Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy With 177Lu-edotreotide Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.

LEVEL trial aims to demonstrate the higher efficacy of 177Lu-edotreotide over everolimus in patients with well to moderately differentiated neuroendocrine tumors of the lung and thymus who require systemic therapy. It is hypothesized that 177Lu-edotreotide may significantly increase the progression-free survival (PFS) compared to everolimus in lung and thymic carcinoids.

开始日期2023-10-27

申办/合作机构

Itm Isotope Technologies Munich SE

NCT06045260

/ Recruiting临床2期

"Receptor Radionuclide Therapy With 177Lu-DOTATOC (177Lu-edotreotide or 177Lu-octreotide) in SSTR Positive Patients: a Multicenter, Prospective, Phase II Trial"

Peptide receptor radionuclide therapy (PRRT) may be recommended in G1- G2 GEP-NET patients with disease progression on somatostatine analogues therapy (LUTATHERA®). However, there are several diseases, including neuroendocrine neoplasia not originating from the digestive tract, for which the efficacy of PRRT has already been demonstrated, but which are not currently within the indications of LUTATHERA and therefore cannot benefit from it (i.e. bronchopulmonary, ovarian, renal NETs and neuroendocrine carcinomas). Moreover, the role of PRRT is also accepted in Pheochromocytomas and paragangliomas (PPGLs), Meningiomas, but also as a salvage therapy in pre-treated NET pts, and other SSTR-positive malignancies (Lymphomas, Gliomas...). Least explored among radiopharmaceuticals for SSTR-positive tumors is 177Lu-DOTATOC. This study aims to investigate the efficacy and safety of lutetium (177Lu) edotreotide (Lu-Dotatoc) on all the above-mentioned diseases that could benefit from receptor radionuclide therapy. We believe that this study, which will involve only patients outside the indication of LUTATHERA, will expand the current knowledge of radionuclide receptor therapy with 177Lu- DOTATOC, particularly with regard to objective response and safety parameters, and may consolidate its in the management of these diseases.

开始日期2023-09-13

申办/合作机构-

100 项与镥[177Lu]依多曲肽相关的临床结果

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100 项与镥[177Lu]依多曲肽相关的转化医学

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100 项与镥[177Lu]依多曲肽相关的专利（医药）

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项与镥[177Lu]依多曲肽相关的文献（医药）

2026-03-01·JOURNAL OF NUCLEAR MEDICINE

Targeted β ⁻ -Particle Plus Conversion and Auger-Electron Therapy with ¹⁶¹ Tb-Labeled Somatostatin Receptor Antagonist DOTA-LM3: A Phase 0 Study

Article

作者: McDougall, Lisa ; Müller, Cristina ; Schmid, David E ; Westerbergh, Frida ; Geistlich, Susanne ; van der Meulen, Nicholas P ; Christ, Emanuel ; Bernhardt, Peter ; Nicolas, Guillaume P ; Fani, Melpomeni ; Fricke, Julia G ; Favaretto, Chiara ; Wild, Damian ; Schibli, Roger ; Borgna, Francesca

The goal of this phase 0 study was to determine the absorbed doses in tumors and relevant organs after a test injection of [¹⁶¹Tb]Tb-DOTA-LM3 and [¹⁷⁷Lu]Lu-DOTATOC in the same cohort of patients with grade 1 and 2 somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. Methods: In this randomized, crossover, prospective, single-center, open-label phase 0 study, 8 patients received 1 GBq of [¹⁶¹Tb]Tb-DOTA-LM3 and 1 GBq of [¹⁷⁷Lu]Lu-DOTATOC, with a 4-wk interval between injections. Quantitative SPECT/CT imaging was performed 3, 24, 72, and 168 h after administration of each radiopharmaceutical to calculate tumor and organ absorbed doses (3-dimensional dosimetry using a Monte Carlo-based ordered-subset expectation maximization algorithm). Results: After injection of 1 GBq of [¹⁶¹Tb]Tb-DOTA-LM3, SPECT/CT revealed excellent image quality with intense tumor uptake in all patients and a median of the mean effective tumor half-life of 103 h (range, 56-152 h) for [¹⁶¹Tb]Tb-DOTA-LM3 and 83 h (range, 30-122 h) for [¹⁷⁷Lu]Lu-DOTATOC (P = 0.012). The medians of the mean tumor absorbed doses of [¹⁶¹Tb]Tb-DOTA-LM3 and [¹⁷⁷Lu]Lu-DOTATOC were 36.6 Gy/GBq (range, 15-196 Gy/GBq) and 7.0 Gy/GBq (range, 2.4-14.2 Gy/GBq), respectively (P = 0.008). The median kidney and bone marrow absorbed doses were 2.4 Gy/GBq (range, 1.8-3.1 Gy/GBq) and 0.31 Gy/GBq (range, 0.24-0.48 Gy/GBq) for [¹⁶¹Tb]Tb-DOTA-LM3 and 0.6 Gy/GBq (range, 0.4-0.8 Gy/GBq) and 0.04 Gy/GBq (range, 0.03-0.06 Gy/GBq) for [¹⁷⁷Lu]Lu-DOTATOC, respectively (both P = 0.008). According to Common Terminology Criteria for Adverse Events version 5.0, grade 1-3 treatment-emergent adverse events occurred in 6 of 8 patients after administration of 1 GBq of [¹⁶¹Tb]Tb-DOTA-LM3. Conclusion: [¹⁶¹Tb]Tb-DOTA-LM3 showed a 7.6-fold-higher median tumor absorbed dose than that of [¹⁷⁷Lu]Lu-DOTATOC. The tumor-to-bone marrow absorbed dose ratio was in the same range for [¹⁶¹Tb]Tb-DOTA-LM3 as for [¹⁷⁷Lu]Lu-DOTATOC. The administration of 1 GBq of [¹⁶¹Tb]Tb-DOTA-LM3 was safe for all patients, without relevant adverse events.

2025-10-01·CLINICAL NUCLEAR MEDICINE

Feasibility of Single Time Point Dosimetry Application in 177Lu-DOTATATE/DOTATOC-treated Pediatric Neuroblastoma

Article

作者: Zheng, Fei ; Yang, Hao ; Liu, Yuxuan ; Li, Pengfei ; Wang, Han ; Sun, Xingyao ; Sun, Xiaorong ; Sun, Yingying

Background::

177Lu-DOTATATE/DOTATOC peptide receptor radionuclide therapy (PRRT) has demonstrated potential for treating pediatric neuroblastoma (NB), and in clinical practice can be measured dosimetry by multi–time point (MTP) dosimetry. However, the high workload and limited patient compliance associated with MTP restrict its application. Consequently, single time point (STP) dosimetry approaches have emerged as a promising alternative, though their effectiveness in pediatric populations has not been thoroughly investigated. This study aimed to assess the dosimetric determination of 177Lu-DOTATATE/DOTATOC in pediatric neuroblastoma patients to determine whether STP could serve as a viable replacement for MTP.

Patients and Methods::

A total of 24 pediatric NB patients who received 1 to 2 cycles of 177Lu-DOTATATE or 177Lu-DOTATOC underwent dosimetric measurement of lesions and critical organs using the 96 hours single time point (STPH) dosimetry method proposed by Hänscheid and colleagues. The results were compared with those obtained from standard MTP.

Results::

In patients treated with 177Lu-DOTATATE, the mean relative deviation absolute values of the STPH-calculated absorbed dose from MTP were <10% for lesions, kidneys, bone marrow, liver, and spleen, with Pearson correlation coefficients of 0.99, 0.93, 0.97, 0.84, and 0.84, respectively. In patients treated with 177Lu-DOTATOC, the mean relative deviation absolute values for kidneys, spleen, and bone marrow were <10%, with Pearson correlation coefficients of 0.97, 0.77, 0.35, 0.48, and 0.93 for lesions, kidneys, bone marrow, liver, and spleen, respectively.

Conclusions::

The findings confirm that the 96 hours STPH method can reliably replace MTP for dosimetric assessment in pediatric NB patients treated with 177Lu-DOTATATE and performed well in renal dosimetry for 177Lu-DOTATOC therapy.

2025-05-01·JOURNAL OF NUCLEAR MEDICINE

Reduced Renal Uptake of Various Radiopharmaceuticals with Sodium Paraaminohippurate Coadministration in a Rat Model

Article

作者: Zhernosekov, Konstantin ; Moré, Margret I ; Schmidt, Theresa ; Bergmann, Ralf ; Ehrenberg, Stefanie ; Meckel, Marian ; Mathe, Domokos ; Ritt, Philipp

The coinfusion of amino acids with targeted radiopharmaceutical therapy aims to reduce renal toxicity. Unfortunately, this requires a prolonged, large-volume infusion and often results in side effects such as nausea, vomiting, and hyperkalemia. Sodium paraaminohippurate is a nontoxic compound that has historically been used to measure renal plasma flow. It is excreted by the kidneys via glomerular filtration and tubular secretion using organic anion transporters. Paraaminohippurate has a favorable safety profile at plasma concentrations that saturate the maximum transport capacity of tubular cells. Therefore, paraaminohippurate may potentially reduce the renal accumulation of small-molecule radiopharmaceuticals. Methods: Preclinical studies, including ex vivo biodistribution, SPECT/CT, and PET analyses, were performed in Wistar rats to evaluate how coinjection of a paraaminohippurate solution affects the renal uptake of various radiopharmaceuticals compared with coinjection of a NaCl or arginine-lysine solution. Results: Paraaminohippurate was well tolerated, with no toxicity observed. Accumulated activity measured in the renal cortex was significantly lower for the small-peptide radiopharmaceuticals (0.9-2.5 kDa)-[¹⁷⁷Lu]Lu-DOTATOC, [¹⁷⁷Lu]Lu-DOTATATE, [¹⁷⁷Lu]Lu-DOTA-JR11, [¹⁷⁷Lu]Lu-DOTA-sargastrin, and [¹⁷⁷Lu]Lu-DOTARGD-when paraaminohippurate was coinjected instead of NaCl. The renal uptake of [¹⁷⁷Lu]Lu-DOTATOC, [¹⁷⁷Lu]Lu-DOTATATE, and [¹⁷⁷Lu]Lu-DOTA-JR11 was reduced by 46%, 83%, and 63%, respectively, at 1 h after injection with paraaminohippurate coinjection from the uptake after injection with NaCl. Kidney area-under-the-curve values were reduced by up to 60%, depending on the compound used. To a lesser extent, paraaminohippurate-mediated nephroprotection was observed with the prostate-specific membrane antigen (PSMA)-targeting molecules [¹⁷⁷Lu]Lu-PSMA-I&T and [⁶⁸Ga]Ga-PSMA-11. The renal uptake of the larger recombinant protein [¹⁷⁷Lu]Lu-DOTA-Affiline-22 (18 kDa) and the folate derivative [^99mTc]Tc-etarfolatide was not affected. These in vivo imaging data were confirmed by ex vivo biodistribution studies. Conclusion: Coinjection of paraaminohippurate at a high concentration was found to significantly reduce the renal uptake of a select number of small-molecule radiopharmaceuticals. This indicates the importance of tubular secretion, as well as the potential role of anion transporters that may be saturated by a high paraaminohippurate plasma concentration. Therefore, paraaminohippurate comedication could serve as a fast, safe, and convenient alternative to amino acid infusion as a nephroprotective agent during targeted radiopharmaceutical therapy.

194

项与镥[177Lu]依多曲肽相关的新闻（医药）

2026-03-12

·动脉网

放射配体疗法市场预计到2034年将实现显著增长，主要驱动力为癌症负担增加和靶向放射性药物的创新 DelveInsightRadioligand Therapies Market Set for Significant Growth by 2034, Driven by Rising Cancer Burden and Targeted Radiopharmaceutical Innovation

The market for radioligand therapies is expected to grow significantly in the coming years. This is due to the increasing number of patients who are being diagnosed with cancer, the growing awareness of radioligand therapies, the increasing number of radioligand therapies that are under clinical trials including Novartis (177Lu-PSMA-617, 225Ac. 放射性配体疗法市场预计将在未来几年显著增长。这是由于被诊断患有癌症的患者数量不断增加，放射性配体疗法的认知度提高，以及越来越多的放射性配体疗法正在进行临床试验，包括诺华公司的177Lu-PSMA-617和225Ac等。‑ ‑PSMA 前列腺特异性膜抗原‑ ‑617, 177Lu-NNS309, 177Lu-NeoB, AAA614, and ESP359), Curium Pharma (177Lu-PSMA-I&T), Lantheus and Eli Lilly and Company (Lu-PNT2002 and LNTH-1095), Fusion Pharmaceuticals and AstraZeneca (FPI-2265), Clarity Pharmaceuticals (67CU SAR-BBN and 64Cu-SAR-BBN), and others. 617、177Lu-NNS309、177Lu-NeoB、AAA614 和 ESP359），Curium Pharma（177Lu-PSMA-I&T），Lantheus 和 Eli Lilly and Company（Lu-PNT2002 和 LNTH-1095），Fusion Pharmaceuticals 和 AstraZeneca（FPI-2265），Clarity Pharmaceuticals（67CU SAR-BBN 和 64Cu-SAR-BBN），以及其他公司。LAS VEGAS 拉斯维加斯, ，March 12, 2026 2026年3月12日/PRNewswire/ -- DelveInsight's Radioligand Therapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Breast cancer, Extensive-stage small cell lung cancer (ES-SCLC), Gastroenteropancreatic neuroendocrine tumors (GEP-NETs), Follicular Lymphoma, Glioblastoma multiforme, and others. /PRNewswire/ -- DelveInsight的放射配体疗法市场规模、目标人群、竞争格局及市场预测报告包含对当前治疗实践、可治疗患者群体的全面理解，其中包括乳腺癌、广泛期小细胞肺癌（ES-SCLC）、胃肠胰神经内分泌肿瘤（GEP-NETs）、滤泡性淋巴瘤、多形性胶质母细胞瘤等主要适应症。The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging Radioligand Therapies, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets (the US, EU4, UK, and Japan).. 所选适应症基于已批准的疗法和正在进行的研发管线活动。报告还提供了新兴放射配体疗法的见解、各疗法的市场份额，以及2020年至2034年当前和预测的市场规模，细分至主要市场（美国、欧盟四国、英国和日本）。Key Takeaways from the Radioligand Therapies Market Report 放射性配体疗法市场报告的关键要点The total market size of radioligand therapies in the leading markets is expected to surge significantly by 2034. 预计到2034年，主要市场中的放射配体疗法的总市场规模将大幅增长。In 2024, the United States holds the largest share of the radioligand therapies market among the 7MM. 2024年，在七大市场中，美国拥有放射配体疗法市场最大的份额。The report provides the total potential number of patients in the indications, such as 该报告提供了适应症中患者的总潜在数量，例如Breast cancer, Extensive-stage small cell lung cancer (ES-SCLC), Gastroenteropancreatic neuroendocrine tumors (GEP-NETs), Follicular Lymphoma, Glioblastoma multiforme, and others 乳腺癌、广泛期小细胞肺癌 (ES-SCLC)、胃肠胰神经内分泌肿瘤 (GEP-NETs)、滤泡性淋巴瘤、多形性胶质母细胞瘤等. 。In 2024, the 7MM had approximately 2024年，7MM大约有240,000 240,000prevalent cases of metastatic prostate cancer. 转移性前列腺癌的普遍病例。Leading radioligand therapies companies, such as 领先的放射配体治疗公司，如Novartis, Curium Pharma, Lantheus, Eli Lilly and Company, Fusion Pharmaceuticals, AstraZeneca, Clarity Pharmaceuticals, Bayer, ITM Isotope Technologies, ARTBIO, Convergent Therapeutics, Perspective Therapeutics, PRECIRIX, Ariceum Therapeutic, Nuclidium, 诺华、Curium制药、Lantheus、礼来公司、Fusion制药、阿斯利康、Clarity制药、拜耳、ITM同位素技术、ARTBIO、Convergent治疗学、Perspective治疗学、PRECIRIX、Ariceum治疗学、Nuclidiumand others, are developing novel radioligand therapies that can be available in the radioligand therapies market in the coming years. 和其他公司正在开发新型放射配体疗法，这类疗法可能在未来几年内投放到放射配体疗法市场。Some of the key radioligand therapies in clinical trials include 一些处于临床试验阶段的关键放射配体疗法包括177Lu-PSMA-617, 225Ac 177Lu-PSMA-617，225Ac‑ ‑PSMA 前列腺特异性膜抗原‑ ‑617, 177Lu-NNS309, 177Lu-NeoB, AAA614, ESP359, 177Lu-PSMA-I&T, Lu-PNT2002, LNTH-1095, FPI-2265, 67CU SAR-BBN, 64Cu-SAR-BBN, 225Ac-PSMA-Trillium, 225Ac-Pelgifatamab, 225Ac-GPC3, ITM-11, 212Pb-NG001, CONV01-α, VMT-α-NET, VMT01, PSV359, CAM-FAP-Ac-225, 225Ac-SSO110, ATT001, NU101, NU201, 617, 177Lu-NNS309, 177Lu-NeoB, AAA614, ESP359, 177Lu-PSMA-I&T, Lu-PNT2002, LNTH-1095, FPI-2265, 67CU SAR-BBN, 64Cu-SAR-BBN, 225Ac-PSMA-Trillium, 225Ac-Pelgifatamab, 225Ac-GPC3, ITM-11, 212Pb-NG001, CONV01-α, VMT-α-NET, VMT01, PSV359, CAM-FAP-Ac-225, 225Ac-SSO110, ATT001, NU101, NU201,and others. 和其他人。Discover how big is the radiopharmaceutical or radioligand therapy market @ 发现放射性药物或放射性配体治疗市场的规模有多大 @https://www.delveinsight.com/sample-request/radioligand-therapies-market-forecast https://www.delveinsight.com/sample-request/radioligand-therapies-market-forecastKey Factors Driving the Radioligand Therapies Market 推动放射配体疗法市场发展的关键因素Rising Global Cancer Burden: 全球癌症负担的增加：The increasing prevalence of cancers such as prostate cancer and neuroendocrine tumors (NETs) is a major factor driving demand for radioligand therapies. These therapies are particularly effective in treating cancers that are difficult to manage with conventional treatments like chemotherapy or external radiation.. 癌症（如前列腺癌和神经内分泌肿瘤 (NETs)）发病率的不断上升是推动放射配体疗法需求增长的主要因素。这些疗法在治疗难以通过传统方法（如化疗或外部放疗）控制的癌症时特别有效。Growing Demand for Targeted and Precision Oncology: 对靶向和精准肿瘤学的需求不断增长：Radioligand therapies deliver radioactive isotopes directly to tumor cells via specific ligands, enabling highly targeted destruction of cancer cells while minimizing damage to healthy tissue. 放射性配体疗法通过特定的配体将放射性同位素直接递送到肿瘤细胞，从而实现对癌细胞的高度靶向杀伤，同时最大限度地减少对健康组织的损害。Potential of 177Lu-PNT2002 for Chemotherapy-Naïve mCRPC Patients: 177Lu-PNT2002在化疗初治mCRPC患者中的潜力：177Lu-PNT2002, a late-stage PSMA-targeted radiotherapeutic candidate, is well-tolerated and holds significant potential in meeting the needs of chemotherapy-naïve mCRPC patients. 177Lu-PNT2002 是一种处于后期阶段的靶向 PSMA 的放射治疗候选药物，具有良好的耐受性，并在满足未接受过化疗的 mCRPC 患者需求方面展现出显著潜力。Rising Radioligand Therapies Clinical Trial Activities: 放射配体疗法临床试验活动的增加： The expected launch of radioligand therapies market are expected to change in the coming years due to the launch of emerging therapies such as 预计放射性配体疗法市场将在未来几年因新兴疗法（如某些疗法）的推出而发生变化，Novartis 诺华(177Lu-PSMA-617, 225Ac‑PSMA‑617, 177Lu-NNS309, 177Lu-NeoB, AAA614, and ESP359), (177Lu-PSMA-617、225Ac‑PSMA‑617、177Lu-NNS309、177Lu-NeoB、AAA614 和 ESP359),Curium Pharma 锔医药公司(177Lu-PSMA-I&T), （177Lu-PSMA-I&T），Lantheus and Eli Lilly and Company 兰索斯和礼来公司(Lu-PNT2002 and LNTH-1095), （Lu-PNT2002 和 LNTH-1095），Fusion Pharmaceuticals and AstraZeneca Fusion制药公司和阿斯利康(FPI-2265), （FPI-2265），Clarity Pharmaceuticals 清晰制药公司(67CU SAR-BBN and 64Cu-SAR-BBN), (67CU SAR-BBN 和 64Cu-SAR-BBN),Bayer 拜耳(225Ac-PSMA-Trillium, 225Ac-Pelgifatamab, and 225Ac-GPC3), （225Ac-PSMA-Trillium、225Ac-Pelgifatamab 和 225Ac-GPC3），ITM Isotope Technologies ITM同位素技术(ITM-11), (ITM-11)，ARTBIO 艺术生物(212Pb-NG001), (212Pb-NG001),Convergent Therapeutics 收敛治疗学(CONV01-α), （CONV01-α），Perspective Therapeutics 景观治疗学(VMT-α-NET, VMT01, and PSV359), （VMT-α-NET、VMT01 和 PSV359），PRECIRIX PRECIRIX(CAM-FAP-Ac-225), (CAM-FAP-Ac-225)，Ariceum Therapeutics 阿里瑟姆治疗公司(225Ac-SSO110 and ATT001), (225Ac-SSO110 和 ATT001),Nuclidium 核素(NU101 and NU201), and others. （NU101 和 NU201），以及其他。According to Sadaf Javed, Manager of Forecasting and Analytics at DelveInsight, the pharmaceutical industry is becoming more interested in targeted radiation therapy as a novel, promising cancer treatment option as a result of the LUTATHERA success story. 据德瓦尔洞察公司预测与分析经理萨达夫·贾韦德称，由于LUTATHERA的成功故事，制药行业对靶向放射治疗作为一种新颖且有前景的癌症治疗选择越来越感兴趣。Radioligand Therapies Market Analysis 放射性配体治疗市场分析Radioligand therapy is increasingly recognized as a promising cancer treatment approach. It is mainly used for patients with metastatic neuroendocrine tumors and those with prostate cancer who no longer respond to standard chemotherapy or radiotherapy. 放射性配体疗法正日益被视为一种有前途的癌症治疗方法。它主要用于转移性神经内分泌肿瘤患者以及那些不再对标准化疗或放疗产生反应的前列腺癌患者。This targeted therapy delivers radioactive agents directly to cancer cells, helping to prolong survival while improving patients' quality of life by reducing harm to surrounding healthy tissues. Several radioligand therapies, including 这种靶向治疗直接将放射性药物递送到癌细胞，有助于延长生存期，同时通过减少对周围健康组织的伤害来改善患者的生活质量。几种放射配体疗法，包括LUTATHERA, PLUVICTO, XOFIGO, and ZEVALIN LUTATHERA、PLUVICTO、XOFIGO 和 ZEVALIN, have already received approval from the US FDA. ，已经获得美国FDA的批准。Among them, LUTATHERA was the first radioligand therapy approved for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults and has recently gained approval for use in pediatric patients as well. 其中，LUTATHERA 是首个获批用于治疗成人胃肠胰神经内分泌肿瘤 (GEP-NETs) 的放射配体疗法，并且最近也获得了用于儿科患者的批准。The TheAmerican Society of Clinical Oncology (ASCO) 美国临床肿瘤学会 (ASCO)has also released a rapid guideline update regarding radiotracers used in PSMA PET imaging to support the selection of patients with mCRPC who may benefit from 还发布了关于PSMA PET成像中使用的放射性示踪剂的快速指南更新，以支持选择可能受益的mCRPC患者lutetium-177–labeled PSMA-617 radioligand therapy 镥-177标记的PSMA-617放射配体治疗. Expanding on the original 2014 guideline and its 2022 revision, the update now recommends three radiotracers, including the newly approved flotufolastat F-18, to evaluate patient eligibility. 在2014年原始指南及其2022年修订版的基础上，此次更新现在推荐使用三种放射性示踪剂，包括新批准的氟托福拉stat F-18，以评估患者的资格。In addition, the 此外，EANM/SNMMI 欧洲核医学协会/美国核医学与分子影像学会 procedural guidelines assist nuclear medicine specialists in identifying suitable candidates for 177Lu-PSMA radioligand therapy, conducting the treatment in line with best practices, and effectively managing potential adverse effects. 程序指南协助核医学专家确定适合进行177Lu-PSMA放射配体治疗的候选人，按照最佳实践进行治疗，并有效管理潜在的不良反应。Meanwhile, 同时，ARTBIO 艺术生物is advancing a new generation of alpha radioligand therapies (ARTs). The company has relocated its European research laboratories to Oslo Science Park in Oslo, Norway, a move that provides enhanced laboratory infrastructure and access to specialized preclinical expertise in radiotherapeutics. 正在推进新一代的α放射配体疗法 (ART)。该公司已将其欧洲研究实验室迁至挪威奥斯陆的奥斯陆科技园，此举提供了更先进的实验室基础设施，并获得了放射治疗领域专业的临床前专业知识。This transition is expected to accelerate the development of ARTBIO's ART pipeline and strengthen its radiation-enabled research and development capabilities. 这一转变预计将加速ARTBIO的ART管道的开发，并增强其辐射研究和开发能力。Learn more about next-generation radiopharmaceutical therapies @ 了解有关下一代放射性药物疗法的更多信息 @Radioligand Therapies Analysis 放射性配体治疗分析Radioligand Therapies Competitive Landscape 放射性配体治疗的竞争格局Some of the radioligand therapies under development include 一些正在开发的放射性配体疗法包括Novartis 诺华(177Lu-PSMA-617, 225Ac‑PSMA‑617, 177Lu-NNS309, 177Lu-NeoB, AAA614, and ESP359), (177Lu-PSMA-617、225Ac‑PSMA‑617、177Lu-NNS309、177Lu-NeoB、AAA614 和 ESP359),Curium Pharma 锔医药公司 (177Lu-PSMA-I&T), (177Lu-PSMA-I&T),Lantheus and Eli Lilly and Company 兰索斯和礼来公司(Lu-PNT2002 and LNTH-1095), （Lu-PNT2002 和 LNTH-1095），Fusion Pharmaceuticals and AstraZeneca 融合制药和阿斯利康 (FPI-2265), （FPI-2265），Clarity Pharmaceuticals 清晰制药公司(67CU SAR-BBN and 64Cu-SAR-BBN), (67CU SAR-BBN 和 64Cu-SAR-BBN),Bayer 拜耳(225Ac-PSMA-Trillium, 225Ac-Pelgifatamab, and 225Ac-GPC3), （225Ac-PSMA-Trillium、225Ac-Pelgifatamab 和 225Ac-GPC3），ITM Isotope Technologies ITM同位素技术(ITM-11), (ITM-11),ARTBIO 艺术生物(212Pb-NG001), (212Pb-NG001),Convergent Therapeutics 收敛治疗学(CONV01-α), （CONV01-α），Perspective Therapeutics 视角治疗学(VMT-α-NET, VMT01, and PSV359), （VMT-α-NET、VMT01 和 PSV359），PRECIRIX PRECIRIX(CAM-FAP-Ac-225), (CAM-FAP-Ac-225)，Ariceum Therapeutics 阿里瑟姆治疗公司(225Ac-SSO110 and ATT001), (225Ac-SSO110 和 ATT001),Nuclidium 核素(NU101 and NU201), and others. （NU101 和 NU201），以及其他。Curium Pharma's 177Lu-PSMA-I&T Curium Pharma的177Lu-PSMA-I&Tis designed to target the prostate-specific membrane antigen (PSMA), which is present in more than 85% of prostate cancer cells. Due to its high specificity for this antigen, the attached radioisotope selectively binds to and destroys PSMA-expressing tumor cells. The therapy is currently being evaluated in the Phase III ECLIPSE Phase III clinical trial (NCT05204927) for patients with mCRPC.. 旨在靶向前列腺特异性膜抗原（PSMA），这种抗原存在于超过85%的前列腺癌细胞中。由于其对该抗原的高特异性，附着的放射性同位素选择性结合并摧毁表达PSMA的肿瘤细胞。该疗法目前正在进行针对mCRPC患者的III期ECLIPSE临床试验（NCT05204927）评估。 Curium Pharma has been advancing its formulation of Lutetium Lu 177 Dotatate for several years, and in July 2024, the company announced the submission of a 505(b)(2) New Drug Application (NDA) for its Lutetium Lu 177 Dotatate Injection. Curium Pharma 多年来一直在推进其 Lutetium Lu 177 Dotatate 的配方，并于 2024 年 7 月宣布提交了其 Lutetium Lu 177 Dotatate 注射液的 505(b)(2) 新药申请 (NDA)。Eli Lilly and Company/Point BioPharma's PNT2002 礼来公司/Point BioPharma的PNT2002is another small-molecule PSMA-targeted radioligand therapy based on 177Lu for the treatment of mCRPC. It combines the PSMA-targeting ligand PSMA-I&T with the beta-emitting radioisotope no-carrier-added 177Lu. Lu‑PNT2002 is currently being studied in a Phase III clinical trial assessing its superiority over the standard of care in pre-chemotherapy mCRPC patients who have progressed after treatment with one androgen receptor pathway inhibitor. 是另一种基于177Lu的小分子PSMA靶向放射配体疗法，用于治疗mCRPC。它将PSMA靶向配体PSMA-I&T与无载体添加的β发射放射性同位素177Lu结合。Lu‑PNT2002目前正在一项III期临床试验中进行研究，评估其在先前接受过一种雄激素受体通路抑制剂治疗后进展的化疗前mCRPC患者中的优越性是否优于标准治疗。In December 2023, Eli Lilly and Company announced the completion of its acquisition of POINT Biopharma.. 2023年12月，礼来公司宣布完成对POINT Biopharma的收购。LNTH‑1095, also developed by Lantheus, is a PSMA-targeted small-molecule radioligand therapy intended for the treatment of mCRPC. The therapy links the PSMA-targeting ligand LNTH-1095 with a beta-emitting radioisotope and is currently being investigated in a Phase II trial for metastatic prostate cancer. LNTH‑1095也是由Lantheus开发的一种靶向PSMA的小分子放射配体疗法，旨在治疗mCRPC。该疗法将靶向PSMA的配体LNTH-1095与发射β射线的放射性同位素结合，目前正在进行一项针对转移性前列腺癌的II期临床试验。The company presented efficacy data for both Lu-PNT2002 and LNTH-1095 at the ESMO Oncology Congress 2024 held in September 2024.. 公司在2024年9月举行的2024年欧洲肿瘤内科学会（ESMO）大会上展示了Lu-PNT2002和LNTH-1095的有效性数据。Meanwhile, 同时，Fusion Pharmaceuticals 融合制药公司is advancing its lead candidate 正在推进其领先候选者FPI 浮动点数指数（FPI）‑ ‑2265 2265, which evaluates 225Ac-PSMA-I&T, a small molecule targeting PSMA expressed in prostate cancer cells. This alpha-emitting radiopharmaceutical is currently being studied in the TATCIST trial and the AlphaBreak trial. At present, BAMF Health is assessing FPI-2265 in collaboration with AstraZeneca and Fusion Pharmaceuticals.. ，评估225Ac-PSMA-I&T，这是一种靶向前列腺癌细胞中表达的PSMA的小分子。这种发射α粒子的放射性药物目前正在TATCIST试验和AlphaBreak试验中进行研究。目前，BAMF Health正与阿斯利康和Fusion Pharmaceuticals合作评估FPI-2265。177Lu-edotreotide 177Lu-edotreotideis ITM's proprietary synthetic targeted radiotherapeutic investigational drug being developed to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The U.S. FDA has assigned a Prescription Drug User Fee Act (PDUFA) target decision date of August 28, 2026. 是ITM公司正在开发的用于治疗胃肠道胰腺神经内分泌肿瘤（GEP-NETs）的专有合成靶向放射治疗研究药物。美国FDA已指定《处方药使用者费用法案》（PDUFA）的目标决定日期为2026年8月28日。Convergent Therapeutics' CONV01-α (Ac-225 rosopatamab tetraxetan) 康维吉恩特治疗公司的CONV01-α（Ac-225罗索帕单抗四乙酸）is a proprietary, best-in-class radioantibody labeled with actinium-225 that has demonstrated encouraging efficacy and safety across several Phase 1/2 clinical studies in patients with prostate cancer. Patient enrollment for the CONVERGE-01 trial is currently in progress, while additional studies are being planned.. 是一种专有的、同类最佳的放射性抗体，标记有锕-225，在前列腺癌患者的多项1/2期临床研究中已显示出令人鼓舞的疗效和安全性。CONVERGE-01试验的患者招募目前正在进展中，同时正在计划更多的研究。The anticipated launch of these emerging therapies are poised to transform the radioligand therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the radioligand therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.. 这些新兴疗法的预期推出将在未来几年内改变放射性配体疗法市场的格局。随着这些尖端疗法不断成熟并获得监管批准，它们有望重塑放射性配体疗法市场，提供新的治疗标准，并为医疗创新和经济增长带来机遇。To know more about which companies are developing radioligand therapies, visit @ 要了解更多正在开发放射配体疗法的公司，请访问 @Radioligand Therapies Treatment 放射性配体治疗Recent Developments in the Radioligand Therapies Market 放射配体疗法市场的最新进展In 在March 2026, ITM Isotope Technologies Munich SE 2026年3月，慕尼黑ITM同位素技术公司presented post-hoc subgroup analyses from the Phase 3 ITM-11 COMPETE trial involving patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 展示了来自3期ITM-11 COMPETE试验的事后亚组分析，涉及1级或2级生长抑素受体（SSTR）阳性的胃肠道胰腺神经内分泌肿瘤（GEP-NETs）患者。In 在March 2026, Lantheus Holdings, Inc. 2026年3月，兰特卢斯控股有限公司announced that the FDA had granted tentative approval to its Abbreviated New Drug Application (ANDA) for Lutetium Lu 177 Dotatate (PNT2003), a radioequivalent version of LUTATHERA (lutetium Lu 177 dotatate). 宣布FDA已对其镥177 Dotatate（PNT2003）的简略新药申请（ANDA）给予暂时批准，该药物是LUTATHERA（镥177 dotatate）的放射性等效版本。In 在January 2026, Zonsen PepLib Biotech Inc. 2026年1月，尊森PepLib生物科技公司announced a global licensing agreement with Novartis for an undisclosed peptide-based candidate in the radioligand therapy (RLT) space. As part of the deal, Novartis has secured exclusive worldwide rights and will oversee the asset's development and commercialization. 宣布与诺华达成了一项全球许可协议，涉及一款未公开的基于肽的放射配体治疗（RLT）候选药物。根据协议，诺华获得了该药物的全球独家权利，并将负责其开发和商业化。In 在January 2026, Swiss Rockets AG and Alloy Therapeutics, Inc. 2026年1月，瑞士火箭公司和合金治疗公司。entered into a Master Research Agreement (MRA) to initiate a multi-target partnership focused on the discovery and development of next-generation radioligand therapeutics (RLTs) for oncology. The collaboration will be carried out through Swiss Rockets' radiotherapeutics subsidiary, Torpedo Pharmaceuticals AG.. 签署了一份主研究协议 (MRA)，以启动一项多目标合作，专注于发现和开发用于肿瘤学的下一代放射配体治疗药物 (RLT)。该合作将通过瑞士火箭公司的放射治疗子公司 Torpedo Pharmaceuticals AG 进行。In 在January 2026, ARTBIO, Inc. 2026年1月，ARTBIO公司began dosing two U.S.-based patient cohorts in the ARTISAN Phase 1 trial of AB001, an alpha radioligand therapy designed to treat metastatic castration-resistant prostate cancer (mCRPC), enrolling patients with and without prior Lu177-PSMA targeted therapy exposure. 开始在ARTISAN第一阶段试验中对两个基于美国的患者队列进行AB001的剂量施用，这是一种旨在治疗转移性去势抵抗性前列腺癌（mCRPC）的α放射配体疗法，纳入了有和无先前Lu177-PSMA靶向治疗暴露的患者。In 在November 2025, ITM Isotope Technologies Munich SE 2025年11月，慕尼黑ITM同位素技术公司announced that the U.S. Food and Drug Administration had completed its filing review and accepted the company's New Drug Application (NDA) for n.c.a. 177Lu-edotreotide, also referred to as ITM-11. 宣布美国食品药品监督管理局已完成其档案审查，并接受了该公司关于n.c.a. 177Lu-edotreotide（也称为ITM-11）的新药申请（NDA）。What are Radioligand Therapies? 什么是放射配体疗法？Radioligand therapies (RLTs) are a class of targeted cancer treatments that combine a radioactive isotope with a ligand, a molecule designed to specifically bind to receptors or proteins that are highly expressed on tumor cells. Once administered, the ligand guides the radioactive payload directly to cancer cells, allowing the radiation to destroy malignant tissue while minimizing damage to surrounding healthy cells. 放射性配体疗法（RLTs）是一类靶向癌症治疗药物，它将放射性同位素与一种配体结合，这种配体是一种专门设计用于与在肿瘤细胞上高表达的受体或蛋白质特异性结合的分子。一旦施用，配体会引导放射性物质直接到达癌细胞，使辐射能够摧毁恶性组织，同时尽量减少对周围健康细胞的损害。This targeted approach improves therapeutic precision and reduces systemic toxicity compared to conventional radiation or chemotherapy. Radioligand therapies have shown significant promise in the treatment of several cancers, particularly prostate and neuroendocrine tumors. By integrating molecular targeting with radiation therapy, RLTs represent an emerging and rapidly evolving modality in precision oncology.. 这种有针对性的方法与传统的放疗或化疗相比，提高了治疗的精确性并减少了全身毒性。放射配体疗法在多种癌症的治疗中显示出显著的前景，特别是前列腺癌和神经内分泌肿瘤。通过将分子靶向与放射治疗相结合，放射配体疗法代表了精准肿瘤学中一种新兴且快速发展的治疗模式。Radioligand Therapies Epidemiology Segmentation 放射性配体疗法流行病学细分The radioligand therapies market report is a comprehensive and specialized analysis, offering in-depth epidemiological insights for the study period 2020–2034 across the leading markets. About 放射性配体治疗市场报告是一份全面且专业的分析，提供了2020-2034年研究期间主要市场的深入流行病学见解。关于80% 80%of SCLC cases were 65 or older, reflecting the advanced median age of diagnosis, 71 years. The radioligand therapies target patient pool is segmented into: 小细胞肺癌病例中65岁及以上的患者占多数，反映了诊断时的中位年龄为71岁。放射性配体疗法针对的患者群体分为：Total Cases of Selected Indications for Radioligand Therapies 所选放射性配体治疗适应症的总病例数Total Eligible Patient Pool for Radioligand Therapies in Selected Indications 特定适应症中放射配体疗法的总合格患者群体 Total Treated Cases in Selected Indications for Radioligand Therapies 选定适应症的放射配体治疗总病例数Radioligand Therapies Report Metrics 放射性配体疗法报告指标Details 详细信息Study Period 学习期2020–2034 2020–2034Radioligand Therapies Report Coverage 放射配体疗法报告覆盖范围7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] 七国集团 [美国、欧盟四国（德国、法国、意大利和西班牙）、英国和日本]Key Indications Covered in the Report 报告中涵盖的关键适应症Breast cancer, Extensive-stage small cell lung cancer (ES-SCLC), Gastroenteropancreatic neuroendocrine tumors (GEP-NETs), Follicular Lymphoma, Glioblastoma multiforme, and others 乳腺癌、广泛期小细胞肺癌 (ES-SCLC)、胃肠胰神经内分泌肿瘤 (GEP-NETs)、滤泡性淋巴瘤、多形性胶质母细胞瘤等Radioligand Therapies Target Patient Pool Segmentation 放射性配体疗法目标患者群体细分Total Cases of Selected Indications for Radioligand Therapies, Total Eligible Patient Pool for Radioligand Therapies in Selected Indications, and Total Treated Cases in Selected Indications for Radioligand Therapies 放射性配体疗法选定适应症的总病例数、选定适应症中放射性配体疗法的总合格患者池、以及选定适应症中放射性配体疗法的总治疗病例数Key Radioligand Therapies Companies 关键放射配体治疗公司Novartis, Curium Pharma, Lantheus, Eli Lilly and Company, Fusion Pharmaceuticals, AstraZeneca, Clarity Pharmaceuticals, Bayer, ITM Isotope Technologies, ARTBIO, Convergent Therapeutics, Perspective Therapeutics, PRECIRIX, Ariceum Therapeutic, Nuclidium, and others 诺华、Curium制药、Lantheus、礼来公司、Fusion制药、阿斯利康、Clarity制药、拜耳、ITM同位素技术、ARTBIO、Convergent治疗学、Perspective治疗学、PRECIRIX、Ariceum治疗学、Nuclidium等Key Radioligand Therapies 关键放射配体疗法177Lu-PSMA-617, 225Ac‑PSMA‑617, 177Lu-NNS309, 177Lu-NeoB, AAA614, ESP359, 177Lu-PSMA-I&T, Lu-PNT2002, LNTH-1095, FPI-2265, 67CU SAR-BBN, 64Cu-SAR-BBN, 225Ac-PSMA-Trillium, 225Ac-Pelgifatamab, 225Ac-GPC3, ITM-11, 212Pb-NG001, CONV01-α, VMT-α-NET, VMT01, PSV359, CAM-FAP-Ac-225, 225Ac-SSO110, ATT001, NU101, NU201, LUTATHERA, XOFIGO, PLUVICTO, ZEVALIN, and others. 177Lu-PSMA-617、225Ac‑PSMA‑617、177Lu-NNS309、177Lu-NeoB、AAA614、ESP359、177Lu-PSMA-I&T、Lu-PNT2002、LNTH-1095、FPI-2265、67CU SAR-BBN、64Cu-SAR-BBN、225Ac-PSMA-Trillium、225Ac-Pelgifatamab、225Ac-GPC3、ITM-11、212Pb-NG001、CONV01-α、VMT-α-NET、VMT01、PSV359、CAM-FAP-Ac-225、225Ac-SSO110、ATT001、NU101、NU201、LUTATHERA、XOFIGO、PLUVICTO、ZEVALIN等。Scope of the 范围Radioligand Therapies 放射性配体疗法Market Report 市场报告Radioligand Therapies Therapeutic Assessment: 放射性配体疗法治疗评估：Radioligand Therapies' current marketed and emerging therapies 放射性配体疗法的当前已上市和新兴疗法Radioligand Therapies 放射配体疗法Market Dynamics: 市场动态：Conjoint Analysis of Emerging Radioligand Therapies Drugs 新兴放射配体治疗药物的联合分析Competitive Intelligence Analysis: 竞争情报分析：SWOT analysis and Market entry strategies SWOT分析与市场进入策略Unmet Needs, KOL's views, Analyst's views, Radioligand Therapies Market Access and Reimbursement 未满足的需求、关键意见领袖的观点、分析师的观点、放射性配体疗法的市场准入和报销Discover upcoming radioligand therapies in oncology @ 发现肿瘤学中即将到来的放射配体疗法 @Radioligand Therapies Clinical Trials 放射性配体治疗临床试验Table of Contents 目录1 1Radioligand Therapies Market Key Insights 放射性配体疗法市场关键洞察2 2Radioligand Therapies Market Report Introduction 放射性配体治疗市场报告介绍3 3Key Highlights from Radioligand Therapies Market Report 放射配体疗法市场报告的关键亮点4 4Executive Summary of Radioligand Therapies 放射配体疗法的执行摘要5 5Key Events 关键事件6 6Epidemiology and Market Forecast Methodology 流行病学与市场预测方法论7 7Radioligand Therapies Market Overview at a Glance in the 7MM 七大市场放射性配体治疗市场概况一览 7.1 7.1Market Share (%) Distribution by Therapies in 2024 2024年各疗法市场份额（%）分布 7.2 7.2Market Share (%) Distribution by Therapies in 2034 2034年各疗法市场份额（%）分布 7.3 7.3Market Share (%) Distribution by Indication in 2024 2024年按适应症划分的市场份额（%）分布7.4 7.4Market Share (%) Distribution by Indication in 2034 2034年按适应症划分的市场份额（%）分布8 8Background and Overview 背景与概述8.1 8.1Introduction 介绍8.2 8.2Treatment 治疗9 9Target Patient Pool 目标患者群体9.1 9.1Key Findings 主要发现9.2 9.2Assumptions and Rationale: 7MM 假设与理由：7MM9.3 9.3Epidemiology Scenario in the 7MM 七大市场（7MM）的流行病学情景 9.3.1 9.3.1Total Cases in Selected Indications for Radioligand Therapies in the 7MM 7MM中放射配体疗法在选定适应症中的总病例数 9.3.2 9.3.2Total Eligible Patient Pool of Selected Indications for Radioligand Therapies in the 7MM 7MM中放射配体疗法选定适应症的总合格患者池9.3.3 9.3.3Total Treated Cases in Selected Indications for Radioligand Therapies in the 7MM 7MM中放射配体疗法在选定适应症中的总治疗病例数10 10Marketed Radioligand Therapies 上市的放射配体疗法10.1 10.1Key Competitors 主要竞争对手10.2 10.2 LUTATHERA (lutetium LU 177 dotatate): Novartis LUTATHERA（镥177 dotatate）：诺华10.2.1 10.2.1Product description 产品描述10.2.2 10.2.2 Regulatory milestones 监管里程碑10.2.3 10.2.3Other developmental activities 其他开发活动10.2.4 10.2.4 Safety and efficacy 安全性与有效性10.2.5 10.2.5 Product profile 产品概况10.3 10.3 PLUVICTO (lutetium lu-177 vipivotide tetraxetan): Novartis PLUVICTO（镥-177 维匹沃肽四乙酸）：诺华List to be continued in the report 报告中待续的列表11 11Emerging Radioligand Therapies 新兴放射配体疗法11.1 11.1Key Competitors 主要竞争对手11.2 11.2Lu-177-PSMA-I&T: Curium Pharma Lu-177-PSMA-I&T：Curium Pharma11.2.1 11.2.1Product description 产品描述11.2.2 11.2.2Other developmental activity 其他开发活动11.2.3 11.2.3Clinical developmental activities 临床发育活动11.2.3.1 11.2.3.1Clinical trial information 临床试验信息11.2.4 11.2.4Safety and efficacy 安全性与有效性11.3 11.3Lu-PNT2002: Lantheus and Eli Lilly and Company/Point BioPharma Lu-PNT2002：Lantheus 和 Eli Lilly and Company/Point BioPharma11.4 11.4FPI-2265: Fusion/Astrazeneca FPI-2265：Fusion/阿斯利康List to be continued in the report 报告中待续的列表12 12Radioligand Therapies Market: 7MM Analysis 放射性配体疗法市场：7MM分析12.1 12.1Key Findings 主要发现12.2 12.2Radioligand Therapies Market Outlook 放射性配体治疗市场展望12.3 12.3Conjoint Analysis 联合分析12.4 12.4Key Radioligand Therapies Market Forecast Assumptions 关键放射配体治疗市场预测假设12.5 12.5Radioligand Therapies Market Size by Indications in the 7MM 7MM中按适应症划分的放射性配体治疗市场大小12.6 12.6Radioligand Therapies Market Size by Therapies in the 7MM 七大市场（7MM）中按疗法划分的放射性配体治疗市场规模12.7 12.7United States Radioligand Therapies Market Size 美国放射配体疗法市场规模12.7.1 12.7.1Market Size by Indications in the US 美国各适应症市场规模12.7.2 12.7.2Market Size by Therapies in the US 美国按疗法划分的市场规模12.8 12.8EU4 and the UK Radioligand Therapies Market Size 欧盟四国和英国放射性配体治疗市场规模12.9 12.9Japan Radioligand Therapies Market Size 日本放射性配体疗法市场规模13 13Radioligand Therapies Market Unmet Needs 放射性配体疗法市场未满足的需求14 14Radioligand Therapies Market SWOT Analysis 放射性配体疗法市场SWOT分析15 15KOL Views on Radioligand Therapies 关键意见领袖对放射配体疗法的看法16 16Radioligand Therapies Market Access and Reimbursement 放射性配体疗法市场准入与报销17 17Bibliography 参考文献18 18Radioligand Therapies Market Report Methodology 放射性配体治疗市场报告方法论Related Reports 相关报告PSMA-targeted Therapy Market PSMA靶向治疗市场PSMA-targeted Therapy Market Size, Target Population, Competitive Landscape & Market Forecast PSMA靶向治疗市场规模、目标人群、竞争格局与市场预测– –2034 2034report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key PSMA-targeted therapy companies, including 报告深入介绍了该疾病的理解、历史和预测流行病学、各疗法的市场份额以及关键的PSMA靶向治疗公司，包括Lantheus, Telix Pharmaceuticals, Novartis 兰泰乌斯、特利克斯制药、诺华, and others. ，以及其他。Prostate Cancer Market 前列腺癌市场Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 前列腺癌市场洞察、流行病学和市场预测 - 2034年report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key prostate cancer companies, including 报告深入介绍了该疾病、历史和预测的流行病学，以及市场趋势、市场驱动因素、市场障碍和关键的前列腺癌公司，包括Sanofi, AstraZeneca, Astellas Pharma, Bayer, Novartis, Curium, Merck, Orion, Janssen Pharmaceutical, Pfizer, Exelixis, Ipsen Pharma, Takeda, AB Science, Lantheus, Eli Lilly, POINT Biopharma, Telix Pharmaceuticals, Tavanta Therapeutics, Jiangsu Hengrui Pharmaceuticals, Kangpu Biopharmaceuticals, Fusion Pharma, Merus, Bristol-Myers Squibb, Syntrix Pharmaceuticals, Promontory Therapeutics, Xencor, Taiho Pharmaceutical, Madison Vaccines, MacroGenics, Zenith Epigenetics, Modra Pharmaceuticals, Arvinas, Laekna Therapeutics, Blue Earth Therapeutics, Oncternal Therapeutics, Essa Pharma, Clarity Pharmaceuticals, BioNTech, DualityBio, Daiichi Sankyo, Fortis Therapeutics, ORIC Pharmaceuticals, Amgen,. 赛诺菲、阿斯利康、安斯泰来制药、拜耳、诺华、Curium、默克、奥立龙、杨森制药、辉瑞、Exelixis、益普生制药、武田、AB Science、Lantheus、礼来、POINT Biopharma、Telix Pharmaceuticals、Tavanta Therapeutics、江苏恒瑞医药、康朴生物医药、Fusion Pharma、Merus、百时美施贵宝、Syntrix Pharmaceuticals、Promontory Therapeutics、Xencor、大鹏制药、Madison Vaccines、MacroGenics、Zenith Epigenetics、Modra Pharmaceuticals、Arvinas、来凯医药、Blue Earth Therapeutics、Oncternal Therapeutics、Essa Pharma、Clarity Pharmaceuticals、BioNTech、DualityBio、第一三共、Fortis Therapeutics、ORIC Pharmaceuticals、安进。and others. 和其他人。Neuroendocrine Tumors 神经内分泌肿瘤Market 市场Neuroendocrine Tumors 神经内分泌肿瘤Market Insights, Epidemiology, and Market Forecast 市场洞察、流行病学和市场预测– –2034 2034report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key neuroendocrine tumors companies including 报告深入介绍了该疾病、历史和预测的流行病学，以及市场趋势、市场驱动因素、市场壁垒和主要神经内分泌肿瘤公司，包括Novartis, Merck, Pfizer, ITM Solucin GMBH, Camurus, Bristol Myers Squibb, Rayzebio, Exelixis, Ipsen, Takeda, Radiomedix, Orano Med, Perspective Therapeutics, Elicera Therapeutics, Chimerix, Enterome, Teclison 诺华、默克、辉瑞、ITM Solucin GMBH、Camurus、百时美施贵宝、Rayzebio、Exelixis、益普生、武田、Radiomedix、Orano Med、Perspective Therapeutics、Elicera Therapeutics、Chimerix、Enterome、Teclison, ，and others. 和其他人。Gastroenteropancreatic Neuroendocrine Tumors Market 胃肠胰神经内分泌肿瘤市场Gastroenteropancreatic Neuroendocrine Tumors Market Insights, Epidemiology, and Market Forecast – 2034 胃肠胰神经内分泌肿瘤市场洞察、流行病学与市场预测——2034report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key GEP-NET companies including 报告提供了对疾病、历史和预测流行病学以及市场趋势、市场驱动因素、市场壁垒和主要GEP-NET公司的深入理解，包括Novartis, Ipsen Biopharmaceuticals, Pfizer, ITM Isotopen Technologien Muenchen, Camurus AB, Hutchison Medipharma Limited, Bristol-Myers Squibb, Eisai Limite, Experior S.L., Tarveda Therapeutics, Roche Pharma A, Exelixis, Merck Sharp & Dohme Corp, Recordati Inc, Eli Lilly and Company, Genentech, Inc., Aveo Oncology Pharmaceuticals, Radiomedix, Orano Med, PharmaMar, Bayer, Trio Medicines,. 诺华、益普生生物制药、辉瑞、慕尼黑ITM同位素技术、Camurus AB、和记黄埔医药有限公司、百时美施贵宝、卫材有限公司、Experior S.L.、Tarveda治疗学、罗氏制药、Exelixis、默克夏普和多姆公司、Recordati公司、礼来公司、基因泰克公司、Aveo肿瘤制药、Radiomedix、Orano Med、PharmaMar、拜耳、Trio医药。and others. 和其他人。About 关于DelveInsight 德莱夫洞察DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance.Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platformPharmDelve. 德尔维洞察（DelveInsight）是一家领先的商业咨询和市场研究公司，专注于生命科学领域。它通过提供全面的端到端解决方案来支持制药公司以提升其业绩。通过我们的订阅平台 PharmDelve，您可以轻松获取所有医疗保健和制药市场研究报告。. 。Contact Us 联系我们Shruti Thakur Shruti Thakur[emailprotected] 电子邮件地址+14699457679 +14699457679Logo: 标志：https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpg https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpgSOURCE DelveInsight Business Research, LLP 来源：DelveInsight商业研究公司21 21% %more press release views with 更多新闻稿浏览量与 Request a Demo 请求演示

放射疗法

2026-03-09

·肽研社

Tides | 胰淀素类似物已成减重药的兵家必争之地

温馨提示肽研社建读者交流群啦~ 行业交流、商务合作、报告咨询请添加小编微信，后续入群哦👇 研究进展 01 Entera Bio 2026-03-04，Entera Bio 宣布已向FDA提交临床方案修订，用于其候选药物 EB613 的 III 期临床研究。EB613 是一种口服甲状旁腺激素片段 PTH(1-34)（即特立帕肽），公司希望将其开发为首个每日一次口服骨形成（anabolic）治疗骨质疏松的药物。根据新的临床方案，III 期研究将采用 12 个月总髋骨骨密度（total hip BMD）变化作为主要终点，而不是此前计划的 24 个月。这一设计基于近期监管机构对骨密度指标作为骨折风险替代终点的认可，可显著缩短试验周期。研究计划纳入 750 名绝经后骨质疏松女性，采用随机、双盲、安慰剂对照设计，并在多个国家开展。公司预计在 2026 年底启动试验，并计划在 2028 年下半年公布顶线结果，比此前开发时间表提前约一年。同时，Entera 还计划在 III 期研究中直接使用最终商业化版本 Next-Gen EB613 单片剂型，取代此前需要多片服用的旧版本。此前完成的一项桥接研究已证明新旧制剂之间具有可比性，因此公司可以直接将单片剂型推进至关键注册研究阶段，这将有利于未来商业化推广。 EB613 的开发策略依赖于 505(b)(2) 注册路径，并参考已上市药物 Forteo 的临床数据。Forteo 是由Lilly开发的特立帕肽皮下注射制剂，自 2002 年获批以来已使用超过 20 年，并具有明确的疗效和安全性基础。Entera 计划申请与 Forteo 相同的适应症，但通过口服剂型改善给药便利性。在此前完成的 II 期研究中（161 名患者，6 个月安慰剂对照试验），EB613 达到了所有生物标志物和骨密度终点。研究显示，该药可快速提高骨形成生物标志物，降低骨吸收指标，并显著提高腰椎、髋部和股骨颈骨密度，其效果与已报道的注射特立帕肽在相同时间点的结果相似。 02 Vasomune Therapeutics 2026-03-04，Vasomune Therapeutics宣布FDA批准其 IND申请，用于开发 Pegevongitide (AV-001)，用于重度烧伤患者急性复苏期的治疗。Pegevongitide 是一种可注射的 Tie2 激动剂，能够抑制血管渗漏，目前还在研究用于急性呼吸窘迫综合征（ARDS）的预防和治疗（NCT05123755）。血管渗漏会破坏内皮屏障完整性，使液体和蛋白质从血管内流向组织间隙，从而干扰氧气输送、器官灌注，并导致血流动力学不稳定。Pegevongitide 通过激活 Tie2 信号通路，直接作用于血管稳定的核心机制，从而抑制血管渗漏和减少血管炎症。在重度烧伤患者中，血管渗漏会导致大量液体、蛋白质和炎症介质从血液流向受伤和未受伤组织，引发严重水肿、休克、氧输送受损及多器官功能障碍。Pegevongitide 的机制可通过稳定血管和改善血流动力学功能来缓解这些危害，预临床数据已显示其在减少血管渗漏和改善循环功能方面具有潜力。 Vasomune Therapeutics成立于2014年，总部位于加拿大多伦多，在美国罗利设有办事处，专注于血管功能紊乱及血管渗漏相关疾病的治疗研发，其候选药物 Pegevongitide 已从实验室阶段推进到临床前沿。 03 Genentech 2026-03-05，Genentech（Roche子公司）公布了长效胰淀素类似物 Petrelintide 在 II 期临床研究 ZUPREME-1 中的积极顶线结果。该研究共纳入 493 名超重或肥胖受试者（平均 BMI 为 37 kg/m²），结果显示，每周一次皮下注射 petrelintide 在 28 周时即达到主要终点，在所有剂量组中均实现统计学显著且具有临床意义的减重效果。体重下降在 42 周时仍保持稳定，最高剂量组平均体重较基线下降 10.7%，而安慰剂组仅为 1.7%（p<0.001）。在耐受性方面，petrelintide 表现出接近安慰剂的安全性特征。在最大有效剂量组中未出现呕吐病例，也没有因胃肠道不良反应导致停药。由于耐受性良好，98% 的受试者能够顺利达到维持剂量。总体来看，由不良事件导致的停药率为 4.8%，与安慰剂组的 4.9% 基本一致。最常见的不良反应为轻度胃肠道症状，其中腹泻和便秘发生率与安慰剂相近，均处于个位数水平。恶心发生率也低于此前采用更快剂量递增方案的 I 期试验，并且在进入维持剂量阶段后几乎不再出现。研究结果还显示，女性受试者在该试验中的减重幅度明显高于男性。整体而言，petrelintide 在实现有效体重下降的同时保持良好的耐受性，这一特征对于肥胖症这种需要长期治疗的慢性疾病尤为重要。研究人员认为，这些数据支持 petrelintide 作为单药用于长期体重管理继续开发，同时其耐受性优势也使其成为未来联合疗法的重要候选药物。 ZUPREME-1 是一项为期 42 周的随机、双盲、安慰剂对照 II 期剂量探索研究，在美国、波兰和罗马尼亚 33 个临床中心开展。研究比较五个剂量的每周一次 petrelintide 与安慰剂，在控制饮食和增加运动的基础上评估体重变化。主要终点为 28 周体重变化百分比，次要终点包括 42 周体重变化、腰围、HbA1c、炎症指标（hsCRP）、血脂及空腹血糖等代谢指标变化。petrelintide 是每周一次给药的长效胰淀素（amylin）类似物。2025 年，Genentech 与 Zealand Pharma达成独家合作协议，共同开发并商业化 petrelintide 用于超重和肥胖治疗。公司预计将在未来医学会议上公布 ZUPREME-1 的完整数据，并利用这些结果优化 III 期临床设计。同时，另一项评估 petrelintide 单药治疗肥胖或超重合并 2 型糖尿病患者的 II 期试验 ZUPREME-2 预计将在 2026 年下半年公布顶线结果，公司还计划在 2026 年启动 petrelintide 与 GLP-1/GIP 双重激动剂 CT-388 的联合治疗 II 期研究。 04 Parabilis Medicines 2026-03-05，Parabilis Medicines公布了其候选药物 Zolucatetide（FOG-001）的初步临床与临床前数据。结果显示，在正在进行的 I/II 期临床试验中，该药物在一名患有家族性腺瘤性息肉病（FAP）的患者中显著减少了十二指肠息肉数量和大小，同时伴随的硬纤维瘤也出现明显缩小，提示其具有潜在疾病修饰作用。在这项临床研究中，一名同时患有FAP和硬纤维瘤的患者接受 zolucatetide 治疗 60 周后，十二指肠息肉病明显改善。与约两年前治疗前评估相比，息肉数量和体积均显著减少，疾病分期从 Spigelman II 期降至 I 期。同时，该患者的硬纤维瘤直径减少 52.2%。截至目前，研究未报告与治疗相关的严重不良事件或因不良反应导致停药的情况。配套的临床前研究进一步支持这些发现。在 APC 突变肿瘤细胞模型中，zolucatetide 能够剂量依赖性抑制 β-catenin 转录活性，并在 FAP 小鼠模型中减少息肉形成，其暴露水平与当前临床研究剂量相当。这些结果与临床观察到的疗效一致，支持通过直接抑制 β-catenin 作为治疗 FAP 的潜在疾病修饰策略。 zolucatetide 是一种first-in-class β-catenin 与 TCF 转录因子相互作用的直接竞争性抑制剂。通过阻断 β-catenin:TCF 蛋白-蛋白相互作用，该药可在 Wnt 信号通路的关键下游节点抑制信号传递，从而阻断由 APC 或 β-catenin 突变驱动的肿瘤发生过程。与传统小分子或抗体不同，该药属于能够进入细胞并作用于细胞内靶点的稳定化 α-螺旋肽（Helicon™）类药物，这是公司利用其肽工程平台开发的一类新型药物形式。目前 zolucatetide 正在一项多中心 I/II 期开放标签研究（NCT05919264）中评估，研究对象为具有 Wnt 通路激活突变的局部晚期或转移性实体瘤患者，药物既作为单药治疗，也探索与其他抗肿瘤疗法联合使用。该药此前已获得FDA授予的快速通道资格，用于治疗硬纤维瘤。除 FAP 外，zolucatetide 还在多个 Wnt/β-catenin 驱动的肿瘤中开展研究，包括肝细胞癌、颅咽管瘤以及结直肠癌等。公司表示，目前已有超过 150 名患者在相关临床试验中接受治疗，并计划在 2026 年公布更多临床数据。 05 ITM 2026-03-05，ITM公布了其 III 期 COMPETE trial 的亚组分析结果。研究显示，放射性肽治疗 177Lu-edotreotide 在胰腺神经内分泌肿瘤患者中，相比靶向药 Everolimus，可显著延长无进展生存期（PFS）并提高客观缓解率（ORR）。在该 III 期研究的胰腺神经内分泌肿瘤患者亚组中，177Lu-edotreotide 治疗组的中位无进展生存期为 24.5 个月，而 everolimus 组为 14.7 个月。同时，客观缓解率显著更高：177Lu-edotreotide 组 33.3%，而 everolimus 组仅 3.6%。总体生存期（OS）在分析时也呈现数值优势，177Lu-edotreotide 组为 65.7 个月，对照组为 49.3 个月，不过该数据仍在随访中。 COMPETE 研究共纳入 309 名患有 Gastroenteropancreatic Neuroendocrine Tumors 的患者，其中 178 名（57.6%）为胰腺神经内分泌肿瘤患者，并按 2:1 随机分配接受 177Lu-edotreotide（119 例）或 everolimus（59 例）。在 P-NET 患者中，大多数（约 84%）为非功能性肿瘤，即肿瘤不分泌导致临床症状的激素；约 16% 为功能性肿瘤，可导致低血糖、腹泻或胃酸过多等症状。进一步分析显示，在非功能性 P-NET 患者中，177Lu-edotreotide 的客观缓解率在不同治疗线和不同 Ki-67 增殖指数患者中均超过 30%。例如，在 Ki-67 ≥10% 的患者中 ORR 达 34.2%，而在非功能性肿瘤患者中 ORR 为 38.1%。安全性方面，177Lu-edotreotide 的整体耐受性与 everolimus 相似甚至略优。严重不良事件（SAE）发生率为 29.1%，低于 everolimus 组的 43.1%。与研究药物相关的不良事件发生率也较低（83.8% vs 96.6%）。总体而言，COMPETE 研究结果表明，177Lu-edotreotide 在胰腺神经内分泌肿瘤患者中相比现有标准靶向治疗 everolimus 具有更好的疗效潜力，并可能成为该类肿瘤新的治疗选择。与此同时，该药还在另一项 III 期研究 COMPOSE trial 中进一步评估，用于治疗更高分级（G2/G3）的 SSTR 阳性 GEP-NET 患者。 06 翰森制药 2026-03-07，翰森制药宣布其首款减重药物——GLP-1R/GIPR双激动剂奥莱泊肽（HS-20094），在中国超重或肥胖成人受试者中开展的首个Ⅲ期临床研究（HS-20094-301）达成主要终点。这项随机、双盲、安慰剂对照研究在中国33个临床中心开展，共入组604例成年受试者，旨在评估每周一次奥莱泊肽对比安慰剂治疗48周的疗效与安全性。研究达到共同主要终点：-治疗48周时，奥莱泊肽组受试者的体重较基线的降幅与安慰剂组相比具有统计学显著性差异，且奥莱泊肽组达成5%体重降幅的受试者比例显著更高。 -奥莱泊肽治疗48周，体重较基线平均降幅最高达19.3%，实现≥5%体重降幅的受试者比例最高达97.2%。 -研究显示，奥莱泊肽治疗组胃肠道耐受性方面表现优异，与现已发表的GLP-1相关双激动剂类药物Ⅲ期试验数据相比，胃肠道不良事件发生率及治疗停药率更低。注册获批 01 Takeda & Protagonist 2026-03-02，Takeda与Protagonist Therapeutics宣布，FDA已接受Rusfertide的NDA申请并授予优先审评资格。Rusfertide是一种首创的肝素模仿肽治疗药物，用于成人真性红细胞增多症（PV）患者。FDA已将处方药用户费法案（PDUFA）目标审评日期定于今年第三季度。此外，Rusfertide还获得了FDA的突破性疗法、孤儿药和快速通道指定。 Rusfertide的新药申请主要基于Phase 3 VERIFY研究（NCT05210790）的32周及52周数据，以及Phase 2 REVIVE/THRIVE研究的四年疗效和安全性数据。VERIFY研究显示，Rusfertide联合标准治疗显著提高临床反应率，包括血细胞比容控制、减少放血次数，以及改善患者疲劳和症状负担。治疗总体耐受性良好，常见不良事件为注射部位反应（47.4%）、贫血（25.6%）和疲劳（19.6%），多为1-2级。严重不良事件发生率为8.1%。 Rusfertide每周皮下注射一次，通过模拟肝素的作用调节铁稳态和红细胞生成，旨在减少红细胞过度产生并维持血细胞比容控制。 02 Lantheus 2026-03-02，放射药物公司Lantheus（NASDAQ：LNTH）宣布FDA已对其Lutetium Lu 177 Dotatate（PNT2003）的ANDA给予暂定批准。PNT2003是一种放射等效药，与LUTATHERA®（Lutetium Lu 177 dotatate）相当，用于治疗生长抑素受体阳性的胃肠胰神经内分泌肿瘤（GEP-NETs），包括前肠、中肠和后肠的神经内分泌肿瘤。 Lantheus专注于放射药物领域，70年来致力于开发创新放射诊疗方案，服务全球多个国家和地区，帮助临床医生更精准地发现、治疗和追踪疾病。 03 Novo Nordisk 2026-03-02，Novo Nordisk宣布加拿大卫生部已批准Ozempic®用于降低2型糖尿病成人患者发生重大不良心血管事件（MACE，包括心血管死亡、非致死性心肌梗死或非致死性中风）的风险，适用于伴有既往心血管疾病和/或慢性肾病的患者，并需配合饮食、运动及标准治疗。这一适应症扩展基于SUSTAIN 6、PIONEER 6、FLOW及SOUL等多项临床试验的综合分析结果，显示Ozempic®可在标准治疗基础上显著降低高心血管风险2型糖尿病患者的重大心血管事件发生率。 04 Novo Nordisk 2026-03-03，Novo Nordisk的司美格鲁肽注射液上市申请获得CDE受理。 05 Lilly 2026-03-05，Lilly的Eloralintide获CDE批准，同步在中国开展3项全球关键Ⅲ期临床研究。用于支持未来该产品在体重管理等多个适应症在中国的注册，以满足肥胖或超重患者及其相关合并症患者的临床需求，提供更多有效且耐受性良好的治疗方案。 Eloralintide是一种强效、选择性、长效胰淀素受体激动剂（AMYR）激动剂，能以高亲和力与AMY1R结合，同时保持对人降钙素受体（hCTR）的选择性，在维持体重减轻效果的同时也改善了胃肠道反应，从而实现疗效和耐受性的平衡。Eloralintide对胰淀素受体的选择性可降低与降钙素受体活性相关的潜在风险。Eloralintide因其血浆半衰期较长（约14天），适用于每周一次皮下（SC）给药。正在开发Eloralintide用于以下适应症： -作为饮食控制和运动的辅助治疗，单独用于肥胖或超重（合并至少1种体重相关合并症）的成人的长期体重管理。 -作为联合治疗，用于在已使用稳定剂量肠促胰岛素类药物但未达到治疗目标的成人患者的长期体重管理。 06 先为达 2026-03-06杭州，Sciwind Biosciences 宣布NMPA已批准 Ecnoglutide 注射液用于中国成人超重或肥胖患者的长期体重管理。该药成为全球首个获批的 cAMP 偏向性GLP-1RA，标志着体重管理领域在作用机制上的重要突破。 Ecnoglutide 通过独特的 cAMP 偏向性机制发挥作用：在激活 GLP-1 受体时选择性增强 cAMP 信号通路，同时减少 β-arrestin 招募，与传统非偏向性 GLP-1RA 形成明显区别。这一机制被认为能够实现更强且更持久的减重效果，并在减重过程中同步改善代谢状态和慢性疾病风险，从而更好契合健康体重管理的目标。此次获批主要基于 III 期临床研究 SLIMMER 的结果。研究在中国超重或肥胖成人中开展，结果显示在 48 周时，最高剂量 2.4 mg 组平均体重较基线下降 15.4%（安慰剂校正 15.1%），且 92.8% 的受试者实现 ≥5% 的临床意义减重，约为安慰剂组反应率的七倍。此外，79.6% 和 63.5% 的患者分别实现 ≥10% 和 ≥15% 的体重下降。值得注意的是，在 48 周时减重曲线仍未出现明显平台期，提示延长治疗时间可能带来进一步体重下降。除减重外，Ecnoglutide 还显著改善多项心代谢指标，包括腰围、血压、血脂、HbA1c、空腹血糖、胰岛素水平以及 HOMA-IR，同时显著降低尿酸水平，最高可下降 54.3 µmol/L，并减少高尿酸血症发生率。在肝脏代谢方面，基线肝脂含量 ≥8% 的受试者在第 40 周时肝脂平均下降 53.1%（2.4 mg 组），并伴随肝酶水平明显改善。 07 Acadia 2026-03-06，Acadia Pharma宣布，EMA下属的 CHMP 对其 trofinetide 用于治疗两岁及以上 Rett 综合征患者的上市申请（MAA）给出了负面意见。Acadia 表示已详细审阅 CHMP 拒绝批准的理由，并计划请求复审。 CHMP 拒绝的主要原因包括： -尽管 LAVENDERTM 关键性试验成功达成了共同主要和关键次要终点，但 12 周疗效虽可测量，却被认为幅度有限。 -试验未覆盖 Rett 综合征的所有核心症状。-对长期疗效的评估受到随访中患者退出影响。 08 Novo Nordisk 2026-03-06，Novo Nordisk的依柯胰岛素司美格鲁肽注射液收到NMPA签发的注册上市证书，批准文号国药准字SJ20260018、国药准字SJ20260019、国药准字SJ20260020。企业发展 01 Novo Nordisk 2026-03-02，Novo Nordisk宣布将在爱尔兰阿斯隆蒙克斯兰的片剂生产厂投资约4.32亿欧元（约合32亿丹麦克朗），以显著提升当前及未来GLP-1口服药物的生产能力。此次投资标志着公司在爱尔兰的长期战略承诺。扩建后，设施将支持现有厂房升级改造、增强供应能力，并将爱尔兰打造为服务美国以外市场的重要枢纽。现有260名员工将继续专注于高质量口服药物生产，整个项目覆盖45英亩（约18公顷），预计创造多达500个建筑就业岗位，建设工作将于2027年底至2028年逐步完成。 02 质肽生物 2026-03-02，质肽生物宣布完成超5亿元人民币C轮融资。本轮融资由奥博资本（OrbiMed）领投，启明创投、知名产业基金、五源资本、杏泽资本、华盖资本跟投，老股东泰福资本、蓝驰创投、泰煜投资持续加码，浩悦资本担任本轮融资的独家财务顾问。质肽生物在慢性代谢疾病领域进行了差异化的超长效、口服多肽、多靶点的布局，以满足不同患者的临床需求，创新技术交叉融合也将引领慢性代谢疾病治疗的未来趋势。其核心产品创新型GLP-1RA月制剂——佐维格鲁肽（ZT002）注射液，正在中国开展减重III期临床研究（HORIZON-1研究），有望成为全球首个上市的每月给药一次的GLP-1多肽。此前，佐维格鲁肽在临床II 期试验中，已展现出具有竞争力的疗效和耐受性，即在第24周时体重减轻高达13.8%，且未出现平台期，胃肠道不良事件导致的停药率几乎为零。据CIC称，GLP-1RA月制剂有望将减重治疗模式从每周给药切换至每月给药，极大地提高患者的依从性，预计到2035年将占全球2095亿美元GLP-1药物市场的约26%。同时，创新型口服多肽GLP-1受体激动剂ZT006片剂正在中国开展减重II期临床研究；其创新型GLP-1/FGF21双靶点激动剂ZT003注射液，正在澳洲开展I期临床试验。公司的司美格鲁肽生物类似药ZT001已经分别与通化东宝和爱美客在糖尿病、减重适应症上展开合作，共同推进其临床和商业化进程。目前，围绕代谢性疾病领域，质肽生物已经建立了4大技术平台:QLLong 超长效技术平台、QLOral 口服多肽技术平台、QLFold 高效包涵体蛋白复性技术平台、QLFusion 融合蛋白技术平台，覆盖了重组蛋白生产的全过程。随着质肽生物商业化生产基地获批生产许可，质肽生物已经具备了从早期药物研发，中试生产到商业化落地的全产业链。相信在本轮资本的助力下，质肽生物也将继续加大研发投入，加速推进管线的临床和申报，在慢性代谢疾病领域不断拓展布局，早日为患者提供更好的药物。市场营销 01 Omada Health 2026-03-05，Omada Health 宣布推出新的企业健康管理方案 GLP-1 Flex Care，旨在帮助雇主在控制成本的同时，为员工提供更便捷的减重药物治疗路径。该方案将为员工提供 GLP-1 药物相关的临床评估、处方开具以及持续的医疗管理和生活方式支持，但药物费用由员工通过现金支付渠道自行购买，从而帮助企业避免承担高昂且不可预测的药品支出。随着肥胖治疗领域对 GLP-1 药物需求的快速增长，许多企业希望为员工提供相关治疗，但全面纳入医保福利往往成本过高。GLP-1 Flex Care提供了一种折衷方案：雇主可以为员工提供结构化的医疗管理与虚拟医疗服务，而药物费用由员工自行承担。通过该模式，员工仍然可以接受医生评估、实验室检查和处方开具，并获得针对副作用管理、剂量递增（titration）、营养与运动指导以及停药管理等方面的持续医疗支持。在该项目中，医生会根据患者的临床情况和可负担能力，为其推荐合适的 FDA 批准 GLP-1 药物，包括注射剂或口服制剂。员工通过现金支付渠道自行购买药物，同时继续接受 Omada 的虚拟医疗服务，包括个性化健康指导、教练支持以及长期生活方式管理。这种模式使企业能够在不承担药品费用的情况下，为员工提供规范化的 GLP-1 治疗路径。 Omada 表示，该方案建立在其现有 GLP-1 治疗管理体系之上，并已在真实世界数据中显示出较好的效果。一项为期 12 个月的分析显示，在 Omada 项目中接受 GLP-1 治疗的患者一年后的用药持续率达到 67%，高于部分公开研究中 47–49% 的水平。同时，坚持用药的患者在一年时平均减重 18.4%，也高于类似真实世界研究中约 11.9% 的减重效果。 GLP-1 Flex Care 预计将在 2026 年晚些时候向企业客户正式推出。作为一家以虚拟医疗为核心的数字健康公司，Omada Health 目前已为超过 200 万名用户提供慢性病管理服务，并与 2000 多家雇主、健康保险计划和医疗机构合作，支持包括肥胖、糖尿病和高血压等慢性疾病的长期管理。 02 Lilly 2026-03-05，Lilly宣布推出新的企业合作平台 Lilly Employer Connect，旨在帮助美国雇主为员工提供更容易获得的肥胖症治疗方案，同时控制医疗福利成本。通过该平台，企业可以与独立项目管理机构合作，设计灵活的福利方案，使员工能够获得肥胖管理药物、医疗评估以及生活方式干预等综合服务。在该平台中，公司的减重药物 Zepbound 的一次性注射装置 KwikPen 将以折扣价向合作药房提供。所有剂量规格的批发价格为$449，并通过企业的共付模式进一步降低员工的自付费用。最终价格取决于雇主选择的药房、项目管理机构以及福利设计方式，但总体目标是让员工在自付成本更低的情况下获得处方减重药物，同时让企业对支出具有更好的可预测性和透明度。该平台目前已与 15 家以上独立项目管理机构合作，并由多家全国性药房提供配送服务，包括 HealthDyne 和 CenterWell。这些合作伙伴提供不同层级的服务，从单纯的福利管理到包含虚拟医疗、行为干预和长期体重管理支持的综合项目，使企业可以根据自身预算和员工需求选择合适方案。部分图文来源于网络，如有侵权，请联系删除旗舰报告专栏推荐肽研社生物医药 · 美妆个护 · 营养健康动物健康 · 绿色农业 · 生物材料专业专注 | 成就客户 | 共生成长

临床3期临床申请AHA会议临床2期

2026-03-05

·BioSpace

ITM Announces Phase 3 COMPETE Trial Post-Hoc Subgroup Analyses with n.c.a. ¹⁷⁷Lu-edotreotide (ITM-11) in Patients with Pancreatic Neuroendocrine Tumors at ENETS 2026 Conference

Median progression-free survival (PFS) in pancreatic neuroendocrine tumor (P-NET) patients was 24.5 months on 177 Lu-edotreotide arm vs. 14.7 months on everolimus arm Objective response rate (ORR) was higher across the majority of P-NETs subgroups Krakow, Poland, March 5, 2026 – ITM Isotope Technologies Munich SE (ITM) , a leading radiopharmaceutical biotech company, today presented post-hoc subgroup analyses of the ITM-11 Phase 3 COMPETE trial in patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In patients with pancreatic neuroendocrine tumors (P-NETs), data showed that n.c.a. 177 Lu-edotreotide (ITM-11) prolonged progression-free survival (PFS) and achieved higher objective response rates (ORR) when compared to everolimus. Data were presented by Thomas Walter, MD, PhD, professor of gastroenterology, Hospices Civil of Lyon, France, in a mini-oral presentation and in an accompanying poster at the 23 rd Annual Meeting of the European Neuroendocrine Tumor Society (ENETS), held March 4-6, 2026 in Krakow, Poland. As previously announced at ENETS 2025 , the COMPETE trial met its primary endpoint of PFS (23.9 vs. 14.1 months; p=0.022; HR 0.67, 95% CI [0.48, 0.95]). At ESMO 2025 , ITM announced that COMPETE also met a key secondary endpoint of ORR (21.9% vs 4.2%, p<0.0001) in patients with GEP-NETs. The COMPETE study enrolled a total of 309 GEP-NET patients, including 178 (57.6%) patients with P-NETs randomized 2:1 to either 177 Lu-edotreotide (n=119) or everolimus (n=59). Of the 178 P-NET patients, 150 (84.3%) had non-functional tumors, meaning they did not produce hormones causing clinical symptoms, and 28 (15.7%) had functional tumors, in which excess hormone production can cause symptoms such as hypoglycemia (insulinoma), or diarrhea and peptic ulcer (Zollinger Elison syndrome). Key findings in the P-NETs population showed: Median PFS was longer in the 177 Lu-edotreotide arm compared to everolimus (24.5 months vs. 14.7 months; p=0.114; HR 0.70, 95% CI [0.45, 1.09]) and ORR in the 177 Lu-edotreotide arm was 33.3% vs. 3.6% in everolimus arm. ORR in the 177 Lu-edotreotide arm was ≥ 30% in P-NET patients with non-functional disease, across all patients regardless of line of therapy and Ki-67 index. This includes 38.1% ORR in P-NET patients with non-functional disease and 34.2% ORR in patients with a Ki-67 index ≥10%. Median overall survival was numerically longer in the 177 Lu-edotreotide arm compared to everolimus (65.7 months vs. 49.3 months) at the time of analyses; data continue to mature with ongoing five-year follow up. The overall safety pro P-NET patients receiving 177 Lu-edotreotide compared to everolimus was similar or potentially improved, and included fewer serious adverse events (SAEs) (29.1% vs. 43.1%). Lower incidence of adverse events suspected to be related to the study drug was seen in the 177 Lu-edotreotide arm vs. everolimus arm (83.8% vs. 96.6%). “Given that the data on peptide receptor radionuclide therapy in pancreatic NETs has been limited to date, we are encouraged by the activity of 177 Lu-edotreotide observed in this prespecified exploratory subgroup of patients with Grade 1 or 2 pancreatic NETs, who represented approximately 58% of trial participants,” said Thomas Walter, MD, PhD, professor of gastroenterology, Hospices Civil of Lyon, France. “These additional results from our Phase 3 COMPETE trial provide important insights into treatment options for patients with pancreatic NETs, and further enhance the robust clinical data of 177 Lu-edotreotide,” said Dr. Celine Wilke, chief medical officer of ITM . 177 Lu-edotreotide (ITM-11) is an investigational product pending review by the U.S. Food and Drug Administration (FDA) and is not approved by any regulatory authority for the safety and/or efficacy of any intended use. ENETS Oral Presentation Details Title : 177 Lu-edotreotide for the Treatment of Pancreatic Neuroendocrine Tumours: A Subgroup Analysis from the COMPETE Study Date and Time : March 5, 2026, 11:00 am-12:30 pm CET Session; 11:50-11:57 am CET Oral Presentation Session and Room Number: Clinical Science, Session 2B: Abstract session; Theatre Hall (S2) Presenter: Thomas Walter, PhD, MD, Professor of Gastroenterology, Hospices Civil of Lyon, France The e-poster will be accessible to registered participants during the event and available on after the conference. About the COMPETE Trial The COMPETE trial (NCT03049189) evaluated 177 Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular standard-of-care therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177 Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177 Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors. About ITM Isotope Technologies Munich SE ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians, and our partners through excellence in development, production, and global supply of medical radioisotopes. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. ITM Contacts: Corporate Communications Kathleen Noonan/Julia Westermeir Phone: +49 89 329 8986 1500 Email: communications@itm-radiopharma.com Investor Relations Ben Orzelek Phone: +49 89 329 8986 1009 Email: investors@itm-radiopharma.com Attachment ITM Announces Phase 3 COMPETE Trial Post-Hoc Subgroup Analyses with n.c.a. ¹⁷⁷Lu-edotreotide (ITM-11) in Patients with Pancreatic Neuroendocrine Tumors at ENETS 2026

临床3期临床结果寡核苷酸

100 项与镥[177Lu]依多曲肽相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
胃肠胰神经内分泌肿瘤	申请上市	美国	Itm Isotope Technologies Munich SE	2025-11-14
SSTR阳性胃肠胰神经内分泌肿瘤	临床3期	中国	ITM Solucin GmbH	2025-02-11
SSTR阳性胃肠胰神经内分泌肿瘤	临床3期	中国	远大医药（中国）有限公司	2025-02-11
肺神经内分泌肿瘤	临床3期	比利时	Itm Isotope Technologies Munich SE	2023-10-27
肺神经内分泌肿瘤	临床3期	法国	Itm Isotope Technologies Munich SE	2023-10-27
肺神经内分泌肿瘤	临床3期	意大利	Itm Isotope Technologies Munich SE	2023-10-27
肺神经内分泌肿瘤	临床3期	西班牙	Itm Isotope Technologies Munich SE	2023-10-27
胸腺肿瘤	临床3期	比利时	Itm Isotope Technologies Munich SE	2023-10-27
胸腺肿瘤	临床3期	法国	Itm Isotope Technologies Munich SE	2023-10-27
胸腺肿瘤	临床3期	意大利	Itm Isotope Technologies Munich SE	2023-10-27

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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


NCT03049189 (COMPETE, Company_Website) 人工标引	临床3期	胃肠胰神经内分泌肿瘤二线 \| 一线 Somatostatin Receptor Positive	309	177Lu-edotreotide	製衊襯醖簾膚廠淵簾觸(鹽夢憲餘壓壓醖顧廠繭) = 鹹壓選顧範願網築築齋膚廠鬱顧憲築獵範構鏇 (衊夢遞網繭顧壓鬱鑰壓 ) 达到更多	积极	2025-10-25
				Everolimus	製衊襯醖簾膚廠淵簾觸(鹽夢憲餘壓壓醖顧廠繭) = 醖醖鏇鹽蓋選簾製淵艱膚廠鬱顧憲築獵範構鏇 (衊夢遞網繭顧壓鬱鑰壓 ) 达到更多
NCT03049189 (COMPETE, Company_Website \| ESMO2025) 人工标引	临床3期	胃肠胰神经内分泌肿瘤二线 \| 一线 Somatostatin Receptor Positive	309	177Lu-edotreotide	築壓醖觸選願蓋膚鹹壓(遞艱衊築簾觸觸遞衊齋) = 遞簾範襯壓遞鬱窪餘憲顧齋齋積憲艱夢憲簾築 (艱鬱選築鹹簾製壓製糧 ) 更多	积极	2025-10-18
				Everolimus	築壓醖觸選願蓋膚鹹壓(遞艱衊築簾觸觸遞衊齋) = 構窪鹹鹽顧築糧簾鹹選顧齋齋積憲艱夢憲簾築 (艱鬱選築鹹簾製壓製糧 ) 更多
NCT03049189 (COMPETE, ESMO2025)	临床3期	somatostatin receptor positive \| Ki-67 ≤20%	309	177Lu-edotreotide	遞鹹製願膚襯襯積鏇遞(獵糧遞願鑰繭鹹選鑰簾) = 餘積艱餘醖簾願築鬱鏇膚積醖壓餘蓋積艱襯齋 (艱遞鹽顧膚獵構製餘鹽 ) 更多	积极	2025-10-17
				Everolimus	遞鹹製願膚襯襯積鏇遞(獵糧遞願鑰繭鹹選鑰簾) = 鏇願糧鑰窪齋鹹淵鑰選膚積醖壓餘蓋積艱襯齋 (艱遞鹽顧膚獵構製餘鹽 ) 更多
NCT03049189 (COMPETE, EANM2025 \| GlobeNewswire) 人工标引	临床3期	胃肠胰神经内分泌肿瘤	309	177Lu-edotreotide (ITM-11)	廠觸壓鏇鹽蓋鏇鏇鏇膚(醖襯鹽襯壓願餘艱齋願) = 夢獵鑰餘膚築憲顧壓範廠繭糧廠鏇襯蓋顧範醖 (齋齋鑰選夢獵糧顧蓋艱 ) 达到更多	积极	2025-10-08
				Everolimus	廠觸壓鏇鹽蓋鏇鏇鏇膚(醖襯鹽襯壓願餘艱齋願) = 壓夢願糧壓窪夢壓壓顧廠繭糧廠鏇襯蓋顧範醖 (齋齋鑰選夢獵糧顧蓋艱 ) 达到更多
NCT03049189 (COMPETE, Company_Website \| NEWS) 人工标引	临床3期	胃肠胰神经内分泌肿瘤	309	ITM-11	鏇積觸觸淵襯餘鹹鏇範(鏇範遞選壓簾顧膚構鏇) = 壓鏇鹹鏇淵衊窪糧淵蓋鹹鏇簾選構選鹽艱夢壓 (夢膚憲餘齋網鬱積廠襯 ) 达到更多	积极	2025-01-28
				Everolimus	鏇積觸觸淵襯餘鹹鏇範(鏇範遞選壓簾顧膚構鏇) = 簾築夢淵選選艱觸醖構鹹鏇簾選構選鹽艱夢壓 (夢膚憲餘齋網鬱積廠襯 ) 达到更多
NCT04194125 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	神经内分泌肿瘤	21	177Lu DOTATOC+ CAPTEM	範簾製糧蓋夢夢遞餘觸(窪鑰範廠窪網顧積範獵) = 築遞構夢艱憲夢鹹淵醖壓積壓夢鹽願鹹糧廠簾 (遞廠憲夢糧齋顧鑰鏇淵, 16.0 ~ NR) 更多	积极	2023-10-22
				177Lu DOTATOC+ CAPTEM (panNET)	範簾製糧蓋夢夢遞餘觸(窪鑰範廠窪網顧積範獵) = 觸壓願構繭襯襯遞餘膚壓積壓夢鹽願鹹糧廠簾 (遞廠憲夢糧齋顧鑰鏇淵, 14.0 ~ NR)
SNMMI2023	N/A	胃肠胰神经内分泌肿瘤	-	4 cycles of PRRT	鹹廠艱顧構廠襯蓋襯衊(膚衊鹽觸鬱願範鹽夢網) = 27 of these 36 patients (75%; 14 SI-NET; 4 CUP-NET; 9 P-NET) experienced PD in iStaging 顧廠製鏇築網淵鏇餘構 (鹽窪餘願襯鹹製築選鬱 ) 更多	-	2023-08-28
NCT03049189 (COMPETE, ESMO2018)	临床3期	胃肠胰神经内分泌肿瘤	300	Everolimus	餘鑰鹹憲繭淵襯鹹憲繭(選齋範糧齋襯遞製廠衊) = 繭顧蓋淵鹽積願壓簾鏇顧膚鑰積糧願廠襯鹹艱 (窪衊網艱積窪遞蓋艱醖 )	-	2018-10-21