Summary Renal Cell Carcinoma (RCC) consists of 2% of all malignencies. RCCs are generally divided to histopathological subtypes as clear cell and non-clear cell variants. Clear cell variant responsible for the 75-80% of all RCCs. It is reported that 20-30% of RCCs are metastatic at the diagnosis and 5 years survival is approximately is 10-20% in this group of patients. Moreover, 60% of patients who are not metastatic at the diagnosis, develop metastates within 2-3 years. 2nd and 3th line effective treatment option in metastatic RCCs patients has been a subject of interest.
PSMA (protatate specific membrane antigen) with the other name glutamate carboxypeptidase, is a transmembrane protein and overexpresses in prostate adenocarcinomas and neoangiogenesis spots of endothelium of other several tumor types. It infronts as a target for theranostic consept for mainly prostate cancer in nuclear medicine. As a radionuclide treatment option, Lu-177 PSMA treatment is proved as safe and effective treatment option in castration resistant prostata cancer patients. After its widely use in prostate cancer, it is reported that PSMA molecule can be used for imaging of RCC patients and PSMA uptake is higher than 18F-FDG. For this reason, Lu-177 PSMA treatment can be a systemic treatment option in RCC patients who have progress afer 1st cycle treatment. In this study we aimed to safety and efficacy of Lu-177 PSMA treatment in metastatic RCC patients as systemic radionuclide treatment option.

开始日期2026-05-01

申办/合作机构

Ankara University

NCT07145177

/ Recruiting临床1期IIT

A Phase 1b Study of 177Lu-PSMA-617 Combined With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer

This is an open label, single arm, phase 1b study to determine the safety of combining sequential Prostate-Specific Membrane Antigen (PSMA)-targeted 177Lu-PSMA-617 radionuclide therapy with liver-directed therapy in metastatic castrate-resistant prostate cancer (mCRPC) patients with liver metastases amenable to liver-directed therapy who have progressed on at least one prior androgen pathway inhibitor.

开始日期2026-03-16

申办/合作机构

The University of California, San Francisco

[+1]

NCT07219147

/ Recruiting临床1期IIT

Pilot Study of ¹⁷⁷Lu-PSMA-617 in Combination With Sipuleucel-T in Patients With Metastatic Castration-Resistant Prostate Cancer

This phase I trial compares the effect of lutetium Lu 177 (177^Lu)-prostate-specific membrane antigen (PSMA)-617 in combination with Sipuleucel-T to 177^Lu-PSMA-617 alone in treating patients with prostate that has spread from where it first started (primary site) to other places in the body (metastatic) and has continued to grow and spread despite surgical or medical intervention to block androgen production (castration-resistant). 177^Lu-PSMA-617, a type of radioconjugate, binds to a protein called PSMA, which is found on some prostate tumor cells. It gives off radiation that may kill the tumor cells. Sipuleucel-T, a type of vaccine and a type of cellular adoptive immunotherapy, is made from immune system cells. The cells are treated with a protein that is made by combining a protein found on prostate tumor cells with a growth factor. When the cells are injected back into the patient, they may stimulate T cells to kill prostate tumor cells. Giving 177^Lu-PSMA-617 in combination with sipuleucel-T may be safe, tolerable, and/or effective compared to 177^Lu-PSMA-617 alone in treating patients with metastatic castration-resistant prostate cancer.

开始日期2026-03-06

申办/合作机构

City of Hope National Medical Center

[+1]

100 项与镥[177Lu] 特昔维匹肽相关的临床结果

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100 项与镥[177Lu] 特昔维匹肽相关的转化医学

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100 项与镥[177Lu] 特昔维匹肽相关的专利（医药）

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663

项与镥[177Lu] 特昔维匹肽相关的文献（医药）

2026-07-01·APPLIED RADIATION AND ISOTOPES

FAERS based pharmacovigilance study and network pharmacology analysis of Lutathera and Pluvicto

Article

作者: Zhang, Shilin ; Li, Shouying ; Feng, Jiaxin

BACKGROUND:

Lutetium Lu 177-based agents Lutathera (targeting SSTR in GEP-NETs) and Pluvicto (targeting PSMA in mCRPC) exhibited significant efficacy in clinical trials, yet real-world safety validation remains imperative.

METHODS:

We performed disproportionality analysis on FAERS reports and applied network pharmacology to identify drug targets, construct protein-protein interaction networks, and elucidate adverse event mechanisms through KEGG pathway enrichment.

RESULTS:

Shared adverse reactions for both agents include pleural effusion (ROR 1.68, 95%CI: 1.03-2.74) and pulmonary embolism (ROR 1.06, 95%CI: 0.61-1.82). Lutathera shows higher risks of gastrointestinal toxicities such as intestinal obstruction (ROR 5.33, 95%CI: 3.82-7.43) and infection-related events like liver abscess (ROR 26.16, 95%CI: 15.73-43.51). Pluvicto is associated with subdural hematoma (ROR 6.91, 95%CI: 3.82-12.5) and loss of libido (ROR 16.29, 95%CI: 10.88-24.38). KEGG pathway enrichment analysis further delineates mechanistic divergence, revealing significant target enrichment in peptide GPCRs (-log10(P) = 62.44) and neuropeptide signaling pathway (-log10(P) = 23.63) for Lutathera versus predominant involvement of proteasome (-log10(P) = 80.59) and peptide ligand-binding receptors (-log10(P) = 22.84) for Pluvicto.

CONCLUSION:

This FAERS analysis characterizes agent-specific safety profiles, informing pharmacovigilance strategies. Mechanistic profiling of adverse drug reactions optimizes evidence-based treatment, enhancing medication safety and refining benefit-risk profiles in clinical practice.

2026-06-01·JOURNAL OF CONTROLLED RELEASE

Radiolabeled cyclic peptides in precision oncology: Current advances and future perspectives

Review

作者: Ai, Dingding ; Ge, Shushan ; Sang, Shibiao ; Shi, Jinyu ; Zhang, Bin ; Deng, Shengming ; Li, Jihui

In recent years, the regulatory approval of radiopharmaceuticals such as [¹⁷⁷Lu]Lu-DOTATATE and [¹⁷⁷Lu]Lu-PSMA-617, alongside their diagnostic counterparts [⁶⁸Ga]Ga-DOTATATE and [⁶⁸Ga]Ga-PSMA-11, has propelled theranostics into the clinical mainstream, marking a transformative shift in nuclear medicine and precision oncology. Amid this dynamic progress, cyclic peptides have emerged as indispensable vectors for targeted delivery in nuclear medicine, owing to their exceptional resistance to enzymatic degradation, superior conformational stability, and high receptor-binding affinity. These properties endow radiolabeled cyclic peptides with favorable pharmacokinetics, elevated tumor accumulation, and excellent target-to-background contrast, features that have enabled their widespread application in imaging and therapy targeting somatostatin receptors, integrins, FAP, PD-L1, and other tumor-associated biomarkers. With their molecular precision, structural versatility, and therapeutic adaptability, cyclic peptides are positioned at the forefront of next-generation radiopharmaceutical development. As the field continues to evolve toward increasingly personalized and molecularly targeted cancer therapies, radiolabeled cyclic peptides are poised to play a pivotal role in redefining the future landscape of radiotherapy.

2026-04-01·CLINICAL NUCLEAR MEDICINE

Assessing PSMA Receptor Availability Using 68Ga-PSMA-11 PET/CT Following 177Lu-PSMA-617 Therapy Administration

Article

作者: Dewaraja, Yuni K. ; Wong, Ka Kit ; Roseland, Molly E. ; Fitzpatrick, Kellen J. ; Suresh, Krithika ; Frey, Kirk A. ; Viglianti, Benjamin L. ; Lu, Zhonglin

Purpose::

Prostate cancer treatment with 177 Lu-PSMA-617 depends on specific binding to the PSMA protein. If receptors become saturated by the radioligand, the uptake of the drug may be affected. Our goal was to measure the pharmacological effect of standard 7.4 GBq (200 mCi) administration of 177 Lu-PSMA-617 based on the uptake of 68 Ga-PSMA-11 on subsequent PET.

Patients and Methods::

We performed 68 Ga-PSMA-11 PET/CT within 0.5–75 hours after cycle 1 of therapy administration in 6 patients with metastatic castrate-resistant prostate cancer who volunteered for imaging. SUV mean of tumors (N=27) and organs, stratified by early (<2 h) and late (~3 d) post-therapy PET imaging, were compared with baseline PET.

Results::

There were large decreases in SUV mean for tumor, kidney, parotid gland, and liver among patients imaged early after therapy, with an average change in tumor SUV of −45% (95% CI: −66% to −25%; P <0.001). In contrast, only mild persistent declines in SUV were observed in those scanned late, with an average change in tumor SUV of −9% (95% CI: −33% to 16%; P =0.42).

Conclusions::

There are measurable decreases in PSMA binding following 177 Lu-PSMA-617 that resolve over time. As trials consider alternative therapeutic strategies, increasing dosage per cycle alone may not proportionally increase tumor uptake. Our findings warrant validation with a larger number of subjects, standardized post-therapy scan timing, and advanced pharmacokinetic analyses.

1,505

项与镥[177Lu] 特昔维匹肽相关的新闻（医药）

2026-04-24

·微瑞研报

实体瘤TCE疗法报告：SCLC、mCRPC治疗中大放异彩，有望突破多靶点、泛癌肿的临床应（一）

如需报告请联系客服或扫码获取更多报告一、TCE已在SCLC、mCRPC中读出成熟的I临床数据，并显示出前线治疗的充分潜力（一）SCLC:DLL3TCE成为后线基石疗法，与PD-(L)1/ADC联用有望进一步扩展适用空间 DLL3是神经内分泌肿瘤治疗的潜力靶点，肿瘤组织内表达特异性强。小细胞肺癌（SCLC是肺癌中侵袭性极强的异源性神经内分泌肿瘤，根据RudinCM(2021）的研究显示，SCLC约占所有肺癌病例的13%-17%，SCLC患者预后较差，广泛期非小细胞肺癌（ES-SCLC）确诊后的中位生存期仅为6-12月。根据《中华肿瘤杂志》的统计数据显示，中国新发ES-SCLC患者约每年11万人；根据Mount Sinai统计数据显示，美国SCLC年新发患者约3-3.5万人。DLL3 是一种Notch信号通路的抑制性配体，它通过阻止Notch受体在细胞表面的呈现来抑制Notch信号，从而促进肿瘤生长、增殖和转移，并抑制肿瘤微环境中的免疫反应。在神经内分泌肿瘤细胞表面异常高表达（尤其在小细胞肺癌中超80%），而在正常组织中表达极低。 DLL3TCE填补SCLC后线治疗的空白。当前SCLC治疗一线治疗以免疫治疗联合铂类化疗为主，而标准二线疗法主要仍为化疗，例如拓扑替康、芦比替尼、紫杉醇等等，缺乏有效的靶向疗法，如今靶向DLL3的双特异性T细胞接合器、ADC、双/三抗等药物研发有望填补SCLC在靶向治疗上的空缺，为SCLC治疗开辟了全新路径。针对DLL3靶点的疗法主要包括多抗、ADC与细胞治疗。DLL3靶向疗法中多抗为代表的药物包括安进的CD3/DLL3双抗塔拉妥单抗，该疗法针对2线与3线的SCLC患者临床试验的疗效突出，已获批上市，并在2025WCLC中在1线化疗免疫联合治疗后联用PD-L1抑制剂维持治疗的DeLLphi-塔拉妥单抗外，泽璟制药ZG006目前已推进至川期临床阶段，BI中国生物制药的obrixtamig、恒瑞医药的SHR-7787、第一三共/默沙东合作的Gocatamig已进入II期临床阶段。ADC疗法方面，再鼎医药的zocilurtatugpelitecan、恒瑞医药/IDEAYA的SHR-7787目前研发进度领先。塔拉妥单抗在1线维持治疗数据亮眼，泽璟制药ZG006临床数据具备较强竞争力，Gocatamig针对ES-SCLC脑转移患者具备差异化疗效。当前在研的DLL3TCE分子中，塔拉妥单抗联合PD-L1抑制剂1线维持治疗ES-SCLC的Ib期临床 DeLLphi-303临床中mOS达25.3个月，与芦比替定IMforte临床中联合阿替利珠单抗1线ES-SCLC维持治疗13.2个月的mOS进行非头对头比较，具备显著的相对优势，当前联合PD-L1抑制剂1线维持治疗ES-SCLC的关键注册临床DeLLphi-312已启动。此外，塔拉妥单抗同时布局DeLLphi-306试验，该临床预计纳入400例完成以铂类为基础的同步放化疗，且无疾病进展局限期小细胞肺癌（LS-SCLC患者，进一步拓展塔拉妥单抗在SCLC的适用范围。泽璟制药ZG006的临床数据展现了较强竞争力，在2025ESMOAsia中，最新ZG006-002数据显示10mgQ2W剂量组中，30例3线及以上的 SCLC患者中mPFS达7.03m，相较塔拉妥单抗DELLphi-304临床2线治疗4.9m的mPFS仍具备相对优势，并展现了良好的安全性。MSD基于TriTAC平台的 CD3/DLL3 双抗Gocatamig当前披露的剂量递增临床结果中展现出了对脑转移患者的差异化疗效，2025ESMO更新的数据中，24mgQ2W剂量组cORR达46%，有望在后续剂量扩展试验与B7H3ADC联用临床中进一步验证其抗肿瘤活性与联用潜力。 SCLCADC疗法靶点选择多样化，具备与TCE联用的临床前景。艾伯维的 Rova-T是首个靶向DLL3的ADC药物，ROva-T在II期和I期临床试验中未达到预期的生存改善，且表现出独特的毒性特征，在2019年，艾伯维官宣终止Rova-T用于SCLC患者的研究和开发计划。再鼎医药的ZL-1310当前已读出初步数据，la期临床中，此前接受过至少一种含铂化疗方案治疗的广泛期小细胞肺癌患者中ORR达68%。相较各靶点ADC疗法，DLL3TCE在SCLC适应症具有更充分的临床数据验证，且3级及以上TRAE发生率低于ADC，更具备前线应用的潜力。此外，DLL3TCE疗法有与ADC联用的潜力，B7-H3 ADCYL201当前已布局与塔拉妥单抗、PD-L1联用用于ES-SCLC的Ib期临床，ZG006在实现向艾伯维的License-out后，我们认为也具有与其SEZ6ADCABBV-706联用的潜力。（二）mCRPC：PSMA、STEAP1、KLK2等靶点均验证抗肿瘤潜力，TCE有望成为mCRCP的基石疗法 PSMA：mCRPC经典靶点，临床适用场景有望推进至Pluvicto前线 PSMA表达特异性强，已成为mCRPC诊疗的关键靶点。PSMA（前列腺特异性膜抗原）是一种由750个氨基酸组成的型跨膜糖蛋白，包含胞内区、跨膜区和胞外区三个结构域。在良性前列腺细胞中，PSMA主要分布于细胞质和腺体顶端面；恶性转化后，其定位转移至前列腺导管腔面，胞外区暴露并形成配体结合位点。前列腺腺癌中PSMA表达水平较良性组织升高100-1000倍，且随肿瘤去分化及转移性CRPC的进展进一步增加，因此PSMA成为诊疗一体化的理想靶点。PSMA胞外区含多个结合位点，可与放射性配体结合用于影像或放射性配体治疗（RLT）：同时，PSMA抑制剂通过叶酸结合位点或锌结合位点，抑制其酶功能并干预肿瘤生长，从而展现出在前列腺痛诊断与治疗中的重要价值。PSMA在前列腺之外，主要表达的器官为唾液腺，因此，唾液腺成为了PSMA靶向疗法主要的剂量限制器官，以JANX007Ia期数据为例，33%的患者（1%为3级及以上）出现口干的TRAE，这一靶点相关不良反应可能会成为相关疗法开发上值得注意的问题。 Pluvicto突破mCRPC后线治疗，当前已在2线治疗中展现获益。在晚期mCRPC领域，传统治疗选择有限，一线主要依靠化疗（如多西他赛）域内分泌治疗（ARPI，如阿比特龙、恩杂鲁胺），而后线方案相对稀少，包括免疫检查点抑制剂（如帕博利珠单抗）或PARP抑制剂（如奥拉帕利），患者在1线及2线治疗失败后往往缺乏有效选择。近年来，PSMA靶向放射性配体治疗代表药物Pluvicto的出现，为mCRPC治疗开辟了新路径。Pluvicto通过衰变产生的β射线精准照射PSMA阳性肿瘤细胞，引发DNA损伤并实现肿瘤杀伤，实现了“精准+放疗+系统治疗”的三位一体模式。Pluvicto已在I期试验中验证出在2线mCRPC治疗中明确的生存获益，PSMAfore试验在1线ARPI进展且未接受过紫杉醇治疗的mCRPC患者中，相比更换ARPI的亚组，mPFS为11.6个月（HR=0.49），mOS约23.7个月，ORR 50%，PSA反应率51%。除RLT外，PSMA靶向药物还包括ADC、TCE、双抗、CAR-T等，大部分适应症为后线mCRPC治疗。 JANX007在5线mCRPC患者中展现出一定比例的肿瘤响应，前线患者中观察到初步疗效信号。根据JANX007在2025年12月1日更新的Ia期临床数据，在27 例目标剂量为2mg以上患者中ORR达30%，在6/9 mg Q2W剂量组的19 名患者中，rPFS达8.9m；安全性方面，在经治的109名患者中，>3级CRS出现在8%患者中，>3 级 AST与ALT 升高分别出现在23%与 17%患者中，显示出一定的肝毒性。此外JANX007已初步在紫杉烷类化疗未经治的前线患者中观察到积极的PSA降低信号，有望在后续更新中读出具备竞争力的前线数据。除TCE外，PSMAADC疗法ARX517 IVII 期结果显示PSA>50%下降率达52%,ARX517的剂量递增临床展现了良好的安全性，>3级不良事件仅出现在9%的患者中。 Pluvicto在针对3 线mCRPC的VISION I临床中,mPFS达 8.7m,ORR 为30%，PSMA TCEJANXO07在5线mCRPC患者中，最优剂量组mPFS与ORR 数据与VISION临床数据相比具有一定的竞争力，但JANXO07较强的肝毒性与CRS风险仍是该疗法后续开发的担忧点。

2026-04-24

·Firstwordpharma

Novartis pulls bid to broaden Pluvicto use after EU pushback

Novartis has withdrawn its application to broaden the EU label of its prostate cancer treatment Pluvicto (lutetium Lu 177 vipivotide tetraxetan) after regulators there made clear the expansion was unlikely to pass muster.The radioligand therapy has been approved in Europe since 2022 for use with androgen deprivation therapy in adults who have PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). The new filing sought to move the therapy into an earlier-line setting, targeting patients who have no or mild symptoms, after their cancer has worsened despite treatment with a hormone-blocking medicine, but who are not yet eligible for chemotherapy.The FDA gave the green light last year to expand Pluvicto's US label to allow use after one androgen receptor pathway inhibitor (ARPI) and before chemotherapy, a move the company said would nearly triple the therapy's patient reach.That decision was based on results from the Phase III PSMAfore trial where Pluvicto was found to reduce the risk of radiographic progression or death by 59%, with median radiographic progression-free survival more than doubling to 11.6 months versus 5.6 months in the control arm.However, it wasn't a straight-line path to approval in the US, where questions surrounding the trial's overall survival (OS) results had previously prompted Novartis to delay its FDA filing. PSMAfore's final OS analysis showed a non-significant trend favouring Pluvicto (HR 0.91), though the company argued that adjusting for a high rate of crossover from the control arm improved the OS benefit to an HR of 0.59.The EMA said its provisional opinion was that it couldn't back the label expansion because the company hasn't provided enough evidence."Although the main study showed that the medicine could increase the time before the cancer grew or spread compared with a hormone-blocking treatment, it was not clear whether this delay provides a meaningful benefit for patients," the EU agency said. "This is because the comparator treatment, a hormone-blocking treatment, was not considered to be adequate for people with this stage of prostate cancer. In addition, treatment with Pluvicto had no impact on how long people lived overall, compared with a hormone-blocking treatment."Pluvicto generated sales of $2 billion in 2025, up 43% year-over-year.

临床3期临床结果上市批准

2026-04-23

·拇指药略

满手王牌，远大医药领跑核药赛道

已然成为“核药新王” 作者：西北哽最近，远大医药（0512.HK）又在国际舞台上秀了一把。4月13日，远大医药公布了DOORwaY90临床研究的最终成果。这项试验是远大医药的核药王牌产品——钇[90Y]微球注射液在美国开展的治疗不可切除的原发性肝细胞癌的临床研究。去年7月，基于该试验突破性的中期数据，FDA提前批准钇[90Y]微球注射液新增适应症。仅凭中期数据就获得FDA提前批准，中国产创新药中，到目前为止一共只有4个品种达到过这样的高度：百济神州的泽布替尼、传奇生物的CAR-T西达基奥仑赛、迪哲的舒沃替尼，还有就是远大医药的钇[90Y]微球注射液。无论从哪个方面看，钇[90Y]微球注射液都是百亿级品种。本次远大医药在钇[90Y]微球注射液DOORwaY90临床研究达到预设的临床终点，使其成为中国企业中第一个独立在海外完成注册性临床的核药。最近核药话题火爆，先是百洋医药投资的诊断性核药“吉伦泰”在中国获批上市，后有开发核药的纽瑞特医疗拿到第六轮10亿元融资。但可能很多人没想到，在中国谈论核药，远大医药必然会排在前面。远大医药这些年已不动声色地构建起了一个覆盖全球的核药研发、生产、销售的庞大产业链，手握近30条核药管线，总量和深度国内数一数二。而且在大多数中国创新药都靠BD伙伴完成海外临床和注册的时候，远大医药靠自己跑通了FDA的上市通路。在国内企业中，远大医药已然成为“核药新王”。 2全球化核药研产销能力 “核药”是放射性药物的俗称，主要分两大类：用于显像和诊断的核药，以及用于治疗的核药。其中诊断性核药占主导地位，而治疗性核药开发难度很大，获批的不多。中华医学会核医学分会2023年时统计，FDA迄今为止一共只批准了14个治疗性核药。远大医药的钇[90Y]微球注射液就是其中之一。（中华医学会和医学分会，2023）钇[90Y]微球注射液最初用于治疗晚期结直肠癌肝转移。但是医学界一直有一种观点：钇90这种核素可以用于治疗原发性肝癌。中国早在1994年就有相关论文发表；美国综合排名第二的克利夫兰诊所很早就在官网上推介钇90疗法治疗晚期肝癌。远大医药2018年布局钇[90Y]微球注射液，开始致力于把这个萦绕医学界二十多年的“传说”变成现实。当时，钇[90Y]微球注射液实际已经获得美国国立综合癌症网络、欧洲肿瘤学内科学会等多个权威指南推荐用于治疗肝癌，甚至纳入了美国和欧洲多国的医保。但最终的疗效还需要通过试验来证明。2021年，远大医药在美国启动钇[90Y]微球注射液治疗肝癌的临床研究。 4月13日公布的最终临床数据结果无可挑剔：完全缓解率高达90%，最佳总体缓解率为99%；所有可评估患者均对治疗产生应答，局部肿瘤控制率100%；同时，75%的患者缓解持续时间超过6个月，中位缓解持续时间295天，95%以上的患者在12个月时维持了稳定的肝功能。这样的数据放在任何疗法面前都称得上是“神器”级别。而且肝肿瘤缓解后，其他靶向、免疫甚至手术等治疗方案都有了施展的空间。可以说，钇[90Y]微球注射液除了本身疗效强大，还提升了其他肝癌疗法的临床价值。远大医药在美国独立完成钇[90Y]微球注射液的临床，有很强的象征意义——这标志着远大医药拥有独立完成创新核药海外注册临床的能力，而目前没有几家中国药企具备这样的能力。在销售方面，这几年，已经实现海外销售的几款国产创新药并非一帆风顺：除了泽布替尼一骑绝尘之外，其他品种虽说找的也是大牌外企合作，但市场效果不尽如人意。这里面的原因也不难理解： ▌”他是你的全部，而你只是他的1%。” 百济泽布替尼的成功，基于关键的两点：确有优势的疗效，和自主可控的海外临床、销售团队。而这两点，现在远大医药的钇[90Y]微球注射液都具备。钇[90Y]微球注射液海外临床的成功，正是远大医药核药产业全球布局优势的有力认证，也是公司持续深耕创新研发的重要成果。远大医药核药板块全球员工超过1000人，产品销售覆盖50多个国家和地区，完全实现了核药的全球自主销售，也是全球仅有的四家成功实现核药全球商业化的药企之一。去年远大医药核药板块收入约9.5亿港元，板块四年实现收入约15倍的增长。钇[90Y]微球注射液去年在美国获批新增肝癌适应症，今年中国国家卫健委已经将其列为《原发性肝癌诊疗指南（2026年版）》中的主流介入治疗选择，随着HCC适应症在各地的陆续获批，钇[90Y]微球注射液的销售将进一步爆发。肝癌治疗的市场需求是极大的。2025年底美国CDC发布最新的癌症趋势报告显示，美国肝癌发病率过去十年上升近40%，是增速最快的癌症。去年7月，《柳叶刀》杂志更是预测，到2050年全球每年新发肝癌患者将增至152万。中国是肝癌重灾区，世卫组织统计：每年新发肝癌病例40%以上在中国。（根据国家癌症中心数据整理）而且复旦大学附属中山医院樊嘉院士指出：中国70%～80%的肝癌患者 ▌“初诊就已是无法切除的中晚期肝癌” 钇[90Y]微球注射液给晚期肝癌带来新的治疗选择。仅是在国内，如果治疗渗透率能达到10%，钇[90Y]微球注射液的年销售额都将会是十亿人民币起步；考虑到美国市场的潜在空间，该产品冲击百亿销售额指日可待。 2“诊疗一体化”管线深度拉满钇[90Y]微球注射液在美国圆满完成临床并获批新增适应症这件事，意义其实远大于其他一般的创新药品种，该产品成功的背后，是远大医药搭建的全球核药产业链的强力支撑。核药有放射性，其原料来源、生产工艺、运输储存乃至临床应用都受到很严格的限制。市场竞争者有限，更鲜有全球布局的企业。远大医药在波士顿、法兰克福、新加坡、成都四地设有核药生产基地，与欧美中新的监管机构及核原料提供方都建有通畅的联络渠道；放射性产品的转运储存能力伴随销售团队，同样能触达全球50多个国家和地区。尤其是公司去年投入运营的成都核药基地，其是全球首个核药全产业链闭环平台，覆盖“同位素制备－核药研发－生产临床－商业化”全链条，为远大医药赋能了从核药早期研发、临床转化到上市销售的全生命周期管理能力，并且实现100%自主生产，破解了核药进口依赖的困局，为公司后续核药国产化落地奠定了基础。布局这样强大的网络，远大医药核药MNC的蓝图已然显现。事实上，远大医药已经布置好了一个覆盖多种肿瘤的“核药军团”。目前远大医药的管线里共有16个核药品种。（摘自远大医药官网）其中在受外界关注的RDC领域，远大医药共储备了10个品种，而且提出了放射诊疗一体化的思路：针对特定癌症，同步推进核诊断用核药和治疗用核药，发挥系统价值。如用于诊断前列腺癌的靶向PSMA核药TLX591-CDx，该产品目前已在澳大利亚、美国、巴西及欧洲20国上市，销售增长迅猛，其在2025年全年取得了超过6亿美元的收入，同比增长超20%，该产品国内NDA申请也已于年初获药监局受理，并有望年内获批上市。前列腺癌是中国男性第六大高发癌种，‌国家癌症中心发布的2022年新发病人数为13.42万人。针对这一癌种，远大医药还布局了同靶点的治疗性核药TLX591， ▌硬刚诺华的“核药之王”Pluvicto 目前TLX591正在开展包括中国在内的国际多中心III期临床。诺华的Pluvicto去年销售额20亿美元，是历史上首个进入全球药品销售TOP100的核药。‌ TLX591未来能与TLX591-CDx形成诊疗一体化产品组合，助力远大医药在前列腺癌诊疗市场占据绝对领导地位，市场空间可对标Pluvicto。这样的“诊疗一体化组合”，远大医药手里至少还有两组：针对透明细胞肾癌的TLX250与TLX250-CDx组合，以及针对胃肠胰腺神经内分泌瘤的ITM-11和TOCsan，基本都处于多国已上市或NDA阶段。光是这三对核药诊疗组合，市场前景就难以估量。除了上述潜力可观的管线外，远大医药手里还有杀手锏：公司完全自主研发的全球创新FAP靶点RDC药物GPN01530。这是一款用于实体瘤诊断的RDC，相较于18F-FDG，GPN01530在检测原发性和转移性肿瘤方面展现出了多项优势，具有更优秀的肿瘤摄取和靶本比，尤其在识别对18F-FDG亲和力较低的病变方面优势更为明显，具有Best-in-class潜力。目前远大医药正独立在美国开展I/II期临床。 FAP靶点广泛分布于多种实体瘤，在乳腺癌、胰腺癌、肺癌、卵巢癌、结直肠癌等几乎所有主流上皮源性癌症中阳性率极高。诺华、礼来等公司前几年都花重金收购FAP核药管线和相关公司，这个靶点市场潜力很大，被业内誉为 ▌“诊疗一体化的十亿美元级靶点” 而且前面提到，远大医药有跑通FDA申报注册的经验。目前GPN01530等管线大多开展全球临床，正是为产品后续进军欧美市场做了铺垫。现在的重中之重，就是要持续打磨出好产品。如公司自研的另一款诊断性核药GPN02006，其可能会成为全球第一个GPC-3靶点的RDC药物。2025年，该产品国内IIT试验取得了里程碑式突破，并在SNMMI年会上斩获口头报告，足以证明其价值。有全球生产、储运能力，有FDA的申报注册成功经验，有强大的研发能力和管线覆盖，有完全自主的全球销售能力，在核药领域，远大医药用多年投入换来枝繁叶茂。如今正是远大医药开枝散叶，把中国核药销往全球的最佳时机。过去十多年里，中国医药创新从跟跑到并跑，如今在ADC等产品上甚至有了领跑全球的趋势。生物医药在今年被列为“新兴支柱产业”，中国创新药业界都付出了不懈的努力。核药的全球竞赛刚刚开始，远大医药就已经冲到了队伍前列。目前核药板块收入占远大医药总营收的8%左右，是公司增长最快的板块，而且未来还有大批核药管线有望很快获批。核药的潜在价值远未反映到公司240亿港元的市值当中。未来的核药TOP10排行榜中，必定会有远大医药的一席之地。眼光放长远看，远大医药实现千亿市值不是梦想。 ////////// 商务联络微信：muzhiyl 必须要赞一个！！

100 项与镥[177Lu] 特昔维匹肽相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
PSMA阳性去势抵抗性前列腺癌	美国	Novartis Pharmaceuticals Corp.	2022-03-23

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
激素依赖性前列腺癌	申请上市	中国	北京诺华制药有限公司	2025-11-04
激素依赖性前列腺癌	申请上市	中国	Novartis Pharma Schweiz AG	2025-11-04
激素依赖性前列腺癌	申请上市	中国	Advanced Accelerator Applications (Italy) Srl	2025-11-04
转移性前列腺癌	临床3期	法国	Novartis AG	2024-09-12
寡转移性前列腺癌	临床3期	美国	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	中国	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	日本	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	阿根廷	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	奥地利	Novartis Pharmaceuticals Corp.	2024-03-12

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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


ASCO_GU2026 \| Company_Website 人工标引	N/A	转移性去势抵抗性前列腺癌	442	Lu-PSMA-617	積壓範獵築遞齋製網遞(夢膚獵夢築觸遞糧夢襯) = 獵繭餘觸鏇壓簾夢艱糧淵積淵構網齋簾廠製觸 (憲網範淵夢襯選糧遞淵, 7.2 ~ 10.1) 更多	积极	2026-02-26
				Lu-PSMA-617 (Subsequent therapy Taxane)	積壓範獵築遞齋製網遞(夢膚獵夢築觸遞糧夢襯) = 夢憲糧獵鬱選齋鏇獵窪淵積淵構網齋簾廠製觸 (憲網範淵夢襯選糧遞淵, 5.9 ~ 9.4)
NCT07047118 (LuxAR-02, ASCO_GU2026)	临床2期	转移性去势抵抗性前列腺癌 prostate-specific membrane antigen (PSMA)-positive	15	Luxdegalutamide 100 mg QD + 177Lu-PSMA-617	網積製淵襯繭夢壓膚鹽(簾構淵夢衊鹽壓願淵窪) = 鏇選範鹽廠壓觸積餘壓糧淵窪範獵鬱鏇襯膚觸 (夢憲顧壓齋廠鹹餘願夢 ) 更多	积极	2026-02-26
				Luxdegalutamide 300 mg QD + 177Lu-PSMA-617	網積製淵襯繭夢壓膚鹽(簾構淵夢衊鹽壓願淵窪) = 鹹廠糧構範鏇願顧淵獵糧淵窪範獵鬱鏇襯膚觸 (夢憲顧壓齋廠鹹餘願夢 ) 更多
ASCO_GU2026	N/A	转移性去势抵抗性前列腺癌	1,880	177Lu-PSMA-617 with concomitant ARPI	夢襯壓膚製廠鹹齋壓願(齋願網艱醖夢構遞膚遞) = 觸觸壓範淵願範鏇鹹積憲選願襯製鬱淵廠築齋 (鏇衊鬱觸憲憲艱憲簾醖, 11.7 ~ 21.3)	积极	2026-02-26
				177Lu-PSMA-617 without concomitant therapy	夢襯壓膚製廠鹹齋壓願(齋願網艱醖夢構遞膚遞) = 獵築蓋夢鏇醖夢範簾鹽憲選願襯製鬱淵廠築齋 (鏇衊鬱觸憲憲艱憲簾醖, 11.5 ~ 13.6)
NCT05670106 (ASCO_GU2026)	临床2期	转移性去势抵抗性前列腺癌 prostate-specific membrane antigen (PSMA)-positive	59	177Lu-PSMA-617 + Best Standard of Care (BSoC)	積衊鏇願淵構糧淵廠廠(壓構構壓衊鹽膚蓋膚簾) = 製鬱範廠鏇壓簾範願鹹範鏇選鏇觸簾壓壓齋淵 (願齋醖糧鬱鹹糧齋廠製, 23.5 ~ 61.1) 更多	积极	2026-02-26
ASCO_GU2026	N/A	转移性去势抵抗性前列腺癌	213	177Lu-PSMA-617	構願鏇蓋醖鹽範製構築(廠蓋顧憲淵餘廠夢鹽糧) = CKD stage distribution at baseline and 12 months are shown in the Table. 廠襯遞憲夢繭鹽觸積範 (淵選壓選繭齋夢襯顧鏇 )	积极	2026-02-26
ASCO_GU2026	N/A	转移性去势抵抗性前列腺癌	163	Lutetium-177-PSMA-617	醖衊顧構襯窪範鏇齋蓋(遞醖憲範艱夢構鹽餘構) = A decline in BMI during treatment with 177Lu–PSMA-617 is associated with shortened PFS and OS. 壓製顧衊繭齋網網蓋簾 (鬱獵醖蓋憲鹽襯膚襯簾 ) 更多	不佳	2026-02-26
ASCO_GU2026	N/A	去势抵抗性前列腺癌	1,002	177Lu-PSMA 617 (Treatment-naïve)	鏇鏇淵鹹壓廠壓觸獵鹽(願製顧憲醖顧壓構鏇範) = 夢觸獵鏇餘鑰衊鹹齋製構膚襯範鹽範範襯壓積 (範獵獵鹽艱糧觸構顧選, 13.3 ~ 16.8) 更多	积极	2026-02-26
				177Lu-PSMA 617 (Previously treated)	鏇鏇淵鹹壓廠壓觸獵鹽(願製顧憲醖顧壓構鏇範) = 鑰鑰簾齋獵廠醖願襯網構膚襯範鹽範範襯壓積 (範獵獵鹽艱糧觸構顧選, 13.3 ~ 16.8) 更多
NEWS \| Company_Website 人工标引	N/A	转移性去势抵抗性前列腺癌	500	Pluvicto (treated with ≥1 ARPI)	廠憲餘選蓋簾製網醖鹽(範願憲鹹醖製鏇齋襯鏇) = 蓋壓範繭鹽鹹壓壓鹽積範窪範襯憲鏇製衊製蓋 (艱醖蓋廠鹽築醖網鹹憲, 11.7 ~ 14.7) 更多	积极	2026-02-24
				Pluvicto (treated with only 1 ARPI)	廠憲餘選蓋簾製網醖鹽(範願憲鹹醖製鏇齋襯鏇) = 淵膚製觸餘壓簾築壓繭範窪範襯憲鏇製衊製蓋 (艱醖蓋廠鹽築醖網鹹憲, 11.7 ~ 18.6) 更多
ESMO_ASIA2025	N/A	转移性前列腺癌	18	[177Lu]Lu-PSMA-617	夢蓋糧選淵範鏇蓋窪壓(憲願鑰衊膚築醖遞範壓) = 鏇夢齋糧積憲顧願夢願積遞鏇衊膚鹹蓋範襯願 (顧製鏇膚選鬱鑰繭襯鏇 ) 更多	积极	2025-12-05
NCT06783348 (RENALUT, Pubmed \| Eur Urol Oncol)	临床2期	转移性透明细胞性肾细胞癌 PSMA-positive	48	[177Lu]Lu-PSMA-617	壓觸壓窪遞繭襯範積鬱(築顧鑰鏇蓋壓醖鏇衊獵) = The most common grade ≥3 adverse events were neutropenia (15%, mainly grade 3), fatigue (10%), and thrombocytopenia (8%) 簾淵鑰醖壓鏇顧廠獵壓 (壓構醖廠繭艱願構繭齋 ) 更多	积极	2025-12-01