Hyperpolarized (HP) gas magnetic resonance imaging (MRI) of the lungs offers additional information that cannot be obtained with CT scan, the current gold standard for imaging this disorder. As a nonionizing technique, MRI is an ideal modality for pulmonary imaging; in particular in the infant and pediatric population. Nevertheless, due to the low proton density of the lung parenchyma (only
20% that of solid tissues), numerous air-tissue interfaces that lead to rapid signal decay, and cardiac and respiratory sources of motion that further degrade image quality , MRI has played a limited role in the evaluation of lung pathologies. In this setting, HP gas (using 129Xe) MRI may play a role in helping determine the regional distribution of alveolar sizes, partial pressure of oxygen, alveolar wall thickness, and gas transport efficiency of the microvasculature within the lungs of infants with a diagnosis of bronchopulmonary dysplasia (BPD).

开始日期2026-08-01

申办/合作机构

Xemed LLC

[+1]

NCT06909201

/ Not yet recruiting早期临床1期IIT

Hyperpolarized Xenon-129 Magnetic Resonance Imaging in Lung Cancer Patients Receiving Radiation Therapy for Investigating Radiation-response and Toxicity

The goal of this clinical research study is to learn if novel type of imaging scan called HP 129Xe MRI can help doctors identify and predict common side effects of radiation therapy. Rather than contrast-enhanced MRIs, the tracer (129Xe) will be inhaled rather than injected.
The 129Xe tracer has not been FDA approved. Its use in this study is investigational.

开始日期2025-09-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT06351345

/ Not yet recruiting临床2期IIT

129Xenon MR Imaging and Spectroscopy Response to Sotatercept in Pulmonary Arterial Hypertension

Determine the ability of 129Xe MRI/MRS biomarker signatures to non-invasively monitor pulmonary vascular reverse remodeling induced by sotatercept in pulmonary arterial hypertension (PAH).

开始日期2025-09-01

申办/合作机构

Duke University

[+1]

100 项与氙[129Xe] 相关的临床结果

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100 项与氙[129Xe] 相关的转化医学

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100 项与氙[129Xe] 相关的专利（医药）

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3,109

项与氙[129Xe] 相关的文献（医药）

2025-06-19·ACS Earth and Space Chemistry

Noble Gases in Archean Barites: Precise Determination of the Isotopic Fractionation of Atmospheric Xenon 3.48 Ga Ago

Article

作者: Reitner, Joachim ; Vayrac, Félix ; Mißbach-Karmrodt, Helge ; Avice, Guillaume

Following the evolution of the composition of the atmosphere informs on the entire geological evolution of our planet. The discovery that Archean atmospheric xenon was isotopically fractionated compared to modern atmospheric xenon paved the way for using this noble gas as a tracer of hydrogen escape on the primitive Earth. The curve of the evolution of the isotopic composition of atmospheric xenon remains, however, poorly defined. Recent studies proposed that the evolution was discontinuous with brief episodes of escape and fractionation of xenon separated by up to several 100 Ma long pauses. Similarly, some major unknowns remain regarding the progressive depletion of xenon in the atmosphere due to the proposed escape mechanism. In this study, we report the noble gas elemental ratios and isotopic compositions of noble gases released from a ca. 3.48 Ga old barite sample from the Dresser Formation (North Pole, Australia) by stepwise crushing in high vacuum. All samples released xenon enriched in light isotopes relative to heavy isotopes compared to modern atmospheric xenon but with various degrees of isotopic fractionation. Krypton is enriched in heavy isotopes relative to light isotopes in some crushed samples. After correction for Kr and Xe loss, results show that 3.48 Ga ago atmospheric xenon was fractionated by -19.1 ± 1.8‰ per atomic mass unit (u^-1). This value is more negative than that reported previously for 3.3 Ga old atmospheric xenon. A new curve for the evolution of the isotopic composition of atmospheric xenon is proposed. Xenon is also enriched relative to Kr in the gas released from the measured samples. While this is consistent with the scenario of a progressive selective escape of xenon from the Archean atmosphere, the exact abundance of Xe in the paleoatmosphere remains elusive.

2025-06-01·JOURNAL OF MAGNETIC RESONANCE

Investigation of 15N-SABRE hyperpolarization at high pressures and in supercritical fluids

Article

作者: Li, Xiaoqing ; Warren, Warren S ; Smith, Loren L ; Lindale, Jacob R

Signal Amplification By Reversible Exchange (SABRE) is a parahydrogen-based hyperpolarization technique that can generate orders-of-magnitude larger signals than thermal spin polarization within a minute. However, this method is limited by the availability of parahydrogen to the solution. Previous work demonstrated SABRE-derived ¹H hyperpolarization at pressures up to 200 bar and using liquid carbon dioxide as a solvent. Here, we extend this work to demonstrate heteronuclear (¹⁵N) SABRE hyperpolarization using conventional solvents with hydrogen pressures up to 400 bar as well as the possibility of using supercritical CO₂ as the solvent. We demonstrate that in both modes, ¹⁵N hyperpolarization comparable to SABRE-SHEATH may be achieved, providing a route for future optimization efforts as well as scale-up. We also present first steps towards exploring SABRE hyperpolarization of ¹²⁹Xe.

2025-04-01·MAGNETIC RESONANCE IN MEDICINE

Evaluation of an integrated variable flip angle protocol to estimate coil B₁ for hyperpolarized MRI

Article

作者: Ng, Kher Lik ; Shinozaki, Ayaka ; Zaccagna, Fulvio ; Axford, Aaron ; McIntyre, Anthony ; Berner, Lise ; Durrant, Marianne ; Ravetz, Zack ; Schulte, Rolf F. ; Ricchi, Mattia ; Lewis, Andrew J. M. ; Sgambelluri, Noemi ; Jacob, Kenneth ; Rider, Oliver J. ; Tyler, Damian J. ; Rayner, Jennifer J. ; Grist, James T. ; Birkhoelzer, Sarah ; Mills, Rebecca ; Gleeson, Fergus V. ; Yeung, Kylie ; McGing, Jordan J.

Abstract:

Purpose:

The purpose of this work is to validate a simple and versatile integrated variable flip angle (VFA) method for mapping B1 in hyperpolarized MRI, which can be used to correct signal variations due to coil inhomogeneity.

Theory and Methods:

Simulations were run to assess performance of the VFA B1 mapping method compared to the currently used constant flip angle (CFA) approach. Simulation results were used to inform the design of VFA sequences, validated in four volunteers for hyperpolarized xenon‐129 imaging of the lungs and another four volunteers for hyperpolarized carbon‐13 imaging of the human brain. B1 maps obtained were used to correct transmit and receive inhomogeneity in the images.

Results:

Simulations showed improved performance of the VFA approach over the CFA approach with reduced sensitivity to T1. For xenon‐129, the B1 maps accurately reflected the variation of signal depolarization, but in some cases could not be used to correct for coil receive inhomogeneity due to a lack of transmit‐receive reciprocity resulting from suboptimal coil positioning. For carbon‐13, the B1 maps showed good agreement with a separately acquired B1 map of a phantom and were effectively used to correct coil‐induced signal inhomogeneity.

Conclusion:

A simple, versatile, and effective VFA B1 mapping method was implemented and evaluated. Inclusion of the B1 mapping method in hyperpolarized imaging studies can enable more robust signal quantification.

项与氙[129Xe] 相关的新闻（医药）

2025-07-19

·行舟Drug

2018—2023年中美创新药审批趋势及创新性分析

点击上方的行舟Drug ▲ 添加关注2018—2023年中美创新药审批趋势及创新性分析来源《中国新药杂志》 2025年第34卷第13期作者张东，任峰，牛寒冬，陈爱萍，张景辰国家药品监督管理局药品审评检查长三角分中心摘要本研究系统梳理2018—2023年中美批准上市的创新药数据，从药物类型、靶点分布、技术路线、治疗领域等方面比对研发趋势和差异，揭示中国创新药从“追赶式布局”向“源头创新”转型的瓶颈与驱动力。数据显示，中美创新药在批准数量上的差距逐年缩小，技术覆盖度逐年提高。国内创新药未来在放射性药物、小核酸药物、创新型生物制品等方面可能形成突破方向。创新药审批趋势和创新性分析数据说明，近年来国家在医药研发投入上的不断增长，培育了一大批医药研发及监管人才，推动了监管科学的突破性改革以及全链条的产业创新能力提升。通过强化基础研究、打通“临床需求—基础研究—产业转化”的闭环、发展监管新工具、加速发展新质生产力，有望全方位促进我国医药产业的高质量发展。关键词创新药；注册申报；药物研发；产业管理；技术创新_正文_创新药研发水平是资金投入、各项国家战略支持及政策引导、市场导向、人才储备、国际合作等多维度的综合体现。自2015年启动药品医疗器械审评审批制度改革，2017年国家药品监督管理局（National Medical Products Administration，NMPA）加入ICH等重大改革举措，推动我国药品注册管理制度迅速与国际接轨，药品注册技术要求与全球协调统一，医药研发与创新药领域实现快速发展[1-2]。目前，我国创新药领域已经进入收获期，获批上市数量不断增加，在研新药数量跃居全球第2位[3]。当前，美国在世界医药研发领域仍占据全球领先地位，每年批准的创新药在分子设计、治疗靶点或作用机制上仍具有优势。本文通过梳理中美两国近年来获批的创新药物数据，总结两国在创新药研发布局的趋势和差异，汇总分析具有创新潜力的先进技术和研发领域，希望为推动国内医药产业的高质量发展提供助力。1数据来源本文的中国创新药参照2021年NMPA药品审评年度报告中的定义，即包含按照现行《药品注册管理办法》（国家市场监督管理总局令第27号）注册分类中药、化药、生物制品1类和原《药品注册管理办法》（国家食品药品监督管理局令第28号）注册分类中药1~6类、化药1.1类、生物制品1类批准上市的药品。统计数据来源于2018—2023年NMPA的药品年度审评报告[4-9]。美国创新药包括美国FDA药物评价和研究中心（Center for Drug Evaluation and Research，CDER）新药申请（new drug application，NDA）下批准的新分子实体（new molecular entity，NME）或在生物制品许可申请（biologic license application，BLA）下批准的新型治疗性生物制品以及美国生物制品审评和研究中心（Center for Biologics Evaluation and Research，CBER）在2018—2023年批准的创新药物，包括血液、疫苗、过敏原、组织、细胞及基因疗法等相关产品。CDER统计数据来源于美国FDA发布的新药年度批准报告（new drug therapy approvals）；CBER统计数据来源于Nature Reviews Drug Discovery等杂志对美国FDA每年批准创新药的年度综述文章，并与CBER官网信息核准。本次统计时间截至2023年12月31日，创新药的药品类型、成分类别、剂型、治疗靶点和适应证等信息通过丁香园INSIGHT数据库检索获得，并通过多数据库交叉检索确认。文章内容由凡默谷小编查阅文献选取，排版与编辑为原创。如转载，请尊重劳动成果，注明【来源：凡默谷公众号】。2中美创新药审批情况2.1 整体趋势NMPA在2018—2023年共计批准147个药品上市，年平均数在24~25个；2021年批准数量最多，达到47个，其中有5款属于药物作用机制与现有药物不同的首创新药（first⁃in⁃class，FIC）。将NMPA药品年度审评报告统计的每年批准的新药按照中药、化药、生物制品的药品类型进行划分，结果见表1。从批准数据可以看出，2020年之前，国内批准的创新药以化药为主；2021年开始，生物制品上市品种显著增加；到2023年批准的创新药中，生物制品和化药的数量已十分接近。近年来，伴随“三结合”的中药注册审评证据体系的应用，以及与中药临床定位相适应的疗效评价标准的建立[10]，国内中药创新药的批准数量也在不断增长。美国FDA在2018—2023年共批准302件创新药，年均50~51件，首创新药批准数量占每年批准创新药总数的比例在不断攀升。美国FDA由CDER批准新药按照化药、生物制品类别进行划分的结果见表2。比较每年NMPA和美国FDA历年批准的创新药总数变化趋势见图1。从图中可以看出，美国历年创新药批准数量一直维持在较高水平，中国创新药批准数量整体呈增长态势。中美创新药在每年批准数量上的差距正在逐年缩小。2.2 技术路线及差异对创新药的药物类型进行统计分析，整体上2018—2023年美国FDA批准的创新化药覆盖传统小分子、放射性药物、合成多肽药物等多种药物类型，其中小分子药物仍占主要地位，包括多款抗感染的酶抑制剂药物，如2020年批准用于治疗新型冠状病毒感染的瑞德西韦（remdesivir），通过模拟核苷酸来阻止病毒RNA的合成；传统小分子联合应用药物也是创新的一个方向，如2018年批准的Biktarvy（Bictegravir，emtricitabine and tenofovir alafenamide）是一种结合酶抑制剂和逆转录酶抑制剂的混合药物，用于治疗人类免疫缺陷病毒（human immunodeficiency virus，HIV）；2019年批准的Trikafta（elexacaftor，tezacaftor，ivacaftor）是一种包含3种药物的三联疗法，用于治疗囊性纤维化（cystic fibrosis，CF）。此外，放射性药物得到不断发展，包括核素偶联药物（radionuclide drug conjugate，RDC）、诊断用放射性药物；近几年美国FDA批准了多款创新小核酸药物[包括反义寡核苷酸（antisense oligonucleotide，ASO）、干扰小RNA（small interfering RNA，siRNA）或适配体类型]、化学合成多肽等新技术路线的药物，在合成技术和复杂制剂等方面不断创新。具体成分类别统计情况见表3。生物制品方面，除单抗、双特异性抗体（以下合并统计为抗体药物类型）、抗体偶联药物（antibody drug conjugate，ADC）、融合蛋白等药物类型外，近年来美国FDA还批准了新型抗体、抗体“鸡尾酒”、生物合成酶类、重组多肽等全新药物类型。例如：2019年批准了首款纳米抗体药物Cablivi（caplacizumab），是一种单结构域抗体，不同于常规单抗的大小（一般相对分子质量≥150kDa），本品相对分子质量大小在12~30 kDa范围内[11]，用于治疗成人获得性血栓性血小板紫癜；2021年批准的重组多肽药物Voxzogo（vosoritide，伏索利肽）是一种大肠埃希菌表达后修饰得到的C型利钠肽类似物，也是第一款用于治疗软骨发育不全症儿童患者的药物。2020年批准的一款抗体“鸡尾酒”药物Inmazeb（atoltivimab，maftivimab，odesivimab⁃ebgn），是针对埃博拉病毒疫情开发的由3种全人IgG1单抗组成的组合，针对埃博拉病毒扎伊尔型糖蛋白的不同表位，在临床上得到了广泛的应用。2022年美国FDA再次在抗肿瘤领域批准了新的抗体鸡尾酒药物Opdualag（nivolumab and relatlimabrmbw），本品由PD⁃1抑制剂纳武利尤单抗与新型抗LAG⁃3抗体relatlimab组合并共同作用，提升整体疗法的抗肿瘤应答，用于治疗不可切除或转移性黑色素瘤，是一种同类首创的双重免疫治疗药物，为患者带来新的治疗选择。美国FDA批准的创新生物制品成分类别统计见表4。我国批准新药的类型呈现类似趋势。在批准的创新化药中，除了传统小分子外，2018，2019，2023年各批准了1款化学合成多肽药物。创新型生物制品方面，近年来批准的类型已经逐渐丰富，除单抗外，自研的首款ADC（注射用维迪西妥单抗，2021年批准）、首款双抗（卡度尼利单抗注射液，2022年批准）、纳米抗体（恩沃利单抗注射液，2021年批准）等产品类型陆续上市。国内近几年批准的创新生物制品成分类别分布见表5。从以上药物技术路线和分子类型比较中可以看出，在传统小分子化药方面，国内更多是同靶点的快速跟进药物（fast⁃follow）或者同类创新药物（me⁃too）。国内对放射性核素在药物应用中的研究和治疗领域覆盖率不高，在小核酸药物研发领域，国外技术转移的比例较高[12]。生物制品方面，自主创新的步伐不断加快，自研的双抗、ADC品种已经开始涌现，但缺少对生物合成多肽、酶类产品的创新研究，应急状态下的被动免疫疗法仍需深入探索。无论是化药还是生物制品，对联合用药或混合抗体的临床应用研究还需要加强。2.3 治疗领域分布NMPA和美国FDA自2018年以来批准的药物适应证统计见表6（不含疫苗、中药），该统计包括了当前药物针对的全部适应证，其中部分药物同时针对多个治疗领域，参与统计的药品总数为117个。除一般性的治疗领域划分外，我们将两国每年批准用于罕见病治疗的创新药数量也进行了统计。2018—2023年美国FDA批准的创新药物主要治疗领域统计见表7。由统计结果可以看出，抗肿瘤药物在中美两国批准的创新药中都占比最大，分别达到49.57%（中国）和38.08%（美国）。但是，美国在其他治疗领域中的分布比较平均，如抗感染药物、免疫系统药物、内分泌系统和代谢药物、神经系统药物和皮肤疾病药物，每年都有一定数量的创新药产出。例如：阿斯利康公司的Saphnelo（anifrolumab）是一种免疫系统药物，通过与Ⅰ型干扰素受体结合来阻断相关细胞因子活性，是2011年后第一个被批准用于系统性红斑狼疮的新药[13]。2023年，美国FDA批准了首个用于治疗成人产后抑郁症的口服药物Zurzuvae（zuranolone）。国内批准的创新药除抗肿瘤领域外，抗感染药物也占据较大比例，其他治疗领域的创新药数量则较少，例如：近6年批准的呼吸系统创新药物仅有3款，包括2023年批准的氢溴酸氘瑞米德韦片（民得维，VV116），用于治疗新型冠状病毒感染。罕见病治疗药物往往在靶点、作用机制或者治疗模式上有所突破。我们统计美国批准的创新药发现，用于治疗罕见病的药物占比达到52.98%，这一数字在中国为32.2%。国外药企在罕见病药物研发上的高投入，以及监管机构针对罕见病用药管理的创新工作，推动了批准创新药治疗领域的多样化，更重要的是推动了对某些疾病治疗的重大突破[14]，例如：2018年批准的Galafold（migalastat），用于治疗法布雷病（代谢疾病）；前文提到的2019年批准的化药三联疗法Trikafta，用于治疗囊性纤维化（呼吸系统疾病）；2022年批准的Spevigo，是首个用于治疗泛发性脓疱型银屑病（皮肤疾病）的治疗药物等。国内在罕见病药物上的研究逐渐发力，下文将结合药物靶点分布情况进一步分析。2.4 药物靶点分析新靶点是创新药物产品分类的重要基础，也反映了基础科学对疾病机制研究的深入程度及转化程度。统计中美两国每年批准的创新药对应的药物靶点总数，具体结果见表8。以2021 年为例,国内批准47 款创新药,美国批准50 款创新药,但中国批准创新药所针对的靶点数为27 个,美国的靶点数为45 个｡如以创新药相同靶点进行统计分析,可以得到以下结果｡见表9｡统计美国FDA每年批准的创新药中，重复靶点较少。针对同一靶点的开发主要涉及2018年批准的3款针对30 SrProteins靶点的抗感染药物、3款针对CGRP靶点的神经系统药物，2023年批准的3款针对ComplementC5靶点的药物。2018年，美国FDA批准了多个CGRP拮抗剂，用于偏头痛的预防性治疗。分析近几年的本土创新药数据，中国创新药针对的靶点最多的是PD⁃1/PD⁃L1靶点，其次是HER2，EGFR家族靶点。对2018—2023年美国FDA批准的针对抗肿瘤相关靶点的创新药物进行统计，针对PD⁃1，HER2靶点各有5款创新药物获批。国产首款PD⁃1抑制剂特瑞普利单抗于2018年底上市，后续每年都有2款新药针对PD⁃1靶点。针对EGFR⁃Ex20Ins（EGFR20号外显子插入突变）这一突变类型有2款创新药获批，分别是2022年获批的琥珀酸莫博赛替尼胶囊和2023年获批的舒沃替尼片。近期的行业研究表明，2024年已有465款在研产品在国内/国外处于相同的研究阶段[15]，以KRAS G12c靶点为例，2021和2022年美国FDA分别批准了首款用于KRASG12c突变的非小细胞肺癌的治疗药物Lumakras（sotorasib）[13]及作用于相同靶点的Krazati（adagrasib）。2024年，我国首款原研的KRAS G12c抑制剂氟泽雷赛片（fulzerasib）获批上市。说明在全球创新药行业竞争激烈的情况下，国内企业在新靶点研发和新技术应用上正在不断追赶国外企业，全球同步研发将是未来的发展趋势。3国内创新药领域研究重点随着产业政策、资本和人才对创新药研发的不断支持，中国药品审评审批制度改革的不断推进，中国创新药企业加速发展，可预期会有越来越多的新药在国内获批上市。我们基于对中美近几年批准创新药的分析，关注放射性药物、小核酸药物、创新型生物制品等的研发现状，并认为这些领域在未来几年具有较高诞生创新药的可能性。3.1 放射性药物放射性药物是指用于临床诊断或治疗的放射性核素制剂或其标记药物，一般由放射性同位素和将放射性同位素输送至特定器官、组织或细胞的分子试剂组成，常用核素包括18F，177Lu，225Ac，131I，90Y等。放射性药物是临床核医学精准诊疗的基础，根据临床用途分为诊断类和治疗类放射性药物。诊断类放射性药物利用示踪技术，从分子层面反映病变组织的功能变化、代谢变化等，实现对疾病的早期诊断；治疗类放射性药物则通过核素的局部电离辐射对病变组织进行靶向性治疗。近年来，由于放射性核素偶联药物的研发推动，放射性药物正在向诊疗一体化的方向发展[16]。目前全球获批上市的放射性药物有60余款，2018—2023年美国FDA批准的创新型放射性药物共10款，8款为诊断类，2款为治疗类。药物信息统计见表10。10款创新型放射性药物中有5款属于首创新药。其中Lutathera，gallium Ga 68 PSMA⁃11和Plu⁃victo均由诺华制药公司研发，Lutathera是全球首款获批上市的RDC药物，gallium Ga 68 PSMA⁃11则是首个靶向PSMA的正电子发射断层扫描（PET）显影剂。Tauvid由礼来制药公司开发，是目前唯一被批准的用于评估大脑中tau神经纤维缠结密度和分布的诊断剂。批准的放射性药物剂型大部分为注射剂，但2022年批准的Xenoview是一种氙 Xe129医用混合气体，用于12岁及以上患者肺部功能检测，是目前唯一一个吸入式磁共振成像超极化造影剂，为存在有害电离辐射的肺部通气评估技术（如CT等）提供了替代方案。在治疗领域方面，10款药物中有4款针对前列腺癌，2款针对神经内分泌肿瘤，这2个是目前全球RDC药物的主要治疗领域。此外，放射性药物在临床适应证范围上还在不断扩展，如Cerianna用于检测复发或转移性乳腺癌的雌激素受体（estrogen receptor，ER）阳性病变，fluorodopa F 18用于疑似帕金森病的成人患者，显示纹状体内多巴胺能神经末梢。截至2023年底，NMPA累计批准42款放射性药物，其中大多数为仿制药。2020年后批准的创新型放射性药物有2款，均为进口注册，分别是2020年批准的拜耳公司的氯化镭[223Ra]，用于治疗伴症状性骨转移且无已知内脏转移的去势抵抗性前列腺癌患者，该药于2013年获得美国FDA批准（商品名：Xofigo）；以及2022年批准的Sirtex、远大医药公司的钇[90Y]树脂微球（商品名：Sirtex），用于治疗经标准治疗失败的不可手术切除的结直肠癌肝转移患者，该药于2002年已由美国FDA批准上市（商品名：SIR⁃Spheres）。行业研究显示，2023年全球放射性药物领域的风险投资交易增长了550%，放射性药物市场规模在不断扩大。目前国内在创新型放射性药物的研发和审批上均存在一定程度的滞后。2023年4月NMPA发布《关于改革完善放射性药品审评审批管理体系的意见》，强调深入研究解决我国放射性药品研发申报及生产经营监管中遇到的矛盾和问题，理顺放射性药品管理要求，推动相关工作顺利开展[17]。2024年，NMPA特药检查中心公开征求《放射性药品生产检查指南》意见，国家药典委员会已经发布了11个放射性药品国家药品标准草案，不断推动行业发展。目前，国内放射药在研管线有30多个，且存在较多创新产品，其中瑞迪奥公司的99mTc⁃3PRGD2是国内首个自主研制的1类创新药，用于肺癌诊断，有望于2025年获批上市。未来在创新放射性药物的研发中可能包括扩大治疗性放射性同位素的范围，推动新核素的应用；探索适用靶点，如正在研究的靶向乳腺癌（HER2靶点）、白血病（CD33，CD45等靶点）、胃泌素释放肽受体（GRPR靶点）等的放射性药物；加强新靶向配体的应用，包括使用纳米抗体、应用双环肽技术等[18-20]；使用微球等吸附材料或开发新药物剂型，加强不同学科的交叉应用；结合行业具体研究品种动向，监管机构及时推动制定放射性药物个药指南等措施，推动更多创新型放射性药物领域的研发上市，为患者带来更多治疗选择。3.2 小核酸药物小核酸药物一般是指长度小于30个碱基的寡核苷酸序列，通过靶向作用于RNA或蛋白质的一类寡核苷酸分子，通过干扰基因表达或修饰RNA功能来调控疾病相关靶点，具有广泛的治疗潜力，主要包括ASO、siRNA、微RNA（microRNA，miRNA）、适配体等类型[21]。目前尚无国内自主研发的小核酸药物上市，美国FDA在2018—2023年共批准6款ASO药物、5款siRNA药物和1款适配体创新药。药物靶点、适应证及批准信息总结见表11。已批准的创新小核酸药物主要分布在罕见病治疗领域，13款创新药中有3款针对杜氏肌营养不良症（Duchenne muscular dystrophy，DMD）、4款针对转甲状腺素蛋白（transthyretin，TTR）介导的淀粉样变性多发性神经病（transthyretin amyloid polyneuropathy，ATTR⁃PN）。但小核酸药物本身具有药物靶点筛选研究快、可成药性强的特点，随着药物开发的进程已快速扩展至其他适应证。2019年批准的Giv⁃laari是首款用于治疗成人急性肝卟啉症的siRNA药物，2021年诺华公司开发的Leqvio是首款用于治疗慢性病的小核酸药物，通过靶向PCSK9 mRNA并诱导降解，从而抑制蛋白表达，降低低密度脂蛋白胆固醇水平，用于治疗动脉粥样硬化性心血管疾病，Leqvio能起到长效降脂作用，极大改善了患者的依从性。2023年批准的Izervay用于治疗年龄相关性黄斑变性的地理性萎缩[22]，该药是一款补体C5蛋白抑制剂，结构设计上有所创新，是聚乙二醇分子共价结合的RNA适配体。可以预见，小核酸药物将逐渐在常见病治疗领域发挥作用。国内布局小核酸药物领域的创新技术公司正在快速发展，在研管线主要分布在心血管系统疾病、肝病和遗传疾病。未来小核酸药物领域的创新性主要集中在核酸序列、修饰改进和载药技术上[23]：①对靶点的筛选和药物序列设计，这是小核酸药物的研究基础。②通过对核酸进行不同水平的化学修饰，通过有效的修饰作用来降低免疫反应，增强半衰期，改善药动学表现。③不断开发新的递送系统，提高递送效率，降低脱靶概率，有效提升安全性[24-25]。最后，还可以关注小激活RNA、转运RNA等类型核酸小分子的临床应用。3.3 生物创新药由于预防性疫苗、血液制品、细胞及基因治疗等产品的监管考量不同，本文对相关产品进行单独讨论，CBER在2018—2023年共批准了43款创新药物，且2023年的批准数量显著增加。主要对其中的疫苗、基因治疗产品和细胞治疗产品进行分析，CB⁃ER批准的创新药物类型分布见表12。近年来，国内在常规抗体、重组蛋白类生物制品的研发路径已非常成熟，创新生物制品的研发水平有了较大提升，未来几年的创新生物制品可能更多出现在细胞和基因治疗产品，以及应对公共健康领域突发情况的新疫苗。3.3.1 预防性疫苗在应对公共健康领域问题方面，疫苗是有效的健康干预措施之一。2018—2023年CBER批准了16款新疫苗，包括无细胞百白破乙型肝炎灭活脊髓灰质炎和b型流感嗜血杆菌结合疫苗、20价肺炎球菌多糖结合疫苗为代表的多联多价疫苗；2款全新技术路线的mRNA疫苗，将抗原蛋白的外源基因直接导入人体，通过体细胞表达抗原蛋白诱导免疫应答，用于预防新型冠状病毒感染；以及针对区域性流行病的登革热、森林脑炎等疫苗产品。其中，无细胞百白破乙型肝炎灭活脊髓灰质炎和b型流感嗜血杆菌结合疫苗是在过往的五联疫苗品种基础上进一步取得突破的儿科六联疫苗，纳入了乙肝抗原，从而进一步减少幼儿接种次数。2018—2023年NMPA共批准7款疫苗，其中5款是新型冠状病毒疫苗（对应不同毒株或技术路线），1款为口服三价重配轮状病毒减毒活疫苗，1款为四价流感病毒亚单位疫苗。目前全球疫苗品种能覆盖的感染性疾病约45种，国内能自产预防40种疾病的疫苗，疫苗技术研发体系较为全面，传统疫苗和新出现的技术路线疫苗并行发展。未来国内疫苗的创新可能集中在以下几方面：①新的联合疫苗，包括多联疫苗和多价疫苗，达到一次注射免疫多种传染病的效果[26]。②针对未被满足的临床需求，既要考虑国内潜在风险的传染病，也要考虑国际公共卫生需求；同时，疫苗研发还可以考虑扩展到慢性疾病领域，如通过疫苗增强免疫系统对自身异常蛋白质的识别和清除能力，开发针对阿尔茨海默病患者的淀粉样β蛋白疫苗、针对心血管疾病领域的降血压疫苗等[27]。③推动创新技术平台的应用，使用新佐剂系统、递送系统和免疫接种途径，开发微针制剂、吸入制剂等疫苗类型[28-29]。3.3.2 细胞和基因治疗产品细胞与基因治疗产品具有技术含量较高、更新迭代快、组成及作用机制复杂等特点[30]，在治疗机制和治疗效果等方面具有传统的小分子和大分子药物难以比拟的优势[31]，也存在较多未被满足的临床需求，特别是肿瘤、心血管和神经系统等疾病领域。CBER在2019年批准首款慢病毒基因治疗药物（Zolgensma），用于治疗脊髓性肌萎缩症，到2022年基因治疗产品迎来新一波热潮，2款慢病毒载体、2款腺病毒载体的基因治疗药物获得批准上市。2023年，首款基于CRISPR/Cas9技术的基因编辑药物（商品名：Casgevy）获批上市，用于治疗地中海贫血，实现了基因编辑技术的临床应用。在细胞治疗产品方面，到2022年CBER批准了包括2款靶向CD19和2款靶向BCMA的CAR⁃T产品；2023年CBER批准了首个胰岛细胞疗法，通过肝门静脉输注同种异体胰岛β细胞来分泌胰岛素，治疗1型糖尿病。国内目前暂无国产基因治疗产品获批上市，2018—2023年共批准了3款创新CAR⁃T产品（细胞治疗产品），传奇生物公司自主研发的西达基奥仑赛已成为第一个成功出海美国的国产CAR⁃T产品。当前国内生物药企业在细胞和基因治疗产品领域的布局较广，在研产品数量众多，多款细胞治疗产品、基因治疗产品即将进入上市申报或确证性临床研究阶段，预期未来几年将催生更多的创新产品。目前细胞和基因治疗产品适应证较为单一，登记的临床试验中占比最大的适应证是肿瘤[32-33]，企业应进行差异化设计，聚焦更多靶点和适应证，如开发双靶点、多靶点CAR⁃T，探索从血液瘤适应证拓展到实体瘤等；细胞和基因治疗产品生产过程操作复杂，对生产运输过程的质量风险控制要求高，需要建立药企、物流、医疗机构的全链条管理模式，例如：CAR⁃T产品的生产使用过程中就面临采血机构、生产场地、医疗机构全过程的特殊控制要求，对研发企业和监管机构都提出了更高的挑战。国内监管机构需通过厘清监管路径、优化监管机制、加强靠前沟通交流、给予加快审批通道等多种方式促进此类产品的研发进展。4总结和展望本研究系统梳理了2018—2023年中美批准上市的创新药数据，当前我国批准的创新药数量呈增长态势，中美在创新药批准数量上的差距逐年减少。结合美国FDA近几年批准的创新药类型分布和当前行业发展趋势，我们预测未来国内创新药将在放射性药物、小核酸药物以及创新型生物制品方面出现较大幅度的数量增长。未来要实现进一步缩小中美差距，促进医药产业高质量发展，还需做到以下几个方面：一是提高基础科学和前沿科技研究水平，提升源头创新能力，加速科研成果转化。基础研究是推动创新药发展的根本要素，科研机构需不断开展药物靶点、成药机制等方面的创新研究，才能为创新药研发提供源头动力。当前我国期刊论文数量已位居世界第一，需要打通“临床需求—基础研究—产业转化”的闭环，充分发挥产学研协作优势。二是提升全链条的创新能力。当前医药产业发展已不再单纯依赖供应链整合或建立产业园区以形成规模化效应。例如：放射性药物、细胞治疗药物在内的创新药生产过程复杂，从原材料供应到临床使用均对时效性提出了更高的要求，企业、行业协会、监管机构需协同攻关，构建创新产品的模块化研发模式，突出各模块的创新技术研究，强化各模块之间的无缝衔接，实现科研成果的快速转化、落地，形成多维度合力推动研发，实现从原材料来源、生产企业、物流运输、临床应用机构的全链条创新药物生产模式，保障临床有效应用。三是提高政策导向能力，持续释放审评审批制度改革红利，推动以临床价值为导向的研发创新，引导企业针对罕见病领域、全球市场需求开展创新药研究，鼓励企业聚焦生物制品研发的关键理论和技术平台，布局细胞及基因治疗、新佐剂、新递呈系统等产业，针对疫苗等公共卫生产品，建立与疾控部门的联席机制，做好产品开发的顶层设计，建立优先病原体清单和优先产品特征，指导重点项目有序开发。构建“需求导向⁃工程化研发⁃监管协同”的新型创新体系路径，助力新质生产力发展。四是完善药品监管科学研究评价体系，引入平台技术等监管工具，建立不同场景下对应的监管途径和研发策略，为特定问题的高难度试验提供可行性评估和解决方案，开发基于AI的审评工具，为药品监管科学赋能。助力我国医药产业迈入新阶段，提升国产创新药在全球的竞争力。参考文献详见《中国新药杂志》 2025年第34卷第13期文章信息源于公众号凡默谷，登载该文章目的为更广泛的传递行业信息，不代表赞同其观点或对其真实性负责。文章版权归原作者及原出处所有，文章内容仅供参考。本网拥有对此声明的最终解释权，若无意侵犯版权，请联系小编删除。学如逆水行舟，不进则退；心似平原走马，易放难收。行舟Drug每日更新欢迎订阅+医药大数据|行业动态|政策解读

放射疗法申请上市医药出海

2024-11-26

·PRNewswire

Long COVID Brain Fog Linked to Lung Function

CHICAGO, Nov. 26, 2024 /PRNewswire/ -- In patients with long COVID, lower pulmonary gas exchange may be associated with impaired cognitive function, according to a study being presented next week at the annual meeting of the Radiological Society of North America (RSNA). According to the National Center for Health Statistics, approximately 17.6% of adults in the U.S. have experienced a post-COVID condition commonly referred to as long COVID. People with long COVID may exhibit a wide variety of symptoms, including difficulty concentrating ("brain fog"), change in sense of smell or taste, fatigue, joint or muscle pain, dyspnea (shortness of breath), digestive symptoms, and more. These symptoms may persist for weeks, months, or even years after COVID-19 infection. Researchers from the University of Iowa in Iowa City set out to assess associations between pulmonary MRI gas exchange, structural and functional brain MRI, and cognition in long COVID patients. In pulmonary gas exchange, oxygen moves from the lungs to the bloodstream, while carbon dioxide moves from the bloodstream to the lungs. "This is the first time that MRI has been used to jointly assess lung and brain function to investigate their relationship in long COVID," said the study's lead author Keegan Staab, B.S., graduate research assistant in the Department of Radiology at the University of Iowa in Iowa City. "This research is new in that it combines multiple unique imaging types to study a multiorgan relationship in a disease population." Senior study author Sean B. Fain, Ph.D., professor and vice chair for research in the Department of Radiology at the University of Iowa, added, "If these findings can be generalized to the long COVID population, the study suggests that there may be a causative relationship between cognitive dysfunction and lung dysfunction, suggesting a potential treatment strategy using methods that target improved gas exchange." For the study, 10 female and 2 male patients (median age: 59 years) who had persistent dyspnea and/or fatigue following the resolution of acute COVID-19 infection were recruited from a post-COVID-19 clinic. Hyperpolarized Xe pulmonary MRI, structural and functional brain MRI, pulmonary function tests and cognitive tests were acquired. "129Xe MRI allows for advanced measurements of ventilation and gas exchange," Staab said. "The literature also indicates that 129Xe may be more sensitive to pulmonary injury compared to standard breathing tests, making it better suited to study long COVID in which patients typically have normal breathing tests." Perceived cognitive difficulties were measured using Patient-Reported Outcomes Measurement Information System, and objective cognitive performance was assessed using the National Institutes of Health Toolbox V3 Cognition Battery. "There was a range of cognitive difficulties among the patients in the study," Staab said. "Some were mild and indicated slight dysfunction, while others were more serious and indicated that some patients have slow thinking and trouble concentrating several times per day." The results showed that lower pulmonary gas exchange may be associated with cognitive dysfunction, as well as lower gray matter and white matter volumes in patients with long COVID. In addition, the researchers observed significant relationships suggesting that increased cerebral blood flow is associated with decreased gas exchange in long COVID patients. Staab said larger studies are needed to investigate the association between gas exchange and cerebral blood flow in long COVID. "This relationship could be a compensatory mechanism where lower lung function is compensated by higher cardiac output and higher brain perfusion," he said. "It's also a possibility that the disease mechanism that impairs pulmonary gas exchange also leads to higher brain perfusion through downstream vascular injury in both lung and brain." Based on the findings of this study, gas exchange abnormalities may help identify long COVID patients who require additional treatment or long-term management. Other co-authors are Marrissa J. McIntosh, Ph.DDD., Jonathan L. Percy, B.S., Andrew D. Hahn, Ph.DDD., Natally AlArab, M.D., Conner J. Wharff, B.S. B.A. RT(R)(MR), Eric Bruening, M.S., Alejandro P. Comellas, M.D., Eric A. Hoffman, Ph.DDD., Carinda Linkenmeyer, M.A.E., Tara Lanning, B.S., and Karin F. Hoth, Ph.DDD. Note: Copies of RSNA 2024 news releases and electronic images will be available online at RSNA.org/press24. RSNA is an association of radiologists, radiation oncologists, medical physicists and related scientists promoting excellence in patient care and health care delivery through education, research and technologic innovation. The Society is based in Oak Brook, Illinois. (RSNA.org) For patient-friendly information on MRI, visit RadiologyInfo.org. SOURCE Radiological Society of North America (RSNA) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果

2024-05-08

·BioSpace

Polarean’s Xenon MRI to be Featured at Upcoming ATS 2024 Conference Featured Company at Respiratory Innovation Summit to Jump Start Robust Presence

DURHAM, NC and LONDON, May 08, 2024 (GLOBE NEWSWIRE) -- Polarean (AIM: POLX), a commercial-stage medical device leader in advanced magnetic resonance imaging (MRI) of the lungs, has been selected as one of the featured companies and a poster presenter at the American Thoracic Society’s (ATS) 2024 Respiratory Innovation Summit (RIS), a testament to the value of our XENOVIEW technology seen across lung clinicians and pulmonary drug developers. The summit is scheduled to take place on May 17th-18th in San Diego, CA, at the Manchester Grand Hyatt San Diego. The Respiratory Innovation Summit, a premier event in the field of pulmonary medicine, unites innovators, investors, clinicians, and advocacy groups. The meeting historically attracts more than 275 global leaders representing all facets of the respiratory industry, including start-ups, venture capital, government, academia, and clinicians. After the dynamic discussions of the Respiratory Innovation Summit, Polarean eagerly anticipates further collaboration within the pulmonary medicine community at the 2024 ATS International Conference, held from May 19th to 22nd. Visit booth #2813 to engage directly with our executive team, including Christopher von Jako, PhD, Chief Executive Officer; Alex Dusek, Chief Commercial Officer; and Kiarash Emami, PhD, VP of Technology & Applications. Discover firsthand how Polarean strives to revolutionize pulmonary medicine through direct visualization of lung ventilation as we share detailed insights, forge valuable connections, and collaborate to shape the future of lung imaging. This year, the breadth of Xenon MRI research and the number of displays outpaced all previous years, with 33 presentations from 10 different sites and multiple categories, including asthma, bronchopulmonary dysplasia, COPD, COVID-19, cystic fibrosis, hematopoietic stem cell transplant, lung cancer resection, radiation-induced lung injury, pulmonary arterial hypertension, and thoracic insufficiency syndrome. Christopher von Jako, PhD, CEO of Polarean, said: “The Respiratory Innovation Summit and the ATS annual conference serve as invaluable venues to spotlight our Xenon MRI platform, especially to those enthusiastic about fostering collaborative partnerships. These events provide an unparalleled opportunity to elevate awareness of our technology among clinicians, regulators, investors, and potential pharmaceutical industry partners. As we strive to advance our commercialization strategy, the increase in Xenon MRI posters and presentations marks significant strides in amplifying understanding and enthusiasm for Xenon MRI and the spectrum of therapeutic disciplines that could benefit from our technology.” See the listing below for details on the presentation title, abstract number, session time, and location. XENOVIEW IMPORTANT SAFETY INFORMATION Indication XENOVIEW™, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging. CONTRAINDICATIONS None. Warnings and Precautions Risk of Decreased Image Quality from Supplemental Oxygen: Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold. Risk of Transient Hypoxia: Inhalation of an anoxic gas such as XENOVIEW may cause transient hypoxemia in susceptible patients. Monitor all patients for oxygen desaturation and symptoms of hypoxemia and treat as clinically indicated. Adverse Reactions Adverse Reactions in Adult Patients: The adverse reactions (> one patient) in efficacy trials were oropharyngeal pain, headache, and dizziness. Adverse Reactions in Pediatric and Adolescent Patients: In published literature in pediatric patients aged 6 to 18, transient adverse reactions were reported: blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria. In at least one published study of pediatric patients aged 6 to 18 years, transient decrease in SpO2% and transient increase in heart rate was reported following hyperpolarized xenon Xe 129 administration. XENOVIEW is not approved for use in pediatric patients less than 12 years of age. Please see full prescribing information at About Polarean ( ) Polarean is a revenue-generating medical imaging technology company revolutionizing pulmonary medicine through direct visualization of lung function by introducing the power and safety of MRI to the respiratory healthcare community. This community is in desperate need of modern solutions to accurately assess lung function. The Company strives to optimize lung health and prevent avoidable loss by illuminating hidden disease, addressing the global unmet medical needs of more than 500 million patients worldwide suffering from chronic respiratory disease. Polarean is a leader in the field of hyperpolarization science and has successfully developed the first and only hyperpolarized Xenon MRI inhaled contrast agent, XENOVIEW™, which is now FDA-approved in the United States. Polarean is dedicated to researching, developing, and commercializing innovative imaging solutions with its non-invasive and radiation-free pulmonary functional MRI platform. This comprehensive drug-device platform encompasses the proprietary Xenon gas blend, gas hyperpolarization system, as well as software and accessories, facilitating fully integrated modern respiratory imaging operations. Founded in 2012, with offices in Durham, NC, and London, United Kingdom, Polarean is committed to increasing global awareness of and broad access to its XENOVIEW MRI technology platform. For the latest news and information about Polarean, please visit . About The American Thoracic Society ( ) The American Thoracic Society (ATS) improves global health by advancing research, patient care, and public health in pulmonary disease, critical illness, and sleep disorders. Founded in 1905 to combat TB, the ATS has grown to tackle asthma, COPD, lung cancer, sepsis, acute respiratory distress, and sleep apnea, among other diseases. ATS Abstract Title Presentation Date Abstract Number Session and Location Hyperpolarized 129Xe MRI: What Additional Information Does It Provide? May 18, 2024 3:10 PM - 3:50 PM Session PG16 San Diego Convention Center, Room 6D (UpperLevel) Quantifying the Impact of Cannabis Smoking in Lungs of Young Adults Using CT and Xe MRI May 19, 2024 9:15 AM - 11:15 AM 1014 Session A29 San Diego Convention Center, Room 6E (UpperLevel) Six-month Longitudinal Changes in129-XE and HRCT Imaging Metrics Tend to Associate With On-study COPD Exacerbations May 19, 2024 9:15 AM - 11:15 AM 1017 Session A29 San Diego Convention Center, Room 6E (UpperLevel) Advanced 4D Hyperpolarized Gas Imaging of Ventilation and Dissolved Gas Biomarkers in COPD May 19, 2024 9:15 AM - 11:15 AM 1016 Session A29 San Diego Convention Center, Room 6E (UpperLevel) 3-month Change in Hyperpolarized Xe MRI Membrane Uptake Predicts 6-month Change in Lung Function in Patients With Idiopathic Pulmonary Fibrosis May 19, 2024 11:30 AM - 1:15 PM P862 Session A47 San Diego Convention Center, Area H (Hall H,Ground Level) Using Xenon MRI to Evaluate the Trajectories of Idiopathic Pulmonary Fibrosis May 19, 2024 2:15 PM - 4:15 PM 914 Session A104 San Diego Convention Center, Room 33A-C(Upper Level) Combining Hyperpolarized Xe MR Imagingand Spectroscopy to Estimate Pulmonary Vascular Resistance May 19, 2024 3:39 PM - 3:51 PM Session A97 San Diego Convention Center, Room 6D (UpperLevel) Magnetic Resonance Imaging Ventilation Phenotypes of Severe Asthma May 19, 2024 3:39 PM - 3:51 PM Session A99 Marriott Marquis San Diego Marina, PacificBallroom 24-26 (Ground Floor, North Tower) Success and Feasibility of MultipleBreath Washout: Prospective Multi-center Results From the Transpire Study May 20, 2024 9:15 AM - 11:15 AM 421 Session B25 San Diego Convention Center, Room 25A-C(Upper Level) Improved Quantification of Ventilation Heterogeneity in Hyperpolarized Xenon MRI Using Physics-rooted Bias-field Correction May 20, 2024 11:30 AM - 1:15 PM P170 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Addressing Healthy Aging Variations in Ventilation From Childhood to Older Age Using Xenon MRI May 20, 2024 11:30 AM - 1:15 PM P171 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Assessing Radiation-induced Lung Injury Using a Chemical Shift Imaging-based CSSR Technique May 20, 2024 11:30 AM - 1:15 PM P176 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Sex and Age-dependence of Xe MRI Cardiopulmonary Oscillations in Healthy Volunteers May 20, 2024 11:30 AM - 1:15 PM P188 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Estimating Physiological Values of Membrane and Red Blood Cell Conductance Using Xe Gas Exchange MRI May 20, 2024 11:30 AM - 1:15 PM P187 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Increased BMI Is Associated With Elevated Membrane Uptake on Xe Gas Exchange MRI in Healthy Subjects May 20, 2024 11:30 AM - 1:15 PM P178 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Establishing a Standardized Healthy Reference Distribution for Multi-site Xe Gas Exchange MRI Across Major Scanner Platforms May 20, 2024 11:30 AM - 1:15 PM P172 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Quantifying Spatial Distribution of Ventilation Defects in Lung Imaging With Hyperpolarized Xenon MRI May 20, 2024 11:30 AM - 1:15 PM P174 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) Assessment of Gas Exchange WithHyperpolarized Xe MR Imaging in Mild Asthmatics When Administered a Vasodilator May 20, 2024 11:30 AM - 1:15 PM P190 Session B80-1 San Diego Convention Center, Area B (Hall A-B2,Ground Level) 129Xe MRI With Optimized Bias Field Correction to Assess Ventilation Gradients in Individuals With Normal Lung Function May 20, 2024 11:30 AM - 1:15 PM P701 Session B80-2 Research and Clinical Applications of Hyperpolarized 129Xe MRI May 20, 2024 3:00 PM - 3:15 PM Session B91 San Diego Convention Center, Room 24A-C(Upper Level) Assessment of Obstructive and Restrictive Lung Disease Via MRI in Bronchopulmonary Dysplasia Patients May 21, 2024 9:15 AM - 11:15 AM 404 Session C29 San Diego Convention Center, Room 25A-C(Upper Level) Changes in Individual Ventilation Defects in Cystic Fibrosis After Initiation of Modulator Therapy, in the Hypoint Trial May 21, 2024 9:15 AM - 11:15 AM 405 Session C29 San Diego Convention Center, Room 25A-C(Upper Level) Xe MRI and Oscillometry Evidence ofImproved Small Airways Dysfunction After 6-weeks ICS/LABA/LAMA Therapy in Moderate Asthma May 21, 2024 9:15 AM - 11:15 AM 407 Session C29 San Diego Convention Center, Room 25A-C(Upper Level) Comparison of CT-based Measurements of Ventilation and Perfusion to Ventilation and Gas Exchange Measurements From Hyperpolarized Xe MRI May 21, 2024 9:15 AM - 11:15 AM 410 Session C29 San Diego Convention Center, Room 25A-C(Upper Level) CT Mucus Score Predicts Response to 6-weeks ICS/LABA/LAMA in Moderate Asthma May 21, 2024 9:15 AM - 11:15 AM 413 Session C29 San Diego Convention Center, Room 25A-C(Upper Level) Xe MR Evidence of Abnormal Gas-exchange in Mild-moderate and Severe Asthma May 21, 2024 9:15 AM - 11:15 AM 418 Session C29 San Diego Convention Center, Room 25A-C(Upper Level) Ventilation Defect Burden Quantified byTechnegas SPECT and Xe MRI Predicts Lung Cancer Resection Outcomes May 21, 2024 9:15 AM - 11:15 AM 420 Session C29 San Diego Convention Center, Room 25A-C(Upper Level) Rapid and Persistent 6-week Responseto ICS/LABA/LAMA in Mild-moderate Asthma May 21, 2024 11:30 AM - 1:15 PM P690 Session C71 San Diego Convention Center, Area F (Hall A-B2,Ground Level) Evaluation of Xenon Gas Phase and Dissolved Phase Delays Using Dynamic 129Xe-hyperpolarized MRI in Pre-clinical Thoracic Insufficiency Syndrome Model May 21, 2024 11:30 AM - 1:15 PM P156 Session C73 San Diego Convention Center, Area F (Hall A-B2,Ground Level) Xe MRI Reveals Regional Gas-exchange Abnormalities in Cystic Fibrosis Lung Disease May 21, 2024 11:30 AM - 1:15 PM P174 Session C74 San Diego Convention Center, Area F (Hall A-B2,Ground Level) Quantitative Characterization of Regional Ventilation and Perfusion in Patients With Persistent COVID-19 Symptoms Using Hyperpolarized Xe MRI and Dual Energy CT May 21, 2024 11:30 AM - 1:15 PM P186 Session C75 San Diego Convention Center, Area F (Hall A-B2,Ground Level) The EXPLAIN (Hyperpolarised Xenon Magnetic Resonance Pulmonary Imaging in Patients With Long-COVID) Study: The Primary Outcome May 21, 2024 11:30 AM - 1:15 PM P195 Session C75 San Diego Convention Center, Area F (Hall A-B2,Ground Level) Same-day and Six-week Repeatability of Hyperpolarized Xe MRI Measures in Patients With Pulmonary Arterial Hypertension May 22, 2024 11:00 AM - 1:00 PM 306 Session D109 San Diego Convention Center, Room 28C-E(Upper Level) Contact Information: Polarean: Chuck Osborne Chief Financial Officer +1 (919) 206-7900, ext. 117 cosborne@polarean.com Polarean Investors: Anna Dunphy / Phillip Marriage +44 (0)20 7933 8780 polarean@wallbrookpr.com Polarean Media Contact: Alexis Opp +1 (919) 206-7900 aopp@polarean.com General inquiries: info@polarean.com Follow Polarean on LinkedIn here Polarean: Chuck Osborne Chief Financial Officer +1 (919) 206-7900, ext. 117 cosborne@polarean.com Polarean Investors: Anna Dunphy / Phillip Marriage +44 (0)20 7933 8780 polarean@wallbrookpr.com Polarean Media Contact: Alexis Opp +1 (919) 206-7900 aopp@polarean.com General inquiries: info@polarean.com

放射疗法

100 项与氙[129Xe] 相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
造影剂	美国	Polarean, Inc.	2022-12-23
肺部疾病	美国	Polarean, Inc.	2022-12-23

未上市

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适应症	最高研发状态	国家/地区	公司	日期
结缔组织病	临床2期	美国	American Heart Association, Inc.	2024-08-12
结缔组织病	临床2期	美国	Duke University	2024-08-12
特发性肺动脉高压	临床2期	美国	American Heart Association, Inc.	2024-08-12
特发性肺动脉高压	临床2期	美国	Duke University	2024-08-12
与结缔组织病相关的肺动脉高压	临床2期	美国	American Heart Association, Inc.	2024-08-12
与结缔组织病相关的肺动脉高压	临床2期	美国	Duke University	2024-08-12
肺动脉高压	临床2期	-	-	2024-03-15
贫血	临床2期	美国	Duke University	2024-01-12
慢性血栓栓塞性肺动脉高压	临床2期	美国	Duke University	2024-01-12
呼吸困难	临床2期	美国	Duke University	2024-01-12

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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


NCT03417687 (CTgov)	临床3期	肺部疾病	38	129Xe MRI	艱齋願築衊選淵鑰醖獵(艱築簾網簾構糧鬱鑰遞) = 鬱繭膚築鹽範獵艱餘遞築淵蓋憲糧繭襯餘簾廠 (鏇獵簾膚膚網齋蓋窪鑰, 2.88)	-	2022-06-28
ASTRO2020	N/A	-	-	Hyperpolarized 129 Xe (Gas exchange-optimized plans)	憲範淵襯淵鬱艱鹽願鬱(餘鏇艱艱積範顧糧鑰壓) = 範廠獵淵夢鏇鏇襯餘齋繭鹽蓋遞簾夢觸衊範糧 (餘築獵繭糧淵憲醖窪餘, 45) 更多	-	2020-11-01
				Hyperpolarized 129 Xe (Ventilation-optimized plans)	憲範淵襯淵鬱艱鹽願鬱(餘鏇艱艱積範顧糧鑰壓) = 壓積餘衊襯簾獵簾壓膚繭鹽蓋遞簾夢觸衊範糧 (餘築獵繭糧淵憲醖窪餘, 31) 更多
ERS2019	N/A	间质性肺疾病	33	Hyperpolarised 129-xenon	獵構糧齋網蓋觸壓構製(網選選遞憲夢鹽製鹽糧) = 構構願艱壓構鏇遞構艱繭繭網淵獵衊願膚繭醖 (鹹積襯廠遞鏇鑰築築憲 )	-	2019-09-28
				Hyperpolarised 129-xenon	獵構糧齋網蓋觸壓構製(網選選遞憲夢鹽製鹽糧) = 簾艱廠觸簾夢壓壓衊鏇繭繭網淵獵衊願膚繭醖 (鹹積襯廠遞鏇鑰築築憲 ) 更多