Flutafuranol F-18

近日,先通医药海外参股公司Meilleur及其用于治疗阿尔茨海默病的新一代Aβ-PET显像剂NAV-4694被纳斯达克上市公司Lantheus收购。 美国国家老龄化研究所和阿尔茨海默病协会（NIA-AA）工作组最新发布的修订版指南指出，阿尔茨海默病应使用基于蛋白质的生物标志物进行生物学定义，包括Aβ和Tau在内的生物标志物可用于诊断阿尔茨海默病并提供其严重程度的指标。1 NAV-4694目前正处于临床Ⅲ期开发阶段，已被广泛用于学术和行业的研究性治疗试验。NAV-4694与Lantheus的下一代18F 标记Tau-PET显像剂MK-6240（florquinitau）形成互补，扩大了Lantheus的阿尔茨海默病诊断产品组合。 MK-6240是一款18F标记的高亲和力Tau蛋白PET显像剂。该药物对Tau蛋白的探测显像对比度高，可无创、精准、定位、定量地呈现阿尔兹海默病患者脑部Tau蛋白沉积的病理变化。此前，Lantheus通过收购Cerveau公司获得了MK-6240的全球权益，而先通医药是Cerveau的股东之一。根据现有的再许可协议，先通医药保留了MK-6240在中国的权益。 Aβ-PET阳性显像能够提示存在AD病理改变，结合Tau-PET检测结果，对AD早期诊断、鉴别诊断、抗Aβ治疗后疗效评价、AD药物临床试验患者筛选具有显著价值。 根据协议条款，Lantheus 将支付预付款及潜在的额外开发和商业里程碑付款。此外，Lantheus 还将为研究收入和商业销售支付特许权使用费。该协议以股票购买的形式签订，规定Meilleur将在交易完成后的规定时间内提供过渡和临床开发服务。 先通医药CEO唐艳旻表示：“这是一次激动人心的收购，我们非常看好Aβ-PET和Tau-PE在阿尔茨海默病早期诊断，临床分期及治疗前后疗效评估等方面的应用潜力,它们的联合使用将为阿尔茨海默病的诊疗决策提供有力的证据。” 在中国,先通医药则通过Aβ-PET显像剂欧韦宁®氟[18F]贝他苯注射液与Tau-PET显像剂MK-6240的组合,助力阿尔茨海默病患者实现早诊早治。 参考文献 1.Jack CR, et.al. Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association Workgroup. Alzheimer’s Dement 2024;1-27. https://doi.org/10.1002/alz.13859 先通医药是中国创新放射性药物领域的领先企业，专注于放射性药物的研发创新及落地应用以改善患者的健康水平。先通医药于2014年正式开展新一代放射性药物的研发，总部位于北京，在上海设有研发中心，在江苏、广东、四川建设有现代化放射性药物智能生产基地；同时，在美国设有分支机构，并与十几家跨国药企达成战略合作。全球放射性药物主要应用于神经、心血管、肿瘤三大疾病领域，先通医药已实现全面布局，并拥有20+精准诊断和靶向治疗放射性药物研发管线。凭借自身的研发优势，先通医药获得了投资机构的青睐，2020年4月至今，已成功募资超20亿元人民币，未来不久将登陆主要资本市场，成为中国放射性药物领域的创新力量。 内容来源于网络，如有侵权，请联系删除。

Lantheus pitched Meilleur’s amyloid-targeting NAV-4694 as a complement to its PET agent MK-6240, which is aimed at Alzheimer’s tau tangles. Lantheus is expanding its holdings of PET imaging agents for Alzheimer’s disease, with the acquisition of Meilleur Technologies.  The deal grants Lantheus exclusive worldwide rights to Meilleur’s radiopharmaceutical diagnostic that highlights beta amyloid plaques in the brain. The injectable agent—known as NAV-4694, or F18-flutafuranol—is currently in phase 3 development.  The acquisition comes just days after the Centers for Medicare and Medicaid Services proposed a separate payment pathway for certain diagnostic radiopharmaceuticals and nuclear medicine imaging agents—instead of bundling them as part of the procedure, as it had in the past.  The change was put forward in CMS’ proposal for payment systems among hospital outpatient services and ambulatory surgical centers, set for the 2025 calendar year. Lantheus’ stock price jumped nearly 60% on the news. The deal also follows the FDA’s approval earlier this month of Eli Lilly’s Kisunla (donanemab-abzt) treatment for Alzheimer’s, seen as a challenger to Biogen and Eisai’s Leqembi in a newly burgeoning area of anti-amyloid therapies. “This acquisition solidifies our commitment to neurology, specifically for Alzheimer’s disease management, and reinforces our radiopharmaceutical leadership,” Lantheus CEO Brian Markison said in a statement, which pitched Meilleur’s NAV-4694 as a complement to the company’s PET agent MK-6240, aimed at Alzheimer’s tau tangles. The companies estimate that nearly 12 million people are living with mild cognitive impairment or Alzheimer’s disease in the U.S. today, a number that may pass 20 million by 2050.  “With the combination of MK-6240 and NAV-4694, we are poised to provide important insights for guiding the use and assessing the impact of novel disease-modifying Alzheimer’s treatments,” Markison said. Lantheus previously acquired MK-6240, an F18-labeled agent also known as florquinitau, in February 2023 through its buyout of Cerveau Technologies.  While the exact financial terms of Lantheus’ deal with Meilleur were not disclosed, the companies said the stock purchase agreement includes an upfront payment as well as additional R&D and commercial milestones, plus royalties. Meilleur will also provide transitional clinical development services for a set time. “We are excited by the potential of NAV-4694 for earlier identification of Alzheimer’s patients, empowering clinicians to select suitable candidates for timely therapeutic interventions,” said Meilleur CEO Rick Hiatt. “With Lantheus’ expertise in radiopharmaceutical diagnostics and ability to scale operations, I am confident that Lantheus is the ideal company to bring this late-stage biomarker through pivotal trials and into commercialization to one day benefit patients at risk of Alzheimer’s disease.”