Core Viewpoint - The company has entered into a memorandum of understanding to acquire a 16.23% stake in China Gene Engineering Company for approximately HKD 40 million to HKD 45 million, which is seen as a strategic investment to enhance its participation in the healthcare sector and create long-term value [1] Group 1: Acquisition Details - The acquisition involves China Gene Engineering Company, which is registered in Hong Kong and holds approximately 67.68% of Shanghai Huaxin Biological High-tech Co., Ltd [1] - The total consideration for the acquisition is estimated to be between HKD 40 million and HKD 45 million [1] Group 2: Business Synergy - China Gene Group is primarily engaged in the internal research and development, manufacturing, and sales of biopharmaceutical products in China [1] - The acquisition aligns with the company's existing businesses in healthcare product trading, medical device leasing, and providing professional contract research organization (CRO) services [1] Group 3: Strategic Importance - The board views the acquisition as an excellent opportunity to increase the company's involvement in the operations of China Gene Group [1] - This strategic investment is expected to generate potential long-term value and facilitate business development in the promising healthcare industry [1]

（原标题：友芝友生物-B(02496)：M 701取得FDA的IND批准） 本次获批的临床试验是一项开放标签、多中心、Ib/II期临床研究，旨在评估注射用重组抗Ep CAM和 CD3人鼠嵌合双特异性抗体M 701经胸腔内输注治疗晚期上皮性肿瘤所致恶性胸腔积液患者的安全性、 有效性、药代动力学、药效学及免疫原性。 智通财经APP讯，友芝友生物-B(02496)发布公告，于2026年1月31日，注射用重组抗上皮细胞黏附分子 (Ep CAM)和分化簇3(CD3)人鼠嵌合双特异性抗体(M 701)获美国食品药物管理局(FDA)临床试验申请 (IND)批准，标志着这款针对恶性胸腔积液(MPE)的创新疗法迈入国际化临床开发新阶段，为全球患者 带来新希望。 恶性胸腔积液是恶性肿瘤常见且严重并发症，多见于晚期肺癌、乳腺癌患者，目前治疗仍以"姑息为 主"，临床亟需创新策略填补临床空白。M 701精准靶向Ep CAM和CD3，其中Ep CAM在上皮来源恶性 胸腔积液肿瘤细胞中高频表达，是关键治疗靶点;CD3可激活机体抗肿瘤免疫，二者协同实现精准治 疗。 ...

本次获批的临床试验是一项开放标签、多中心、Ib/II期临床研究，旨在评估注射用重组抗EpCAM和 CD3人鼠嵌合双特异性抗体M701经胸腔内输注治疗晚期上皮性肿瘤所致恶性胸腔积液患者的安全性、 有效性、药代动力学、药效学及免疫原性。 智通财经APP讯，友芝友生物-B(02496)发布公告，于2026年1月31日，注射用重组抗上皮细胞黏附分子 (EpCAM)和分化簇3(CD3)人鼠嵌合双特异性抗体(M701)获美国食品药物管理局(FDA)临床试验申请 (IND)批准，标志着这款针对恶性胸腔积液(MPE)的创新疗法迈入国际化临床开发新阶段，为全球患者 带来新希望。 恶性胸腔积液是恶性肿瘤常见且严重并发症，多见于晚期肺癌、乳腺癌患者，目前治疗仍以"姑息为 主"，临床亟需创新策略填补临床空白。M701精准靶向EpCAM和CD3，其中EpCAM在上皮来源恶性胸 腔积液肿瘤细胞中高频表达，是关键治疗靶点;CD3可激活机体抗肿瘤免疫，二者协同实现精准治疗。 ...

Core Viewpoint - The company EPS Creative Technology (03860) has signed a memorandum of understanding to acquire a 16.23% stake in China Gene Engineering Co., Ltd. from Hongshida Medical Co., Ltd. for approximately HKD 40 million to HKD 45 million, which is seen as a strategic investment to enhance its involvement in the healthcare sector and create long-term value [1][1][1] Group 1 - The acquisition involves China Gene Engineering, a Hong Kong-registered company that holds about 67.68% of Shanghai Huaxin Bio-Technology Co., Ltd. [1] - The transaction is expected to complement the company's existing businesses in healthcare product trading, medical device leasing, and providing professional contract research organization (CRO) services [1][1] - Upon completion, the investment in China Gene will be recognized as an investment in an associate company in the group's consolidated financial statements [1]

Core Viewpoint - The company, EPS Creation Technology (03860.HK), has signed a memorandum of understanding to acquire a 16.23% stake in China Gene Engineering Co., Ltd, which is seen as a strategic investment to enhance its involvement in the biopharmaceutical sector and create long-term value [1] Group 1: Acquisition Details - The acquisition involves China Gene Engineering Co., Ltd, a company registered in Hong Kong, which holds approximately 67.68% of Shanghai Huaxin Biological High-Tech Co., Ltd [1] - The acquisition is expected to be recognized as an investment in an associate company in the consolidated financial statements of the group upon completion [1] Group 2: Strategic Importance - The board believes that this acquisition presents an excellent opportunity for the group to expand its operational involvement with China Gene Group [1] - The investment aligns with the group's existing business in healthcare product trading, medical device leasing, and providing professional contract research organization (CRO) services, thereby complementing its current operations [1]

Core Viewpoint - The approval of the clinical trial application for M701 by the FDA marks a significant advancement in the international clinical development of an innovative therapy targeting malignant pleural effusion (MPE), providing new hope for patients globally [1] Group 1: Product Development - The product M701 is a recombinant bispecific antibody targeting epithelial cell adhesion molecule (Ep CAM) and cluster of differentiation 3 (CD3), specifically designed for treating MPE [1] - M701 targets Ep CAM, which is highly expressed in tumor cells associated with epithelial-derived malignant pleural effusion, making it a critical therapeutic target [1] - The clinical trial is an open-label, multicenter, Phase Ib/II study aimed at evaluating the safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of M701 in patients with malignant pleural effusion caused by advanced epithelial tumors [1] Group 2: Clinical Need - Malignant pleural effusion is a common and severe complication of malignant tumors, particularly in patients with advanced lung and breast cancers, highlighting the urgent need for innovative treatment strategies to fill the clinical gap [1] - Current treatment approaches primarily focus on palliative care, indicating a significant opportunity for new therapeutic options in this area [1]

香港交易及結算所有限公司以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，概不會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。 本公司董事（「董事」）會（「董事會」）謹此向本公司股東（「股東」）及本公司潛在投資者提供 更新資料，經進一步策略性考量後，本集團正考慮收購目標公司的間接少數權益，而非 先前該公告所披露的控股權。 於二零二六年二月三日，本公司（作為買方）與鴻事達醫療有限公司（「賣方」）（作為賣方） 就建議收購中國基因工程有限公司（「中國基因」）16.23%股權（「建議收購事項」）訂立諒解 備忘錄（「諒解備忘錄」）。中國基因為一間於香港註冊成立的公司，實益擁有上海華新生 物高技術有限公司（「華新」）約67.68%股權。華新為一間於中華人民共和國（「中國」）註冊 成立的公司，連同中國基因及其附屬公司統稱「中國基因集團」。 訂約方協定將以真誠原則進行磋商，確保儘快就建議收購事項訂立正式協議（「正式協 議」），惟無論如何不得遲於二零二六年三月六日或訂約方或會協定的任何較後日期。除 包括獨家及保密等對訂約方具有約束力的若干條款 ...

Core Viewpoint - The approval of the clinical trial application for M701, a bispecific antibody targeting EpCAM and CD3, marks a significant advancement in the international clinical development of a novel therapy for malignant pleural effusion (MPE), providing new hope for patients globally [1] Group 1: Product Development - The clinical trial for M701 has been approved by the U.S. Food and Drug Administration (FDA) and is set to begin on January 31, 2026 [1] - M701 specifically targets EpCAM and CD3, with EpCAM being highly expressed in tumor cells associated with malignant pleural effusion, making it a critical therapeutic target [1] - The trial is an open-label, multicenter, Phase Ib/II study aimed at evaluating the safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of M701 in patients with advanced epithelial tumors causing malignant pleural effusion [1] Group 2: Market Need - Malignant pleural effusion is a common and severe complication of malignant tumors, particularly in late-stage lung and breast cancer patients, highlighting the urgent need for innovative treatment strategies to fill clinical gaps [1] - Current treatment approaches primarily focus on palliative care, indicating a significant opportunity for new therapeutic options in this area [1]

Group 1 - The company has indicated that its 120-ton recombinant human albumin production line is expected to be completed by 2026, with new capacity dependent on equipment debugging and approval from the drug regulatory authority [2] - The company's drug, Ofumin®, is anticipated to be approved for market entry in July 2025, with steady progress in hospital access and distribution channel development [2] - There is currently a supply-demand imbalance in the market, indicating a strong demand for the company's products [2]

1、原发性免疫球蛋白缺乏症，如X联锁低免疫球蛋白血症，常见变异性免疫缺陷病，免疫球蛋白G亚型 缺陷病等。 格隆汇2月3日丨派林生物(000403.SZ)公布，近日，公司之全资子公司广东双林生物制药有限公司收到 国家药品监督管理局核准签发的静注人免疫球蛋白药品补充申请《受理通知书》。 静注人免疫球蛋白主要适应症包括： 经查询，目前国内拥有静注人免疫球蛋白(5g/瓶，10%，50ml)上市批件的企业包括成都蓉生药业有限责 任公司、贵州泰邦生物制品有限公司以及华润博雅生物制药集团股份有限公司。 2024年5月，广东双林收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，同意广东双 林开展静注人免疫球蛋白(10%)适应症为原发免疫性血小板减少症(ITP)的临床试验；2025年4月，广东 双林收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，同意广东双林开展静注人免疫 球蛋白(10%)新增适应症为治疗慢性炎性脱髓鞘性多发性神经根神经病(CIDP)的临床试验；2025年12 月，广东双林收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，同意广东双林开展静 注人免疫球蛋白(pH4)生产工艺变更后 ...