每经记者｜金喆 每经实习记者｜许立波 林姿辰 每经编辑｜宋思艰 到了审批期的最后一个月，美国食品药品监督管理局（FDA）还是决定对这个全球首款延缓阿尔茨海默 症进程的新药放行。 当地时间6月7日，FDA宣布批准渤健/卫材公司Aβ（β淀粉样蛋白）抗体Aduhelm（Aducanumab）用于 治疗早期阿尔茨海默症（AD）患者的生物制品许可（BLA）申请，这是继2003年后FDA批准的首款阿 尔茨海默药。 消息传出后，渤健股价一度暴涨近60%，国内资本市场也跃跃欲试，绿谷制药等多家布局阿尔茨海默病 的国内企业备受市场关注。 不过，《每日经济新闻》记者注意到，与资本市场的热情不同，业界对这款药的态度"冰火两重天"。回 望此前国内获批的阿尔兹海默药，也难逃被质疑的命运。 靶向Aβ药加速审批，临床效益仍需验证 本次Aducanumab获批之所以引爆舆论，或许主要因为两个因素，一个是阿尔茨海默症本身的热度，另 一个是其一波三折的上市之路。 阿尔茨海默病（AD）又称老年痴呆症，是一种起病隐匿的进行性发展的神经系统退行性疾病。根据世 界卫生组织估计，目前全球约有3500万至5000万阿尔茨海默症患者，并且每年预计将有1000 ...

Core Viewpoint - Alzheimer's disease (AD) is a severe neurodegenerative disorder with significant impacts on individuals and society, yet drug development has faced numerous failures despite substantial investments from major pharmaceutical companies [2][3]. Drug Development and FDA Approvals - In June 2021, the FDA accelerated the approval of Aducanumab, developed by Eisai and Biogen, marking the first new drug for Alzheimer's since 2003, although its approval was controversial due to associated risks like ARIA (Amyloid-related Imaging Abnormalities) [3][6]. - Following Aducanumab, the FDA approved two additional antibody drugs targeting Aβ: Donanemab by Eli Lilly and Lecanemab by Eisai and Biogen, both of which also present ARIA-related side effects [3][6]. Denali Therapeutics' Research - Denali Therapeutics published a study in August 2025 on a new antibody transport carrier, ATV cisLALA, which utilizes transferrin receptor (TfR) to enhance brain delivery of anti-Aβ antibodies while mitigating ARIA risks [4][9]. - The ATV cisLALA carrier shows improved distribution in brain tissue compared to traditional Aβ antibodies, which tend to accumulate around blood vessels, potentially triggering inflammatory responses and ARIA [9][11]. Mechanism of Action - Traditional Aβ antibodies enter the brain through cerebrospinal fluid and perivascular spaces, where amyloid deposits are located, leading to inflammation and ARIA. In contrast, the ATV carrier enhances delivery through capillaries, reducing ARIA side effects [11][12]. - Denali's TfR-based approach is not limited to Aβ; the company is also developing therapies targeting tau protein using the same delivery mechanism, aiming to address two key toxic proteins in Alzheimer's simultaneously [11].