Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide Combined With Metastasis-Directed Stereotactic Body Radiotherapy for Oligorecurrent Prostate Adenocarcinoma (ANDROMEDA)

This phase II trial compares the use of 225Ac-PSMA-617 to 177Lu-PSMA-617, along with stereotactic body radiotherapy for the treatment of prostate cancer that has come back after a period of improvement (recurrent) and that has spread from where it first started (primary site) to multiple other places in the body (oligometastatic). 225Ac-PSMA-617 and 177Lu-PSMA-617 are radioactive drugs. They bind to a protein called a PSMA receptor, which is found on some prostate tumor cells. 225Ac-PSMA-617 or 177Lu-PSMA-617 builds up in these cells and gives off either alpha or beta radiation that may kill them. It is a type of radioconjugate and a type of PSMA analog. Stereotactic body radiation therapy (SBRT) is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving 225Ac-PSMA-617 or 177Lu-PSMA-617 and metastasis directed stereotactic body radiotherapy may be effective in treating patients with recurrent, oligometastatic prostate cancer.

开始日期2025-10-31

申办/合作机构

Jonsson Comprehensive Cancer Center

[+1]

NCT06855277

/ Recruiting临床3期

A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer

The purpose of this study is to determine whether [225Ac]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.

开始日期2025-07-01

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

CTR20252315

/ Recruiting临床3期

AcTFirst：一项比较AAA817 + ARPI与标准治疗在PSMA阳性转移性去势抵抗性前列腺癌成人参与者中的开放、多中心、随机III期研究

本研究的目的是在PSMA阳性转移性去势抵抗性前列腺癌（mCRPC）成人参与者中，确定与研究者选择的标准治疗（SOC）相比，AAA817联合雄激素受体通路抑制剂（ARPI）是否可改善影像学无进展生存期（rPFS）。

开始日期2025-07-01

申办/合作机构

诺华（中国）生物医学研究有限公司

[+2]

100 项与 Actinium (225Ac) vipivotidum tetraxetanum 相关的临床结果

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项与 Actinium (225Ac) vipivotidum tetraxetanum 相关的文献（医药）

2025-08-01·JOURNAL OF NUCLEAR MEDICINE

Efficacy, Safety, Blood Kinetics, and ²¹³Bi Distribution Studies of [²²⁵Ac]Ac-SibuDAB in Prostate Cancer Patients

Article

作者: Mitterhauser, Markus ; Patronas, Eva-Maria ; Hacker, Marcus ; Kramer, Gero ; Nics, Lukas ; Schmitl, Stefan ; Weisbrod, Maximilian ; Ritt, Philipp ; Fuchs, Elisabeth ; Kretschmer-Chott, Elisabeth

²²⁵Ac-labeled (S)-ibuprofen-diaminobutyric acid-PSMA (SibuDAB) is a novel, albumin-binding compound in prostate-specific membrane antigen (PSMA)-targeted α-therapy of prostate cancer. It showed superior preclinical efficacy results to [²²⁵Ac]Ac-PSMA-617. ²²⁵Ac decays via multiple α-particle emissions. The full therapeutic potential requires fast tumor uptake and retention of parent and daughter nuclides, such as ²¹³Bi, in the tumor. High decay energies lead to daughter nuclide recoil of the chelator and, therefore, altered pharmacokinetics and potential irradiation of off-target organs. We hereby present clinical efficacy and safety data for [²²⁵Ac]Ac-SibuDAB, as well as blood kinetics and the ²¹³Bi distribution between blood and urine samples. Methods: Fifteen prostate cancer patients who received [²²⁵Ac]Ac-SibuDAB between December 2021 and August 2024 were included in this retrospective study. Patients were scheduled to receive 6 MBq of [²²⁵Ac]Ac-SibuDAB every 8 wk. The prostate-specific antigen (PSA) response was evaluated, and adverse events were categorized according to Common Terminology Criteria for Adverse Events, version 5.0. Blood pharmacokinetics were determined after blood sampling at different time points and measured in ²²⁵Ac/²²¹Fr equilibrium. The ²¹³Bi distribution was determined in blood and urine samples before reaching ²²⁵Ac/²¹³Bi equilibrium. Results: Fifteen patients received a total of 25 cycles with a median exposure of 6.55 MBq (range, 4.65-30.60 MBq). The Gleason score was available for 12 of the 15 patients, with 10 patients having a Gleason score of 8 or higher. The patients were heavily pretreated, including 13 patients with prior [¹⁷⁷Lu]Lu-PSMA therapy. Nine of the 15 patients showed any PSA decline, and 5 of the 15 patients showed a PSA decline of 50% or more. All patients showed grade 1 xerostomia. Treatment was stopped because of grade 3 thrombocytopenia in 1 of the 15 patients. [²²⁵Ac]Ac-SibuDAB blood kinetics were evaluated in 6 patients. ²¹³Bi blood and urine distribution studies were conducted on 3 patients and showed a vast net ²¹³Bi excess in urine immediately after application, a moderate excess at later time points, and a lack of ²¹³Bi in blood at any time point. Conclusion: [²²⁵Ac]Ac-SibuDAB initial clinical data show efficacy in heavily pretreated prostate cancer patients, with 1 patient experiencing treatment-limiting toxicity. Only limited signs of xerostomia were observed after the treatment. ²¹³Bi generated by recoil is rapidly distributed into urine after application of [²²⁵Ac]Ac-SibuDAB.

2025-08-01·JOURNAL OF NUCLEAR MEDICINE

Evaluation of ¹³⁴Ce/¹³⁴La-PSMA-617 for PET Imaging and Auger Electron Therapy of Prostate Cancer

Article

作者: Raveendran, Athira ; Garcia, Luis ; Seo, Youngho ; Bobba, Kondapa Naidu ; Greenland, Nancy ; Wilson, David M ; Wadhwa, Anju ; VanBrocklin, Henry F ; Flavell, Robert R ; Bidkar, Anil P

The ¹³⁴Ce/¹³⁴La radionuclide pair has been proposed as a PET imaging surrogate for targeted α-radiotherapeutics. ¹³⁴Ce decays to ¹³⁴La via electron capture, emitting Auger electrons (AEs), which could be used for targeted radionuclide therapy. Additionally, the positron emission during this transition enables PET imaging, making ¹³⁴Ce/¹³⁴La a promising theranostic pair for prostate cancer. In this work, we investigated the potential of ¹³⁴Ce for AE capture therapy using prostate-specific membrane antigen (PSMA)-617 for targeted radionuclide delivery. Methods: Radiolabeling of [¹³⁴Ce]Ce-PSMA-617 proceeded as previously described, and C18 cartridge purification was optimized. In vitro, cell-binding and toxicity assays were performed on PSMA-positive PC3 PIP cells. In vivo PET imaging and ex vivo biodistribution studies were conducted on mice bearing dual PSMA-positive PC3 PIP and PSMA-negative PC3 flu tumor xenografts at various time points ranging from 1 to 72 h after injection. Additionally, an in vivo single-dose-treatment study was performed using 37- and 111-MBq doses in nude mice with PC3 PIP tumor xenografts. Results: PSMA-617 was successfully radiolabeled with ¹³⁴Ce/¹³⁴La and purified using the C18 cartridge method, achieving high molar activity (21.02 ± 0.11 MBq/nmol). Stability studies showed more than 95% stability in mouse serum at day 5. PSMA-positive PC3 PIP cells demonstrated 89.6% ± 0.55% cell binding, 55.45% ± 0.96% internalization at 24 h, and a dissociation constant of 32.9 ± 3.9 nM, comparable to other reported [¹⁷⁷Lu]Lu/[²²⁵Ac]Ac-PSMA-617 radiocomplexes. In contrast, no cellular uptake or internalization was observed in PSMA-negative PC3 flu cells. Clonogenic assay of [¹³⁴Ce]Ce-PSMA-617 showed a significant dose-dependent reduction in cell proliferation (P = 0.002). PET imaging revealed high tumor-specific uptake at early time points (1 and 4 h), followed by a gradual decline from 24 to 72 h, with rapid clearance from normal tissues. These results were corroborated by ex vivo biodistribution studies. In vivo therapy with [¹³⁴Ce]Ce-PSMA-617 in tumor-bearing mice demonstrated a significant increase in median survival compared with control animals (saline, 33 d; 37 MBq, 50 d; and 111 MBq, 80 d, end of the study). Conclusion: [¹³⁴Ce]Ce-PSMA-617 exhibited excellent in vitro and in vivo characteristics, providing significant survival benefits in mice. Collectively, these findings suggest that [¹³⁴Ce]Ce-PSMA-617 is an effective theranostic agent for PET imaging and AE therapy of prostate cancer.

2025-07-01·European Journal of Nuclear Medicine and Molecular Imaging

Development of [225Ac]Ac‑LNC1011 for targeted alpha-radionuclide therapy of prostate cancer

Article

作者: Chen, Xiaoyuan ; Zou, Maosheng ; Shi, Mengqi ; Fu, Jiayu ; Wee, Xin Jie ; Zhao, Tianzhi ; Yang, Hongzhang ; Wu, Xiaoming ; Lin, Min ; Zhang, Zhenyue ; Green, David ; Zhang, Jingjing ; Wen, Xuejun

PURPOSE:

Prostate-specific membrane antigen (PSMA) radioligand therapy (PRLT) has become a promising option for treating metastatic castration-resistant prostate cancer (mCRPC). Radioligands labelled with the ⁶⁸Ga/¹⁷⁷Lu theranostic pair have been most widely used in the clinic for diagnosis and therapy, respectively. This study aims to develop a novel PSMA-targeted radioligand, LNC1011, radiolabeled with alpha-emitter ²²⁵Ac, to optimise pharmacokinetic properties and assess its potential for targeted alpha therapy (TAT) in prostate cancer treatment.

METHODS:

LNC1011 (Dan-PSMA) was synthesised based on a PSMA-binding ligand with the addition of a dansylated amino acid. Systematic radiochemical analyses were conducted to confirm the successful synthesis and radiolabelling of [²²⁵Ac]Ac-LNC1011. Cell uptake and competition binding assays were performed in PSMA-positive PC3-PIP tumour cells to evaluate the binding affinity and PSMA targeting specificity. The pharmacokinetics properties and tumour uptake were characterised by biodistribution studies using healthy mice and a PC3-PIP xenograft mouse model injected with [²²⁵Ac]Ac-LNC1011. Radioligand therapy studies and maximum tolerated dose (MTD) assays were conducted to systematically evaluate the therapeutic efficacy and the safety of [²²⁵Ac]Ac-LNC1011.

RESULTS:

[²²⁵Ac]Ac-LNC1011 was successfully radiolabelled with high radiochemical purity (> 97%) and high stability within 96 h (radiochemical purity > 96%). The high binding affinity of LNC1011 (IC₅₀ = 16.28 nM) to PSMA was comparable to that of PSMA-617 (IC₅₀ = 27.93 nM). Biodistribution studies confirmed that [²²⁵Ac]Ac-LNC1011 had moderate blood elimination half-life (T_1/2z = 13.4 ± 0.57 h), which was at an optimised level between [²²⁵Ac]Ac-PSMA-617 (T_1/2z = 5.19 ± 0.12 h) and [²²⁵Ac]Ac-PSMA-EB-01 (T_1/2z = 25.18 ± 2.78 h). In addition, high tumour uptake of [²²⁵Ac]Ac-LNC1011 was identified to be 38.28 ± 10.04%ID/g at 1 h post-injection. The specific uptake gradually increased and peaked at 24 h (80.57 ± 3.00%ID/g) and persisted at a high level up to 72 h post-injection (50.58 ± 5.37%ID/g). Targeted alpha therapy results showed the complete inhibition of PC3-PIP tumour growth after administration of a single dose of 1 µCi and 0.5 µCi of [²²⁵Ac]Ac-LNC1011 similar to 0.5 µCi [²²⁵Ac]Ac-PSMA-617. At the 0.1 µCi dose level, partial remission was observed for [²²⁵Ac]Ac-LNC1011, as recurrence was found 20 days after administration. In contrast, mice treated with 0.1 µCi [²²⁵Ac]Ac-PSMA-617 showed incomplete tumour inhibition under the same conditions.

CONCLUSION:

[²²⁵Ac]Ac-LNC1011 was successfully radiolabelled with high radiochemical purity and stability. With significantly improved tumour uptake and retention over PSMA-617, [²²⁵Ac]Ac-LNC1011 showed significantly better therapeutic efficacy than [²²⁵Ac]Ac-PSMA-617 for targeted alpha therapy of prostate cancer.

项与 Actinium (225Ac) vipivotidum tetraxetanum 相关的新闻（医药）

2025-10-25

·氨基观察

2025年ESMO，“核”势力的崛起

氨基观察-创新药组原创出品作者 | 沙晓威在医药圈，每年的ESMO大会就像一场“行业考试”，热门赛道的每一点动静都能引发关注。 2025年这场大会上，核药赛道依旧热度不减。既有诺华Pluvicto这样的明星药拓展新适应症，也有赛诺菲以α核素为基础的药物AlphaMedix刷新现有核药治疗记录。值得注意的是，中国企业带着首个国产核药PRRT药物站上国际舞台——先通制药的XTR008在神经内分泌瘤治疗上效果优异，且更符合中国患者的特征。此次ESMO大会的展示，也是核药崛起的一个缩影。从核素的选择、到递送方式，再到适应症的优化，核药的新一轮较量已经开始。 / 01 / Pluvicto：往更前线推进，忧喜参半提到核药，绕不开诺华的Pluvicto。作为第一款获批上市的核药，将这一“小众赛道”拉到了聚光灯下。 2024年狂揽14亿美元销售额，成为首个迈入重磅炸弹行列的放射性药物。但诺华显然不满足于此，PSMAfore试验的结果，帮助Pluvicto拓展了市场空间。2025年3月，FDA批准Pluvicto用于PSMA阳性的mCRPC患者化疗前的早期治疗，该审批将符合条件的患者数量增加了3倍。不过，Pluvicto的进击之路并未结束，今年ESMO上，它带着PSMAddition 3期试验数据，向激素敏感性前列腺癌（HSPC）这个更前线的适应症发起冲击。市场逻辑明确：Pluvicto目前获批的是mCRPC，人数较少。而HSPC患者处于疾病更早期阶段，患者人群庞大。诺华肿瘤学全球负责人Dushen Chetty更是直言，一旦该适应症获批，Pluvicto的合格患者群将直接翻倍，并大胆预测Pluvicto销售峰值将超过50亿美元。但现实却稍显冷静，这次ESMO大会上公布的PSMAddition数据可以说是“喜忧参半”。好消息是，Pluvicto联合SoC在放射学无进展生存期（rPFS）方面具有临床意义的改善，且与单独SoC相比，可将进展及死亡风险降低28%。延缓了HSPC进展为mCRPC的时间。坏消息是，关键的OS数据还没成熟，且HR是0.84。虽然Pluvicto组表现出积极趋势，但没有达到统计学意义上的显著差异。墨尔本Peter MacCallum癌症中心的肿瘤学家Arun Azad更是直接泼了冷水：“虽然PSMAddition中观察到的放射学无进展生存期益处可能会获得监管部门的批准，但即使进行更长时间的随访，也不可能看到OS益处。” 这样的担忧不是空穴来风。一方面是PSMAAddition出现了交叉病例的情况，即对照组中16%的患者后期转用了Pluvicto，这对OS的判断具有干扰性。另一方面，现阶段ADT联合ARPI的治疗手段虽疗效不及Pluvicto，但好在安全性更优。作为前列腺癌早期阶段，HSPC患者身体状态相对好，但Pluvicto的口干和胃肠道毒性，以及潜在恶性肿瘤的风险问题是否真的改善了患者生存质量仍需打个问号。尽管受到质疑，诺华仍是计划年底前根据最终的rPFS数据及更新后的OS结果，像FDA提交申请。此外，诺华还在积极筹备Pluvicto在寡转移前列腺癌患者的疗效（PSMA-DC），该适应症也是对疾病早期阶段的探索。在核药领域，诺华绝对是长期的领跑者：核心产品治疗前列腺癌的Pluvicto以及用于治疗GEP-NETs的Lutathera共同创造年净销售额超20亿的数据。除两款上市药物外，还有包括177Lu-NeoB、225Ac-PSMA-617在内的多款在研核药。2024年，公司还以17.5亿美元收购核药公司Mariana Oncology，继续加码。 / 02 / 新势力崛起 2025年ESMO，诺华的背后，是一众玩家在核药赛道的集体冒头。其中68Ga-OncoACP3-DOTA（诊断）和177Lu-OncoACP3-DOTA（治疗）的组合备受关注。2025年6月，Philochem AG以潜在总金额13.5亿美元的价格将药物授予BMS子公司RayzeBio。在治疗前列腺癌已有Pluvicto的背景下，这两款药物的优势在于靶向的酸性磷酸酶3（ACP3）相较于PSMA靶点更具肿瘤异质性，这一特性有效解决了PSMA低表达或不表达的治疗失效问题。此次大会公布的早期结果也符合预期，诊断性能优于PSMA，且治疗安全性更佳。 ITM公司的177Lu-edotreotide（ITM-11）则对标的是诺华的另一款药Lutathera，在治疗胃肠胰神经内分泌肿瘤（GEP-NETs）的3期COMPETE试验中同样表现出色，ORR达到21.9%，且全亚组实现mPFS延长。同样是针对GEP-NETs，赛诺菲的核药AlphaMedix（212Pb-DOTAMTATE）在缓解率上更是刷新了认知。此次EMSO大会上AlphaMedix针对GEP-NETs的Alphamedix-02试验结果进行了两次演示。首先是针对未经过放射治疗的患者，ORR为57%，效果上显著优于Lutathera。而针对既往接受过Lutathera治疗的患者，AlphaMedix的ORR达到19%，虽无差异化优势，但是具有临床意义。 AlphaMedix也代表新核药的迭代。作为一种基于α粒子的靶向疗法，AlphaMedix由用铅-212标记的生长抑素受体靶向肽复合物组成，可在患者体内产生α粒子攻击肿瘤。差异就在于此：α核素相较于Lutathera使用的β核素能量更高，能造成更频繁的双链DNA断裂，对肿瘤细胞杀伤更彻底，而且半衰期和电离半径短，对患者的毒副作用更小。目前FDA已授予AlphaMedix突破性疗法认定，用以治疗未接受过肽受体放射性疗法的GEP-NETs肿瘤患者。形成对比的是，同样基于铅-212的Perspective Therapeutics核药212Pb-VMT-α-NET的表现并不乐观。在未接受过核药治疗的NET患者的1/2期临床试验中，23例可评估患者的ORR为35%，在16名表达SSTR2患者（不同肿瘤）的亚组中，ORR为44%。但市场显然对这种“凑数”行为不满意，Perspective Therapeutics股价随之下跌。无论结局如何，此次ESMO已经展示了当前核药的研发热潮，而以新靶点、新核素、新适应症组成的新势力正在崛起。尽管还有许多药企并未在ESMO大会上展示，但是极具设计的思路也值得关注：比如，Cellectar Biosciences的磷脂药物偶联递送平台，能让核素穿过细胞膜精准送到肿瘤细胞。目前其管线Iopofosine I 131已经进入3期临床，针对的是多种实体瘤。 Oncoinvent则把目光放在了“冷门癌种”上。它用α核素镭-224开发的Radspherin，专门针对卵巢癌、结直肠癌的腹膜转移。这种转移灶位置隐蔽，传统治疗甚至免疫治疗也很难起效，但核药能通过放射性达到精准杀伤，目前已经进入2期临床。 / 03 / 中国力量没有缺席在2025年ESMO大会上，中国企业也有突破——先通医药公布了XTR008治疗GEP-NETs中国3期研究成果（XT-XTR008-3-01），同步登上了肿瘤学顶刊，拿到了国际顶级认证。临床结果显示：XTR008组的PFS达到24.77个月，疾病进展风险降低了86%（HR=0.14），ORR 55.6%（vs 2.1%），DCR更是高达94.9%（vs 72.2%）。所有患者亚组疗效一直，而且研究没有交叉设计，能够无偏移的评估XTR008的单药疗效。需要明确的是，该试验是完全基于中国患者数据做的试验。徐建明教授在ESMO大会点评时说：“XTR008的研究人群，比诺华之前的NETTER系列研究更符合中国NET特征。” 此次试验是全球首个针对“标准剂量长效生长抑素类似物治疗失败的GEP-NETs”开展的PRRT（肽受体放射性核素治疗）3期临床研究，也是中国第一个NET领域PRRT 3期研究。在ESMO官方媒体《ESMO Daily Reporter》针对NET的下一代放射性药物讨论中也出现了对XTR-008的积极评价：“令人鼓舞的疗效和非常轻微的毒性”。从临床需求上看，目前中国每年GEP-NETs新发患者不少，诺华的Lutathera并没有在中国获批，治疗手段很有限。今年4月XTR008的NDA已在受理，预计2026年就能获批，或将成为中国首个获批的靶向SSTR的治疗性放射性配体疗法。先通药业的表现也代表了中国药企在核药上的崛起。尽管如今以诺华、赛诺菲、BMS在内的MNCs在核药赛道进度领先，但国内包括中国同辐、东诚药业、纽瑞特医疗、远大医药、晶核生物在内的20多家药企也在竞逐。而先通药业管线更是构筑了10余款核药产品，多款药物已进入中后期临床试验。用于AD诊断的XTR005，已经在中国获批上市。当然核药赛道看着火热，想真正“跑起来”，没那么容易。除了早期的临床试验要过关，后期的生产以及临床应用，都是躲不开的问题。但已经明确的是，属于核药的“黄金时代”，开始了。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

临床3期

2025-10-24

·PRNewswire

Actinium Pharmaceuticals Presents New Data Demonstrating Potent and Durable Efficacy of ATNM-400, a First-in-Class Multi-Tumor Actinium-225 Radiotherapy, at the 32nd Annual Prostate Cancer Foundation Scientific Retreat

- ATNM-400 targets a novel, non-PSMA antigen implicated in disease biology with continued expression following androgen receptor pathway inhibitor (ARPI) therapy and 177Lu-PSMA-617 therapy, enabling potent activity independent of PSMA expression- ATNM-400 demonstrated superior efficacy over PSMA-targeted radioligand therapy (177Lu-PSMA-617 and 225Ac-PSMA-617) with enhanced tumor control and prolonged survival in low-PSMA and treatment-resistant models- Demonstrated durable anti-tumor responses, exceeding those achieved with the ARPI enzalutamide- Combination of ATNM-400 with enzalutamide achieved complete tumor regression in 40% of prostate cancer-bearing animals, demonstrating strong mechanistic synergy with AR pathway inhibition NEW YORK, Oct. 24, 2025 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of differentiated targeted radiotherapies, today highlighted new preclinical data for ATNM-400, its novel, first-in-class antibody radioconjugate armed with the potent alpha-emitter Actinium-225 (Ac-225) at the 32nd Annual Prostate Cancer Foundation (PCF) Scientific Retreat being held October 23 – 25, 2025 in Carlsbad, CA. Continue Reading Potent and Durable Tumor Control, Increased Overall Survival and Synergistic Activity in Enzalutamide Resistant Prostate Cancer Subsequent treatment with ATNM-400 achieved robust tumor control and extended survival, highlighting its potential in post-enzalutamide settings Highly Effective and Increased Overall Survival in 177Lu-PSMA-617 Resistant Prostate Cancer Potent Therapeutic Activity Independent of PSMA Expression Levels

放射疗法临床结果

2025-10-22

·中国同位素与辐射行业协会

9月核医疗产业动态速览

1. 蓝纳成肺癌诊断新药氟[18F]阿法肽注射液临床获批 2025年9月4日，烟台蓝纳成生物技术股份有限公司申报的1类新药氟[18F]阿法肽注射液获临床试验默示许可。该药物为靶向整合素αvβ3的广谱诊断药，首个适应症为肺癌显像诊断。其权益于2024年2月从合作方江苏新瑞药业转回蓝纳成，并将由蓝纳成继续开展III期临床，以实现诊疗一体化开发。 2. 通瑞生物前列腺癌诊断新药64Cu-TR2205注射液临床获批 2025年9月4日，通瑞生物制药（成都）有限公司申报的1类新药64Cu-TR2205注射液获临床试验默示许可。该药是通瑞生物首个放射性诊断药物及自研核素药物，拟用于诊断PSMA阳性复发转移性前列腺癌。 3. 诺华加码投资siRNA领域，神经科学与心血管布局双线并进近日，诺华在siRNA疗法领域连续达成两项重大合作：2025年9月2日，其以最高22亿美元获得Arrowhead公司针对帕金森病的临床前siRNA疗法ARO-SNCA的全球权益。9月3日，与中国的舶望制药就多项心血管siRNA疗法展开新合作，潜在交易总额高达52亿美元。这两项投资总额近76亿美元，诺华加码RNAi疗法及深化外部创新的战略布局。 4. 远大医药钇[90Y]微球注射液在欧洲获批新增适应症 2025年9月8日，远大医药全球创新产品SIR-Spheres®钇[90Y]微球注射液近日在欧洲获批新增适应症，适用范围从此前的肝细胞癌和结直肠癌肝转移，扩展至肝内胆管癌、神经内分泌瘤肝转移等更多肝癌类型。该产品此前也已获美国FDA批准新增肝细胞癌适应症，成为全球首个获批用于上述两大适应症的选择性内放射疗法。 5. 24亿美元收购成果落地，阿斯利康在华申报首款核药 2025年9月9日，阿斯利康在中国提交的首个核药临床试验申请获受理。该申请包括放射性诊断药物[111In]-FPI-2107及其配套靶向抗体FPI-2053，这两款产品均源自其今年3月以24亿美元对Fusion Pharmaceuticals的收购，阿斯利康的全球核药战略正式在中国落地。 6. 全球首例AcTFirst研究的[225Ac]Ac-PSMA-617用药顺利完成 2025年9月9日，中山大学肿瘤防治中心团队顺利完成AcTFirst研究的全球首例[225Ac]Ac-PSMA-617用药。该研究是由诺华申办、覆盖全球的III期临床试验，针对PSMA阳性转移性去势抵抗性前列腺癌。这款新型放射配体疗法采用α核素，能更精准杀伤肿瘤，标志着我国在该领域迈入国际前沿。 7. 蓝纳成双靶点治疗核药177Lu-LNC1009临床试验申请获受理 2025年9月24日，蓝纳成生物研发的1类放射性治疗药物177Lu-LNC1009注射液临床试验申请获受理。该药是首个双靶点（FAP和αvβ3）治疗核药，拟用于治疗相关阳性实体瘤。相比单靶点药物，双靶点设计有望克服肿瘤异质性，提高靶向效率和治疗效果，是放射性核素偶联药物的重要研发方向。转载丨磐美迪微信公众号内容源丨远大医药、小核说药、谈核容易、夸克医药等立足中国放眼世界积极推动行业的发展和技术进步振兴我国同位素与辐射事业促进国家社会主义现代化建设

临床3期放射疗法siRNA并购临床结果

100 项与 Actinium (225Ac) vipivotidum tetraxetanum 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
转移性去势抵抗性前列腺癌	临床3期	美国	Novartis Pharmaceuticals Canada, Inc.	2025-02-27
转移性去势抵抗性前列腺癌	临床3期	中国	Novartis Pharmaceuticals Canada, Inc.	2025-02-27
转移性去势抵抗性前列腺癌	临床3期	日本	Novartis Pharmaceuticals Canada, Inc.	2025-02-27
转移性去势抵抗性前列腺癌	临床3期	澳大利亚	Novartis Pharmaceuticals Canada, Inc.	2025-02-27
转移性去势抵抗性前列腺癌	临床3期	以色列	Novartis Pharmaceuticals Canada, Inc.	2025-02-27
转移性去势抵抗性前列腺癌	临床3期	新加坡	Novartis Pharmaceuticals Canada, Inc.	2025-02-27
转移性去势抵抗性前列腺癌	临床3期	韩国	Novartis Pharmaceuticals Canada, Inc.	2025-02-27
转移性去势抵抗性前列腺癌	临床3期	中国台湾	Novartis Pharmaceuticals Canada, Inc.	2025-02-27
PSMA阳性去势抵抗性前列腺癌	临床3期	以色列	Novartis Pharmaceuticals Canada, Inc.	2025-02-27
PSMA阳性去势抵抗性前列腺癌	临床3期	韩国	Novartis Pharmaceuticals Canada, Inc.	2025-02-27

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临床结果

适应症

分期

评价

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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


Ac-PSMA-617 (EANM2024)	N/A	转移性去势抵抗性前列腺癌 PSMA	12	[225Ac]Ac-PSMA-617	顧壓餘獵蓋製範醖繭製(淵製網壓顧鏇壓築觸憲) = 齋餘獵築鹽夢艱壓艱鏇餘鬱範鏇願簾選選鬱衊 (遞選糧餘憲壓積衊膚膚 ) 更多	积极	2024-09-27
EANM2024	N/A	prostate-specific membrane antigen (PSMA)	15	Actinium-225 PSMA-617 RLT	觸鏇鹽憲積艱廠積鏇餘(簾艱壓積窪鏇衊製範選) = xerostomia requiring nasogastric tube feeds in 1; anemia in 1; thrombocytopenia in 1; and nephrotoxicity requiring dialysis in 1 遞襯遞鹹襯醖糧廠積鏇 (夢廠構淵繭餘選繭鏇範 ) 更多	积极	2024-09-27
EANM2024	N/A	prostate-specific membrane antigen (PSMA)	15	Lutetium-177 PSMA-617 RLT		积极	2024-09-27
SNMMI2023	N/A	转移性去势抵抗性前列腺癌	-	225Ac-PSMA-617 TAT	願憲觸艱範鑰醖膚艱遞(鏇夢艱簾鑰淵鬱顧膚壓) = fatigue (any grade 70%; ≥grade 3: 2%) which were transient and resolved without intervention prior to the next cycle of treatment 醖選遞淵窪範糧齋淵顧 (醖繭願糧襯觸餘膚襯製 ) 更多	-	2023-08-28
SNMMI2022	N/A	转移性前列腺腺癌	-	225Ac-PSMA-617	餘簾鑰壓淵鏇淵齋網夢(顧願艱繭衊夢願糧衊襯) = 鏇願膚鏇顧積網鑰蓋蓋範壓廠餘構鑰壓廠鬱築 (鹹鑰遞蓋餘憲遞鬱築齋 )	-	2022-08-08
225 Ac-PSMA-617 (SNMMI2021)	N/A	转移性去势抵抗性前列腺癌 PSMA	40	225Ac-PSMA-617 TAT	憲鹽構襯膚觸夢糧築齋(鏇窪憲繭襯夢糧積選壓) = 壓艱積鬱鹹壓艱範蓋襯鏇蓋糧範範艱範醖襯鹹 (遞鑰窪襯憲構襯積齋廠 ) 更多	积极	2021-05-18
Ac-PSMA-617 (EANM2020)	N/A	转移性去势抵抗性前列腺癌 serum prostate-specific antigen (PSA)	28	225 Ac-PSMA-617 Targeted AlphaTherapy	網憲製網壓糧醖鏇簾積(齋鑰餘膚醖簾壓網觸簾) = 齋膚醖顧觸選鏇鏇淵鹽鑰膚網製糧願鏇齋醖鹽 (願選簾製憲齋構觸鑰蓋, 13 ~ 16) 更多	积极	2020-09-18
SNMMI2020	N/A	转移性去势抵抗性前列腺癌 PSMA	28	225Ac-PSMA-617 TAT	襯網繭夢選鏇積築鹹艱(淵淵築餘衊鑰簾簾範繭) = None of the patients demonstrated grade 3 or 4 hematologic or kidney function toxicity and xerostomia 簾構積鏇願構製膚範襯 (遞範簾簾製淵糧積簾願 )	积极	2020-05-15
SNMMI2020	N/A	转移性去势抵抗性前列腺癌	-	225Ac-PSMA-617	襯糧鑰製窪鏇壓築醖鏇(廠壓願築醖製選壓鹽鹽) = There was no haematological toxicity seen 窪壓艱鏇醖齋積窪鏇願 (鬱壓觸顧製鏇觸壓膚餘 ) 更多	-	2020-05-15
SNMMI2019	N/A	转移性去势抵抗性前列腺癌	-	225Ac-PSMA-617 TAT	窪艱蓋膚齋積鏇夢憲獵(鬱築齋製鹹顧簾築廠鹹) = No death was observed in the patient population 壓範鏇範顧鹹鏇觸鹹憲 (鹽蓋築餘觸憲遞獵範艱 ) 更多	-	2019-05-21
SNMMI2019	N/A	转移性前列腺癌	-	Ac-225 PSMA-617	製構憲餘衊築醖餘廠鹽(繭衊選蓋鑰顧鑰鏇範積) = There was no severe xerostomia and no discontinuation of treatment 廠願衊獵選觸鑰範觸遞 (網願簾範夢簾衊範糧願 ) 更多	-	2019-05-21
SNMMI2019	N/A	转移性前列腺癌	-	Lu-177 PSMA-617		-	2019-05-21