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-

NCT05359146

/ Recruiting早期临床1期IIT

Combined Beta- Plus Auger Electron Therapy Using a Novel Somatostatin Receptor Subtype 2 Antagonist Labelled With Terbium-161 (161Tb-DOTA-LM3): Beta Plus Study

The goal of this phase 0 proof-of concept study is to measure the therapeutic index (tumour to dose-limiting-organ dose ratios) of 161Tb-DOTA-LM3 in comparison to the current standard 177Lu-DOTATOC in the same gastroenteropancreatic neuroendocrine tumour (GEP-NET) patients in a randomized, cross-over design, in all patients.
Population to be studied are patients with diagnosed and metastasized secreting and non-secreting GEP-NEN (grade 1 and 2). The number of participants will be limited to 4 - 8 patients (phase 0a) and 4 - 8 patients (phase 0b). All patients will get the same treatment in a balanced cross-over order. The study will be divided into a phase 0a and phase 0b. Beforehand the selected patients will be randomised into two groups. In phase 0a one test injection with 161Tb-DOTA-LM3 and 177Lu-DOTATOC will administered in both randomised groups in a different order followed by
3 cycles PRRT with 177Lu-DOTATOC in both groups. In phase 0b two test injections with 161Tb-DOTA-LM3 (with different peptide amounts) will administered in both randomised groups in a different order followed by
2 cycles PRRT with 161Tb-DOTA-LM3 in both groups.

开始日期2023-03-28

申办/合作机构

Universitätsspital Basel

[+2]

100 项与镥[177Lu]依多曲肽相关的临床结果

登录后查看更多信息

100 项与镥[177Lu]依多曲肽相关的转化医学

登录后查看更多信息

100 项与镥[177Lu]依多曲肽相关的专利（医药）

登录后查看更多信息

项与镥[177Lu]依多曲肽相关的文献（医药）

2024-06-01·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

Safety and Efficacy ofPara-Aminohippurate Coinfusion for Renal Protection During Peptide Receptor Radiotherapy in Patients with Neuroendocrine Tumors

Article

作者: Jentzen, Walter ; van Echteld, Cees J A ; Meckel, Marian ; Fendler, Wolfgang P ; Himmen, Stephan ; Coelho, Marta ; Fragoso Costa, Pedro ; Sraieb, Miriam ; Herrmann, Ken ; Moraitis, Alexandros ; Kersting, David

Para-aminohippurate, also known as p-aminohippuric acid (PAH), is used clinically to measure effective renal plasma flow. Preclinically, it was shown to reduce ¹⁷⁷Lu-DOTATOC uptake in the kidneys while improving bioavailability compared with amino acid (AA) coinfusion. We report the safety and efficacy of PAH coinfusion during peptide receptor radiotherapy in patients with neuroendocrine tumors. Methods: Twelve patients with metastatic or unresectable gastroenteropancreatic neuroendocrine tumors received ¹⁷⁷Lu-DOTATOC in 33 treatment cycles. Either 8 g of PAH or a mixture of 25 g of arginine and 25 g of lysine were coinfused. Safety was assessed by monitoring laboratory data, including hematologic and renal data, as well as electrolytes obtained before and 24 h after treatment. For radiation dosimetry, whole-body scans were performed at 1, 24, and 48 h and a SPECT/CT scan was performed at 48 h, along with blood sampling at 5 min and 0.5, 2, 4, 24, and 48 h after administration. Absorbed dose estimations for the kidneys and bone marrow were performed according to the MIRD concept. Results: In 15 treatment cycles, PAH was coinfused. No changes in mean creatinine level, glomerular filtration rate, and serum electrolytes were observed before or 24 h after treatment when using PAH protection (P ≥ 0.20), whereas serum chloride and serum phosphate increased significantly under AA (both P < 0.01). Kidney-absorbed dose coefficients were 0.60 ± 0.14 Gy/GBq with PAH and 0.53 ± 0.16 Gy/GBq with AA. Based on extrapolated cumulative kidney-absorbed doses for 4 cycles, 1 patient with PAH protection and 1 patient with AA protection in our patient group would exceed the 23-Gy conservative threshold. The bone marrow-absorbed dose coefficient was 0.012 ± 0.004 Gy/GBq with PAH and 0.012 ± 0.003 Gy/GBq with AA. Conclusion: PAH is a promising alternative to AA for renal protection during peptide receptor radiotherapy. Further research is required to systematically investigate the safety profile and radiation dosimetry at varying PAH plasma concentrations.

2024-01-01·Theranostics

Long-term Nephrotoxicity after PRRT: Myth or Reality

Article

作者: Yu, Fei ; Zhang, Jingjing ; Baum, Richard P ; Schuchardt, Christiane ; Fan, Xin ; Chen, Xiaoyuan ; Jakobsson, Vivianne

Rationale: The kidneys are commonly considered as the potential dose-limiting organ for peptide receptor radionuclide therapy (PRRT), making the risk of nephrotoxicity a primary concern. This retrospective analysis with prospective documentation and long-term follow-up aims to assess the risk of nephrotoxicity after PRRT in a large cohort of patients with neuroendocrine neoplasms (NENs) treated at our institution over the past 18 years. Methods: A total of 1361 NEN patients treated with 1-10 cycles of ¹⁷⁷Lu-DOTA-TOC/-NOC/-TATE, ⁹⁰Y-DOTA-TOC/-NOC/-TATE, DUO-PRRT (sequential administration of ⁹⁰Y- and ¹⁷⁷Lu-), or TANDEM-PRRT (combination of ⁹⁰Y- and ¹⁷⁷Lu- on the same day concomitantly) were included in this analysis. All parameters were prospectively documented in a structured database comprising over 250 items per patient and retrospectively analyzed. Kidney function, including serum creatinine, blood urea nitrogen, cGFR, and electrolytes, was evaluated before each PRRT cycle and during follow-up. Restaging was regularly performed at 6-month intervals until death. Treatment-related adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0). Results: Between 2000 and 2018, a total of 5409 cycles of PRRT were administered to 1361 NEN patients. Follow-up after complete treatment was available for 1281 patients receiving 4709 cycles of PRRT, with a median follow-up time of 69.2 months (interquartile range, 32.8-110.5 months) and a maximum follow-up time of 175 months. Baseline creatinine levels were normal in 1039/1281 (81.1%) subjects, while grade 1 (G1) renal insufficiency was present in 221/1281 (17.3%) prior to PRRT. G2 was present in 19/1281 (1.5%), and G3 in 2/1281 (0.2%). After treatment, the proportion of G3/G4 grade patients only increased from 0.2% to 0.7%. Mean creatinine levels increased from a baseline of 0.90 ± 0.30 to 1.01 ± 0.57 mg/L (80.0 ± 26.7 to 89.4 ± 50.8 μmol/L) after treatment. In our main analysis cohort of 1244 patients (4576 cycles), 200 patients experienced an increase in CTCAE creatinine grade. Age, number of treatment cycles, type of radionuclides, and length of follow-up time were the main factors affecting CTCAE creatinine grading after treatment. When comparing the subgroups treated with different radionuclides, the risk of nephrotoxicity after ⁹⁰Y treatment alone and the ⁹⁰Y/¹⁷⁷Lu combination group was higher than after ¹⁷⁷Lu treatment alone. In the ⁹⁰Y treatment subgroup, the two significant risk factors for an increased CTCAE creatinine grade were identified to be age (≥60) and a long follow-up time. Conclusions: This retrospective analysis with prospective documentation in a large cohort of 1281 NEN patients receiving 4709 cycles of PRRT co-administered with renal protection, treated through the individualized approach at a single institution over 18 years, did not reveal any evidence of long-term PRRT-related renal toxicity. The results of our study suggest that with the use of proper renal protection, nephrotoxicity due to PRRT is more likely a myth than a reality.

2023-07-01·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

¹⁶¹Tb-DOTATOC Production Using a Fully Automated Disposable Cassette System: A First Step Toward the Introduction of ¹⁶¹Tb into the Clinic.

Article

作者: Landolt, Stefan ; van der Meulen, Nicholas P ; Grundler, Pascal V ; Talip, Zeynep ; Köster, Ulli ; Sepini, Lebogang ; Schibli, Roger ; Favaretto, Chiara ; Geistlich, Susanne ; Müller, Cristina

¹⁶¹Tb is an interesting radionuclide for application in the treatment of neuroendocrine neoplasms' small metastases and single cancer cells because of its conversion and Auger-electron emission. Tb has coordination chemistry similar to that of Lu; therefore, like ¹⁷⁷Lu, it can stably radiolabel DOTATOC, one of the leading peptides used for the treatment of neuroendocrine neoplasms. However, ¹⁶¹Tb is a recently developed radionuclide that has not yet been specified for clinical use. Therefore, the aim of the current work was to characterize and specify ¹⁶¹Tb and to develop a protocol for the synthesis and quality control of ¹⁶¹Tb-DOTATOC with a fully automated process conforming to good-manufacturing-practice guidelines, in view of its clinical use. Methods: ¹⁶¹Tb, produced by neutron irradiation of ¹⁶⁰Gd in high-flux reactors followed by radiochemical separation from its target material, was characterized regarding its radionuclidic purity, chemical purity, endotoxin level, and radiochemical purity (RCP) in analogy to what is described in the European Pharmacopoeia for no-carrier-added ¹⁷⁷Lu. In addition, ¹⁶¹Tb was introduced into a fully automated cassette-module synthesis to produce ¹⁶¹Tb-DOTATOC, as used for ¹⁷⁷Lu-DOTATOC. The quality and stability of the produced radiopharmaceutical in terms of identity, RCP, and ethanol and endotoxin content were assessed by means of high-performance liquid chromatography, gas chromatography, and an endotoxin test, respectively. Results: ¹⁶¹Tb produced under the described conditions showed, as the no-carrier-added ¹⁷⁷Lu, a pH of 1-2, radionuclidic purity and RCP of more than 99.9%, and an endotoxin level below the permitted range (175 IU/mL), indicating its appropriate quality for clinical use. In addition, an efficient and robust procedure for the automated production and quality control of ¹⁶¹Tb-DOTATOC with clinically applicable specifications and activity levels, that is, 1.0-7.4 GBq in 20 mL, was developed. The radiopharmaceutical's quality control was also developed using chromatographic methods, which confirmed the product's stability (RCP ≥ 95%) over 24 h. Conclusion: The current study demonstrated that ¹⁶¹Tb has appropriate features for clinical use. The developed synthesis protocol guarantees high yields and safe preparation of injectable ¹⁶¹Tb-DOTATOC. The investigated approach could be translated to other DOTA-derivatized peptides; thus, ¹⁶¹Tb could be successfully applied in clinical practice for radionuclide therapy.

项与镥[177Lu]依多曲肽相关的新闻（医药）

2025-05-27

·EINPresswire

ITM Secures Up to $262.5m in Non-dilutive Debt Financing with Blue Owl Managed Funds

Debt capital to support commercial readiness and potential U.S. launch of n.c.a. 177 Lu-edotreotide (ITM-11), following positive Phase 3 results Flexible funding structure enables continued advancement of ITM’s targeted radiopharmaceutical pipeline and leading radioisotope manufacturing business Garching / Munich, Germany, May 27, 2025 – ITM Isotope Technologies Munich SE (ITM) , a leading radiopharmaceutical biotech company, today announced a debt financing agreement for up to USD 262.5 million from funds managed by Blue Owl Capital, Inc (“Blue Owl”). The capital will be used to prepare for commercial readiness and potential market launch of the company’s lead candidate, n.c.a. 177 Lu-edotreotide (also known as ITM-11 or 177 Lu-edotreotide). ITM-11 recently met the primary endpoint in the COMPETE Phase 3 study as a potential treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM plans to submit a New Drug Application (NDA) for this asset to the U.S. FDA in 2025. In addition, the company will continue to accelerate the development of its innovative targeted radiopharmaceutical pipeline and the scale-up of Actinium-225 manufacturing through its joint venture, Actineer. Under the terms of the agreement, ITM will receive USD 140 million upon closing and can exercise additional tranches. Further details of the agreement have not been disclosed. “ Blue Owl is a highly regarded investor with a deep appreciation for the potential of radiopharmaceuticals, and we see their debt capital for ITM as a validation of our position as a cornerstone of the radiopharmaceutical industry ,” said Dr. Andrew Cavey, CEO of ITM . “ This strategic funding agreement enables us to move rapidly toward the potential U.S. commercialization of ITM-11, subject to FDA approval, and provides flexibility for the development and expansion of our innovative pipeline of targeted radiopharmaceuticals across a broad range of indications .” “ With its vertically integrated approach that combines a profitable radioisotope manufacturing business with radiopharmaceutical pipeline development, we believe ITM is uniquely positioned to positively impact the precision oncology sector. We look forward to supporting ITM’s continued growth and mission to bring innovative treatment options to people living with cancer ,” said Sandip Agarwala, Managing Director and Head of Life Sciences at Blue Owl . About n.c.a. 177 Lu-edotreotide (ITM-11) 177 Lu-edotreotide is a radiolabeled peptide conjugate that delivers beta radiation specifically to SSTR-positive tumor cells, sparing healthy organs and tissue. The drug candidate, delivered intravenously, is comprised of non-carrier-added Lutetium-177, a therapeutic β-emitting radioisotope, and edotreotide, a synthetic SSTR agonist. 177 Lu-edotreotide was granted orphan drug designation in the E.U. and the U.S., and fast track designation in the U.S. for the treatment of GEP-NETs, based on positive results from a retrospective Phase 2 study with 177 Lu-edotreotide. 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. www.itm-radiopharma.com About Blue Owl Blue Owl (NYSE: OWL) is a leading asset manager that is redefining alternatives ® . With $273 billion in assets under management as of March 31, 2025, Blue Owl invests across three multi-strategy platforms: Credit, GP Strategic Capital, and Real Assets. Anchored by a strong permanent capital base, we provide businesses with private capital solutions to drive long-term growth and offer institutional investors, individual investors, and insurance companies differentiated alternative investment opportunities that aim to deliver strong performance, risk-adjusted returns, and capital preservation. Together with over 1,200 experienced professionals globally, Blue Owl brings the vision and discipline to create the exceptional. To learn more, visit www.blueowl.com . ITM Contact 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 20250527_ITM Secures Up to $262.5m in Non-dilutive Debt Financing with Blue Owl Managed Funds Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床结果临床3期孤儿药临床2期快速通道

2025-05-27

·Firstwordpharma

ITM lands $262.5M debt deal to fund targeted radiotherapy in GEP-NETs

ITM Isotope Technologies said Tuesday it secured up to $262.5 million in debt financing to help advance its lead cancer treatment toward potential US commercialisation. Specifically, the non-dilutive financing from Blue Owl Capital will support preparation for the market launch of ITM-11 (177Lu-edotreotide) following positive results from the Phase III COMPETE trial.The study demonstrated that ITM-11 significantly outperformed Novartis' Afinitor (everolimus) in treating patients with Grade 1 or 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs), extending median progression-free survival to 23.9 months compared with 14.1 months for the established therapy. That translated to a 33% reduction in the risk of disease progression or death, with ITM-11 also demonstrating a more favourable safety profile, according to results unveiled in March.ITM reiterated plans to submit a filing to the FDA in 2025. ITM-11 — which combines the therapeutic β-emitting radioisotope lutetium-177 with the synthetic SSTR agonist edotreotide — is also being investigated in the Phase III COMPOSE trial in patients with well-differentiated, aggressive Grade 2 or 3 SSTR-positive GEP-NETs.The German radiopharmaceutical biotech will receive $140 million upon closing the Blue Owl agreement, with additional tranches available as needed."This strategic funding agreement enables us to move rapidly toward the potential US commercialisation of ITM-11, subject to FDA approval, and provides flexibility for the development and expansion of our innovative pipeline of targeted radiopharmaceuticals across a broad range of indications," stated CEO Andrew Cavey.The radiopharmaceuticals space has gained momentum following successful launches by companies like Novartis, which already markets the radionuclide therapy Lutathera (lutetium Lu 177 dotatate) for GEP-NETs that are positive for the somatostatin receptor. Lutathera brought in sales of $724 million last year.Something that differentiates ITM from other players, however, is that it has worked in the radiopharma space for over 20 years and has manufacturing in-house, in addition to its drug development programmes, a combination that has attracted backing from previous investors including Temasek and BlackRock in earlier funding rounds totalling about €615 million ($700 million) since 2022.

临床3期临床结果财报寡核苷酸

2025-05-14

·抗体圈

数十年磨一剑：远大医药以全球首创核药矩阵点燃创新药“核爆点”

中美地缘政治高度不确定性的扰动背景下，远大医药近6个交易日累计上涨近40%，无惧行业波动。值得注意的是，国际大行中金在5月13日上调目标价20.0%至9.6港币，这是中金年内第三次上调远大医药的目标价。大涨背后是远大医药密集的创新进展等积极消息的释放，包括：脓毒症创新药STC3141的二期临床成功、创新核素偶联药物TLX591加入国际多中心三期申请获受理、诊断RDC产品TLX591-CDx完成三期患者全部入组并计划在年内递交上市、肝癌创新精准诊断RDC产品GPN02006临床结果将亮相SNMMI大会，以及公司成都温江核药基地计划今年投入运营等等，这充分印证了公司厚积薄发的科技创新战略正在逐渐兑现，2025年公司创新药布局爆发正当时。随着公司更多的创新药布局一一开花结果，公司的投资与成长逻辑已全面蜕变，凸显港股创新药龙头气势。01核药爆发：批量颠覆性大品种蓄势待发核药板块，是远大医药创新药布局的最强尖兵之一。公司首个商业化核药品种为易甘泰®（钇[90Y]微球注射液），为全球唯一获批用于结直肠癌肝转移选择性内放射治疗（SIRT）的产品，2022-2024年分别实现销售额超过6000万港元、2亿港元和4.9亿港元，呈现了高速放量增长。易甘泰®的增长潜力还远远未被释放，其未来不仅有望惠及国内每年36万新发的肝癌患者，并且有望进一步探索后线治疗的潜力（如肝癌术后辅助治疗、联合靶向治疗等）。易甘泰®只是“商业化先锋”，远大医药核药板块处于一个全面爆发的关键窗口，要探析公司的强劲布局，诺华便是一个很好的对标或参照例子。2024年诺华核药两大商业化核心产品Pluvicto、Lutathera分别实现13.92亿美元（yoy+42%）、7.24亿美元（yoy+20%），整体板块收入超过20亿美元，而Jefferies更是给出了Pluvicto销售峰值将超过50亿美金的预测，另外Lutathera在2024年扩大适应症纳入了12岁及以上SSTR+胃肠胰神经内分泌肿瘤儿童患者，也即将步入10亿美元分子行列。‌显然，无论是Pluvicto还是Lutathera都分别在前列腺癌、神经内分泌适应症中展现了强大市场扩张力，这一势头未有减弱迹象并且有着加速迹象。远大医药，目前在Pluvicto、Lutathera对应的PSMA靶点、SSTR靶点核药RDC上分别布局了对应的me-better管线TLX591和ITM-11，如今正在奔向关键临床里程碑。TLX591是一款基于J591单抗的RDC药物，其通过抗体靶向PSMA，搭载治疗性放射性核素177Lu，精准输送至肿瘤部位。相比诺华Pluvicto，TLX591在多个方面具备潜在me better的特质：1）更精准的靶向治疗： TLX591通过抗体特异性除了更精准外，药物在PSMA阳性肿瘤的穿透性和滞留时间更长，有望达到更好的疗效；2）给药依从性：相比市面上长达六周期、持续30周的放射性配体治疗方案，TLX591仅需间隔14天的双剂给药（总周期约1个月），大幅缩短治疗周期；3）安全性：TLX591通过肝脏代谢清除，有效避免了肾脏毒性，而且其大分子结构使其对唾液腺和泪腺的摄取率极低，减少口干症和干眼症等常见不良反应发生率，改善患者生活质量。核药诊疗一体化的组合可以进一步发挥产品的效能。基于PSMA成像的优越性，TLX591-CDx是欧美最受医患青睐的诊断性核药，其基于放射性核素-小分子偶联技术的靶向PSMA（在90%以上的原发性和转移性前列腺癌细胞表面过表达），可用于检测基于血清PSA水平升高的复发前列腺癌患者。2024年TLX591-CDx实现近5.17亿美元的销售额，并于2025Q1取得近1.51亿美元的销售额，同比增长近35%。目前Pluvicto尚未在国内上市，随着TLX591-CDx预计在年内递交NDA，远大医药TLX591-CDx将有望在Pluvicto上市后搭乘其放量的东风；同时，待未来TLX591顺利加入国际多中心三期临床，其与TLX591-CDx有望为国内前列腺疾病患者带来更精准、高效的诊疗方案，并为远大医药实现前列腺癌的“诊疗一体化”。ITM-11是一款无载体177Lu与生长抑素类似物结合的RDC，其同样是一款潜在me better产品。其具体优势包括：1）ITM-11采用无载体技术，更高的比活度和纯度，生产杂质少，可提升肿瘤靶向效率；2）ITM-11半衰期更长，其采用每8周一次间隔给药，具备更高的患者依从性；3）ITM-11的潜在安全性更高，在过往临床中未观察到严重不良事件（SAE）。药物有效性来看，ITM-11的全球三期临床COMPOSE研究显示：在侵袭性2/3级SSTR阳性的胃肠或胰腺来源的神经内分泌肿瘤GEP-NETs患者中，患者的mPFS高达34.5个月，且未观察到严重的不良事件。与Lutathera非头对头数据比较下，ITM-11有望在整体的疗效（mPFS显著提升，Lutathera一线治疗在22个月左右）、安全性上成为同类最佳产品。目前诺华Lutathera并未在国内上市，远大医药ITM-11国内三期临床在今年三月已经实现首例患者入组，其有望成为国内首个商业化靶向SSTR的RDC产品，享受市场独占期。多款创新核药的管线为远大医药未来增长赋予了稳健的确定性，同时核药的商业化供应背后必须有着强大的产业链保障，经过多年深耕，远大医药在核药领域已实现了研发、生产、销售、监管资质等多个环节的全方位布局，建立了完整的产业链。同时，远大医药预计投入30亿的成都温江放射性药物全球研发及生产基地，将于今年投入运营，有望加速创新核药管线的落地，并进一步公司核药领域的领先地位。该基地是全球首个零辐射智能核药工厂，是目前国际范围内核素种类最全、自动化程度最高的智能工厂，未来将巩固远大医药全球核药研发中心网络的布局，其预计将于今年年底至2026年陆续实现产品的FDA临床申报。值得一提的是，今天远大医药还公布了其用于治疗肝细胞癌（HCC）的创新RDC产品GPN02006将于2025年SNMMI（核医学与分子影像学会）年会公布重磅临床结果。GPN02006是一款基于放射性核素-抗体偶联技术的靶向磷脂酰肌醇蛋白聚糖3 (GPC-3)的诊断型放射性药物。该产品早前临床研究数据展现了卓越的安全性和显像效能：所有受试者给药后均未报告任何药物相关不良反应，安全耐受性表现优异；给药后30分钟即可实现高质量显像，充分满足肝细胞癌临床快速诊断需求。本次其亮相SNMMI，不仅体现了GPN02006的潜力——有望成为全球首个针对GPC-3靶点的HCC诊断类RDC产品，同时也标志着远大医药核药产业全球化发展迈入新的阶段。02STC3141：全球脓毒症创新药FIC远大医药自研创新药STC3141脓毒症临床结果一鸣惊人，让市场重新审视公司的创新实力。脓毒症是全球市场公认最难攻克的适应症之一，由于发病机制复杂且病理过程涉及感染、免疫反应、代谢紊乱等多重机制，难以通过单一靶点药物全面干预，这也让远大医药的STC3141价值凸显。脓毒症领域缺乏有效治疗药物，目前抗生素类、免疫调节剂等传统药物为主，21世纪以来仅有重组活化蛋白C获批治疗脓毒症（后因疗效不确切撤市）。但由于脓毒症是美国住院患者的第一大死因（死亡率高达35% ~54%），并且中国每年约有近250万脓毒症患者，市场空间广阔；据Wise Guy Reports数据，2024年全球脓毒症治疗药物市场规模为125.4亿美元，预计到2032年市场规模将达到193.7亿美元，年均复合增长率为5.58%。远大医药STC3141的治疗机制围绕脓毒症治疗的核心目标——维持免疫稳态，其活性成分是一种多阴离子分子，研究表明脓毒症患者体内循环组蛋白水平升高与疾病严重程度相关，STC3141能够通过中和细胞外游离组蛋白和中性粒细胞陷阱网（NETs），减少炎症反应和组织损伤。STC3141国内治疗脓毒症二期临床结果显示，高剂量治疗组在主要终点第7天序贯器官衰竭评估（SOFA）评分较基线变化的表现显著优于安慰剂组，同时次要终点趋势与主要终点一致，患者安全性、耐受性良好。尽管未披露具体数据，但从“显著优于安慰剂组”的口径在脓毒症这样危重症适应症来说显然是大获成功。另外，STC3141的疗效和安全性也可以在过往的早期临床中初见端倪，STC3141在多个临床中帮助患者脱离呼吸机、脱离升压药和缩短ICU住院时间等有效性指标方面均体现了积极信号。值得注意的是，2024年底NIH公示的STC3141一期临床研究，在26名SOFA评分≥2的脓毒症患者中，大部分患者安全性、耐受性良好，有18名（69.2%）完成了ICU第8天的完整治疗方案，其余8名患者有4名提前出院、1名过早出ICU、1名SAE、1名需要其他治疗和1名死亡，这彰显了STC3141在患者中的安全性与耐受性。STC3141在国内二期临床明确了初步成药性的背景下，成为全球脓毒症潜在First in class药物候选毋庸置疑，若未来远大医药顺利申请STC3141突破性治疗药物资格，该产品的开发也有望进一步提速，并早日惠及广大脓毒症患者。而更大的悬念，在于STC3141对外授权的价值判断。由于脓毒症验证性创新临床管线稀缺，并且欧美住院患者用药花费不菲，巨额BD是可以预期的。从过往可参考的案例看，脓毒症药物开发商AM-Pharma的重组人碱性磷酸酶ilofotase alfa在脓毒症相关急性肾损伤适应症曾经未达到二期临床终点的背景下，仍基于对肾功能显著、渐进和持续改善潜力被协和麒麟看中，后2021年协和麒麟以2000万欧元首付+3000万欧元及1.95亿欧元监管里程碑费用买下日本开发权益。远大医药STC3141作为疗效、安全性已被验证并且拥有部分海外人群临床数据的FIC药物，拿下总额巨大的BD，想必市场不会感到意外。除了STC3141之外，远大医药还布局了一款脓毒症新药APAD，通过拮抗多种病原体相关分子（PAMPs），抑制免疫细胞过度活化，阻断脓毒症早期炎症风暴的启动，据介绍APAD与STC3141存在协同作用。03逻辑体系转变随着多年创新药的布局在2025年开始爆发，远大医药显然形成一套全新成长性逻辑。首先是各个创新药板块未来两年有一大批产品将迎来商业化放量，这些产品的体量将至少“再造一个”远大医药：（图源：远大医药2024年年报）1）核药领域除了易甘泰®（预计未来国内销售峰值有望超过50亿人民币）之外，公司诊断性核药TLX591-CDx国内三期临床完成全部患者入组并将于年内递交国内NDA申请、肾透明细胞癌诊断产品TLX250-CDx国内III期已完成首例入组、治疗性核药ITM-11国际多中心III期临床国内完成首例入组，以及治疗性核药TLX591加入国际多中心III期临床获受理，未来这些后期产品预计至少能贡献30亿人民币的收入（核心为治疗性核药），这还没有考虑后续其他早期管线。2）眼药方面，目前公司干眼症FIC产品酒石酸伐尼克兰鼻喷雾剂OC-01已经商业化，鉴于目前干眼症常规药物人工泪液玻璃酸钠滴眼液等药物在2023年均突破10亿规模，OC-01未来市场潜力亦值得期待；同时公司两款治疗蠕形螨睑缘炎滴眼液GPN01768和白内障术后抗炎滴眼液GPN00833均处于商业化冲刺阶段，两者销售峰值均有望冲刺10亿人民币的规模。3）吸入制剂方面公司拥有国内针对过敏性鼻炎的轻、中、重症全方位布局，目前包括已上市的布地奈德鼻喷雾剂及丙酸氟替卡松鼻喷剂、冲击商业化阶段的糠酸莫米松鼻喷雾剂，以及处于新药上市审核阶段的Ryaltris创新复方鼻喷剂，尽管前三款是仿制药，但具备良好的竞争格局和一定剂型壁垒，能够贡献可观的现金流，另外Ryaltris作为起效迅速并能治疗季节性过敏性鼻炎（SAR）的创新药物，重磅产品潜质凸显，保守预计公司吸入制剂产品组合未来至少可贡献25-30亿人民币收入。仅统计上述三大创新板块，未来就有望为远大贡献超过130亿人民币的营收，考虑到创新药的净利率高于传统品种，保守以20%净利率测算，将创造近30亿人民币的净利润，相当于再造一个远大医药。这只是远大医药向全球展示其真正内核实力的开始，如今随着脓毒症FIC管线STC3141验证性临床的开花结果，以及创新眼药、核药板块管线的产学研转化和自主开发，迅速打开了市场对公司在海外市场发展的想象空间，其中最大的预期要属STC3141海外授权的推进。再从估值重估的角度而言，公司作为股息率高达5-6%的业绩稳健增长的医药龙头，目前远大医药从估值体系并未反应或计价上述两大逻辑的价值，或许如今的起点，仅仅只是一个市场价值发现的起点。结语：远大医药2025年创新药里程碑的密集井喷，不仅得益于公司过去多年的前瞻性创新布局，还得益于公司坚定转型创新的卓越执行力，以及打造国际化差异竞争力的不懈坚持。如今远大医药在核药、呼吸及危重症和眼药领域等前沿板块的持续创新兑现，恰恰是公司厚积薄发的正向反馈，而股价的不断新高，是市场给予公司坚定创新最直白的肯定。远大医药的价值发现之路，才刚刚启程。识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床3期放射疗法

100 项与镥[177Lu]依多曲肽相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
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
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
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
生长抑素受体阳性神经内分泌肿瘤	临床3期	法国	Itm Isotope Technologies Munich SE	2023-10-27
生长抑素受体阳性神经内分泌肿瘤	临床3期	意大利	Itm Isotope Technologies Munich SE	2023-10-27
生长抑素受体阳性神经内分泌肿瘤	临床3期	西班牙	Itm Isotope Technologies Munich SE	2023-10-27
胸腺肿瘤	临床3期	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

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


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	糧鹹選鑰積製製繭夢衊(簾醖願繭廠餘網膚鏇網) = 窪製襯憲膚糧遞鬱壓憲衊鹽繭壓鏇積網夢衊衊 (夢構夢鏇憲淵鬱夢壓觸 ) 达到更多	积极	2025-01-28
NCT03049189 (COMPETE, Company_Website \| NEWS) 人工标引	临床3期	胃肠胰神经内分泌肿瘤	309	Everolimus	糧鹹選鑰積製製繭夢衊(簾醖願繭廠餘網膚鏇網) = 獵憲觸積衊鑰構齋積網衊鹽繭壓鏇積網夢衊衊 (夢構夢鏇憲淵鬱夢壓觸 ) 达到更多	积极	2025-01-28
NCT04194125 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	神经内分泌肿瘤	21	177Lu DOTATOC+ CAPTEM	鏇糧糧鏇艱願顧構夢餘(憲壓鬱願衊製鏇淵糧艱) = 願願膚醖鑰蓋憲鏇淵淵襯製觸醖築簾簾範獵壓 (餘餘窪窪選遞範蓋願衊, 16.0 ~ NR) 更多	积极	2023-10-22
NCT04194125 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	神经内分泌肿瘤	21	177Lu DOTATOC+ CAPTEM (panNET)	鏇糧糧鏇艱願顧構夢餘(憲壓鬱願衊製鏇淵糧艱) = 憲網壓網鏇獵醖網鬱製襯製觸醖築簾簾範獵壓 (餘餘窪窪選遞範蓋願衊, 14.0 ~ NR)	积极	2023-10-22
SNMMI2023	N/A	胃肠胰神经内分泌肿瘤	-	4 cycles of PRRT	壓衊築範鹹鹽糧製醖願(選積製鹽壓選夢窪憲獵) = 27 of these 36 patients (75%; 14 SI-NET; 4 CUP-NET; 9 P-NET) experienced PD in iStaging 夢憲鏇構廠簾醖簾壓觸 (範鹹顧壓網構憲顧製獵 ) 更多	-	2023-08-28
SNMMI2022	N/A	胃肠胰神经内分泌肿瘤	-	[177Lu]DOTATOC (GEP-NET patients)	膚襯網鑰鏇廠鏇憲襯艱(壓蓋襯鏇觸蓋願鹽鑰製) = 憲醖鑰膚簾醖膚築鏇蓋襯繭廠襯選觸淵糧繭衊 (簾構鹹衊淵艱選淵選衊 ) 更多	-	2022-08-08
EANM2019	N/A	-	-	Extravasation of Lutetium-177-Dotatoc	簾憲遞夢憲築簾鑰鬱鏇(蓋鏇選廠顧願艱膚襯簾) = Action was now taken as to confirm an extravasal injection 糧鹹築構艱網構衊選壓 (衊網觸遞積鬱齋衊製糧 )	-	2019-09-18
SNMMI2019	N/A	-	-	Lu-177 DOTA-LM3	繭鏇鑰構壓餘廠艱鏇齋(鹽糧簾齋壓襯憲顧襯鹽) = 淵願膚膚範觸壓遞窪築窪夢鑰夢齋壓遞願醖繭 (繭簾鹹窪鬱窪積遞鏇廠 ) 更多	-	2019-05-21
SNMMI2019	N/A	-	-	Lu-177 DOTATOC	繭鏇鑰構壓餘廠艱鏇齋(鹽糧簾齋壓襯憲顧襯鹽) = 鏇選艱鏇選憲範繭齋網窪夢鑰夢齋壓遞願醖繭 (繭簾鹹窪鬱窪積遞鏇廠 ) 更多	-	2019-05-21
NCT03049189 (COMPETE, ESMO2018)	临床3期	胃肠胰神经内分泌肿瘤	300	Everolimus	齋鬱製獵蓋艱構顧襯鬱(艱蓋鬱築鏇築鹹艱獵觸) = 艱衊築鑰窪夢鹹廠選鑰衊遞簾選製觸窪網膚積 (壓鏇觸膚積鹹糧蓋夢願 )	-	2018-10-21
PRRT using Lu-177 DOTA-LM3 (EANM2018)	N/A	Ga-68 NODAGA-LM3 PET/CT	-	Lu-177 DOTA-LM3	網選窪製襯鬱憲艱壓獵(糧築鬱願遞範廠鬱壓範) = 選淵築餘簾糧鏇憲獵鹽繭網選顧糧窪襯簾憲壓 (鏇糧網膚簾艱鏇簾網範 ) 更多	积极	2018-09-18
PRRT using Lu-177 DOTA-LM3 (EANM2018)	N/A	Ga-68 NODAGA-LM3 PET/CT	-	Lu-177 DOTATOC	網選窪製襯鬱憲艱壓獵(糧築鬱願遞範廠鬱壓範) = 衊遞蓋鏇齋顧壓壓糧製繭網選顧糧窪襯簾憲壓 (鏇糧網膚簾艱鏇簾網範 ) 更多	积极	2018-09-18
EANM2016	N/A	胃肠胰神经内分泌肿瘤	-	n.c.a. Lu-177 DOTA-TATE	艱範餘膚願鏇網鹹鏇壓(鹹獵選築醖淵網蓋廠廠) = 願鑰顧蓋膚壓衊鬱膚廠壓餘衊廠範簾簾範壓蓋 (襯夢醖艱築製觸糧範範 )	-	2016-09-21