The goal of this clinical trial is to evaluate an investigational ultralow dose positron emission tomography (PET) imaging technique for known or suspected coronary artery disease (for detecting myocardial ischemia or infarction) detection and monitoring. The main question it aims to answer is:
Can the investigators optimize the timing, scan duration, and image reconstruction to reduce the radiation dose 10-100 fold of the current clinical standard? Participants will be injected with a radioactive tracer called Fluorine-18 (18F)-flurpiridaz and be imaged on a new type of high sensitivity PET scanner for up to 3 hours

开始日期2025-12-01

申办/合作机构

Nuclear Energy Institute

NCT04594941

/ Completed临床2期

A Descriptive, Comparative, Randomized, Crossover Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion Imaging Quality Using High Performance Liquid Chromatography (HPLC) and Solid Phase Extraction (SPE) Manufacturing Processes

This was a Phase 2 prospective, randomized, crossover study of Flurpiridaz (18F) Injection for PET-MPI in participants referred for evaluation of known coronary artery disease (CAD) or for suspected CAD with intermediate to high pre-test probability (PTP). The objective is to assess the difference and variability between 2 sets of rest images synthesized by the same or 2 different manufacturing processes. Twenty-eight evaluable [participants were enrolled in this study and underwent 2 Flurpiridaz (18F) Injection PET-MPI at rest. Each participant attended a Screening Visit at least 2 days and up to 14 days prior to the first Flurpiridaz (18F) Injection PET-MPI. The participants were randomized 1:1:1:1 to 4 possible sequences of receiving 2 doses of Flurpiridaz (18F) Injection: 2 groups of 7 participants received 2 Flurpiridaz (18F) Injection doses synthesized by the same manufacturing processes (either HPLC or SPE) and 2 groups of 7 subjects will receive 2 Flurpiridaz (18F) Injection doses synthesized by different manufacturing processes (1 dose by HPLC followed by 1 dose by SPE or 1 dose by SPE followed by 1 dose by HPLC). All participants were followed up by telephone for adverse events (AEs) and serious AEs (SAEs) at 24 (+8) hours following each Flurpiridaz (18F) Injection administration.

开始日期2022-01-27

申办/合作机构

GE Healthcare Holdings, Inc.

NCT03354273

/ Completed临床3期

A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease

This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.

开始日期2018-06-05

申办/合作机构

GE Healthcare Holdings, Inc.

100 项与 Flurpiridaz F 18 相关的临床结果

登录后查看更多信息

100 项与 Flurpiridaz F 18 相关的转化医学

登录后查看更多信息

100 项与 Flurpiridaz F 18 相关的专利（医药）

登录后查看更多信息

项与 Flurpiridaz F 18 相关的文献（医药）

2025-11-01·JACC-Cardiovascular Imaging

General Purpose Deep Learning Attenuation Correction Improves Diagnostic Accuracy of SPECT MPI

Article

作者: Einstein, Andrew J ; Builoff, Valerie ; Fish, Mathews B ; Ruddy, Terrence D ; Berman, Daniel S ; Kavanagh, Paul ; Liang, Joanna X ; Buckley, Christopher ; Van Kriekinge, Serge ; Martins, Monica ; Kaufmann, Philipp A ; Dey, Damini ; Miller, Robert J H ; Shanbhag, Aakash D ; Lemley, Mark ; Halcox, Julian P ; Slomka, Piotr J ; Bateman, Timothy M ; Marcinkiewicz, Anna M

BACKGROUND:

Single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) uses computed tomography (CT)-based attenuation correction (AC) to improve diagnostic accuracy. Deep learning (DL) has the potential to generate synthetic AC images, as an alternative to CT-based AC.

OBJECTIVES:

This study evaluated whether DL-generated synthetic SPECT images could enhance accuracy of conventional SPECT MPI.

METHODS:

Study investigators developed a DL model in a multicenter cohort of 4,894 patients from 4 sites to generate simulated SPECT AC images (DeepAC). The model was externally validated in 746 patients from 72 sites in a clinical trial (A Phase 3 Multicenter Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD; NCT01347710) and in 320 patients from another external site. In the first external cohort, the study assessed the diagnostic accuracy for obstructive coronary artery disease (CAD)-defined as left main coronary artery stenosis ≥50% or ≥70% in other vessels-for total perfusion deficit (TPD). In the latter, the study completed change analysis and compared quantitative scores for AC, DeepAC, and nonattenuation correction (NC) with clinical scores.

RESULTS:

In the first external cohort (mean age, 63 ± 9.5 years; 69.0% male), 206 patients (27.6%) had obstructive CAD. The area under the receiver-operating characteristic curve (AUC) of DeepAC TPD (0.77; 95% CI: 0.73-0.81) was higher than the NC TPD (AUC: 0.73; 95% CI: 0.69-0.77; P < 0.001). In the second external cohort, DeepAC quantitative scores had closer agreement with actual AC scores compared with NC.

CONCLUSIONS:

In a multicenter external cohort, DeepAC improved prediction performance for obstructive CAD. This approach could enhance diagnostic accuracy in facilities using conventional SPECT systems without requiring additional equipment, imaging time, or radiation exposure.

2025-11-01·Annals of Medicine and Surgery

Flurpiridaz F18: a new era in nuclear cardiac imaging – the first FDA-approved radiotracer in 30 years

作者: Seid, Firdowes Feki ; Khaliq, Nawal ; Ahmedelhadi, Ekram Muhammedasrar ; Marsool, Ali Dheyaa ; Smith, David N. ; Ayalew, Biruk Demisse ; Kashif, Aayat ; Teweldeberhan, Agazi ; Ul-Haq, Muhammad Areeb

2025-11-01·JOURNAL OF NUCLEAR MEDICINE

Comparison, Agreement, and Significance Cutoffs of ¹⁸ F-Flurpiridaz PET Myocardial Blood Flow Quantitation Methods and Software Packages

Article

作者: Thompson, David ; Maddahi, Jamshid ; Cooke, C David ; Packard, René R Sevag ; Slomka, Piotr ; Wangerin, Kristen A ; Renaud, Jennifer M ; Buckley, Christopher ; Van Train, Kenneth F ; Van Kriekinge, Serge D ; Moody, Jonathan B

¹⁸F-flurpiridaz is a novel PET myocardial perfusion radiotracer with a high myocardial extraction fraction and low positron range, providing high-resolution images. Additionally, the linear relationship between ¹⁸F-flurpiridaz myocardial extraction and myocardial blood flow (MBF) over a wide range of flow values permits accurate MBF measurement. Several groups have developed strategies to quantitate ¹⁸F-flurpiridaz MBF with methodologic differences. These methods have not previously undergone head-to-head comparisons. Methods: Three methods of ¹⁸F-flurpiridaz MBF quantitation were compared using Emory Cardiac Toolbox (ECTb; Syntermed), 4DM (INVIA), and Quantitative PET (QPET; Cedars-Sinai) software. All evaluable pharmacologic stress patients from the phase 3 ¹⁸F-flurpiridaz PET trial (NCT03354273) of ¹⁸F-flurpiridaz were included (n = 405). We adopted Bland-Altman plots to determine absolute differences between MBF quantitative methods, Fleiss κ for agreement across software packages, and Cohen κ for agreement of pairwise comparisons. Diagnostic performances of stress MBF and myocardial flow reserve (MFR) were determined by performing receiver-operating-characteristic analysis for areas under the curve (AUCs), using quantitative invasive coronary angiography as the reference standard. Results: Differences in mean stress MBF and MFR between methods across coronary territory distributions ranged from 0.23 to 0.29 mL/min/g and from 0.37 to 0.40 mL/min/g for ECTb and 4DM, respectively; from 0.09 to 0.11 mL/min/g and from 0.36 to 0.38 mL/min/g for ECTb and QPET, respectively; and from 0.25 to 0.26 mL/min/g and from 0.39 to 0.40 mL/min/g for QPET and 4DM, respectively. There was substantial agreement across software packages, with the Fleiss κ ranging from 0.77 to 0.79 and 0.72 to 0.75 for stress MBF and MFR, respectively. Similar results were found in pairwise comparisons. For coronary artery territories with at least 70% stenosis, median stress MBF and MFR AUCs were 0.73-0.74 and 0.71-0.73, respectively, when evaluated on a per-patient basis, and 0.75-0.77 and 0.74-0.75, respectively, in pooled coronary distributions on a per-vessel basis across all methods. Conclusion: All software packages demonstrated high agreement and similar ¹⁸F-flurpiridaz MBF quantitation, paving the way for the interoperability of these platforms in clinical practice.

项与 Flurpiridaz F 18 相关的新闻（医药）

2025-11-17

·Business Wire

GE HealthCare announces Flyrcado milestone: Strong pilot results drive broader rollout at CVAUSA

CVAUSA, the largest network of private cardiology groups in the U.S., plans to broadly adopt Flyrcado in line with its mission to deliver the highest quality cardiovascular care for patients. CVAUSA currently performs approximately 85,000 cardiac positron emission tomography (PET) procedures annually, highlighting the potential opportunity for Flyrcado as adoption grows. GE HealthCare remains committed to driving innovation and collaborating with leading cardiology groups to advance PET myocardial perfusion imaging (MPI) technology. ARLINGTON HEIGHTS, Ill.--(BUSINESS WIRE)--GE HealthCare (Nasdaq: GEHC) today announced that Cardiovascular Associates of America (CVAUSA), the largest network of private cardiology groups in the U.S., plans to broaden its adoption of GE HealthCare’s FDA-approved cardiac positron emission tomography (PET) radiotracer Flyrcado™ (flurpiridaz F 18) injection, across approximately 25 sites following a successful pilot at Cardiovascular Medicine in Davenport, Iowa. This planned rollout marks a significant milestone for advancing PET myocardial perfusion imaging (MPI) in community cardiology settings and reflects growing confidence in Flyrcado’s role in shaping the future of cardiac imaging. The pilot at Cardiovascular Medicine provided cardiologists with an opportunity to evaluate Flyrcado in real-world workflows. “The pilot demonstrated that Flyrcado can be seamlessly integrated into a high-volume cardiac PET practice,” said Dr. Edmund Coyne, former President of Cardiovascular Medicine. “In our Davenport location, we routinely perform 12+ cardiac PET scans a day, and during our two-week, 21 patient pilot, we found that Flyrcado fits smoothly into that workflow without disruption. We saw firsthand the benefits in diagnostic confidence and efficiency, as well as excellent image quality, and we look forward to seeing these advantages scaled across CVAUSA’s network.” “Our mission is to deliver the highest quality cardiovascular care, and expanding the use of advanced cardiac PET imaging is a key part of that,” said Tim Attebery, Chief Executive Officer of CVAUSA. “We perform approximately 85,000 cardiac PET procedures annually across our network, and following a successful pilot with Flyrcado, we’re excited to bring this technology to more of our sites—helping our partner cardiologists make more informed decisions for patients with known or suspected coronary artery disease.” “We are encouraged by the adoption of Flyrcado in a variety of real-world settings—including large academic institutions, integrated delivery networks (IDNs), mobile PET/CT settings, and customers transitioning from SPECT to PET MPI,” said Eric Ruedinger, Vice President and General Manager of GE HealthCare’s Pharmaceutical Diagnostics division for the U.S. and Canada. “The accumulating real-world evidence shows Flyrcado’s versatility and efficacy across diverse clinical environments, laying the foundation for continued growth and confidence in this game-changing tracer.” Recent milestones underscore the growing importance of Flyrcado in clinical practice. GE HealthCare announced a distribution and services agreement with CDL Nuclear Technologies to support implementation across multiple sites of care, including private cardiology practices. In addition, Flurpiridaz F 18 is now featured in a new international procedure standard co‑published by leading societies—SNMMI, ASNC, EANM, and ACNM—in The Journal of Nuclear Medicine1 and Journal of Nuclear Cardiology. These guidelines highlight Flurpiridaz F 18 high myocardial uptake, almost linear extraction fraction relationship, and superior spatial resolution compared to SPECT and outline best practices for patient selection, rest/stress protocols, and workflow integration—further validating the tracer’s role in delivering high‑quality, safe, and effective cardiac PET imaging. GE HealthCare’s Pharmaceutical Diagnostics division is a global leader in imaging agents used to support around 130 million procedures per year globally, equivalent to four patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology and oncology, with an innovative pipeline, all aimed at enabling better informed diagnosis and monitoring for improved therapy decision making and clinical outcomes. About GE HealthCare Technologies Inc. GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient’s journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits. GE HealthCare is proud to be among 2025 Fortune World’s Most Admired Companies™. Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com for more information. Forward-Looking Statements This release contains forward-looking statements. These forward-looking statements might be identified by words, and variations of words, such as “will,” “expect,” “may,” “would,” “could,” “plan,” “believe,” “anticipate,” “intend,” “potential,” and similar expressions. These forward-looking statements may include, but are not limited to, statements about Flyrcado and GE HealthCare Technologies Inc.’s (the “Company’s”) performance, growth opportunities, and strategy. These forward-looking statements involve risks and uncertainties, many of which are beyond the control of the Company. Factors that could cause the Company’s actual results to differ materially from those described in its forward-looking statements include, but are not limited to, uncertainties regarding the commercial success of Flyrcado, the Company’s ability to receive pass-through status from the US Centers for Medicaid and Medicare, and decisions by regulatory authorities impacting labeling, manufacturing processes, safety, or other matters that could affect the availability or commercial potential of Flyrcado. Other factors that may cause such a difference also include those discussed in the "Risk Factors" section of the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission and any updates or amendments it makes in future filings. There may be other factors not presently known to the Company or which it currently considers to be immaterial that could cause the Company’s actual results to differ materially from those projected in any forward-looking statements the Company makes. The Company does not undertake any obligation to update or revise its forward-looking statements except as required by applicable law or regulation. Important Safety Information and Usage of Flyrcado™ (flurpiridaz F 18) injection FLYRCADO™ (flurpiridaz F 18) injection, for intravenous use important safety information Indications and Usage FLYRCADO is a radioactive diagnostic drug indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction. Contraindications None Warnings and Precautions Risk associated with exercise or pharmacologic stress: Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent’s prescribing information. Radiation risks: FLYRCADO 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 minimize radiation exposure to patients and health care providers. Advise patients to hydrate before and after administration and to void. Adverse Reactions Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia. Use in Specific Populations Pregnancy There are no data on use of flurpiridaz F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flurpiridaz F 18 and the gestational timing of exposure. FLYRCADO contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol). If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy. There are no data on use of flurpiridaz F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flurpiridaz F 18 and the gestational timing of exposure. FLYRCADO contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol). If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy. Lactation Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 8 hours after FLYRCADO administration. Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 8 hours after FLYRCADO administration. Pediatric Use Safety and effectiveness of FLYRCADO in pediatric patients have not been established. Safety and effectiveness of FLYRCADO in pediatric patients have not been established. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 800-FDA-1088 or www.fda.gov/medwatch For full prescribing information, click here. For important safety information, please click here. 1 Packard, R. R. S., Maddahi, J., Pelletier-Galarneau, M., Al-Mallah, M. H., Coelho, M., Dorbala, S., Galt, J., Hyun, M., Menon, N., Miller, E. J., Shetty, M., & Saraste, A. (2025). SNMMI/EANM/ASNC/ACNM procedure standard/practice guideline for 18F-flurpiridaz PET myocardial perfusion imaging and blood flow quantitation. Journal of Nuclear Medicine and Journal of Nuclear Cardiology. https://doi.org/10.2967/jnumed.125.270873

2025-11-13

·丁香园 Insight 数据库

核药，杀红眼了

11 月 5 日，诺华的镥 177Lu 特昔维匹肽（Pluvicto）双适应症正式在华获批，中国前列腺癌治疗迈入「核药时代」。这款名为 Pluvicto 的 RDC 药物，自上市以来销售额便一路高歌猛进，成为核药领域首个「重磅炸弹」药物，并在全球创下年销近 14 亿美元的佳绩。曾被视为边缘地带的核药，正成为 MNC 争相布局的「下一个百亿美元战场」。诺华身后，拜耳、罗氏、礼来、BMS、阿斯利康等巨头早已悄然入场；与此同时，本土药企也正崭露头角，力求在这一新兴领域占据一席之地。驶入快车道核药，即放射性药物，是指含有放射性同位素，用于疾病诊断、治疗或医学研究的一类特殊药物。近年来，核药已成为全球医药板块最热门的资产。据 Precedence Research 发布的报告，2024 年全球核药市场规模为 67.4 亿美元，预计到 2034 年将增长至 144.4 亿美元，复合年增长率达 8.2%（图 1）。在中国，核药市场同样呈现快速发展态势。中国核安全局数据显示，预计 2025 年中国放射性药物市场规模将达到 93 亿元人民币，2030 年有望进一步提升至 260 亿元人民币。图 1、2024-2034 年放射性药物市场规模图片来源：Precedence Research 核药可分为诊断用核药与治疗用核药两大类。在诊断用核药方面，首个靶向前列腺特异性膜抗原（PSMA）的 PET 诊断药物为 Lantheus 开发的 Plarify，该药采用 F18 核素标记，在 2021 年 5 月获 FDA 批准。同年 12 月，Telix 公司开发的 Ga68 标记 PSMA 诊断药物 Illuccix 也获批上市。 2024 年，这两款诊断药物合计销售额达 16 亿美元，同比增长 33%。其中，诊断核药 Pylarify 表现尤为突出，过去三年销售额实现翻倍，2024 年全年销售额已突破 10 亿美元，显示出诊断核药市场放量速度超出预期。治疗性核药的发展更为引人注目。Pluvicto 和 Lutathera 是该领域的两个代表性药物。Pluvicto 是诺华于 2018 年以 21 亿美元收购 Endocyte 所得，而 Lutathera 则来自法国 AAA 公司，诺华在 2017 年以 39 亿美元将其收购。 2024 年，Pluvicto 实现销售收入 13.92 亿美元，同比增长 42%，成为核药领域首个重磅炸弹药物；Lutathera 收入达 7.24 亿美元，同比增长 20%，连续两年保持快速增长。两款药物合计为诺华贡献 21.16 亿美元收入，体现了核药的商业化潜力。总体来看，2024 年，Pluvicto、Lutathera、Plarify 和 Illuccix 四款核心核药产品合计销售额已达到约 37 亿美元。适应症的不断拓展进一步打开了核药市场的增长空间。2025 年 3 月，Pluvicto 获 FDA 批准用于紫杉烷类药物治疗前的转移性去势抵抗性前列腺癌（mCRPC）患者，推动其销售额持续攀升。2025 年前三季度，该药销售收入达 13.89 亿美元，同比增长 45%。11 月 5 日，Pluvicto 在中国获批双适应症上市，有望进一步提升其销售增速。根据诺华在 2025 年 JP 摩根医疗大会上的预测，Pluvicto 的销售峰值预计将突破 50 亿美元。另一方面，Lutathera 于 2024 年 5 月获批用于治疗 12 岁以上胃肠胰神经内分泌肿瘤（GEP-NET）儿童患者，扩大了其目标患者群体。2025 年前三季度，Lutathera 实现营收 6.13 亿美元，同比增长 14%。目前，诺华正积极推进 Lutathera 在小细胞肺癌（SCLC）和胶质母细胞瘤（GBM）等新适应症的拓展，未来市场潜力可期。 MNC 重磅出击当前，核药研发以放射性核素偶联药物（RDC）为主。RDC 的结构与 ADC 类似，通常由靶向配体、连接臂、螯合剂和放射性核素四部分构成。与传统核药相比，RDC 具有精准性高、安全性好、适应症广及可满足更多临床需求等优势。 2018 年，全球首个真正意义上的 RDC 药物 Lutathera 获批上市。然而，核药领域的爆发性增长始于 2023 年诺华旗下的 RDC 药物 Pluvicto 的商业化成功，此后 MNC 纷纷加速在该领域的布局（图 2）。图 2 MNC 近年来在核药领域的交易数量截图来源：Insight 数据库礼来无疑是近年来这一领域最为活跃的投资者，在 2023 年 10 月以 14 亿美元收购了 Point Biopharma，获得包括 PSMA、SSTR 在内的多个重要靶点技术平台，以及基于铅-212 的α核素研发能力。随后在 2024 年，礼来又通过两项交易累计投入 23 亿美元，进一步巩固其在核药领域的地位。值得关注的是，2025 年 2 月礼来与 AdvanCell 达成的战略合作，将利用后者的 Pb-212 生产技术平台，共同开发靶向α疗法。此外，阿斯利康也在 2020 年 11 月与 Fusion Pharmaceuticals 合作开发下一代α发射放射性药物和治疗癌症联合疗法，正式切入核药领域，并于 2024 年 3 月斥资 24 亿美元将其收购，获得了包括α核素标记的 PSMA 靶向药物 FPI-2265 在内的四款在研核药，进一步完善产业布局。值得关注的是，在这一轮投资热潮中，并购规模最大的当属 BMS。2023 年 12 月，BMS 以 41 亿美元的高价收购 RayzeBio，将其基于α核素的差异化放射性药物技术平台和多款在研创新产品收入囊中。作为核药领域的先行者，拜耳早在 2014 年 2 月就以 26 亿美元收购了 ALGETA 公司，获得基于镭-223 和锕-225 的α核素技术平台。尽管起步较早，但拜耳后续发展相对缓慢，直到 2021 年和 2023 年才又达成三项重要合作，布局靶向小分子α疗法及 RDC 药物。截至 2024 年底，拜耳已建立起包含 7 款临床前阶段和 2 款早期临床阶段在研 RDC 产品的研发管线。核药龙头诺华在尝到并购甜头后，持续加大投资力度。2024 年 4 月，其与 PeptiDream 达成共同开发大环肽靶向偶联核药的合作，5 月又以 17.5 亿美元收购 Mariana Oncology，加码放射性配体疗法（RLT）。目前，除了已上市的两款产品外，诺华还拥有包括 177Lu-NeoB、225Ac-PSMA-617 在内的多款在研核药管线。并于 2024 年 7 月启动建设中国首个外资核药生产基地，预计 2026 年底建成投产。国产核药崛起中国资产不会缺席核药浪潮。根据 Insight 数据库，目前中国企业和科研院所开发的临床阶段核药管线已有 288 款（仅统计积极状态）。从研发趋势来看，国产核药管线从 2022 年开始进入爆发式增长，过去三年间，每年新增的临床管线数量连创新高。图 3 每年新增的临床阶段国产核药管线数量截图来源：Insight 数据库远大医药是国内核药龙头企业之一。2025 年 H1 ，远大医药核药抗肿瘤诊疗板块收入约 4.2 亿港元，连续实现超 100% 的增长，其核心产品易甘泰®钇 [90Y] 微球注射液已在肝癌选择性内放射治疗中取得显著成效，是全球仅有的四家在肿瘤治疗领域实现创新核药商业化的企业之一。同时，远大医药还构建了涵盖 5 种放射性核素、覆盖 7 个癌种的 15 款创新产品管线。其中，前列腺癌诊断药物 TLX591-CDx 计划年内递交上市申请。此外，还有 3 款 RDC 药物处于 III 期临床阶段。图 4 远大医药核药抗肿瘤诊疗管线图片来源：远大医药 2025 年中期报告东诚药业则聚焦诊断核药的商业化，其氟 [18F] 化钠已获批上市，锝 [99mTc]-GSA 等产品有望在年内提交新药申请。在治疗性核药领域，其 FAP 靶点药物 177Lu-LNC1004 获得 FDA 快速通道资格，全球研发进度领先。2025 年 H1，东诚药业核药业务实现收入 5.03 亿元，同比增长 1%，其中 18F-FDG 产品贡献收入 2.12 亿元，同比增长 9%。另外，先通医药则构建了从核素研发、制造、流通到商业化的端到端全产业链，并采取「跟随式创新」与「全球竞争力」双轨并进的研发策略，在神经、心血管、肿瘤三大领域完成了包括 15 项资产的「诊+疗」一体化布局。在先通医药的「跟随式创新」管线中，XTR008 已于 2025 年 4 月递交新药申请，预计 2026 年获批，有望成为国内首个 SSTR 治疗核药；XTR005 作为国内首款 Aβ-PET 显像剂，已进入商业化阶段；XTR012 可能成为拜耳前列腺癌药物 Xofigo®的国内首仿，已于 2025 年 1 月递交新药申请。而在「全球竞争力」管线中，XTR003 和 XTR004 均为 PET 心肌显影剂，对标通用医疗的 Flyrcado，瞄准 50 亿美元市场；XTR021 则有望成为 PSMA 核药领域的 BIC 药物，展现出比 Pluvicto 更快速的抗原反应和内化效率。此外，诺宇医药、智核生物、辐联医药、中国同辐、恒瑞医药、云南白药、百利天恒、纳安生物等企业也纷纷入场布局，积极推动核药管线的研发进展。结语核药赛道已从边缘走向中心。MNC 重金布局，国产企业加速追赶，百亿美元市场正被引爆，下一个「PD-1 级」风口已至。参考资料： [1]Precedence Research 报告 [2] 平安证券研报 [3] 远大医药、先通医药、东城药业等各企业官公开资料 [4] 丁香园 Insight 数据库封面来源：站酷海洛免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn

并购上市批准放射疗法

2025-09-18

·EINPresswire

New International Guideline Provides Expert Guidance for PET Imaging of Patients with Coronary Artery Disease

This new clinical guideline is intended to assist practitioners in the optimal application of 18F-flurpiridaz PET for MPI. Our hope is that the guideline enhances decision-making, standardizes clinical practice, improves diagnostic accuracy, and optimizes resource utilization to ensure safety and improve patient outcomes.” — Guideline Authors FAIRFAX, VA, UNITED STATES, September 18, 2025 / EINPresswire.com / -- The American Society of Nuclear Cardiology (ASNC), Society of Nuclear Medicine and Molecular Imaging (SNMMI), European Association of Nuclear Medicine (EANM), and American College of Nuclear Medicine (ACNM) have issued a new clinical guideline for 18F-flurpiridaz PET myocardial perfusion imaging (MPI) and blood flow quantitation. The guideline, co-published in the Journal of Nuclear Cardiology and The Journal of Nuclear Medicine, is intended to assist nuclear cardiology practitioners in the optimal application of 18F-flurpiridaz PET for MPI, including recommendations for patient selection, imaging protocols, and interpretation of results. Coronary artery disease (CAD) is the leading cause of death worldwide and is responsible for the hospitalization, functional decline, and reduced quality of life for millions of patients each year. Early and accurate diagnosis and risk stratification of CAD are essential for guiding treatment and improving patient outcomes. MPI is a cornerstone of non-invasive assessment of myocardial ischemia. MPI can be performed with SPECT or PET. 18F-flurpiridaz is a novel PET radiotracer that has demonstrated favorable imaging and physiological properties compared to conventional SPECT agents. Clinical studies have shown that it provides superior image quality, improved diagnostic accuracy, and greater sensitivity in detecting clinically significant coronary artery stenosis compared with conventional SPECT agents. It is particularly valuable in patients for whom SPECT may be less effective, such as those with obesity or small left ventricles. “Multiple phase II and two phase III clinical trials have further established the utility of 18F-flurpiridaz as a valuable PET radiotracer for the non-invasive evaluation of CAD,” noted René R. Sevag Packard, MD, PhD. “Owing to its favorable molecular imaging characteristics and extended half-life, 18F-flurpiridaz is poised to become a valuable agent for cardiac stress PET imaging, offering clinicians a robust tool for the evaluation of CAD.” The guideline includes information on clinical indications, contraindications, and considerations for 18F-flurpiridaz PET. It addresses qualifications and responsibilities of personnel performing cardiac stress testing using 18F-flurpiridaz, protocol (and potential protocol modifications), biodistribution and dosimetry, and the 18F-flurpiridaz PET workflow. Technologist considerations are also included. “This document is designed to promote high-quality, safe, and effective nuclear medicine practice in the evaluation of CAD,” emphasized the authors. “Our hope is that the guideline enhances clinical decision-making, standardizes clinical practice, improves diagnostic accuracy, and optimizes resource utilization to ensure safety and improve patient outcomes.” ASNC, SNMMI, EANM, and ACNM periodically define new procedure standards/practice guidelines for nuclear medicine practice to help advance the science of nuclear medicine and to deliver effective and safe medical care to patients. Each standard/guideline, representing a policy statement by these groups, undergoes a thorough consensus process in which it is subjected to extensive review. The authors of “ASNC/SNMMI/EANM/ACNM Procedure Standard/Practice Guideline for 18F-Flurpiridaz PET Myocardial Perfusion Imaging and Blood Flow Quantitation” include René R. Sevag Packard, Division of Cardiology, Department of Medicine; Department of Physiology; California NanoSystems Institute; and David Geffen School of Medicine, UCLA, Los Angeles, California; Jamshid Maddahi, Division of Cardiology, Department of Medicine; Department of Molecular and Medical Pharmacology; and David Geffen School of Medicine, UCLA, Los Angeles, California; Matthieu Pelletier-Galarneau, Department of Medical Imaging, Montreal Heart Institute, University of Montreal, Quebec, Canada; Mouaz H. Al-Mallah, Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas; Marta Coelho, Department of Nuclear Medicine, West German Cancer Center, University Hospital Essen and University of Duisburg–Essen, Essen, Germany; Sharmila Dorbala, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology; Cardiovascular Imaging Program, Departments of Medicine and Radiology; and Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts; James Galt, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, Georgia; Mark Hyun, Department of Imaging and Cedars-Sinai Medical Center, Los Angeles, California; Nandakumar Menon, Department of Radiology, University of Wisconsin, Madison, Wisconsin; Edward J. Miller, Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Connecticut; Mrinali Shetty, Division of Cardiovascular Medicine, Department of Medicine, University of Louisville School of Medicine, Louisville, Kentucky; and Antti Saraste, Heart Center and PET Centre, University of Turku and Turku University Hospital, Turku, Finland. ### About the American Society of Nuclear Cardiology The American Society of Nuclear Cardiology is the international home for nuclear cardiology and the largest professional society devoted exclusively to the field. ASNC’s membership includes more than 5,700 nuclear cardiology professionals from around the world. Founded in 1993, ASNC’s mission is to improve cardiovascular outcomes through image-guided patient management. ASNC establishes standards for excellence in cardiovascular imaging through the development of clinical guidelines, professional medical education, advocacy, and research. ASNC’s official publication is the Journal of Nuclear Cardiology. Learn more at http://www.asnc.org . About the Society of Nuclear Medicine and Molecular Imaging The Society of Nuclear Medicine and Molecular Imaging (SNMMI) is an international scientific and medical organization dedicated to advancing nuclear medicine, molecular imaging, and theranostics—precision medicine that allows diagnosis and treatment to be tailored to individual patients in order to achieve the best possible outcomes. For more information, visit snmmi.org. Kathy David American Society of Nuclear Cardiology (ASNC) +1 717-422-1181 kdavid@asnc.org Visit us on social media: LinkedIn Bluesky Instagram Facebook YouTube X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床3期临床结果AHA会议

100 项与 Flurpiridaz F 18 相关的药物交易

登录后查看更多信息

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
冠心病	美国	GE Healthcare, Inc.	2024-09-27

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
心血管疾病	申请上市	-	Lantheus Holdings, Inc.	-
缺血	临床2期	美国	Lantheus Medical Imaging, Inc.	2009-01-01
肿瘤	临床1期	德国	Bayer AG	2009-04-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01347710 (FDA_CDER) 人工标引	临床3期	冠心病	755	FLYRCADO (Reader 1)	鑰觸構網願窪糧鹽醖憲(製簾選壓製積製範齋顧) = 鏇鏇齋鑰鏇餘齋蓋壓觸醖衊觸選艱築窪鑰廠憲 (願淵顧遞鑰鬱繭範廠憲, 68 ~ 78) 更多	积极	2024-09-27
				FLYRCADO (Reader 2)	鑰觸構網願窪糧鹽醖憲(製簾選壓製積製範齋顧) = 積廠夢鹽範廠糧襯窪觸醖衊觸選艱築窪鑰廠憲 (願淵顧遞鑰鬱繭範廠憲, 57 ~ 67) 更多
NCT03354273 (FDA_CDER) 人工标引	临床3期	冠心病	578	FLYRCADO (Reader 1)	願顧膚蓋膚齋鏇醖襯蓋(網構憲齋糧淵獵鹹獵淵) = 膚簾選積製鬱鑰憲齋壓鏇鑰齋築觸餘獵蓋壓獵 (衊廠構鬱築齋製範範鏇, 72 ~ 82) 更多	积极	2024-09-27
				FLYRCADO (Reader 2)	願顧膚蓋膚齋鏇醖襯蓋(網構憲齋糧淵獵鹹獵淵) = 積網顧衊構糧衊繭膚獵鏇鑰齋築觸餘獵蓋壓獵 (衊廠構鬱築齋製範範鏇, 68 ~ 79) 更多
NCT03354273 (An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz [18F] Injection PET MPI in the Detection of Coronary Artery Disease [CAD], Pubmed \| J Am Coll Cardiol)	临床3期	冠心病	730	Flurpiridaz F-18 PET	廠簾憲襯衊築鹽鬱壓積(顧繭選鹽網顧簾鑰膚膚) = 糧淵夢鹹餘鹹選鹽蓋鹹遞鬱繭憲構醖蓋製膚衊 (觸壓願簾壓顧簾襯襯廠 ) 更多	积极	2023-10-01
				Flurpiridaz F-18 (Tc-99m-labeled single photon emission computed tomography (SPECT))	廠簾憲襯衊築鹽鬱壓積(顧繭選鹽網顧簾鑰膚膚) = 選積鹹窪顧鬱觸鬱鹹鏇遞鬱繭憲構醖蓋製膚衊 (觸壓願簾壓顧簾襯襯廠 ) 更多
NCT03354273 (SNMMI2023)	临床3期	冠心病	730	Flurpiridaz PET MPI	遞淵餘範糧製製簾窪積(憲遞鹽壓衊繭淵膚製窪) = 淵築鏇積獵糧網襯築廠網壓壓膚鹽網膚鏇顧獵 (餘遞築窪憲築鑰衊願鑰 ) 更多	积极	2023-08-28
				Flurpiridaz F-18 (Tc-99m SPECT MPI)	遞淵餘範糧製製簾窪積(憲遞鹽壓衊繭淵膚製窪) = 膚鏇鏇蓋簾積餘繭憲膚網壓壓膚鹽網膚鏇顧獵 (餘遞築窪憲築鑰衊願鑰 ) 更多
SNMMI2023	N/A	冠心病	-	Flurpiridaz-18FFlurpiridaz F-18 (Flurpiridaz-18F PET MPI)	範蓋範襯憲壓網製願築(築鑰襯蓋顧鏇獵選淵鹽) = 壓選糧範蓋衊網夢鹹夢艱醖鏇網觸窪襯範繭艱 (衊淵範窪觸選壓築積鹽, 0.7) 更多	-	2023-08-28
				Flurpiridaz F-18 (99mTc-SPECT MPI)	範蓋範襯憲壓網製願築(築鑰襯蓋顧鏇獵選淵鹽) = 窪餘衊糧網膚選醖齋鑰艱醖鏇網觸窪襯範繭艱 (衊淵範窪觸選壓築積鹽, 2.7) 更多
NCT04594941 (CTgov)	临床2期	冠心病	38	Flurpiridaz (18F) (Flurpiridaz (18F): SPE)	鏇鏇淵觸簾範齋憲衊壓(繭築淵夢糧齋繭製顧遞) = 壓繭顧蓋觸憲廠鏇遞遞構壓夢構顧鏇鬱衊觸憲 (膚鏇簾構積鑰壓糧繭鑰, 1.818) 更多	-	2023-08-01
				Flurpiridaz (18F) (Flurpiridaz (18F): HPLC)	鏇鏇淵觸簾範齋憲衊壓(繭築淵夢糧齋繭製顧遞) = 範鏇積鹽範鬱觸鏇範遞構壓夢構顧鏇鬱衊觸憲 (膚鏇簾構積鑰壓糧繭鑰, 1.818) 更多
NCT03354273 (NCT03354273 \| An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz [18F] Injection PET MPI in the Detection of Coronary Artery Disease [CAD], CTgov)	临床3期	冠心病	730	Flurpiridaz (18F) (Flurpiridaz (18F))	遞齋選鑰夢醖範襯構廠 = 壓願獵憲憲憲觸餘鬱壓範鹽範鏇製淵鹽憲壓觸 (鏇糧獵繭鏇築壓壓襯網, 顧憲繭顧願糧遞遞遞襯 ~ 艱憲繭鬱築繭築繭鏇鏇) 更多	-	2023-07-12
				Flurpiridaz (18F) (Flurpiridaz (18F) PET MPI)	淵齋鬱積積壓蓋鑰選鹹 = 鏇獵築築齋夢獵築餘衊鬱構鑰壓壓製製艱築範 (膚構顧鹹壓鹹淵鏇襯艱, 遞遞蓋襯糧窪糧餘艱觸 ~ 夢蓋糧鹽蓋壓餘餘蓋艱) 更多
NCT01347710 (Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients with CAD, Pubmed \| J Am Coll Cardiol) 人工标引	临床3期	冠心病	755	Fluorine-18 Flurpiridaz (PET)	願壓積糧窪餘觸鹽願衊(窪艱鏇醖積淵衊鹹衊積) = 繭顧膚願鏇觸壓艱觸蓋糧鹹簾衊壓夢獵窪鬱遞 (範艱衊積夢夢壓鏇觸淵, 0.4) 更多	积极	2020-07-28
				Fluorine-18 Flurpiridaz (SPECT)	願壓積糧窪餘觸鹽願衊(窪艱鏇醖積淵衊鹹衊積) = 範糧製餘觸鏇膚鏇獵築糧鹹簾衊壓夢獵窪鬱遞 (範艱衊積夢夢壓鏇觸淵, 3.2) 更多
NCT01347710 (Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients with CAD, CTgov)	临床3期	冠心病	795	Flurpiridaz F18 (Flurpiridaz F18 PET MPI)	顧鬱壓鹹築夢壓鹹願蓋 = 淵廠窪範鏇夢鬱範網獵選鑰積願顧餘廠獵鑰廠 (蓋願餘製願衊鹽憲範築, 壓膚獵構艱窪鹽醖顧選 ~ 夢鬱鏇窪齋鑰齋餘糧壓) 更多	-	2016-04-05
				Flurpiridaz F (Flurpiridaz F 18)	膚壓艱鬱範膚鑰壓艱齋 = 壓蓋遞鹽製糧蓋糧鹹衊製遞製鑰膚構糧齋憲鬱 (鏇齋鹽構鏇選範鑰衊鏇, 鑰夢範艱觸觸簾壓鬱簾 ~ 築選鹹窪鑰鹹積鹽遞壓) 更多
NCT00849108 (CTgov)	临床2期	缺血	176	BMS747158	繭鏇廠鬱夢憲壓構願顧(構蓋願範窪範築簾構憲) = 範觸繭獵壓夢廠製夢糧鏇齋獵蓋齋鏇鏇範齋遞 (餘簾繭繭蓋廠獵遞糧艱, 鏇網艱壓壓膚觸鹹鹹齋 ~ 窪餘範憲憲獵積鹽鬱顧) 更多	-	2015-01-19