双特异性分子药物研发
Search documents
宜明昂科-B(01541):药品审评中心批准IMM0306治疗复发╱难治性滤泡性淋巴瘤的III期临床研究方案
Zhi Tong Cai Jing· 2025-11-27 04:45
Core Viewpoint - The approval of the Phase III clinical study protocol for IMM0306 by the National Medical Products Administration marks a significant advancement in innovative therapies for relapsed/refractory follicular lymphoma [1] Group 1: Company Developments - The company has received approval for the Phase III clinical study of IMM0306 in combination with lenalidomide for treating relapsed/refractory follicular lymphoma [1] - 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 company holds global intellectual property and commercialization rights for IMM0306 [1] Group 2: Product Mechanism - IMM0306 works by inhibiting the CD47-SIRPα interaction to block the "don't eat me" signal, enhancing the interaction between Fc-FcγRIIa and Fc-FcγRIIIa 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 treatment outcomes [1]
宜明昂科-B(01541.HK):药品审评中心批准IMM0306治疗复发/难治性滤泡性淋巴瘤的III期临床研究方案
Ge Long Hui· 2025-11-27 04:28
由集团独立研发的IMM0306是一种靶向分化簇47(CD47)及分化簇20(CD20)的双特异性分子,是全球首 个进入临床阶段的CD47和CD20双靶向双特异性分子。IMM0306透过抑制CD47-SIRPα相互作用来阻断 「别吃我」讯号,增强FcFcγRIIa和Fc-FcγRIIIa相互作用来激活巨噬细胞和NK细胞,并优先结合CD20而 非CD47,以有效消除恶性B细胞,同时将毒性降至最低,从而可改善治疗效果。截至公告日期,集团 拥有IMM0306的全球知识产权及商业化权利。 格隆汇11月27日丨宜明昂科-B(01541.HK)宣布,公司已获得国家药监局药品审评中心批准IMM0306联合 来那度胺治疗复发╱难治性滤泡性淋巴瘤的III期临床研究方案,标志着复发╱难治性滤泡性淋巴瘤创新 疗法的发展加速。 ...
宜明昂科(01541) - 自愿公告 - 药品审评中心批准IMM0306治疗復发╱难治性滤泡性淋巴瘤...
2025-11-27 04:18
ImmuneOnco Biopharmaceuticals (Shanghai) Inc. 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。 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 由本集團獨立研發的IMM0306是一種靶向分化簇47(CD47)及分化簇20(CD20) 的雙特異性分子,是全球首個進入臨床階段的CD47和CD20雙靶向雙特異性 分子。IMM0306透過抑制CD47-SIRPα相互作用來阻斷「別吃我」訊號,增強Fc- FcγRIIa和Fc-FcγRIIIa相互作用來激活巨噬細胞和NK細胞,並優先結合CD20而 非CD47,以有效消除惡性B細胞,同時將毒性降至最低,從而可改善治療效果。 – 1 – 截至本公告日期,本集團擁有IMM0306的全球知識產權及商業化權利。 藥品審評中心批准IMM0306治療復發╱難治性濾泡性淋巴瘤的III期 臨床研究方案 本公告由宜明昂 ...
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]