Establish the First International Database on Semi-quantitative Values Obtained in Scintigraphy With Datscan® in Cadmium-Zinc-Telluride (CZT) Camera (VERITON-CT)

Datscan scintigraphy is a nuclear medicine examination allowing the diagnosis of neurodegenerative pathologies linked to damage to dopaminergic pathways, such as Parkinson's disease (essential for the differential diagnosis of essential tremor).

开始日期2025-04-30

申办/合作机构

Centre Hospitalier Regional de Nancy

CTR20201646

/ Completed临床1期

一项在中国健康志愿者中评估单剂量DaTSCAN碘[123I]氟潘注射液的安全性、生物分布和内辐射剂量的1期非随机、非比较性、开放性研究

经过与药品审评中心的沟通交流，进行一项在中国健康志愿者中评估单剂量DaTSCAN碘[123I]氟潘注射液的安全性、生物分布和内辐射剂量的1期非随机、非比较性、开放性研究

开始日期2021-05-14

申办/合作机构

GE Healthcare B.V.

[+2]

NCT04564092

/ Completed临床1期

A Phase 1, Non-randomised, Noncomparative, Open-label Study to Assess the Safety, Biodistribution, and Internal Radiation Dosimetry of a Single Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers

This is a phase 1, single-centre, single-group, nonrandomized, noncomparative, open-label, single-dose study to evaluate the safety, biodistribution, internal radiation dosimetry, and effective dose of DaTSCAN™ ioflupane (123I) injection in Chinese Healthy Volunteers.

开始日期2021-05-13

申办/合作机构

GE Healthcare Holdings, Inc.

[+1]

100 项与碘[123I]氟潘相关的临床结果

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100 项与碘[123I]氟潘相关的转化医学

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100 项与碘[123I]氟潘相关的专利（医药）

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384

项与碘[123I]氟潘相关的文献（医药）

2025-03-01·Brain disorders (Amsterdam, Netherlands)

A proposal of visual assessment of serotonergic deficits in parkinsonian syndromes: An 123I-FP-CIT SPECT study

作者: Yoshioka, Masaru ; Sugimura, Yoko ; Takeda, Atsushi ; Totsune, Tomoko ; Tanaka, Hiroyasu ; Takahashi, Toshiaki ; Oizumi, Hideki ; Baba, Toru ; Nagamatsu, Ken-ichi

¹²³I-FP-CIT, primarily used for imaging dopamine transporters in the nigrostriatal pathway, also shows some affinity for the serotonin transporter (SERT), which is predominantly distributed in the raphe nuclei in the brainstem.Recent imaging studies have demonstrated that compared with Parkinson′s disease (PD), atypical parkinsonian syndromes (PS) exhibit pronounced SERT reduction using semiquant. methods.However, the utility of qual. visual assessment methods for SERT has been poorly discussed to date.The aims of this study were to propose a visual assessment grading system of brainstem ¹²³I-FP-CIT uptake and investigate the ability of this method to differentiate PD from PS.We analyzed the imaging data of 97 parkinsonian patients who underwent ¹²³I-FP-CIT SPECT.First, we graded ¹²³I-FP-CIT uptake in the midbrain and pons with a 4-degree scale and analyzed the interrater agreement of our grading method.Next, we compared the visual grading data of the PD (n = 59) and PS (n = 11) groups and analyzed the diagnostic utility of the qual. visual assessment method.The interrater agreement of the visual grading of ¹²³I-FP-CIT uptake among the three raters was moderate (Fleiss′ Kappa 0.480 for midbrain, 0.488 for pons).The patterns of ¹²³I-FP-CIT uptake in the pons differed significantly between patients with PD and PS (p = 0.035).The visual assessment-based classification showed 81.8 % sensitivity, 61.0 % specificity, 28.1 % pos. predictive value, and 94.7 % neg. predictive value in distinguishing PS from PD.Visual assessment of SERT abnormalities with ¹²³I-FP-CIT may contribute to differentiating PD and PS in clin. settings.

2025-02-01·Revista espanola de medicina nuclear e imagen molecular

Justification and impact of SPECT ¹²³I-FP-CIT use in the differential diagnosis and management of movement disorders (MD) in a national referral hospital

Article

作者: Mitjavila Casanovas, M ; Ruiz Solís, S ; Canales Rodríguez, L

AIM:

To evaluate the adequacy and impact of ¹²³I-FP-CIT SPECT in the diagnosis and management of MD according to clinical guidelines.

PATIENTS AND METHODS:

Retrospective study involving 249 patients with suspected parkinsonism (PK) of uncertain origin. All underwent ¹²³I-FP-CIT SPECT and had a clinical follow-up of exceeding 12 months. Requests were classified based on their adherence to clinical guidelines. Variables analyzed included sex, age, justification for the request, management after SPECT, and final diagnosis.

RESULTS:

91.57% of the requests were appropriate, while 8.43% did not adhere to the guidelines. Diagnosis changed in 48.6% of cases and management in 70.68% after the scan, especially in inconclusive cases and initiation of therapy. General neurologists evaluated more cases and made more appropriate requests (96.3% vs 76.67%; p < 0.001). However, MD specialists, despite less appropriate use of the guidelines, achieved a higher number of conclusive diagnoses in complex cases.

CONCLUSION:

¹²³I-FP-CIT SPECT has significant clinical impact when used in accordance with clinical guidelines, improving the diagnosis and management of MD. Unjustified scans reduce its utility. Collaboration between general neurologists and MD specialists is fundamental; the latter, although showing less adherence to guidelines in requesting the test, achieve a higher number of conclusive diagnoses in complex cases.

2025-01-01·Asia Oceania journal of nuclear medicine & biology

Use of the specific binding ratio distribution to characterise multiple system atrophy in advanced iodine-123-labelled N-(3-fluoropropyl)-2β-carbomethoxy-3β-(4-iodophenyl) nortropane serotonin transporter imaging.

Article

作者: Nagao, Ryunosuke ; Ishiguro, Masanobu ; Shang, Cong ; Motomura, Nobutoku ; Watanabe, Hirohisa ; Inui, Yoshitaka ; Takahashi, Kazuya ; Ichihara, Takashi ; Mizutani, Yasuaki ; Toyama, Hiroshi ; Ito, Mizuki

Objectives:

Sudden death in multiple system atrophy (MSA) is caused by decreased serotonergic innervation, but there is no routine test method for this decrease. In addition to dopamine transporters, iodine-123-labelled N-(3-fluoropropyl)-2β-carbomethoxy-3β-(4-iodophenyl) nortropane (¹²³I-FP-CIT) binds serotonin transporters (SERTs). We noted a binding potential to quantify the total quantity of ¹²³I-FP-CIT binding to its receptors.Following Mintun's binding-potential concept, this study aimed to evaluate the relationship between the specific binding ratio (SBR) and total SERT tissue amount, but not SERT binding, and to develop an SBR imaging method to measure brain-stem SERT. We sought to establish a binding-potential imaging procedure using SBR images to examine differences in the brain-stem SERT distribution between healthy subjects and MSA patients.

Methods:

Single-photon emission computed tomography (SPECT) and T1-weighted magnetic resonance (MR) images were aligned. The MR (T1) images were used to set a reference site for the occipital-lobe SBR in each subject, and measurements were made from the SPECT image at the same position. The pixel values and accumulation ratios compared with the occipital lobe were calculated, and a regional SBR distribution image was created. We identified areas with SERT accumulation above a certain level.

Results:

The SERT accumulation site was visualised as an SBR value on MR images. The accumulation distribution (SERT distribution) on the SBR images significantly differed between the healthy subjects and patients with MSA.

Conclusion:

SERT accumulation was noted in the brain-stem region, indicating that SBR imaging was useful for viewing and quantifying SERT accumulation.

项与碘[123I]氟潘相关的新闻（医药）

2025-02-06

·化学经纬

书籍分享||新药化学全合成路线手册

内容介绍本书归纳和综述了新药的化学合成路线。覆盖范围为近5年美国FDA批准上市的新分子实体药共109个。针对每一个药物，本书给出了药物简介，药物化学结构信息，产品上市信息，药品专利保护和市场独占权保护信息，化学全合成路线和参考文献等。这些合成路线大多是目前制药工业中正在使用的化学合成工艺，有较高的实用性和学术价值。对参与反应的起始原料、中间体、反应产物都给出了详细的化学结构。每一步化学合成反应都给出了重要的化学试剂、催化剂、所使用的溶剂、合成反应条件及文献出处等。本书的特点是：作者从浩如烟海的科技文献中，精心挑选出最新、最有实用价值的合成方法，汇编成化学合成路线图，内容简洁，深入浅出，逻辑性强，容易理解，以最少的篇幅表达最多的技术信息，可帮助读者很快找到他们需要的药物合成方法及最可靠的原始科学论文。读者对象： 1.任何从事与化学合成、药物合成、精细化工相关专业的科研人员、企业管理人员。 2.有机化学专业、药学专业、生物制药专业等大专院校的高年级学生、研究生、教师及科研人员。 3.从事客户委托的药物原料与药物中间体合成的科研人员、企业管理人员。编辑推荐对于制药企业而言,一个好的药物全合成路线, 可以大大缩短生产周期,简化生产工艺,降低生产成本,节约能源,减少或消除对环境的化学污染与排放。本书为了顺应我国近年来生物制药及医药工业飞速发展的潮流编写的，详细介绍了近五年美国FDA批准上市的所有（109个）新分子实体药的化学全合成路线。这些全合成路线多数是国外制药厂目前正在使用的工艺，其经济效益及社会效益都是极为显著，因此本书既有较高的科学价值又有很大的实用性。作者简介陈清奇，旅美药学家和化学家，担任美国MedKoo生物医药科研公司总裁，同时兼任美国数家生物制药公司的技术顾问，中国国内数个大学的客座教授。研究领域为药物化学，纳米医学体外诊断技术。书籍目录 Abiraterone Acetate（醋酸阿比特龙）001 Aclidinium Bromide（阿克利溴铵）006 Afatinib（阿法替尼）009 Alcaftadine（阿卡他定）014 Alogliptin（阿格列汀）017 Apixaban（阿哌沙班）022 Apremilast（阿普斯特）028 Avanafil（阿伐那非）033 Axitinib（阿西替尼）038 Azilsartan Kamedoxomil（阿齐沙坦酯钾盐）044 Bazedoxifene（巴多昔芬）048 Bedaquiline（贝达喹啉）053 Belinostat（贝利司他）060 Boceprevir（波西普韦）064 Bosutinib（博舒替尼）071 Cabozantinib（卡博替尼）075 Canagliflozin（卡格列净）078 Carfilzomib（卡非佐米）083 Ceftaroline Fosamil（头孢洛林酯）087 Ceftolozane（噻呋特啰嗪）094 Ceritinib（色瑞替尼）098 Clobazam（氯巴占）101 Cobicistat（可比司他）104 Crizotinib（克里唑蒂尼）112 Dabigatran Etexilate Mesylate（甲磺酸达比加群酯）118 Dabrafenib（达拉菲尼）123 Dapagliflozin（达格列净）127 Dasabuvir（达沙布韦）132 Deferiprone（去铁酮）136 Dienogest（地诺孕素）138 Dolutegravir（度鲁特韦）141 Droxidopa（屈昔多巴）145 Efinaconazole（艾氟康唑）149 Eliglustat（依利格鲁司特）152 Elvitegravir（埃替格韦）155 Empagliflozin（依帕列净）161 Enzalutamide（恩杂鲁胺）166 Eribulin Mesylate（甲磺酸艾日布林）168 Eslicarbazepine Acetate（艾利西平醋酸酯）175 Estradiol Valerate（雌二醇戊酸酯）180 Ezogabine（依佐加滨）185 Finafloxacin（非那沙星）193 Fingolimod Hydrochloride（盐酸芬戈莫德）197 Florbetapir F 18（氟比他匹）205 Flutemetamol F 18（富特米他）211 Gabapentin Enacarbil（加巴喷丁恩那卡比）214 Gadobutrol（钆布醇）218 Gadoterate Meglumine（钆特酸葡甲胺）224 Ibrutinib（依鲁替尼）227 Icatibant（艾替班特）232 Idelalisib（艾代拉里斯）234 Indacaterol （茚达特罗）236 Ingenol Mebutate（巨大戟醇甲基丁烯酸酯）240 Ioflupane 123I（碘[123I]氟潘）242 Ivacaftor（依瓦卡特）247 Ledipasvir（雷迪帕韦）250 Linaclotide（利那洛肽）259 Linagliptin（利拉利汀）261 Lomitapide（洛美他派）267 Lorcaserin（氯卡色林）270 Lucinactant（芦西纳坦）274 Luliconazole（卢立康唑）276 Lurasidone（鲁拉西酮）279 Macitentan（马西替坦）283 Miltefosine（米替福新）286 Mipomersen Sodium（米泊美生钠）290 Mirabegron（米拉贝隆）292 Naloxegol（纳罗克格）296 Netupitant（奈妥吡坦）299 Nintedanib（尼达尼布）303 Olaparib（奥拉帕尼）307 Olodaterol（奥达特罗）311 Omacetaxine Mepesuccinate（高三尖杉酯碱）315 Ombitasvir（艾姆伯韦）319 Ospemifene（奥培米芬）323 Paritaprevir（帕瑞它韦）327 Pasireotide（帕瑞肽）331 Peramivir（帕拉米韦）333 Perampanel（吡仑帕奈）337 Pirfenidone（吡非尼酮）343 Pomalidomide（泊马度胺）345 Ponatinib（泊那替尼）351 Regorafenib（瑞戈非尼）355 Rilpivirine（利匹韦林）357 Riociguat（利奥西呱）366 Rivaroxaban（利伐沙班）370 Roflumilast（罗氟司特）378 Ruxolitinib（鲁索替尼）384 Simeprevir（司美匹韦）388 Sofosbuvir（索非布韦）396 Suvorexant（苏沃雷生）401 Tafluprost（他氟前列腺素）405 Tasimelteon（他司美琼）409 Tavaborole（它瓦波罗）413 Tedizolid Phosphate（磷酸特地唑胺）415 Telaprevir（替拉瑞韦）418 Teriflunomide（特立氟胺）426 Ticagrelor（替格瑞洛）430 Tofacitinib（托法替尼）438 Trametinib（曲美替尼）443 Umeclidinium（芜地溴铵）447 Vandetanib（凡德他尼）450 Vemurafenib（威罗菲尼）456 Vilanterol（维兰特罗）460 Vilazodone Hydrochloride（盐酸维拉佐酮）463 Vismodegib（维莫德吉）468 Vorapaxar（沃拉帕沙）470 Vortioxetine（沃替西汀）473 附录1本书使用的期刊名称缩写表477 附录2专利文献代码481 附录3美国药品专利中的用途代码定义484 附录4美国药品市场独占权代码定义530 附录5美国FDA于2010—2014批准上市的药物名单563 英文索引607 中文索引611 CAS登记号索引613 下载方式现在，这份资料分享给大家。小编在公众号设置了自动回复功能，在公众号后台回复关键词：新药全合成 ●书籍分享||有机氧化反应原理与应用 ●书籍分享||有机卤化反应原理及应用 ●推荐合成书籍【有机缩合反应原理与应用】 ●推荐合成书籍【有机环合反应原理与应用】 ●书籍分享||有机还原反应原理与应用 ●ChemDraw使用让你从化学菜鸟变成老鸟 ●干货分享||有机合成: 策略与控制 ●干货分享||有机合成工艺研发-副反应抑制法 ●基础有机化学(邢其毅)第3、4版教材+习题解析 ●ChemDrawV20最新版详细安装图文教程 ●干货分享||核磁共振二维谱 ●书籍分享||全合成中的经典:更多的目标、战略和方法 ●书籍分享||实用药物化学 ●书籍分享||基于模仿创新的小分子药物发明 ●书籍分享||制药工艺开发-目前的化学与工程挑战 ●书籍分享||手性合成:不对称反应及其应用(第5版) ●书籍分享||新药研发案例研究--明星药物如何从实验室走向市场 ●书籍分享||英汉·汉英化学化工词汇 ●书籍分享||有机化学结构与功能（第四版） ●书籍分享||过渡金属有机化学(原著第6版） ●重磅书籍分享||不对称催化基础 ●书籍分享||药物设计学-唐赟

上市批准高管变更

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

2024-02-06

·BioSpace

Curium Announces Ioflupane I 123 Injection Availability for Friday Patient Use

ST. LOUIS, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that beginning Friday, April 5, 2024, Ioflupane I 123 Injection will be available for Friday patient administration in the US. This additional day of production allows customers to access the product and capitalize on early morning availability on a day not previously available from Curium. Ioflupane I 123 Injection is a radioactive diagnostic agent indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). Customers may begin ordering for Friday patient use immediately for administration on and after April 5, 2024. This expansion in capacity should help address a growing need for SPECT brain imaging. Approximately 90,000 people in the US each year are diagnosed with Parkinson’s1 and nearly 1.24 million will be diagnosed by 20302. Additionally, one in four patients with dementia suffers from DLB, making it the second most common form of degenerative dementia after Alzheimer’s Disease3. The clinical signs and symptoms of DLB can be atypical and overlap with other forms of dementia, leading to up to 70% of patients with DLB being misdiagnosed, often as having Alzheimer’s Disease4. Robert Burke, North American Senior Vice President of Commercial at Curium, commented: “Curium’s expanded capacity on Fridays will allow our customers and their patients greater scheduling flexibility. Our customers have asked for this expansion and Curium is thrilled to be able to satisfy this request. We look forward to launching Friday patient use on April 5.” About Ioflupane I 123 Injection INDICATION AND USE Ioflupane I 123 is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). Important Risk Information CONTRAINDICATIONS Ioflupane I 123 Injection is contraindicated in patients with known serious hypersensitivity to Ioflupane I 123. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions, including dyspnea, edema, rash, erythema, and pruritus, have been reported following Ioflupane I 123 Injection administration. Thyroid Accumulation: The Ioflupane I 123 Injection may contain up to 6% of free iodide (iodine-123). Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia. To decrease thyroid accumulation of I-123, block the thyroid gland before administration of Ioflupane I 123 Injection. Radiation Risk: Ioflupane I 123 Injection emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients. ADVERSE REACTIONS In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness of mild to moderate severity were reported. In postmarketing experience, hypersensitivity reactions and injection-site pain have been reported. DRUG INTERACTIONS Drugs that bind to the dopamine transporter with high affinity may interfere with the Ioflupane I 123 Injection image. The impact of dopamine agonists and antagonists on Ioflupane I 123 Injection imaging results has not been established. USE IN SPECIFIC POPULATIONS Pregnancy: Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of a thyroid blocking agent is recommended before the use of Ioflupane I 123 Injection in a pregnant woman. All radiopharmaceuticals have potential to cause fetal harm. There are no available data on Ioflupane I 123 Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Advise pregnant women of the potential risks of fetal exposure to radiation with the administration of Ioflupane I 123 Injection. Lactation: Iodine 123 (I 123), the radionuclide in Ioflupane I 123 Injection, is present in human milk. There is no information on the effects on breastfed infants or on milk. Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for at least 6 days after Ioflupane I 123 Injection administration to minimize radiation exposure to a breastfeeding infant. Pediatric Use: The safety and efficacy of Ioflupane I 123 Injection have not been established in pediatric patients. Geriatric Use: There were no differences in responses between elderly patients and younger patients that would require a dose adjustment observed in the parkinsonian syndrome studies. Renal Impairment: Ioflupane I 123 Injection is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and altered Ioflupane I 123 Injection images. OVERDOSAGE The risks of overdose relate predominantly to increased radiation exposure, with the long-term risk for neoplasia. In case of overdosage of radioactivity, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient. Please see full Prescribing Information by clicking here or visit References: 1 Willis AW, Roberts E, Beck JC, et al. “Incidence of Parkinson disease in North America.” NPJ Parkinsons Disease. 2022;8:170. 2 Marras C, Beck JC, Bower JH, et al. “Prevalence of Parkinson’s disease across North America.” NPJ Parkinsons Disease. 2018;4:21. doi:10.1038/s41531-018-0058-0 3 Barker, Warren W, Luis, Cheryl A, Kashuba A, et al. “Relative frequencies of Alzheimer disease, Lewy body, vascular and frontotemporal dementia, and hippocampal sclerosis in the State of Florida Brain Bank.” Alzheimer Disease and Associated Disorders vol. 16,4 (2002): 203-12. doi:10.1097/00002093-200210000-00001 4 Warr L, Walker Z. “Identification of biomarkers in Lewy-body disorders.” Quarterly Journal of Nuclear Med Mol Imaging; 2012; 56: 39-54 About Curium Curium is a world leader in nuclear medicine. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit curiumpharma.com. For more information about this press release, please contact Ross Bethell ross.bethell@curiumpharma.com or +44.7827.833.176.

放射疗法诊断试剂临床研究

100 项与碘[123I]氟潘相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10014	碘[123I]氟潘	V09AB03	DB08824

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
路易体病	美国	GE Healthcare, Inc.	2022-11-01
帕金森病	加拿大	GE Healthcare Canada, Inc.	2017-12-07
诊断试剂	日本	Nihon Medi-Physics Co., Ltd.	2013-09-20
帕金森障碍	欧盟	GE Healthcare B.V.	2000-07-27
帕金森障碍	冰岛	GE Healthcare B.V.	2000-07-27
帕金森障碍	列支敦士登	GE Healthcare B.V.	2000-07-27
帕金森障碍	挪威	GE Healthcare B.V.	2000-07-27

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
特发性震颤	临床3期	中国	通用电气药业（上海）有限公司	2020-06-28
特发性震颤	临床3期	中国	GE Healthcare Holdings, Inc.	2020-06-28
特发性震颤	临床3期	中国	GE Healthcare B.V.	2020-06-28
特发性震颤	临床3期	中国	GE Healthcare Pvt Ltd.	2020-06-28
多系统萎缩	临床3期	中国	GE Healthcare Holdings, Inc.	2020-06-28
多系统萎缩	临床3期	中国	GE Healthcare B.V.	2020-06-28
多系统萎缩	临床3期	中国	通用电气药业（上海）有限公司	2020-06-28
多系统萎缩	临床3期	中国	GE Healthcare Pvt Ltd.	2020-06-28
进行性核上性麻痹	临床3期	中国	GE Healthcare Pvt Ltd.	2020-06-28
进行性核上性麻痹	临床3期	中国	GE Healthcare B.V.	2020-06-28

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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


One-Stop-Shop SynNeurGe assessment (EANM2024)	N/A	帕金森病 DaT-SPECT \| MIBG scintigraphy	5	[123I]-Ioflupane dopamine transporter single-photon-emission-computed tomography (DaT-SPECT)	選餘觸鹽繭積觸構願構(製糧遞夢餘蓋觸築顧餘) = 夢餘範觸糧範憲構選遞簾願淵壓餘積遞鹽夢膚 (構憲網製遞淵餘網積壓 )	-	2024-09-27
EANM2024	N/A	帕金森障碍	485	123I-Ioflupane (Standard-dose group)	簾衊獵觸糧遞構廠範壓(網觸積網積窪壓鏇鹹鹽) = 膚餘觸積餘廠願鏇蓋鬱積鑰夢醖壓夢顧鹹網網 (夢夢範衊夢願簾蓋夢醖 )	不佳	2024-09-27
				123I-Ioflupane (Half-dose group)	簾衊獵觸糧遞構廠範壓(網觸積網積窪壓鏇鹹鹽) = 繭網淵鏇醖簾鹽選夢壓積鑰夢醖壓夢顧鹹網網 (夢夢範衊夢願簾蓋夢醖 )
P8-4.001 (AAN2024)	N/A	-	270	[123I] Ioflupane (African Americans)	鹹鏇觸獵醖餘網糧夢廠(顧願遞鑰鹽簾淵蓋壓繭): P-Value = 0.002 更多	-	2024-04-09
				[123I] Ioflupane (Caucasians)
NCT04193527 (CTgov)	临床3期	特发性震颤 \| 进行性核上性麻痹 \| 多系统萎缩 ... 更多	172	DaTSCAN™ ioflupane (123I) (DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS))	鏇廠餘繭鏇壓構選鏇醖 = 簾窪選遞築廠構蓋衊選齋構衊築襯簾壓膚簾遞 (鑰淵鬱襯構簾鹹蓋蓋選, 憲膚鑰鏇顧憲壓餘壓構 ~ 製選襯鬱簾簾憲選衊窪) 更多	-	2023-10-16
				DaTSCAN™ ioflupane (123I) (DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET))	鬱願築糧醖顧膚網鏇願 = 鹽簾築簾壓艱醖願鏇選鏇夢鬱艱簾憲選網夢繭 (膚鑰範築鏇鏇淵選壓構, 餘範顧繭鏇築範壓鑰窪 ~ 糧選鹹鬱鬱範築襯憲醖) 更多
NCT04564092 (CTgov)	临床1期	-	9	DaTSCAN™ Ioflupane (123I) Injection	構夢遞繭願壓窪齋觸艱 = 簾鏇憲觸齋醖夢壓壓憲簾繭廠構願衊積衊製鏇 (獵鹽齋網製壓齋遞顧鏇, 鹹糧範築淵選鹹鏇簾願 ~ 範齋淵範選遞膚願衊鹽) 更多	-	2023-08-02
EANM2022	N/A	16型肌张力障碍	32	123 I-FP-CIT (DaTscan) (Pathological patients)	齋糧壓製構壓遞糧鬱壓(襯製壓顧築夢齋襯鬱窪) = 齋蓋選鬱顧衊遞鹽遞膚齋廠鏇觸網壓遞觸壓簾 (網繭衊鑰構衊憲廠夢獵 ) 更多	-	2022-09-22
MDS2022	N/A	帕金森障碍 nigrostriatal dopaminergic degeneration	81	I123-FP-CIT	鬱壓觸製繭憲夢艱鹹鏇(壓選獵築積餘獵糧範淵) = 獵選艱憲廠膚選顧醖鹹鏇構簾鹽範繭構蓋憲齋 (範糧簾願鏇簾製積廠齋, 1.4) 更多	积极	2022-09-15
AAN2022	N/A	REM睡眠行为障碍	34	123I-FP-CIT	膚鏇醖鑰餘繭廠網餘範(壓範鹽憲簾構範淵選選) = 製願糧願廠齋壓繭構鹹觸築糧膚簾鹽糧窪範鹹 (鏇襯糧範積鹽選積繭襯 ) 更多	-	2022-05-03
				123I-FP-CIT	膚鏇醖鑰餘繭廠網餘範(壓範鹽憲簾構範淵選選) = 襯簾願網範獵醖窪築鹹觸築糧膚簾鹽糧窪範鹹 (鏇襯糧範積鹽選積繭襯 ) 更多
SNMMI2021	N/A	-	-	I-123-Ioflupane (Caudate Nucleus)	築簾簾衊淵鹹願窪鑰選(憲衊鏇窪醖夢壓壓襯壓) = 醖齋願窪觸鹹襯醖淵艱壓衊艱壓鹹廠範鑰鬱夢 (遞鹽糧蓋廠選艱夢鬱觸, 5.3 ~ 8.2) 更多	-	2021-05-18
				I-123-Ioflupane (Putamen)	築簾簾衊淵鹹願窪鑰選(憲衊鏇窪醖夢壓壓襯壓) = 鏇繭廠淵艱簾餘構簾夢壓衊艱壓鹹廠範鑰鬱夢 (遞鹽糧蓋廠選艱夢鬱觸, 4.3 ~ 10.5) 更多
MDS2020	N/A	123I-FP-CIT SPECT	20	123I-FP-CIT	繭醖廠鏇襯醖憲繭繭廠(積鹹製觸壓蓋觸鏇構鹹) = 鑰網廠夢鏇廠遞簾壓壓憲鏇醖鑰淵觸憲選衊鏇 (鹽積醖鹹鏇壓構製鑰積, 2.64)	-	2020-09-12
				123I-FP-CIT	繭醖廠鏇襯醖憲繭繭廠(積鹹製觸壓蓋觸鏇構鹹) = 壓廠願餘顧壓製襯淵糧憲鏇醖鑰淵觸憲選衊鏇 (鹽積醖鹹鏇壓構製鑰積, 3.46)