NeoPSMA: A Phase I/II, Open-label, Multi-center Study of Neoadjuvant Treatment With [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Adults With Prostate-specific Membrane Antigen (PSMA) Positive High-risk Localized Prostate Cancer (HRLPC) Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection

The purpose of this trial is to learn more about the effects of AAA602 and AAA802 in men with prostate-specific membrane antigen (PSMA) positive high-risk localized prostate cancer (HRLPC) before surgery to remove the prostate and lymph nodes present in the pelvis area. Lymph nodes are small structures near the prostate that help fight infections. These lymph nodes are removed during surgery because they are a site the disease can spread to.

开始日期2026-06-29

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

NCT07011342

/ RecruitingN/AIIT

Utility of 18F-rhPSMA-7.3 in the Diagnosis of Prostate Cancer After Focal Gland Treatment

To evaluate the effectiveness of a PSMA-PET scan in identifying recurrent prostate cancer after focal therapy

开始日期2025-10-01

申办/合作机构

Hackensack Meridian Health, Inc.

NCT07185165

/ Not yet recruiting临床2期IIT

Eclipse: Flotufolastat F 18 to Determine Treatment Success Following Prostate Focal Therapy

This phase II trial evaluates how well flotufolastat F 18 positron emission tomography (PET)/computed tomography (CT) imaging works to detect cancer that remains (residual) or that has come back (recurrent) after the completion of focal therapy for prostate cancer. Flotufolastat F 18 is a radioactive tracer that binds to prostate specific membrane antigen (PSMA), a protein over-expressed on prostate tumor cells. This allows for visualization of PSMA-expressing cells upon imaging. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, flotufolastat F 18. Because prostate cancer takes up flotufolastat F 18, it can be seen with PET. CT utilizes x-rays that track the body from the outside. CT images provide an exact outline of the organs and potential inflammatory tissue where it occurs in the body. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. Metabolic information means how much of the injected tracer is taken up by inflammatory tissue. Flotufolastat F 18 PET/CT imaging may be an effective and less invasive way to detect residual or recurrent disease in prostate cancer patients, compared to other methods.

开始日期2025-09-30

申办/合作机构

Jonsson Comprehensive Cancer Center

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100 项与氟[18F]妥司特相关的临床结果

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100 项与氟[18F]妥司特相关的转化医学

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100 项与氟[18F]妥司特相关的专利（医药）

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项与氟[18F]妥司特相关的文献（医药）

2025-06-01·CLINICAL NUCLEAR MEDICINE

Utility of Novel Radiohybrid PSMA Ligands in PET Imaging of Biochemical Recurrence of Prostate Cancer—A Systematic Review and Meta-analysis

Review

作者: Chandekar, Kunal Ramesh ; Satapathy, Swayamjeet ; Bal, Chandrasekhar

Purpose::

Radiohybrid prostate-specific membrane antigen (rhPSMA) ligands are a novel class of radiopharmaceuticals developed for potential theranostic application in prostate cancer (PCa). We aimed to consolidate existing evidence on utility of 18F-rhPSMA-7/7.3 for PET imaging in PCa in the setting of biochemical recurrence (BCR).

Patients and Methods::

A comprehensive literature search was performed using relevant keywords in PubMed, Scopus, and EMBASE. Articles evaluating utility of 18F-rhPSMA-7/7.3 PET in PCa BCR, published through September 30, 2024, were included. rhPSMA PET detection rate (DR) in BCR was calculated on a per-patient basis, with pooled proportion and 95% confidence interval. Furthermore, pooled DRs using different cutoff values of serum prostate-specific antigen (PSA) were obtained.

Results::

Five studies with 1513 patients (overall) were included. The pooled DR of 18F-rhPSMA-7/7.3 PET in BCR was 81.7% (95% confidence interval: 76.3%–86.5%). The pooled DRs stratified by serum PSA levels were 60.7% for PSA <0.5 ng/mL, 80.1% for PSA between 0.5 and <1.0 ng/mL, 85.9% for PSA between 1.0 and <2.0 ng/mL, and 95.1% for PSA ≥2.0 ng/mL, respectively.

Conclusions::

Our results suggest that novel radiotracers 18F-rhPSMA-7/7.3 have excellent diagnostic utility as PET imaging agents in BCR of PCa. Further prospective multicenter studies are required to validate these novel tracers in diverse clinical settings with larger patient cohorts and assess their diagnostic accuracy in comparison to the PSMA ligands in current clinical practice.

2024-08-01·Advances in Radiation Oncology

Impact of Clinical Factors on 18F-Flotufolastat Detection Rates in Men With Recurrent Prostate Cancer: Exploratory Analysis of the Phase 3 SPOTLIGHT Study

Article

作者: Davis, Phillip ; Uchio, Edward M ; Lowentritt, Benjamin H ; Chau, Albert ; Helfand, Brian T ; Schuster, David M ; Morris, Michael A ; Michalski, Jeff M ; Chapin, Brian F ; Jani, Ashesh B

Purpose:

¹⁸F-Flotufolastat (¹⁸F-rhPSMA-7.3) is a newly approved prostate-specific membrane antigen targeting radiopharmaceutical for diagnostic imaging of prostate cancer (PCa). SPOTLIGHT (National Clinical Trials 04186845) evaluated ¹⁸F-flotufolastat in men with suspected PCa recurrence. Here, we present results of predefined exploratory endpoints from SPOTLIGHT to evaluate the impact of clinical factors on ¹⁸F-flotufolastat detection rates (DR).

Methods and Materials:

The impact of baseline prostate-specific antigen (PSA), PSA doubling time (PSAdt), and International Society of Urologic Pathology Grade Group (GG) on ¹⁸F-flotufolastat DR was evaluated among all SPOTLIGHT patients with an evaluable scan, with DR stratified according to the patients' prior treatment (radical prostatectomy ± radiation therapy [RP] or radiation therapy only [RT]). The patients underwent positron emission tomography 50 to 70 minutes after receiving ¹⁸F-flotufolastat (296 MBq IV), and scans were read by 3 blinded central readers, with the majority read representing agreement between ≥2 readers.

Results:

In total, 389 men (median PSA: 1.10 ng/mL) were evaluable. By majority read, ¹⁸F-flotufolastat identified distant lesions in 39% and 43% of patients treated with prior RP or RT, respectively. The overall DR broadly increased with increasing PSA (<0.2 ng/mL: 33%; ≥10 ng/mL: 100%). Among patients with PSA <1 ng/mL, 68% had positive scans, and 27% had extrapelvic findings. PSAdt was available for 145/389 (37%) patients. PSAdt did not appear to influence ¹⁸F-flotufolastat DR (77%-90% across all PSAdt categories). Among patients with prior RP, DR ranged from 70% to 83% across PSAdt categories, and 100% DR was reported for all post-RT patients. In total, 362/389 (93%) patients had baseline GG data. Overall DRs were uniformly high (75%‒95%) across all GG. When stratified by prior treatment, DRs across all GG were 69% to 89% in patients with prior RP and ≥96% in patients with prior RT.

Conclusions:

¹⁸F-Flotufolastat-positron emission tomography enabled the accurate detection of recurrent PCa lesions across a wide range of PSA, PSAdt, and International Society of Urologic Pathology GG, thus supporting its clinical utility for a broad range of patients with recurrent PCa.

2024-08-01·JOURNAL OF NUCLEAR MEDICINE

Interreader and Intrareader Reproducibility of¹⁸F-Flotufolastat Image Interpretation in Patients with Newly Diagnosed or Recurrent Prostate Cancer: Data from Two Phase 3 Prospective Multicenter Studies

Article

作者: Esposito, Giuseppe ; Chau, Albert ; Chapin, Brian F ; Zukotynski, Katherine ; Miller, Matthew P ; Penny, Ross ; Yoo, Don ; Ulaner, Gary A ; Ravizzini, Gregory C ; Schuster, David M ; Kuo, Phillip H ; Davis, Phillip

Interreader and intrareader reproducibility of ¹⁸F-flotufolastat PET/CT scans in newly diagnosed and recurrent prostate cancer patients was assessed from masked image evaluations from two phase 3 studies. Methods: ¹⁸F-flotufolastat PET/CT images of newly diagnosed (n = 352) or recurrent (n = 389) patients were evaluated by 3 masked readers. Cohen κ was used to assess pairwise patient- and region-level interreader agreement. Agreement among all readers was assessed using Fleiss κ. Intrareader agreement between the first and repeat read (20% of images, ≥4 wk later) was assessed using Cohen κ. Results: Pairwise interreader agreement was 95% or better (newly diagnosed) and 75% or better (recurrent). The κ coefficients were impacted by the high-agreement-low-κ paradox: Cohen κ ranged from not estimable to 0.55, whereas Fleiss κ was 0.50 (newly diagnosed) and 0.41 (recurrent). Agreement was highest in the prostate of newly diagnosed patients (≥95%) and in the pelvic lymph nodes in recurrent patients (≥87%). Intrareader agreement was 86% or better across both populations. Conclusion: ¹⁸F-flotufolastat PET/CT images can be reliably interpreted, with a high degree of inter- and intrareader agreement.

项与氟[18F]妥司特相关的新闻（医药）

2025-09-24

·氨基观察

6个月，先通XTR020中国III期临床全部受试者入组；映恩ADAM9 ADC获FDA临床许可

氨基观察-创新药组原创出品作者 | 黄凯中国核药新动态。 9月24日，先通医药宣布，用于前列腺癌诊断的创新放射性药物XTR020近日已完成中国III期临床研究全部受试者入组及给药，标志着该产品在中国的开发取得重要进展。值得注意的是，中国III期临床全部受试者入组仅用时6个月。映恩生物ADAM9靶向ADC获FDA临床试验批准。 9月24日，映恩生物宣布，其自主研发的ADAM9靶向抗体偶联药物（ADC）DB-1317全球1a/1b期临床研究已在澳大利亚完成首例受试者给药，并获得美国食品药品监督管理局（FDA）的新药临床试验（IND）批准。在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。 / 01 / 市场速递 1）恒瑞医药签署瑞康曲妥珠单抗项目授权许可协议 9月24日，恒瑞医药公告，瑞康曲妥珠单抗（SHR-A1811）项目有偿许可给Glenmark Specialty，获得1800万美元首付款，并有资格获得最高可达10.93亿美元的里程碑付款及销售提成。 / 02 / 资本信息 1）百奥赛图通过科创板上会审议 9月24日，百奥赛图通过科创板安排上会审议，成为“H+A”模式实现两地上市的创新药企。 / 03 / 医药动态 1）仅用时6个月，先通医药XTR020中国III期临床全部受试者入组 9月24日，先通医药宣布，用于前列腺癌诊断的创新放射性药物XTR020近日已完成中国III期临床研究全部受试者入组及给药，标志着该产品在中国的开发取得重要进展。值得注意的是，中国III期临床全部受试者入组仅用时6个月。 2）映恩生物ADAM9靶向ADC获FDA临床试验批准 9月24日，映恩生物宣布，其自主研发的ADAM9靶向抗体偶联药物（ADC）DB-1317全球1a/1b期临床研究已在澳大利亚完成首例受试者给药，并获得美国食品药品监督管理局（FDA）的新药临床试验（IND）批准。 3）康泰生物三价流感病毒裂解疫苗上市许可申请获得受理 9月24日，康泰生物公告，三价流感病毒裂解疫苗上市许可申请近日获得国家药品监督管理局出具的《受理通知书》。 4）华东医药HDM1005体重管理适应症有望年底获2期topline数据 9月24日，华东医药在互动平台表示，公司自研创新药HDM1005的体重管理和糖尿病适应症2期临床正分别按计划开展，且进展顺利。体重管理适应症有望于今年底获得2期topline数据，后续将根据项目进展以公告/新闻的形式或者选择在国际重要学术会议上发布。此外，HDM1005体重管理适应症的3期临床准备工作目前已同步启动。 5）信达生物宣布苏立信®在澳门获批上市 9月24日，信达生物宣布，全人源化重组人抗肿瘤坏死因子-α（TNF-α）单克隆抗体苏立信®日前（阿达木单抗注射液，国际商标：SULINNO®）正式获得中国澳门特别行政区药品监管部门批准上市。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

临床3期抗体药物偶联物临床2期引进/卖出疫苗

2025-09-24

·先通医药

创新核药XTR020中国III期临床研究完成全部受试者入组给药

点蓝色字关注“先通医药” 中国，北京 — 先通医药欣然宣布，用于前列腺癌诊断的创新放射性药物XTR020近日已完成中国III期临床研究全部受试者入组及给药，标志着该产品在中国的开发取得重要进展。虽然临床需求明确且迫切，但目前中国尚无获批上市的靶向PSMA PET示踪剂。我们计划于2026年初完成III期临床研究并提交上市申请。 XTR020(Posluma ®，18F-Flotufolastat)是一款由18F标记，靶向PSMA的创新PET示踪剂，可用于诊断前列腺癌的原发灶及转移灶、辅助疾病分期、筛选适用于靶向PSMA放射配体疗法的患者及疗效评估等多种临床场景。XTR020在美国已完成的两项关键性III期临床研究*，已显示出良好的有效性和安全性，并于2023年5月获得美国FDA批准上市。前列腺癌为男性中最常见的恶性肿瘤之一。早期且准确的诊断，尤其是对于微小转移或复发病灶的识别，对于患者临床疗效至关重要。传统的成像方法（如CT或MRI)在检测早期或微小病灶方面存在局限性。PSMA在前列腺癌细胞内高度表达，是PET成像的理想分子靶点。作为一种18F标记的放射性药物，XTR020的放射性半衰期为109.7分钟，相较于68Ga标记药物(放射性半衰期为67.7分钟）更长。这一特性使其在物流运输方面更具优势，能够实现更广泛的区域配送和更高效的临床工作流程，从而有力地支持其上市后在临床上的潜在广泛应用。 ▌*注： 18F-Flotufolastat（亦称XTR020）最早由Blue Earth Diagnostics公司开发，我们已获得该产品在中国内地开发、生产及商业化的独家权益。其在美国已完成LIGHTHOUSE和SPOTLIGHT两项关键性III期研究。 END 关于先通医药北京先通国际医药科技股份有限公司（简称“先通医药”），始创于2005年，是中国放射性药物市场的领跑者，具备从放射性核素开发及生产、放射性药物研发、制造及商业化的全行业价值链端对端能力。先通医药秉持“做好核药，惠及大众”的使命，立足中国，放眼世界，公司总部位于北京，在上海设有研发中心，在江苏、广东、四川建设有现代化放射性药物生产基地；同时，在美国设有分支机构。以未满足的临床需求为导向，先通医药重点布局神经退行性疾病、心血管疾病、肿瘤学三大领域，建立了全面、差异化及具有协同效应的产品矩阵，于放射性诊疗一体化方面具有巨大潜力。其中，欧韦宁®为近20年来中国首个获准上市的创新性PET示踪剂；处于不同阶段的多款产品管线广泛覆盖全球放射性药物创新靶点，彰显我们管线的强大竞争力，引领创新放射性药物发展新速度。前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，目的均是要指明其属前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述乃基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确定性及其他因素的影响，有些超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、中国政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本新闻稿所载前瞻性表述之任何义务；及 (b) 倘因任何前瞻性表述不能实现或变成不正确。 ▲滑动查看更多

临床3期放射疗法上市批准并购临床2期

2025-07-01

·药明康德

穿越血脑屏障小分子上市申请递交在即；2-4周一针，罗氏创新双抗使凝血功能恢复正常…… | 一周盘点

▎药明康德本期看点1. ROS1选择性抑制剂zidesamtinib用于接受过酪氨酸激酶抑制剂（TKI）治疗的晚期ROS1阳性非小细胞肺癌（NSCLC）患者，在一项1/2期临床试验中取得积极结果，其上市申请递交在即。2. 早期数据表明，罗氏（Roche）的在研双特异性抗体NXT007有望使血友病A患者的凝血功能恢复正常。3. 用于治疗慢性乙型肝炎病毒（HBV）感染的下一代衣壳组装调节剂ABI-4334在1b期临床试验中展现强力的抗病毒活性，高剂量组患者接受治疗28天，血浆HBV DNA平均降低3.2 log IU/mL。NXT007：公布1/2期临床试验数据罗氏宣布，其新一代在研双特异性抗体NXT007在治疗血友病A的1/2期临床试验中取得积极数据，将推进至3期临床试验。NXT007由罗氏旗下的Chugai Pharmaceutical公司研发，基于已上市药物Hemlibra的框架优化设计，旨在模拟因子VIII功能，同时延长半衰期，提高疗效和用药便利性。该药通过将凝血因子IXa和X桥接在一起，激活体内自然凝血级联反应，有望使血友病A患者的凝血功能恢复正常，并减少治疗负担。在这项研究中，30名12至65岁、无因子VIII抑制剂，且既往未接受过Hemlibra治疗的血友病A患者在接受了4至6周的负荷剂量后，在维持期每2至4周皮下注射递增剂量的NXT007。结果显示，高剂量组（B-3和B-4）的患者在整个维持期内均保持止血正常化状态，未出现需治疗的出血事件。安全性方面，NXT007的耐受良好，目前未报告血栓栓塞事件。Zidesamtinib：公布1/2期临床试验数据Nuvalent公司公布了其新型ROS1选择性抑制剂zidesamtinib在1/2期临床试验ARROS-1中的关键积极数据。该试验针对接受过TKI治疗的晚期ROS1阳性NSCLC患者。Zidesamtinib是一种具脑渗透性的ROS1抑制剂，设计用以治疗那些对现有ROS1抑制剂具抗性的癌症，包含那些带有G2032R、S1986Y/F、L2026M或D2033N突变的肿瘤。结果显示，在117例曾接受过TKI治疗的ROS1阳性NSCLC患者中（其中50%曾接受过≥2种ROS1 TKI±化疗），由盲态独立中心审查（BICR）评估的客观缓解率（ORR）为44%，初步估计的缓解持续率在12个月时为78%，18个月时为62%。在其中55名曾接受过1种ROS1 TKI（克唑替尼或恩曲替尼）±化疗的患者中，ORR为51%，初步估计的缓解持续率在12和18个月时均为93%。Zidesamtinib还显示出颅内抗肿瘤活性，对携带ROS1 G2032R耐药突变的肿瘤也有作用，整体安全性良好，剂量减少和停药的比例较低，分别为10%和2%。该公司计划于2025年7月启动滚动提交zidesamtinib的新药申请（NDA），目标在2025年第三季度完成。ABI-4334：公布1b期临床试验数据Assembly Biosciences公司公布了其在研下一代衣壳组装调节剂ABI-4334用于治疗慢性HBV感染患者的1b期临床试验数据。此前公布的150 mg剂量组的结果显示，ABI-4334显示出很强的抗病毒活性，在28天的治疗中，血浆HBV DNA平均降低了2.9 log IU/mL。此次公布的400 mg剂量组的结果类似于先前的报道，在28天的治疗中，血浆HBV DNA平均降低了3.2 log IU/mL。此外，在400 mg剂量下继续观察到ABI-4334良好的安全性和耐受性，半衰期支持每日一次口服给药。TERN-601：公布1期临床试验数据Terns Pharmaceuticals公司公布了其每日一次在研减重疗法TERN-601在肥胖或超重健康成年人中进行的1期试验积极结果。TERN-601是一种口服小分子胰高血糖素样肽-1（GLP-1）受体激动剂，由Terns内部研发。TERN-601通过Terns内部基于结构的药物研发技术设计，采用该公司专有的三维定量构效关系（QSAR）模型所开发。此次公布的结果显示，TERN-601在治疗肥胖方面表现出显著的疗效和良好的安全性。在28天内，每日一次给药可实现统计学显著且呈剂量依赖性的体重减轻。在最高剂量组中，有67%的患者体重减轻≥5%。其独特的药代动力学特性使其在24小时内维持平稳的血药浓度曲线，有效半衰期为9-10小时，支持每日一次给药。此外，药物在肠道中的暴露量高于血浆，且游离药物比例低，从而在不牺牲耐受性的前提下实现了有意义的体重减轻。安全性方面，未出现因治疗导致的中断、减量或停药，＞95%的胃肠道不良事件为轻度，患者的肝酶、生命体征和心电图均无明显变化。ENT-03：公布1a期临床试验数据Metabolics Pharma公司公布了其候选药物ENT-03在肥胖和糖尿病患者中开展的1a期临床试验的的初步结果。该研究数据显示，在所有测试剂量下，ENT-03均表现出良好的安全性和耐受性。在较高剂量组中，ENT-03在减轻体重和提高胰岛素敏感性方面呈现出积极趋势。ENT-03是一种新型中枢神经系统作用的氨基类固醇化合物，具有蛋白酪氨酸磷酸酶1B（PTP1B）抑制活性。它通过作用于大脑中调控能量代谢和血糖平衡的神经回路，达到调节葡萄糖水平、改善胰岛素敏感性并促进体重减轻的效果。临床前研究表明，ENT-03作为单药疗法有效，并且在与GLP-1受体激动剂联合使用时表现出累加效应。此外，ENT-03在停药后仍可维持较长时间的体重降低以及血糖和胰岛素水平的正常化。APR-1051：公布联合治疗1期试验的初步数据Aprea Therapeutics公司公布了其下一代口服WEE1抑制剂APR-1051治疗HPV阳性头颈部鳞状细胞癌患者的新临床数据。APR-1051是一种口服、高选择性的WEE1抑制剂，旨在最大限度地减少脱靶活性并优化药理选择性。该疗法目前正在1期临床试验ACESOT-1051中对携带DDR相关通路基因突变（DDR）的晚期实体瘤患者进行评估。该试验中，一名62岁HPV阳性的晚期口咽鳞状细胞癌男性患者，既往接受过三线铂类治疗后进展，在接受每日口服一次70 mg亚治疗剂量的APR-1051后实现疾病稳定，首次影像学评估时肿瘤缩小了5%。该患者对治疗的耐受性良好，未报告剂量限制性毒性。参考资料（可上下滑动查看）[1] LOMOND THERAPEUTICS ANNOUNCES U.S. FDA CLEARANCE OF IND APPLICATION FOR LONITOCLAX, A SELECTIVE BCL2 INHIBITOR WITH LIMITED IMMUNE SUPPRESSION AND IMPROVED SAFETY COMPARED TO VENETOCLAX AND VENETOCLAX- LIKE MOLECULES. Retrieved June 27, 2025, from https://www.prnewswire.com/news-releases/lomond-therapeutics-announces-us-fda-clearance-of-ind-application-for-lonitoclax-a-selective-bcl2-inhibitor-with-limited-immune-suppression-and-improved-safety-compared-to-venetoclax-and-venetoclax--like-molecules-302487020.html[2] Archeus Technologies Receives FDA Clearance of Investigational New Drug Application for ART-101 in Development for the Treatment of Prostate Cancer. Retrieved June 27, 2025, from https://www.businesswire.com/news/home/20250620911569/en/Archeus-Technologies-Receives-FDA-Clearance-of-Investigational-New-Drug-Application-for-ART-101-in-Development-for-the-Treatment-of-Prostate-Cancer[3] Terns Pharmaceuticals Presents Positive Data from Phase 1 Study of TERN-601 Once-daily Oral GLP-1R Agonist for Treatment of Obesity at 85th Annual American Diabetes Association Scientific Sessions. Retrieved June 27, 2025, from https://www.globenewswire.com/news-release/2025/06/23/3103837/0/en/Terns-Pharmaceuticals-Presents-Positive-Data-from-Phase-1-Study-of-TERN-601-Once-daily-Oral-GLP-1R-Agonist-for-Treatment-of-Obesity-at-85th-Annual-American-Diabetes-Association-Sci.html[4] Forte Biosciences Announces Positive Data in FB102 Celiac Disease Phase 1B Study. Retrieved June 27, 2025, from https://www.fortebiorx.com/investor-relations/news/news-details/2025/Forte-Biosciences-Announces-Positive-Data-in-FB102-Celiac-Disease-Phase-1B-Study/default.aspx[5] Nuvalent Announces Positive Pivotal Data from ARROS-1 Clinical Trial of Zidesamtinib for TKI Pre-treated Patients with Advanced ROS1-positive NSCLC. Retrieved June 27, 2025, from https://investors.nuvalent.com/2025-06-24-Nuvalent-Announces-Positive-Pivotal-Data-from-ARROS-1-Clinical-Trial-of-Zidesamtinib-for-TKI-Pre-treated-Patients-with-Advanced-ROS1-positive-NSCLC[6] Cellarity Initiates Phase 1 Clinical Study of CLY-124, a First-in-Class Globin-Switching Oral Medicine for the Treatment of Sickle Cell Disease. Retrieved June 24, 2025 from https://www.prnewswire.com/news-releases/cellarity-initiates-phase-1-clinical-study-of-cly-124-a-first-in-class-globin-switching-oral-medicine-for-the-treatment-of-sickle-cell-disease-302492168.html[7] Contineum Therapeutics Provides Update on Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791. Retrieved June 24, 2025 from https://www.businesswire.com/news/home/20250625697950/en/Contineum-Therapeutics-Provides-Update-on-Phase-1b-Positron-Emission-Tomography-PET-Trial-of-PIPE-791[8] Sangamo Therapeutics Announces Positive Topline Results From Registrational STAAR Study in Fabry Disease. Retrieved June 24, 2025 from https://www.businesswire.com/news/home/20250624043784/en/Sangamo-Therapeutics-Announces-Positive-Topline-Results-From-Registrational-STAAR-Study-in-Fabry-Disease[9] Immutep Announces Positive Update from Phase I Study of IMP761, a First-in-Class LAG-3 Agonist Antibody for Autoimmune Diseases. Retrieved June 24, 2025 from https://www.immutep.com/detail/immutep-announces-positive-update-from-phase-i-study-of-imp761-a-first-in-class-lag-3-agonist-antibody-for-autoimmune-diseases.html#:~:text=SYDNEY%2C%20AUSTRALIA%2C%20June%2023%2C%202025%20--%20Immutep%20Limited,a%20first-in-class%20LAG-3%20agonist%20antibody%20for%20autoimmune%20diseases.[10] Aclaris Therapeutics Initiates Phase 1a/1b Program for its Novel Bispecific Antibody ATI-052. Retrieved June 24, 2025 from https://www.globenewswire.com/news-release/2025/06/23/3103239/37216/en/index.html[11] Early data suggest Roche’s NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A. Retrieved June 24, 2025 from https://www.globenewswire.com/news-release/2025/06/23/3103084/0/en/Early-data-suggest-Roche-s-NXT007-may-have-the-potential-to-provide-haemostatic-normalisation-in-people-with-haemophilia-A.html[12] Verdiva Bio to Present New Data Highlighting Once-Weekly Potential of Its Investigational Oral Obesity Candidates at the ADA 85th Scientific Sessions. Retrieved June 24, 2025 from https://www.businesswire.com/news/home/20250620108098/en/Verdiva-Bio-to-Present-New-Data-Highlighting-Once-Weekly-Potential-of-Its-Investigational-Oral-Obesity-Candidates-at-the-ADA-85th-Scientific-Sessions[13] Plus Therapeutics Announces FDA Clearance of its Investigational New Drug Application using REYOBIQTM for the Treatment of Childhood Brain Cancer. Retrieved June 24, 2025 from https://www.globenewswire.com/news-release/2025/06/25/3104980/0/en/Plus-Therapeutics-Announces-FDA-Clearance-of-its-Investigational-New-Drug-Application-using-REYOBIQTM-for-the-Treatment-of-Childhood-Brain-Cancer.html[14] Assembly Biosciences Reports Positive Topline Results from Phase 1b Clinical Trial of Next-Generation Investigational Capsid Assembly Modulator ABI-4334 in Chronic Hepatitis B. Retrieved June 24, 2025 from https://www.globenewswire.com/news-release/2025/06/25/3105003/16259/en/Assembly-Biosciences-Reports-Positive-Topline-Results-from-Phase-1b-Clinical-Trial-of-Next-Generation-Investigational-Capsid-Assembly-Modulator-ABI-4334-in-Chronic-Hepatitis-B.html[15] Biogen to Advance Investigational Spinal Muscular Atrophy Asset to Registrational Studies Based on Positive Interim Phase 1 Results. Retrieved June 24, 2025 from https://www.globenewswire.com/news-release/2025/06/25/3104985/0/en/Biogen-to-Advance-Investigational-Spinal-Muscular-Atrophy-Asset-to-Registrational-Studies-Based-on-Positive-Interim-Phase-1-Results.html[16] Blue Earth Therapeutics: SNMMI Presentation of Results from Lutetium (177Lu) rhPSMA-10.1 Injection Phase 1 Clinical Trial. Retrieved June 24, 2025 from https://www.prnewswire.com/news-releases/blue-earth-therapeutics-snmmi-presentation-of-results-from-lutetium-177lu-rhpsma-10-1-injection-phase-1-clinical-trial-302490153.html[17] Metabolics Pharma Announces Positive Top-Line Results from Phase 1a Clinical Trial of ENT-03 in Obese and Diabetic Subjects. Retrieved June 24, 2025 from https://www.businesswire.com/news/home/20250625436712/en/Metabolics-Pharma-Announces-Positive-Top-Line-Results-from-Phase-1a-Clinical-Trial-of-ENT-03-in-Obese-and-Diabetic-Subjects[18] Aprea Reports Anti-Proliferative Results and Promising Early-Stage Clinical Data for Next-Generation WEE1 Inhibitor, APR-1051, in HPV+ Head and Neck Squamous Cell Carcinoma (HNSCC) in Collaboration with MD Anderson Cancer Center. Retrieved June 24, 2025 from https://www.globenewswire.com/news-release/2025/06/25/3105158/0/en/Aprea-Reports-Anti-Proliferative-Results-and-Promising-Early-Stage-Clinical-Data-for-Next-Generation-WEE1-Inhibitor-APR-1051-in-HPV-Head-and-Neck-Squamous-Cell-Carcinoma-HNSCC-in-C.html[19] CRISPR Therapeutics Reports Positive Additional Phase 1 Data for CTX310™ Targeting ANGPTL3 and Provides Update on In Vivo Cardiovascular Pipeline. Retrieved June 24, 2025 from https://www.globenewswire.com/news-release/2025/06/26/3105698/0/en/CRISPR-Therapeutics-Reports-Positive-Additional-Phase-1-Data-for-CTX310-Targeting-ANGPTL3-and-Provides-Update-on-In-Vivo-Cardiovascular-Pipeline.html免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果临床3期临床2期临床成功申请上市

100 项与氟[18F]妥司特相关的药物交易

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适应症	国家/地区	公司	日期
前列腺癌	美国	Blue Earth Diagnostics Ltd.	2023-05-25

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适应症	最高研发状态	国家/地区	公司	日期
前列腺腺癌	临床3期	美国	Blue Earth Diagnostics Ltd.	2020-03-02
前列腺腺癌	临床3期	芬兰	Blue Earth Diagnostics Ltd.	2020-03-02
前列腺腺癌	临床3期	德国	Blue Earth Diagnostics Ltd.	2020-03-02
前列腺腺癌	临床3期	荷兰	Blue Earth Diagnostics Ltd.	2020-03-02
非转移性前列腺癌	临床2期	美国	Blue Earth Diagnostics Ltd.	2023-04-27
复发性前列腺癌	临床2期	美国	Blue Earth Diagnostics Ltd.	2023-04-27
PSMA阳性前列腺癌	临床1期	中国	北京先通国际医药科技股份有限公司	2025-05-29

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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


NCT04186845 (SPOTLIGHT, Biospace) 人工标引	临床3期	复发性前列腺癌 Prostate specific antigen	119	POSLUMA (PSA < 1 ng/mL)	壓網廠鹽簾廠憲壓鏇廠(繭餘鬱淵範淵鏇鹽願艱) = 繭獵鹹願構繭願糧蓋醖製衊鑰選膚鏇鏇鏇蓋鬱 (繭衊網積廠製鏇壓襯糧 )	积极	2024-10-01
NCT04186845 (SPOTLIGHT, Biospace) 人工标引	临床3期	复发性前列腺癌 Prostate specific antigen	119	POSLUMA (PSA< 0.5 ng/mL)	壓網廠鹽簾廠憲壓鏇廠(繭餘鬱淵範淵鏇鹽願艱) = 構鏇壓艱觸鹽窪艱憲醖製衊鑰選膚鏇鏇鏇蓋鬱 (繭衊網積廠製鏇壓襯糧 )	积极	2024-10-01
ASTRO2024	N/A	前列腺癌	-	18F-flotufolastat	鬱憲鬱齋憲艱範衊範襯(蓋繭壓網壓觸膚壓選鏇) = 觸齋鏇蓋構鹹積獵憲製鹽構鬱醖齋醖顧顧齋糧 (襯顧構壓觸艱淵鑰選憲 )	-	2024-10-01
ASTRO2024	N/A	前列腺癌	-	F-Flotufolastat (Radical Prostatectomy)	鬱憲鬱齋憲艱範衊範襯(蓋繭壓網壓觸膚壓選鏇) = 夢膚願觸壓糧顧鹹網糧鹽構鬱醖齋醖顧顧齋糧 (襯顧構壓觸艱淵鑰選憲 )	-	2024-10-01
ASTRO2024	N/A	非转移性前列腺癌	-	F-18 rhPSMA 7.3 PET/MRI	網醖願齋獵鹽獵顧觸選(積網壓鑰廠糧淵構夢壓) = 廠網網憲淵製衊鑰鹹積淵願襯夢壓餘鏇憲鹹壓 (鏇願壓顧衊襯壓壓鬱鏇 ) 更多	-	2024-10-01
NCT04186819 \| NCT04186845 (SPOTLIGHT, Literature) 人工标引	临床3期	前列腺癌	712	POSLUMA	蓋餘壓簾遞餘繭衊鹹襯(製膚衊餘簾夢製顧簾網) = 鑰鏇蓋網鏇壓醖觸壓餘壓獵構願繭夢鬱艱齋鏇 (鬱窪餘積簾獵簾顧選襯 ) 更多	积极	2023-11-06
NCT04186819 (LIGHTHOUSE, ASTRO2023)	临床3期	前列腺癌 PSMA	197	18F-rhPSMA-7.3 PET	築憲襯艱簾憲憲鏇遞網(夢構範齋觸築淵繭醖膚) = 簾壓構淵蓋齋製襯鑰憲蓋顧壓範鹹鹹鬱壓構襯 (範夢襯構遞廠艱蓋糧艱 ) 更多	积极	2023-10-01
NCT04186819 (LIGHTHOUSE, ASCO_GU2023) 人工标引	临床3期	前列腺癌	335	18F-rhPSMA-7.3	艱廠醖積淵遞醖窪醖憲(顧廠獵襯範遞齋鏇選壓) = 夢顧構襯鬱餘襯蓋蓋蓋廠醖餘鬱衊壓襯醖餘鬱 (醖築鬱積網範顧衊膚齋, 4.2 ~ 9.8) 更多	积极	2023-02-21
NCT04186845 (SPOTLIGHT Study, EANM2022)	临床3期	复发性前列腺癌	366	18 F-rhPSMA-7.3 PET	簾醖夢醖鏇選觸壓膚壓(壓觸壓觸範鬱廠膚壓齋) = 簾襯繭鏇鹹鏇簾夢艱鹹選衊繭憲願願鹹齋餘獵 (觸簾襯壓積繭遞鏇繭簾, 12.9 ~ 23.9)	积极	2022-09-22
NCT04186845 (SPOTLIGHT, ASCO_GU2022) 人工标引	临床3期	前列腺癌 PSA	389	18 F-rhPSMA-7.3	觸憲廠鹽網鑰鬱鏇鑰鑰(衊淵鏇襯構網憲糧築淵) = 壓襯簾積鏇廠鏇淵鹽遞鹹蓋壓鹹齋憲願簾選艱 (艱構壓窪獵築積製蓋觸, 51.6 ~ 62.0) 更多	积极	2022-02-16
NCT04186845 (SPOTLIGHT, ASCO_GU2022) 人工标引	临床3期	前列腺癌 PSA	389	18 F-rhPSMA-7.3 (patients with a histopathology-only SoT)	觸憲廠鹽網鑰鬱鏇鑰鑰(衊淵鏇襯構網憲糧築淵) = 積齋鹽襯簾鬱蓋襯憲壓鹹蓋壓鹹齋憲願簾選艱 (艱構壓窪獵築積製蓋觸, 69.9 ~ 89.6) 更多	积极	2022-02-16
SNMMI2019	N/A	非转移性前列腺癌	-	18F-rhPSMA-7 PET/CT	獵衊選廠遞顧願膚構積(艱製網餘鹹鬱醖鹹選廠) = 網憲網網壓蓋醖簾糧衊壓憲衊糧襯簾遞醖鹹艱 (築簾願網鏇糧蓋選範糧 )	-	2019-05-21