancer [1] - Data from a Phase I study presented at the 2025 World Lung Cancer Conference (WCLC) showed an objective response rate (ORR) of 35.3% and a disease control rate (DCR) of 76.5% among 17 evaluable patients with advanced squamous NSCLC who had previously received immune therapy [1] - The median duration of response (DoR) was reported as 7.59 months, and the median progression-free survival (PFS) was 9.4 months [1] Group 2: Future Plans - Based on the promising results from the Phase I study, the company plans to further validate the efficacy and safety of IMM2510 through the Phase III clinical trials [1] - The aim is to provide more effective treatment options for lung cancer patients [1]
宜明昂科(01541) - 自愿公告 - IMM2510的III期临床试验申请
2025-10-02 00:17
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 (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 IMM2510的III期臨床試驗申請 田文志 中國上海,2025年10月2日 於本公告日期,董事會由以下成員組成:(i)執行董事田文志博士、李松先生、關梅女士及 張如亮先生;(ii)非執行董事徐聰博士及付大偉女士;及(iii)獨立非執行董事朱禎平博士、 Kendall Arthur Smith博士及楊志達先生。 於2025年世界肺癌大會(「WCLC」)發表的I期研究數據近期顯示,針對曾接受 免疫治療的晚期鱗狀非小細胞肺癌(SQ-NSCLC)的17例可評估患者,IMM2510 達到了35.3%的客觀緩解率(ORR)及76.5%(13/17)的疾病控制率(DCR)。中位緩解 持續時間(DoR)為7.5 ...
宜明昂科-B午后涨超4%
Mei Ri Jing Ji Xin Wen· 2025-09-30 06:56
每经AI快讯,宜明昂科-B(01541.HK)午后涨超4%,截至发稿,涨2.59%,报13.49港元,成交额3731.57 万港元。 (文章来源:每日经济新闻) ...
港股异动 | 宜明昂科-B(01541)午后涨超4% IMM0306递交III期临床实验申请 有望成为自免领域重磅药物
Zhi Tong Cai Jing· 2025-09-30 06:56
Core Viewpoint - The company, Iminconco-B (01541), has submitted an application for the III phase clinical trial of IMM0306, a dual-targeting bispecific molecule targeting CD47 and CD20, marking it as the first of its kind to enter clinical stages globally [1] Group 1: Clinical Developments - The company has independently developed IMM0306, which targets both CD47 and CD20, and holds global intellectual property and commercialization rights for this molecule [1] - The company previously announced I phase data for IMM2510 at the 2025 World Lung Cancer Conference, reporting an overall response rate (ORR) of 35.3% and a progression-free survival (PFS) of 9.4 months, indicating excellent clinical data and safety [1] Group 2: Market Position and Valuation - The company is recognized as a global innovator in CD47 fusion proteins, with a rich pipeline and broad application prospects in oncology and autoimmune diseases [1] - Current market capitalization is approximately 5.7 billion HKD, suggesting that the company's value is significantly underestimated, prompting recommendations for active monitoring [1]
宜明昂科-B午后涨超4% IMM0306递交III期临床实验申请 有望成为自免领域重磅药物
Zhi Tong Cai Jing· 2025-09-30 06:53
Core Viewpoint - The company has submitted an application for the III phase clinical trial of IMM0306 to the National Medical Products Administration, marking it as the world's first dual-targeting bispecific molecule for CD47 and CD20 to enter clinical stages [1] Group 1: Company Developments - The stock price of the company increased by over 4% in the afternoon, with a current price of 13.49 HKD and a trading volume of 37.32 million HKD [1] - The company holds global intellectual property and commercialization rights for IMM0306 [1] - The company previously announced I phase data for IMM2510 at the 2025 World Lung Cancer Conference, reporting an overall response rate (ORR) of 35.3% and a progression-free survival (PFS) of 9.4 months, indicating excellent clinical data and safety [1] Group 2: Market Position and Valuation - The company is recognized as a global innovator in CD47 fusion proteins, with a rich pipeline and broad application prospects in oncology and autoimmune fields [1] - The current market capitalization of the company is only 5.7 billion HKD, suggesting it is significantly undervalued [1] - Analysts recommend actively monitoring the company due to its promising clinical efficacy data for the CD47CD20 bispecific antibody (IMM0306) and its enhanced risk resilience [1]
宜明昂科-B(01541):IMM0306治疗滤泡性淋巴瘤的III期临床试验申请
智通财经网· 2025-09-29 15:07
Core Viewpoint - The company has submitted an application for the Phase III clinical trial of IMM0306 to the National Medical Products Administration of China, marking a significant step in its development of a dual-targeting bispecific molecule for cancer treatment [1] Group 1: Product Development - IMM0306 is a dual-targeting bispecific molecule that targets CD47 and CD20, making it the first of its kind to enter clinical stages globally [1] - The mechanism of IMM0306 involves inhibiting the CD47-SIRPα interaction to block the "don't eat me" signal, enhancing the interaction between Fc-FcɣRIIa and Fc-FcɣRIIIa to activate macrophages and NK cells [1] - The molecule preferentially binds to CD20 rather than CD47, effectively eliminating malignant B cells while minimizing toxicity, which could improve treatment outcomes [1] Group 2: Intellectual Property and Commercial Rights - The company holds global intellectual property and commercialization rights for IMM0306 as of the date of the announcement [1]
宜明昂科-B(01541.HK)已向药监局提交IMM0306治疗滤泡性淋巴瘤的III期临床试验申请
Ge Long Hui· 2025-09-29 15:06
Core Viewpoint - The company has submitted an application for the Phase III clinical trial of IMM0306 to the National Medical Products Administration of the People's Republic of China, marking a significant step in its development of a novel dual-targeting bispecific molecule [1] Group 1: Product Development - IMM0306 is a dual-targeting bispecific molecule that targets CD47 and CD20, making it the first of its kind to enter clinical stages globally [1] - The mechanism of IMM0306 involves inhibiting the CD47-SIRPα interaction to block the "don't eat me" signal, thereby enhancing the activation of macrophages and NK cells [1] - The molecule preferentially binds to CD20 rather than CD47, which allows for effective elimination of malignant B cells while minimizing toxicity, potentially improving treatment outcomes [1] Group 2: Intellectual Property and Commercialization - The company holds global intellectual property and commercialization rights for IMM0306 as of the date of the announcement [1]
宜明昂科-B:IMM0306治疗滤泡性淋巴瘤的III期临床试验申请
Zhi Tong Cai Jing· 2025-09-29 15:04
Core Viewpoint - The company has submitted an application for the Phase III clinical trial of IMM0306 to the National Medical Products Administration of China, marking a significant step in the development of a novel dual-targeting bispecific molecule for cancer treatment [1] Group 1: Product Development - IMM0306 is a dual-targeting bispecific molecule that targets CD47 and CD20, making it the first of its kind to enter clinical stages globally [1] - The mechanism of IMM0306 involves inhibiting the CD47-SIRPα interaction to block the "don't eat me" signal, enhancing the interaction between Fc-Fc RIIa and Fc-Fc RIIIa to activate macrophages and NK cells [1] - The molecule preferentially binds to CD20 rather than CD47, effectively eliminating malignant B cells while minimizing toxicity, thereby improving therapeutic outcomes [1] Group 2: Intellectual Property and Commercialization - The company holds global intellectual property and commercialization rights for IMM0306 as of the date of the announcement [1]