[18F]Florbetazine ([18F]92) is a molecularly targeted imaging agent for Aβ protein with a novel diaryl-azine scaffold. It has shown specific binding affinity to Aβ aggregates in postmortem human AD brains and excellent brain pharmacokinetic properties with little non-specific retention in white matter in animal studies and a limited number of patients with Alzheimer's Disease (AD).
The purpose of the current study is to examine the binding properties of [18F]Florbetazine in human subjects and to compare the cortical and white matter binding with [11C]PiB or [18F]Florbetapir in the same subjects.
Imaging of the brain will be completed in healthy adult normal control participants and participants with cognitive impairment (including probable AD and dementia due to other conditions) to characterize [18F]Florbetazine uptake in the brain and its binding properties. [11C]PIB or [18F]Florbetapir PET imaging along with MRI will be completed in the same participants and the data will be compared with 18F-[18F]Florbetazine.

开始日期2023-01-30

申办/合作机构

北京协和医院

NCT05184088 / Recruiting临床3期

An Open-label, Multi-center, Non-randomized Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of [18F]Florbetaben Positron Emission Tomography (PET) Imaging to Diagnose Cardiac AL Amyloidosis

This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with suspected cardiac amyloidosis.

开始日期2023-01-13

申办/合作机构

Life Molecular Imaging Ltd.

[+1]

NCT05361382 / Recruiting临床1期IIT

Longitudinal Multicenter Head-to-Head Harmonization of Tau PET Tracers

The purpose of this study is to compare/harmonize cross-sectional and longitudinal tau tangle measurements obtained with the tau PET radiopharmaceuticals Flortaucipir and MK-6240 to elucidate the advantages and caveats of their use in clinical trials/practice and provide parameters to integrate their estimates.

开始日期2021-11-23

申办/合作机构

University of Pittsburgh

[+1]

100 项与氟[¹⁸F]贝他苯相关的临床结果

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100 项与氟[¹⁸F]贝他苯相关的转化医学

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100 项与氟[¹⁸F]贝他苯相关的专利（医药）

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项与氟[¹⁸F]贝他苯相关的文献（医药）

2024-02-21·ACS Chemical Neuroscience

Design, Synthesis, and Biological Investigation of Quinazoline Derivatives as Multitargeting Therapeutics in Alzheimer’s Disease Therapy

Article

作者: Singh, Namrata ; Singh, Neha ; Bhardwaj, Bhagwati ; Verma, Akash ; Trigun, Surendra Kumar ; Krishnamurthy, Sairam ; Waiker, Digambar Kumar ; Saraf, Poorvi ; Shrivastava, Sushant Kumar ; Roy, Anima

An efficient and promising method of treating complex neurodegenerative diseases like Alzheimer's disease (AD) is the multitarget-directed approach. Here in this work, a series of quinazoline derivatives (AV-1 to AV-21) were rationally designed, synthesized, and biologically evaluated as multitargeted directed ligands against human cholinesterase (hChE) and human β-secretase (hBACE-1) that exhibit moderate to good inhibitory effects. Compounds AV-1, AV-2, and AV-3 from the series demonstrated balanced and significant inhibition against these targets. These compounds also displayed excellent blood-brain barrier permeability via the PAMPA-BBB assay. Compound AV-2 significantly displaced propidium iodide (PI) from the acetylcholinesterase-peripheral anionic site (AChE-PAS) and was found to be non-neurotoxic at the maximum tested concentration (80 μM) against differentiated SH-SY5Y cell lines. Compound AV-2 also prevented AChE- and self-induced Aβ aggregation in the thioflavin T assay. Additionally, compound AV-2 significantly ameliorated scopolamine and Aβ-induced cognitive impairments in the in vivo behavioral Y-maze and Morris water maze studies, respectively. The ex vivo and biochemical analysis further revealed good hippocampal AChE inhibition and the antioxidant potential of the compound AV-2. Western blot and immunohistochemical (IHC) analysis of hippocampal brain revealed reduced Aβ, BACE-1, APP/Aβ, and Tau molecular protein expressions levels. The pharmacokinetic analysis of compound AV-2 demonstrated significant oral absorption with good bioavailability. The in silico molecular modeling studies of lead compound AV-2 moreover demonstrated a reasonable binding profile with AChE and BACE-1 enzymes and stable ligand-protein complexes throughout the 100 ns run. Compound AV-2 can be regarded as the lead candidate and could be explored more for AD therapy.

2024-02-01·European Journal of Nuclear Medicine and Molecular Imaging

Impact of simulated reduced injected dose on the assessment of amyloid PET scans

Article

作者: Gispert, Juan Domingo ; Perissinotti, Andrés ; Niñerola-Baizan, Aida ; Collij, Lyduine E ; Zaidi, Habib ; Rieckmann, Anna ; Lubberink, Mark ; Young, Peter ; Frisoni, Giovanni B ; Axelsson, Jan ; Sanaat, Amirhossein ; Schöll, Michael ; Heeman, Fiona ; Garibotto, Valentina ; Hitzel, Anne ; Baker, Suzanne ; Barkhof, Frederik ; Farrar, Gill

AbstractPurposeTo investigate the impact of reduced injected doses on the quantitative and qualitative assessment of the amyloid PET tracers [18F]flutemetamol and [18F]florbetaben.MethodsCognitively impaired and unimpaired individuals (N = 250, 36% Aβ-positive) were included and injected with [18F]flutemetamol (N = 175) or [18F]florbetaben (N = 75). PET scans were acquired in list-mode (90–110 min post-injection) and reduced-dose images were simulated to generate images of 75, 50, 25, 12.5 and 5% of the original injected dose. Images were reconstructed using vendor-provided reconstruction tools and visually assessed for Aβ-pathology. SUVRs were calculated for a global cortical and three smaller regions using a cerebellar cortex reference tissue, and Centiloid was computed. Absolute and percentage differences in SUVR and CL were calculated between dose levels, and the ability to discriminate between Aβ- and Aβ + scans was evaluated using ROC analyses. Finally, intra-reader agreement between the reduced dose and 100% images was evaluated.ResultsAt 5% injected dose, change in SUVR was 3.72% and 3.12%, with absolute change in Centiloid 3.35CL and 4.62CL, for [18F]flutemetamol and [18F]florbetaben, respectively. At 12.5% injected dose, percentage change in SUVR and absolute change in Centiloid were < 1.5%. AUCs for discriminating Aβ- from Aβ + scans were high (AUC ≥ 0.94) across dose levels, and visual assessment showed intra-reader agreement of > 80% for both tracers.ConclusionThis proof-of-concept study showed that for both [18F]flutemetamol and [18F]florbetaben, adequate quantitative and qualitative assessments can be obtained at 12.5% of the original injected dose. However, decisions to reduce the injected dose should be made considering the specific clinical or research circumstances.

2024-02-01·Journal of Nuclear Medicine

Early-Frame [¹⁸F]Florbetaben PET/MRI for Cerebral Blood Flow Quantification in Patients with Cognitive Impairment: Comparison to an [¹⁵O]Water Gold Standard

Article

作者: Vossler, Hillary ; Moseley, Michael ; Zhao, Moss ; Henderson, Victor W ; Mormino, Elizabeth ; Zeineh, Michael ; Zaharchuk, Greg ; Jovin, Maria ; Chen, Kevin T ; Boada, Fernando ; Davidzon, Guido ; Fettahoglu, Ates ; Khalighi, Mehdi

Cerebral blood flow (CBF) may be estimated from early-frame PET imaging of lipophilic tracers, such as amyloid agents, enabling measurement of this important biomarker in participants with dementia and memory decline. Although previous methods could map relative CBF, quantitative measurement in absolute units (mL/100 g/min) remained challenging and has not been evaluated against the gold standard method of [¹⁵O]water PET. The purpose of this study was to develop and validate a minimally invasive quantitative CBF imaging method combining early [¹⁸F]florbetaben (eFBB) with phase-contrast MRI using simultaneous PET/MRI. Methods: Twenty participants (11 men and 9 women; 8 cognitively normal, 9 with mild cognitive impairment, and 3 with dementia; 10 β-amyloid negative and 10 β-amyloid positive; 69 ± 9 y old) underwent [¹⁵O]water PET, phase-contract MRI, and eFBB imaging in a single session on a 3-T PET/MRI scanner. Quantitative CBF images were created from the first 2 min of brain activity after [¹⁸F]florbetaben injection combined with phase-contrast MRI measurement of total brain blood flow. These maps were compared with [¹⁵O]water CBF using concordance correlation (CC) and Bland-Altman statistics for gray matter, white matter, and individual regions derived from the automated anatomic labeling (AAL) atlas. Results: The 2 methods showed similar results in gray matter ([¹⁵O]water, 55.2 ± 14.7 mL/100 g/min; eFBB, 55.9 ± 14.2 mL/100 g/min; difference, 0.7 ± 2.4 mL/100 g/min; P = 0.2) and white matter ([¹⁵O]water, 21.4 ± 5.6 mL/100 g/min; eFBB, 21.2 ± 5.3 mL/100 g/min; difference, -0.2 ± 1.0 mL/100 g/min; P = 0.4). The intrasubject CC for AAL-derived regions was high (0.91 ± 0.04). Intersubject CC in different AAL-derived regions was similarly high, ranging from 0.86 for midfrontal regions to 0.98 for temporal regions. There were no significant differences in performance between the methods in the amyloid-positive and amyloid-negative groups as well as participants with different cognitive statuses. Conclusion: We conclude that eFBB PET/MRI can provide robust CBF measurements, highlighting the capability of simultaneous PET/MRI to provide measurements of both CBF and amyloid burden in a single imaging session in participants with memory disorders.

项与氟[¹⁸F]贝他苯相关的新闻（医药）

2024-04-09

·同写意

风口上的核药

为打造全球ADC/RDC未来产业高地，成都医学城拟于2024年4月18日-19日举办首届未来XDC新药大会！大会以“共创偶联药物产业未来”为主题，由同写意策划，安排一场主论坛和九场主题论坛，邀请“政、产、学、研、金、媒”各领域专家，通过“成果发布、主题演讲、热点对话、表彰颁奖、展览展示”五位一体的多元化的组织形式，迸发更多XDC产业新科技、新业态、新模式，构建XDC产业全新生态，触摸医药产业未来脉动。2024年，多家Biotech逆势获得大额的融资，他们之前的共同点是：核药。为什么？1895年，伦琴发现了X射线，这后来被医疗行业用于CT，成为CT诊断技术的核心。1898年，居里夫人发现了放射性元素钋和镭。随后，20世纪初，在居里夫人的指导下，人们第一次将放射性同位素用于治疗癌症。诊断和治疗，两种完全不同的效果，竟然可以来源于同一种药物，这就是日渐“翻红”的放射性核素药物（简称：核药）。近几年，诺华、礼来、默沙东、阿斯利康等跨国药企纷纷通过并购/合作加码核药管线。▲核药的分类（来源：中伦视界）在“翻红”之前，核药经历过漫长的“冰河时代”，尤其在治疗端。1951年，全球首个核药碘[131I]化钠获FDA批准上市，用于甲状腺疾病的诊断和治疗，随后，碘[123I]氟潘、18F-FDG（氟[131F]脱氧葡糖注射液）等产品相继获批，核药在诊断方面的应用进一步加深。但核药治疗端受限于上游核素产能、监管要求过严和安全性存疑等原因，发展停滞不前。2002年和2003年在美国上市的Zevalin（替伊莫单抗，来自日本IDEC公司）和Bexxar（碘[ 131I]托西莫单抗，Corxia与葛兰素史克公司联合研制）即便安全性和疗效都不错，也由于当时市场教育不足、医保报销困难等，商业化难言成功。2013年，拜耳Xofigo（氯化镭[223Ra]）上市用于治疗前列腺癌，其销售额便稳步上升，2017年达到4.71亿美元。虽然这种传统疗法无法迁移运用到其他癌种之上，但并不影响诺华看到核药的潜力。2017年，诺华39亿美元收购法国核药创新公司Advanced Accelerator Applications（AAA），获得了放射性配体疗法Lutathera 和相关技术平台。2018年，诺华又以21亿美元收购Endocyte公司，进而获得更多放射性配体疗法，如治疗前列腺癌的177Lu-PSMA-617和255AC-PSMA-617等。两起并购树立了诺华在核药领域的领先地位。2018年，诺华收购得来的新型靶向放射性疗法（也称放射性核素偶联药物，即RDC）Lutathera（靶点为SSTR）获FDA批准；2022年，诺华又宣布另一RDC产品Pluvicto（靶点为PSMA）上市。自2016年以来，FDA批准了近10款RDC产品，其中8成为诊断药物，唯2款为治疗药物，也就是诺华的这两款。RDC这种新型核药的原理与大热的ADC（抗体偶联药物）基本一致，只不过杀伤癌细胞的小分子毒素等被替换成了放射性核素，通过靶向分子将放射性核素递送至肿瘤细胞组织，近距离精准杀伤癌细胞，不仅高效低毒，还让行业看到了此类产品在其它靶点和适应症拓展的潜力。2023年，Ludera营收6.05亿美元，同比+28%; 上市不到两年的Pluvicto营收爆发，2023年达到惊人的9.80亿美元，同比+262%。核药市场被彻底引爆。1Biotech与MNC的接力游戏当前的环境下，存量资本在寻找最有市场想象力和商业回报的投资方向。核药这一小众赛道颇受制药企业和投资人青睐。根据医药魔方数据库，2023年核药赛道的融资金额已经达到了60亿美元。此外，诺华、礼来、强生等MNC或通过并购合作，或通过股权投资，也在不断加码核药，呈现出一派欣欣向荣的景象。不过，在这场核药翻红过程中，核药Biotech难逃被收购/BD的命运。这其中，除了MNC拥有大量的资金可以通过并购/BD弯道超车以外，也是由核药这个赛道的特殊属性所决定的。居里夫人成功分离出放射性同位素，却也因为过度暴露于辐射中而罹患白血病。这让放射性核素的危险性深入人心。核药的放射性，决定了它既要遵循药品研发生产的一般性规定，也要在从上游生产、中游运输到下游的临床应用遵循关于核药的特殊安全性规定，建设防辐射设施、减少人员的辐射暴露。同时，放射性同位素的活性在特定时间段内减弱，因此需要及时递送和施用给患者。由于给药时间窗口有限，这些药物通常以单人剂量的形式生产，并需要考虑运输包装、运输距离、以及周期的药物递送；使用也需要在有核药临床使用资质的医疗机构，医院也需要为患者配备专门的病房。即便是诺华，也在核药的商业化上遭遇过瓶颈。诺华Pluvicto的有效期从工厂包装好开始计时只有5天；Lutathera更短，只有3天。这让全球分散建厂成为刚需，但核药的放射性原料与生产获批又面临着不同国家的资质审查以及海关限制。2018年上市的Lutathera，前两年销售额增长非常迅猛，在获批的第一年就实现了1.67亿美元的营收，第二年就增长到了4.41亿美元，但是随后便停留在顶峰。究其原因，Lutathera的适应症（胃肠胰腺神经内分泌肿瘤）市场空间本就有限固然是一部分原因，医疗机构资质和生产运输周期限制了Lutathera的大面积推广也是关键因素。为了解决这一问题，诺华已在意大利、西班牙、美国、中国分别设立了多个放射性药物生产基地。其中在中国投资设立的全新放射性药物生产基地落地在浙江省嘉兴市，投资总额预计将超过6亿元人民币，预计在2026年底投入生产。同时，要保证核药在有效期内，配送大多需要用飞机运输，地面运输采用的是高端私人快递。据说诺华专门管物流的团队就有30-40人。诺华预计在解决产能问题之后，2024年以后每年至少供应25万剂Pluvicto，销售峰值将达到20亿美元。种种要求使得核药行业的商业化存在极高的壁垒。成熟、完备的核药上下游产业链，本身就存在极高的壁垒，也都指向了大量的资金投入。做核药的Biotech如果没有办法自己走通这条路，就只有卖给财大气粗的MNC；而并购/合作领先核药公司快速进入核药市场是MNC的常用方式。拜耳、诺华目前已经上市的核药都是通过并购得来；近年来，礼来、BMS也先后通过并购进军核药市场。2023年10月，礼来也以14亿美金收购Point Biopharma进军核药领域。2023年12月，BMS以41亿美金收购成立仅三年多的核药公司RayzeBio，将核药市场推向新的高潮。罗氏、默沙东目前在核药市场的布局主要是合作。其中，默沙东早在2021年就与Fusion达成合作，主要是评估核药与Keytruda的联合疗法；2023年3月，默沙东又与Ratio Therapeuticsd合作推进核药研发。罗氏则通过在2023年9月与PeptiDream达成一项超10亿美金核药研发合作进入核药领域。阿斯利康布局核药的方式是先合作试水，进展良好之后直接收购。近日，阿斯利康斥资24亿美元收购的核药公司Fusion，早在2020年两家公司就已经开展了合作。从合作到并购，Biotech和MNC完成一场核药领域的接力赛。2中国核药双寡头，老牌药企加码破局中国市场上，核药产业是一个方兴未艾的领域。在以中国同辐、东诚药业为核心的双寡头局面之下，老牌药企正在加速进入，双方形成一定的错位竞争。先来看双寡头。据药智数据不完全统计，目前国内上市的核药152个（按品种计），中国同辐和东诚药业两家企业产品数量占比73%。中国同辐的背后是央企中核集团。中国同辐是中国核工业集团的控股子公司，于2011年在原中国同位素有限公司基础上重组设立，该企业是国内少有的集研发、生产、销售、服务于一体的核技术应用龙头企业，包括核药、医学诊断、核医疗装备等七个业务单元，旗下又设有10多个主要子公司，覆盖核医学各环节业务。东诚药业凭借硫酸软骨素和肝素钠两款产品起家，在2015年以7.5亿元收购成都云克药业52%股权，正式进军核药领域。此后，又收购（或通过全资子公司收购）GMS全部股权、中泰生物70%的股权、益泰医药83.5%的股权、安迪科全部股权，进而形成了一个分布于研产供销全链条的核药体系——成都云克药业作为核药生产平台，上海益泰作为核药研发平台，上海欣科作为核药标记与配送平台（核药房），南京安迪科作为正电子药物生产和销售平台。近年来，东诚药业又通过收购布局核药CRO产业链。2020年5月，东诚药业全资子公司安迪科通过收购分子影像CRO公司南京米度生物48%的股权。2022年12月，东诚药业下属米度生物以3020万美元（2.11亿元）的现金收购美国核药转化及临床试验影像CRO服务公司XING IMAGING LLC. 100%股权，收购溢价高达16倍。核药推广关键步骤的核药房上，中国的核药房资源基本也集中在中国同辐、东诚药业两家公司。双寡头之外，老牌制药企业正在加速入局核药市场。国产医药“一哥”恒瑞医药进展快速。恒瑞医药旗下的天津恒瑞在2023年末已有四款核药产品获批临床试验；取得了首个放射性药品生产许可证，标志着恒瑞的核药从研发迈向生产；同时，由天津恒瑞牵头组建的天津市放射性药物创新联合体获批复；依托于天津恒瑞的天津市核素精准诊疗药物重点实验室也获批筹建。远大医药也通过密集收并购来完善产业链布局，百洋集团投资的瑞迪奥也是核药领域的重要参与者。核药领域的新生力量也不容小觑，尤其是先通医药。2023年7月，核药企业先通医药获得了一笔超11亿元的巨额融资，投资机构中包括多个“国家队”。这也是国内医疗健康领域2023年最大一笔融资。2023年9月，先通医药用于测定阿尔茨海默病和其他认知功能下降成年患者脑内Aβ神经炎性斑块的水平的氟[18F]贝他苯注射液获得NMPA正式批准，这是国内核医学领域近20年首个获批上市的新药。虽然获批的新药是用于检测端而非治疗端，但不妨碍资本的热情。2024年初，放射性药物治疗公司辐联医药完成B轮融资，其中包括4730万美元的B轮股权融资和1600万美元的授信额度。此外，智核生物、核欣医药、艾博兹医药、四体康宸等新生代核药公司，逆势斩获高融资。核药领域特点就是：资产资质门槛极高而增长强势。全球市场蓬勃发展，根据Medraysintell数据，2019年全球核药市场规模约60亿美元，其中诊断药物占据主要市场，但随着越来越多的治疗性药物上市，将推动2030年全球核药市场达到300亿美元左右。高速发展的同时，布局的企业也要关注到目前的核药布局倾向于靶点同质化、适应症同质化的苗头，避免“产品真正上市时，市场已成红海”的尴尬局面。参考文献：1. 中伦视界 | 解密核医学之核药行业监管概览及投资合规关注要点2. 药智网 | 中国核药，撕开了一个口 3. 药智网 | 恒瑞给了核药市场一个「小震撼」更多优质内容，欢迎关注↓↓↓

抗体药物偶联物并购上市批准放射疗法

2024-04-05

·PRNewswire

Life Molecular Imaging and SOFIE announce Neuraceq® availability in Cleveland

Improved supply capabilities of Neuraceq® to provide better patient access to beta-amyloid PET BOSTON, April 5, 2024 /PRNewswire/ -- Life Molecular Imaging (LMI) and SOFIE Biosciences (SOFIE), a national US manufacturer and developer of PET radiopharmaceuticals, announce that the companies have expanded their strategic partnership and licensing agreement to provide and distribute Neuraceq® out of SOFIE's radiopharmaceutical manufacturing site located in Cleveland, Ohio. The first doses have been made available on April 4, 2024. Neuraceq® is an FDA-approved imaging agent for the detection of beta-amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. Neuraceq® is used in clinical routine and is also a powerful imaging biomarker for the appropriate characterization of subjects assessed for treatment eligibility with newly approved anti-amyloid drugs, or for enrollment in clinical trials to further support drug development in neurodegenerative diseases. "By adding Cleveland to our distribution network, Life Molecular Imaging is thrilled to provide additional availability of Neuraceq®, an important imaging tool for the detection of beta-amyloid plaques in the brain. Our continued collaboration with SOFIE provides greater availability of our approved beta-amyloid tracer Neuraceq®. We believe this additional access to Neuraceq® benefits physicians and patients, as well as our pharma partners for routine clinical and research use," said Ludger Dinkelborg, Ph.D., Managing Director at LMI. Brian Schumer, PharmD, SOFIE COO states, "We are excited to bring Neuraceq® availability to another SOFIE network site. The continued growth and advancement in Alzheimer's disease diagnosis and treatment is very promising for patients and their families. SOFIE is committed to the further expansion and availability of LMI's Neuraceq® PET diagnostic tracer throughout our national PET manufacturing and dispensing network." About Neuraceq (florbetaben 18F) Indication Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations. Limitations of Use A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder. Safety and effectiveness of Neuraceq have not been established for: Predicting development of dementia or other neurologic conditions Monitoring responses to therapies. Important Safety Information Risk for Image Interpretation and Other Errors Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future. Radiation Risk Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure. Common Adverse Reactions The overall safety profile of Neuraceq is based on data from 1,090 administrations of Neuraceq to 872 subjects. No serious adverse reactions related to Neuraceq administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq were injection site reactions consisting of erythema (1.7%), irritation (1.1%) and pain (3.4%). For more information please visit: neuraceq.com About Life Molecular Imaging (LMI) Life Molecular Imaging (LMI) is an international pharma company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit . About Life Healthcare Group Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years' experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: | For media queries Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging Tel: +1.484.735.2840 | [email protected] SOURCE Life Molecular Imaging

引进/卖出

2024-02-06

·PRNewswire

Life Molecular Imaging and Oryx Isotopes Industrial Company announce a Strategic Partnership for the Production and Distribution of Florbetaben (18F) in the Kingdom of Saudi Arabia and other countries in reach

Improved supply capabilities of Florbetaben (18F) to provide further access to Amyloid-PET to patients throughout the Middle East and North Africa (MENA) region BERLIN and DAMMAM, Saudia Arabia, Feb. 6, 2024 /PRNewswire/ -- Life Molecular Imaging (LMI) and Oryx Isotopes Industrial Company (Oryx) have announced a strategic partnership for the production and distribution of Florbetaben (18F) in the Kingdom of Saudi Arabia and other reachable countries, aiming to enhance the supply of this tracer for Amyloid-PET imaging in the Middle East and North Africa (MENA) region. The partnership grants Oryx the rights to manufacture Florbetaben (18F) at their Dammam production facility and distribute it in Saudi Arabia and nearby regions. Oryx is set to commence manufacturing once the technical setup is finalized. "Establishing this crucial manufacturing and distribution agreement for the production of Florbetaben (18F) will broaden access to Amyloid-PET through our innovative molecular imaging agent for patients in the Middle Eastern Region", said Ludger Dinkelborg, Ph.D., Managing Director at LMI, and added that "the strategic collaboration with Oryx Isotopes will contribute significantly to combating Alzheimer's disease and other causes of cognitive decline." "The collaboration between LMI and Oryx Isotopes will bring excellent opportunities for the Alzheimer's Disease patients in Saudi Arabia and the region to be diagnosed earlier and thus treated with more efficiency. Oryx Isotopes is very enthusiastic for being the first company in GCC to produce F18FBB." Dr. Husain Ahmed (Head of Board) and Dr Aiman Alnahawi (CEO) stated "We are driven by a passion for improving patient care and are dedicated to advancing the field of nuclear medicine through groundbreaking research and the development of novel therapies; definitely our collaboration with LMI will have a significant impact on patients and their relatives quality of life." About Florbetaben (18F)* Florbetaben (18F) is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. A negative Florbetaben (18F) scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Florbetaben (18F) scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Florbetaben (18F) is an adjunct to other diagnostic evaluations. Most Common Adverse Reactions: In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 1090 Florbetaben (18F) administrations were injection/application site erythema (1.7%), injection site irritation (1.1%), and injection site pain (3.4%). *Source: US Neuraceq Prescribing Information, Revision 05/2023) About Life Molecular Imaging (LMI) Life Molecular Imaging (LMI) is an international pharma company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centred, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit . About Life Healthcare Group Life Healthcare is a global people-centred, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 38 years' experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, imaging and occupational health and wellness services. The Group also owns Life Molecular Imaging, an R&D molecular imaging business of innovative PET tracers to reduce the burden of diseases through improved early detection. Learn more at About Oryx Isotopes Industrial Company (Oryx) Oryx Isotopes was established in 2021 in the eastern province of Saudi Arabia. The company is proud with its certifications (GMP, ISO9001: 2015, and NRRC) which ensure the quality of products and services and safety of the environment. Oryx Isotopes has emerged from leading companies which have long experiences in the field of radiopharmaceutical production, logistics, nuclear medicine management. It is driven by a set of great values, which are sufficiently reflected in all aspects of the business. Oryx Isotopes aims to enhance the "quality of life" for the patients and this objective will be achievable more with our partnership with LMI. Since its commencement, Oryx Isotopes has grown to be a leading manufacturer for diagnostic and therapeutic radiopharmaceutical. Its powerful presence in the market is built by growing up our loyal customer not only in Saudi Arabia but also in the whole GCC countries. For more information, please visit our website: For media queries Alya Schalabi | Marketing Europe | Life Molecular Imaging Tel#: +49 151 1456 9895 | [email protected] SOURCE Life Molecular Imaging

引进/卖出

100 项与氟[¹⁸F]贝他苯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	氟[¹⁸F]贝他苯	V09AX06	DB09148

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
认知功能障碍	美国	Life Molecular Imaging Ltd.	2014-03-19
阿尔茨海默症	挪威	Life Molecular Imaging Ltd.	2014-02-20
阿尔茨海默症	列支敦士登	Life Molecular Imaging Ltd.	2014-02-20
阿尔茨海默症	欧盟	Life Molecular Imaging Ltd.	2014-02-20
阿尔茨海默症	冰岛	Life Molecular Imaging Ltd.	2014-02-20
诊断试剂	冰岛	Life Molecular Imaging Ltd.	2014-02-20
诊断试剂	列支敦士登	Life Molecular Imaging Ltd.	2014-02-20
诊断试剂	欧盟	Life Molecular Imaging Ltd.	2014-02-20
诊断试剂	挪威	Life Molecular Imaging Ltd.	2014-02-20

未上市

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适应症	最高研发状态	国家/地区	公司	日期
家族性淀粉样神经病	临床3期	英国	Life Molecular Imaging Ltd.	2023-01-13
家族性淀粉样神经病	临床3期	德国	Life Molecular Imaging Ltd.	2023-01-13
家族性淀粉样神经病	临床3期	美国	Life Molecular Imaging Ltd.	2023-01-13
脑淀粉样血管病	临床2期	德国	Life Molecular Imaging Ltd.	2009-11-01
脑淀粉样血管病	临床前	美国	Life Molecular Imaging Ltd.	2009-11-01
脑淀粉样血管病	临床前	法国	Life Molecular Imaging Ltd.	2009-11-01
阿尔茨海默症	药物发现	日本	Life Molecular Imaging Ltd.	2009-11-01
阿尔茨海默症	药物发现	澳大利亚	Life Molecular Imaging Ltd.	2009-11-01
脑淀粉样血管病	药物发现	日本	Life Molecular Imaging Ltd.	2009-11-01
脑淀粉样血管病	药物发现	澳大利亚	Life Molecular Imaging Ltd.	2009-11-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


P2-12 (CTAD2015)	N/A	neuritic beta-amyloid plaques	78	18F-FLORBETABEN	蓋衊淵齋製淵齋廠窪艱(繭憲衊蓋艱襯範廠膚範) = 構繭鹹構夢糧艱顧壓範獵簾鏇積襯壓淵艱憲窪 (願願顧顧遞壓築觸膚艱 )	积极	2015-11-04
				18F-FLORBETABEN	蓋衊淵齋製淵齋廠窪艱(繭憲衊蓋艱襯範廠膚範) = 繭鹽襯憲鹽鬱衊築艱網獵簾鏇積襯壓淵艱憲窪 (願願顧顧遞壓築觸膚艱 )
AAIC2017	N/A	-	-	18F-FLORBETABEN (MR-based CapAIBL)	淵鑰獵糧簾鑰積選繭艱(範鹽鬱糧範鹹餘鹹廠獵) = 廠齋選顧憲網艱網鏇蓋鹽憲窪襯淵夢鑰願範蓋 (簾憲製獵鹹壓壓構淵膚 ) 更多	-	2017-07-01
				18F-FLORBETABEN (MR-less CapAIBL)	淵鑰獵糧簾鑰積選繭艱(範鹽鬱糧範鹹餘鹹廠獵) = 鏇願淵鬱淵廠築襯繭觸鹽憲窪襯淵夢鑰願範蓋 (簾憲製獵鹹壓壓構淵膚 ) 更多
AAIC2018	N/A	轻度痴呆 \| 轻度认知障碍	152	[F-18] FLORBETABEN (Cognitively Normal)	築鬱壓蓋壓選餘憲襯繭(範糧構鬱廠鬱顧衊顧夢) = 顧壓壓餘憲鏇鏇窪糧鏇齋遞廠獵襯顧觸網鬱繭 (獵壓選壓鬱衊膚壓鏇壓 )	-	2018-07-01
				[F-18] FLORBETABEN (Mild Cognitive Impairment)	築鬱壓蓋壓選餘憲襯繭(範糧構鬱廠鬱顧衊顧夢) = 簾構願廠遞膚襯築壓廠齋遞廠獵襯顧觸網鬱繭 (獵壓選壓鬱衊膚壓鏇壓 )
CHARIOTPRO Substudy (CPSS) (CTAD2022)	N/A	increased cerebral amyloid burden	1,170	Florbetapir	(願簾衊鏇糧齋顧鹽壓製) = 齋夢繭遞齋蓋選遞膚積憲膚製築窪繭夢餘膚繭 (製蓋觸鹽淵鏇窪簾壓襯 ) 更多	-	2022-12-03
				Florbetaben	(願簾衊鏇糧齋顧鹽壓製) = 積製遞選齋蓋淵夢築鏇憲膚製築窪繭夢餘膚繭 (製蓋觸鹽淵鏇窪簾壓襯 ) 更多
NCT01020838 (Pubmed \| J Prev Alzheimers Dis)	临床3期	阿尔茨海默症	216	Florbetaben PET imaging	(憲鏇蓋憲壓窪蓋積淵網) = 廠艱醖鑰齋製製鹽獵齋願簾簾鏇餘積壓構範築 (廠選構蓋遞構築製網製, 93.8 ~ 100) 更多	-	2015-08-01
EudraCT: 2014-000562-21 (AAIC2017)	N/A	amyloid PET	502	[18F]florbetaben PET	網願艱壓願膚網衊窪淵(膚鑰齋壓餘鏇壓顧獵構) = 淵積窪網遞網觸襯衊構膚淵糧窪膚膚簾餘廠鹽 (鑰壓簾獵願壓襯築網膚 )	-	2017-07-01
NCT02681172 (AAIC2017)	临床4期	轻度痴呆	205	Florbetaben PET imaging	壓製繭膚鹹遞遞醖積膚(淵膚醖獵觸廠製遞構鹹) = 積願艱築艱選蓋顧觸觸選網膚餘淵遞襯夢範獵 (鹹獵選積鹽齋獵糧廠蓋, 59.9 ~ 73.2) 更多	-	2017-07-01
NCT01020838 (Pubmed \| J Nucl Med)	临床3期	阿尔茨海默症 \| 脑淀粉样血管病	82	18F-Florbetaben (In-person-trained interpreters)	顧積觸遞鹹蓋糧簾鹹網(艱衊餘積衊鏇餘糧餘齋) = 齋遞窪膚淵願簾鏇齋夢糧憲簾遞壓鏇鹹糧遞製 (鬱衊膚選憲憲構廠觸簾 ) 更多	-	2016-06-01
				18F-Florbetaben (Electronic training method)	顧積觸遞鹹蓋糧簾鹹網(艱衊餘積衊鏇餘糧餘齋) = 廠構鹹顧蓋鹽獵壓觸襯糧憲簾遞壓鏇鹹糧遞製 (鬱衊膚選憲憲構廠觸簾 ) 更多
NCT01138111 (Pubmed \| J Neurol Neurosurg Psychiatry)	临床1期	阿尔茨海默症	45	18F-florbetaben (FBB+)	(獵繭醖鏇艱構製製選窪) = 鏇壓窪窪夢餘餘製獵艱齋構顧製製鑰廠範艱顧 (鏇餘糧壓遞窪鑰蓋醖膚 ) 更多	-	2015-04-01
				18F-florbetaben (FBB-)	(鏇顧製鑰襯鹽夢繭簾積) = 壓鏇膚醖衊繭鑰艱範積網廠膚壓壓艱餘淵夢廠 (獵醖壓獵膚選鹹範鹹襯 )