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宜明昂科-B午后涨超9% IMM0306的III期临床研究方案获CDE许可
Zhi Tong Cai Jing· 2025-11-27 06:02
Core Viewpoint - The approval of the clinical research plan for IMM0306 marks a significant advancement in innovative therapies for relapsed/refractory follicular lymphoma, leading to a notable increase in the company's stock price [1] Company Summary - 宜明昂科-B (01541) experienced a stock price increase of over 9%, currently trading at 7.31 HKD with a transaction volume of 10.70 million HKD [1] - The company has received approval from the National Medical Products Administration for the III phase clinical research plan of IMM0306 in combination with lenalidomide for treating relapsed/refractory follicular lymphoma [1] - IMM0306 is the world's first clinical-stage dual-targeting bispecific molecule targeting CD47 and CD20, designed to block the "don't eat me" signal, activating macrophages and NK cells [1] - The drug preferentially binds to CD20 rather than CD47, effectively eliminating malignant B cells while minimizing toxicity, thereby improving treatment outcomes [1] - The company holds global intellectual property and commercialization rights for IMM0306 [1]
港股异动 | 宜明昂科-B(01541)午后涨超9% IMM0306的III期临床研究方案获CDE许可
智通财经网· 2025-11-27 05:58
Core Viewpoint - Yiming Oncology-B (01541) experienced a significant stock increase of over 9%, currently trading at 7.31 HKD, following the approval of its clinical research protocol for IMM0306 by the National Medical Products Administration [1] Group 1: Company Developments - Yiming Oncology announced that it has received approval for the Phase III clinical study of IMM0306 in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma [1] - IMM0306 is the world's first dual-targeting bispecific molecule targeting CD47 and CD20, designed to block the "don't eat me" signal, thereby activating macrophages and NK cells [1] - The drug preferentially binds to CD20 rather than CD47, effectively eliminating malignant B cells while minimizing toxicity, which could enhance treatment outcomes [1] Group 2: Market Reaction - Following the announcement, Yiming Oncology's stock price rose by 7.98%, with a trading volume of 10.70 million HKD [1]
宜明昂科: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
Ge Long Hui A P P· 2025-11-27 04:49
Core Viewpoint - The approval of the III phase clinical research protocol for IMM0306 in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma marks a significant advancement in innovative therapies for this condition [1] Group 1 - The company has received approval from the National Medical Products Administration (NMPA) for the clinical study [1] - The study focuses on relapsed/refractory follicular lymphoma, indicating a targeted approach to a specific patient population [1] - This development accelerates the progress of innovative treatments in the field of oncology [1]
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: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 04:41
Core Viewpoint - The company has received approval from the National Medical Products Administration for the Phase III clinical study of IMM0306 in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma, marking a significant advancement in innovative therapies for this condition [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-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] 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):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.HK)完成配售2420万股 净筹3.451亿港元
Ge Long Hui· 2025-10-16 04:21
Core Viewpoint - Yiming Anke-B (01541.HK) has successfully completed a placement agreement, raising approximately HKD 345.1 million for various research and operational purposes [1] Group 1: Placement Details - The placement involved the successful allocation of 24.2 million shares at a price of HKD 14.50 per share, representing about 5.94% of the company's issued share capital prior to the placement [1] - The shares allocated account for approximately 6.11% of the total issued H-shares before the placement and about 5.61% and 5.76% of the issued share capital and H-shares, respectively, after the placement [1] Group 2: Use of Proceeds - Approximately 40% of the net proceeds will be allocated to fund the research and development of IMM2510 and IMM27M for the treatment of solid tumors [1] - About 20% will be used for the development of IMM01 (Tideglusib) [1] - Approximately 10% will be directed towards the research of IMM0306 [1] - The remaining 30% will be utilized to supplement the company's working capital and for general corporate purposes [1]
簡訊:宜明昂科折讓13%配股筹3.5亿港元
Xin Lang Cai Jing· 2025-10-09 04:58
Group 1 - Company Innovent Biologics (1541.HK) announced a placement of 24.2 million new H-shares, representing approximately 5.61% of the enlarged share capital, to raise HKD 351 million (USD 45 million) at a price of HKD 14.5 per share, which is a discount of about 12.97% from the previous closing price of HKD 16.66 [3] - The estimated net proceeds of approximately HKD 345 million will be used to fund the research and development of IMM2510 and IMM27M for the treatment of solid tumors, as well as for the development of IMM01 (Tislelizumab) and IMM0306, and to supplement working capital and general corporate purposes [3] - The company has submitted an application to the National Medical Products Administration for a Phase III clinical trial of IMM2510 for the treatment of immune-resistant non-small cell lung cancer (NSCLC) [3] Group 2 - The company's stock opened lower on Thursday, trading at HKD 14.46 at noon, down 13.21%. However, the stock has increased by 180% year-to-date [3]
宜明昂科-B拟配售2420万股 净筹约3.45亿港元
Zhi Tong Cai Jing· 2025-10-09 00:34
Core Viewpoint - The company plans to issue a total of 24.2 million new H-shares at a price of HKD 14.50 per share, representing a discount of approximately 12.97% from the closing price of HKD 16.66 on October 8, 2025 [1] Fundraising Details - The total estimated gross proceeds from the placement are approximately HKD 350.9 million, with net proceeds estimated at around HKD 345 million [1] - The net proceeds will be allocated as follows: - Approximately 40% for funding the research and development of IMM2510 and IMM27M for the treatment of solid tumors - Approximately 20% for funding the research and development of IMM01 (Tideglusib) - Approximately 10% for funding the research and development of IMM0306 - Approximately 30% for supplementing the company's working capital and general corporate purposes [1]