A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).

The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to <18 years of age with somatostatin receptor (SSTR)-positive tumors.

开始日期2025-01-01

申办/合作机构

ITM Solucin GmbH

NCT05918302 / Recruiting临床3期IIT

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

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori SRL

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）

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 ; Meckel, Marian ; van Echteld, Cees J A ; 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 ; Grundler, Pascal V ; van der Meulen, Nicholas P ; Talip, Zeynep ; Köster, Ulli ; Sepini, Lebogang ; Schibli, Roger ; Müller, Cristina ; Geistlich, Susanne ; Favaretto, Chiara

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）

2024-11-29

·远大医药官微

远大医药全球创新RDC药物TLX250-CDx国内III期临床研究完成首例患者入组给药

TLX250-CDx已于2020年7月获美国FDA突破性疗法认定； TLX250-CDx海外III期临床研究结果表明，其有望为临床提供一种准确性高且无创的ccRCC诊断方案，并有潜力成为全新的ccRCC临床诊断标准；目前，远大医药是进入中国III期临床研究中诊断和治疗类RDC创新药总计储备最多的企业，也是全球范围内在核药抗肿瘤领域拥有最丰富产品管线和诊疗一体化布局的创新药企之一。近日，远大医药(0512.HK)用于诊断肾透明细胞癌(ccRCC)的全球创新放射性核素偶联药物(RDC) TLX250-CDx在中国开展的III期临床研究已完成首例患者入组并给药。这是远大医药在核药抗肿瘤诊疗领域的又一次重大的研发进展。 TLX250-CDx全球研发进展顺利关于TLX250-CDx及其临床研究 TLX250-CDx (89Zr-TLX250)是一款全球创新的适用于ccRCC诊断的放射性核素偶联药物，其靶点为碳酸酐酶IX (CAIX)，CAIX在ccRCC和其他许多癌种中过度表达。基于其可能在最常见且最具侵袭性的一种肾癌——ccRCC的无创诊断以及患者后续治疗与管理决策方面产生重要突破，TLX250-CDx在2020年7月获美国FDA突破性疗法认定。本次临床研究是一项单臂、开放标签的III期临床研究，拟入组82名不确定性肾肿块患者，旨在评估TLX250-CDx通过正电子发射断层显像/计算机断层扫描(PET/CT)成像对患者进行无创检测ccRCC的安全性、耐受性以及有效性。 TLX250-CDx海外III期临床研究(ZIRCON)已于2022年11月成功达到全部主要临床终点和次要临床终点。试验结果显示，对于通过目前临床常用诊断方法电子计算器断层扫描(CT)或磁共振成像(MRI)提示存在肾脏肿块但无法判断是否为ccRCC的患者，TLX250-CDx通过正电子发射断层成像(PET)在诊断ccRCC的敏感性和特异性上分别达到86%和87%，远超过美国FDA要求的预设阈值（敏感性和特异性均大于或等于70%），阳性预测值可达93%。此外，针对目前难以诊断的处于T1a期的早期ccRCC（即肿瘤局限于肾内，肿瘤最大径少于或等于4cm），TLX250-CDx诊断的敏感性和特异性分别达到85%和89%。这些突破性的临床结果表明，TLX250-CDx将有望为临床提供一种准确性高且无创的ccRCC诊断方案，并有潜力成为全新的ccRCC临床诊断标准。 TLX250-CDx将于2024年12月向FDA递交生物制品上市许可申请(BLA)，并申请优先审评，若TLX250-CDx成功获批，该产品有望成为美国肾癌领域首个靶向放射性药物成像剂。中国注册方面，TLX250-CDx于2022年9月底获批开展I/III期临床研究，并于2024年上半年完成了I期临床研究，目前III期临床研究已完成首例患者入组。此次TLX250-CDx的III期临床研究首例患者入组将进一步加快该产品在中国的上市进程。持续推进创新产品研发夯实全球核药领军地位核药抗肿瘤诊疗板块是远大医药的重点布局的领域之一。围绕肿瘤诊疗一体化的治疗理念，公司核药抗肿瘤诊疗板块目前已储备12款创新产品，涵盖68Ga、177Lu、131I、90Y、89Zr在内的5种放射性核素，覆盖了肝癌、前列腺癌、脑癌等在内的7个癌种；在产品种类方面，涵盖诊断和治疗两类核素药物，为患者提供多适应症治疗选择、多手段且诊疗一体化的全球领先的抗肿瘤方案。目前，远大医药在核药抗肿瘤诊疗板已有4款 RDC创新药获批开展临床研究，其中3款已进入III期临床阶段，包括诊断前列腺癌的产品TLX591-CDx、诊断透明细胞肾细胞癌产品TLX250-CDx，以及治疗GEP-NETs的产品ITM-11。截至目前，远大医药是进入中国III期临床研究中诊断和治疗类RDC创新药总计储备最多的企业，也是全球范围内在核药抗肿瘤领域拥有最丰富产品管线和诊疗一体化布局的创新药企之一。关于远大医药核药抗肿瘤诊疗平台核药抗肿瘤诊疗平台是公司在抗肿瘤领域重点打造的高端技术平台，目前本集团已实现了研发、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。远大医药联合Sirtex Medical Pty Limited并与Telix Pharmaceutical Limited (ASX: TLX, Nasdaq: TLX)和ITM Isotope Technologies Munich SE合作，搭建了具有国际化一流水平的肿瘤介入研发平台和RDC药物研发平台，已拥有近650名员工，是本集团全球化程度最高的板块之一。同时，公司与山东大学联合成立了远大医药-山东大学放射药物研究院，并以该研究院为核心建立了核药早期研发平台，进行RDC药物的自主研发。目前早期研发阶段的产品储备已达12款。远大医药正在有序推进甲级资质核素生产平台的建设。未来，公司将持续加强核药抗肿瘤诊疗板块的研发和建设，丰富和完善产品管线及产业布局，形成以易甘泰®钇[90Y]微球注射液为核心的核药抗肿瘤诊疗产品集群，持续夯实公司在全球核药抗肿瘤诊疗领域领军企业地位。远大医药集团有限公司董事会表示：“本集团一直高度重视创新产品和先进技术的研发，未来将持续加大对全球创新产品和先进技术的投入，丰富和完善产品管线及产业布局，坚持‘全球化运营布局，双循环经营发展’策略，充分发挥本集团的产业优势和研发实力，快速将科技创新产品落地上市，为全球患者提供更先进更多样的治疗方案。” 大家都在看 ▲聆听“新”声 | 远大医药新员工“拍了拍”你 ▲ 创新疗法引入中国让中晚期肝癌患者看到希望 ▲警惕！立冬已至，这几类疾病进入高发期 ↑↓ 上下滑动了解更多 ➤关于远大医药远大医药是一家科技创新型国际化医药企业，核心业务横跨制药科技、核药抗肿瘤诊疗及心脑血管精准介入诊疗科技、生物科技三大领域。公司以医药及生物工业为基础，以患者需求为核心，以科技创新为源动力，针对尚未满足的临床需求，加大对全球创新产品和先进技术的投入，丰富和完善产品管线，巩固和强化产业链布局，充分发挥产业优势和研发实力，为全球患者提供更先进更多样的治疗方案。「稳增长、强创新、谋布局」，远大医药将继续秉承「综合优势、创新引领和全球拓展」的发展理念，采用「自主研发和全球拓展双轮驱动，全球化运营布局和双循环经营发展」策略，形成国内国外双循环联动发展并相互促进的新格局，致力于成为一家受医生和患者尊重并还原于社会的科技创新型国际化医药企业。 ➤前瞻性声明本新闻稿中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本集团有关的，均属于前瞻性表述。本集团并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本集团管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险不确性及其他因素的影响，有些是超出本集团的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本集团、本集团董事及雇员代理概不承担(1)更正或更新本网站所载前瞻性表述的任何义务;及(2)若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

临床3期突破性疗法优先审批

2024-10-31

·远大医药官微

中西结合共筑鼻咽喉健康 | 远大医药亮相全国耳鼻咽喉头颈外科学术会议

近日，中华医学会第二十一次耳鼻咽喉头颈外科学术会议在安徽省合肥市滨湖国际会展中心如期举办。为促进我国耳鼻咽喉头颈外科学学科繁荣发展，本次大会邀请了来自各地的专家学者齐聚一堂，交流学术思想，讨论学科前沿问题，分享最新研究进展。会议内容聚焦耳科及侧颅底外科、鼻科及鼻颅底外科、头颈外科、咽喉嗓音等，旨在搭建不同学术思想融合，产学研结合转化，为医学发展服务，为医、患服务的综合交流平台，推动耳鼻咽喉头颈外科学进步与创新。远大医药深耕五官科领域，为推进五官科事业蓬勃发展，公司旗下西安碑林药业、湖北远大天天明两家成员企业应邀参加本次会议，积极支持中国耳鼻咽喉头颈外科的高质量发展。会议期间，公司携旗下企业喉科中成药、鼻科化药产品亮相大会展台。展出的产品有喉科中成药产品：金嗓开音胶囊/颗粒、金嗓散结胶囊/颗粒、金嗓清音胶囊、金嗓利咽胶囊。鼻科化药产品：诺通®盐酸赛洛唑啉鼻用喷雾剂/滴鼻液（10ml:10mg;10ml:5mg）、晶通®高渗海水鼻腔喷雾器。中西结合，锚定耳鼻咽喉头颈外科，护嗓通窍，多领域协同发展。为增进与会专家的学术热情，本次会议特举办了第六届“金嗓灵”专家论坛，邀请八位学术大咖分享疾病最新诊疗进展以及临床用药体会，分享的内容包括声带息肉的个体化治疗、经口弧形喉镜咽喉手术、嗓音病的治疗、内镜下喉癌微创手术分类标准解读、咽喉反流性疾病（LPR）最新研究总结-2024年更新版、科学用嗓与咽喉保健、职业用嗓人群常见嗓音疾病的治疗、婴幼儿呼吸困难常见疾病的诊治。讲座现场座无虚席，学术氛围浓厚。会议当中，展台通过举办扫码签到、问卷调查等活动与到场专家进行临床答疑、产品满意度调查等。通过和专家面对面沟通，提供产品新信息、维护用户新需求、拓展产品新方向，积极推动公司五官科领域稳步发展。会场内人头攒动，专家热情高涨，对公司产品传达了高度满意和正面评价的反馈。远大医药于五官科板块在售产品管线数量位居行业前列，治疗领域覆盖包括眼科、耳鼻喉科、口腔科等多科室疾病，覆盖了化学制剂、中药制剂及健康产品，包含处方药、OTC、器械、消费品等几大类别，院内院外全渠道覆盖，打造集“保健+治疗+预防”为一体的“大五官生态圈”。我们将始终秉持中西结合理念，响应国家健康中国战略的号召，为患者提供高质量产品，为市场注入多元动力，打造五官科“好产品”，守护鼻咽喉健康，助力人民健康防线的搭建。 ▲创新疗法引入中国让中晚期肝癌患者看到希望 ▲ 临床试验招募 | 远大医药招募偏头痛患者 ▲远大医药全球创新放射性核素偶联药物ITM-11国内III期临床试验申请获药监局受理 ↑↓ 上下滑动了解更多 ➤关于远大医药远大医药（0512.HK）是一家科技创新型国际化医药企业，核心业务横跨制药科技、核药抗肿瘤诊疗及心脑血管精准介入诊疗科技、生物科技三大领域。集团以医药及生物工业为基础，以患者需求为核心，以科技创新为源动力，针对尚未满足的临床需求，加大对全球创新产品和先进技术的投入，丰富和完善产品管线，巩固和强化产业链布局，充分发挥本集团的产业优势和研发实力，为全球患者提供更先进更多样的治疗方案。经过近年的不懈努力，本集团发展基础更加稳健，经营规模更加巩固，业务结构逐步优化，经营方式持续提升，转型升级步伐加快，创新布局多点开花。本集团盈利能力持续增强，助力研发创新；良好的并购与整合能力，继续巩固发展规模；原料制剂一体化，完善产业链结构；业务与实体多元化，有效加强综合优势。 “稳增长、强创新、谋布局”，本集团将继续秉承“综合优势、创新引领和全球拓展”的发展理念，采用“自主研发和全球拓展双轮驱动，全球化运营布局和双循环经营发展”策略，形成国内国外双循环联动发展并相互促进的新格局，致力于成为一家受医生和患者尊重并还原于社会的科技创新型国际化医药企业。 ➤前瞻性声明本新闻稿中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本集团有关的，均属于前瞻性表述。本集团并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本集团管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险不确性及其他因素的影响，有些是超出本集团的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本集团、本集团董事及雇员代理概不承担(1)更正或更新本网站所载前瞻性表述的任何义务;及(2)若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

2024-10-22

·远大医药官微

远大医药首款国产可调节颅内取栓支架产品获药监局批准上市

鸬鹚是首款国产的可调节颅内取栓支架产品，其上市将为急性缺血性卒中取栓治疗提供新的选择；根据弗若斯特沙利文数据，中国急性缺血性卒中致残率超过30%，一年病死率超过15%；远大医药心脑血管精准介入诊疗板块已布局14款产品，其中通路管理方向已有9款产品在中国获批上市。近日，远大医药(0512.HK)与联营公司南京凯尼特医疗技术有限公司共同研发的用于治疗急性缺血性卒中的可调节颅内取栓支架产品(鸬鹚)近日获得国家药监局颁发医疗器械注册证书。这是公司在心脑血管精准介入诊疗领域神经介入方向的又一次里程碑进展。关于鸬鹚鸬鹚是首款国产的可调节颅内取栓支架产品。该款支架采用圆丝编织结构设计，可在体外进行手动调控至理想直径以匹配目标血管，同时支架植入过程中全程可视、全程显影，能够更好的辅助术者根据血栓部位与总长度，来调节支架以更好的适应闭塞血管，实现更高的血管再通率。根据注册性临床研究的结果，试验组鸬鹚和对照组美敦力的Solitaire FR血管成功再通率分别为98.3%和95.8%；第一次取栓后血管成功再通率分别为68.9%和68.0%；术后24小时症状性颅内出血发生率分别为2.7%和3.4%；术后90天严重不良事件发生率分别为32.8%和35.3%。该研究结果表明，鸬鹚用于急性缺血性卒中患者的血管内治疗是安全和有效的。关于急性缺血性卒中急性缺血性卒中(acute ischemic stroke, AIS)又称脑梗死，发作后的24小时内往往会留下后遗症且常因病情危重而死亡。根据弗若斯特沙利文数据，中国AIS致残率超过30%，一年病死率超过15%。从2017年到2021年，中国急性缺血性卒中发病人数从323.2万人增长到376.6万人，年复合年增长率为3.9%。到2026年和2032年，中国急性缺血性卒中发病人数将增长到约479.5万人和597.2万人。目前临床上治疗AIS的方法主要是静脉溶栓和介入治疗，静脉溶栓首选用于治疗发病在4.5小时内的AIS患者，相比之下，介入治疗的治疗窗口期则相对较长，而介入治疗中首选就是机械取栓治疗。目前临床上普遍应用的取栓支架大多为统一直径大小，遇到较大或较窄血管闭塞部位往往无法适应，为手术的顺利开展造成了困扰。鸬鹚的可调节特性，一方面提高了支架与血栓嵌合能力，提高了手术的有效性，另一方面减少了对血管的损伤，提高了手术的安全性。此外，鸬鹚为全支架显影，更便于医生精准操作，鸬鹚的上市将为急性缺血性卒中取栓治疗提供新的选择。持续推进高端医疗器械研发打造全球领先精准介入诊疗平台心脑血管精准介入诊疗领域是远大医药核心战略领域之一，公司秉承“介入无植入”的治疗理念，围绕通路管理、结构性心脏病、电生理以及心衰三个方向进行全方位布局，搭建高端医疗器械产品集群，目前该板块已布局14款产品，其中通路管理方向已有9款产品在中国获批上市。远大医药在该板块已实现“无源+有源”创新器械平台的全面建设，其中，武汉光谷有源器械研发生产基地和常州无源器械研发生产基地已投入使用，聚焦结构性心脏病领域的上海器械研发中心正式揭牌成立。目前该板块已经和加拿大、德国、意大利、瑞士等多国临床中心或者研发平台进行技术合作，逐步开启迈向全球化研发新进程。公司致力于将该板块打造成为中国乃至全球领先的“心脑血管精准介入诊疗平台”。远大医药集团有限公司董事会表示：“本集团一直高度重视创新产品和先进技术的研发，未来将持续加大对全球创新产品和先进技术的投入，丰富和完善产品管线及产业布局，坚持‘全球化运营布局，双循环经营发展’策略，充分发挥本集团的产业优势和研发实力，快速将科技创新产品落地上市，为全球患者提供更先进更多样的治疗方案。” 大家都在看 ▲临床试验招募 | 远大医药招募偏头痛患者 ▲ 砥砺三载共赴山海 | 数说钇90这三年 ▲远大医药全球创新放射性核素偶联药物ITM-11国内III期临床试验申请获药监局受理 ↑↓ 上下滑动了解更多 ➤关于远大医药远大医药是一家科技创新型国际化医药企业，核心业务横跨制药科技、核药抗肿瘤诊疗及心脑血管精准介入诊疗科技、生物科技三大领域。公司以医药及生物工业为基础，以患者需求为核心，以科技创新为源动力，针对尚未满足的临床需求，加大对全球创新产品和先进技术的投入，丰富和完善产品管线，巩固和强化产业链布局，充分发挥产业优势和研发实力，为全球患者提供更先进更多样的治疗方案。「稳增长、强创新、谋布局」，远大医药将继续秉承「综合优势、创新引领和全球拓展」的发展理念，采用「自主研发和全球拓展双轮驱动，全球化运营布局和双循环经营发展」策略，形成国内国外双循环联动发展并相互促进的新格局，致力于成为一家受医生和患者尊重并还原于社会的科技创新型国际化医药企业。 ➤前瞻性声明本新闻稿中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本集团有关的，均属于前瞻性表述。本集团并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本集团管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险不确性及其他因素的影响，有些是超出本集团的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本集团、本集团董事及雇员代理概不承担(1)更正或更新本网站所载前瞻性表述的任何义务;及(2)若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

上市批准临床研究

100 项与镥[177Lu]依多曲肽相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
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	2024-12-12
SSTR阳性胃肠胰神经内分泌肿瘤	临床3期	中国	ITM Solucin GmbH	2024-12-12
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
Somatostatin Receptor-Positive Neuroendocrine Tumor	临床3期	法国	Itm Isotope Technologies Munich SE	2023-10-27
Somatostatin Receptor-Positive Neuroendocrine Tumor	临床3期	意大利	Itm Isotope Technologies Munich SE	2023-10-27
Somatostatin Receptor-Positive Neuroendocrine Tumor	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

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临床结果

适应症

分期

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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


NCT04194125 (ESMO2023) 人工标引	临床2期	神经内分泌肿瘤	21	177Lu DOTATOC+ CAPTEM	範築願襯願積淵遞範糧(築選鏇簾糧襯繭憲憲廠) = 網願網觸艱膚齋淵齋廠鹹構鑰艱選醖鹽壓願構 (鹹顧壓淵簾壓製糧遞蓋, 16.0 ~ NR) 更多	积极	2023-10-22
NCT04194125 (ESMO2023) 人工标引	临床2期	神经内分泌肿瘤	21	177Lu DOTATOC+ CAPTEM (panNET)	範築願襯願積淵遞範糧(築選鏇簾糧襯繭憲憲廠) = 顧獵衊網窪鹹淵餘醖醖鹹構鑰艱選醖鹽壓願構 (鹹顧壓淵簾壓製糧遞蓋, 14.0 ~ NR)	积极	2023-10-22
SNMMI2022	N/A	胃肠胰神经内分泌肿瘤	-	[177Lu]DOTATOC (GEP-NET patients)	窪簾壓獵簾憲夢壓鹹鑰(遞鑰構齋壓網獵鹹繭獵) = 遞獵選齋遞構獵鹹簾觸窪壓艱鏇選遞壓壓獵遞 (淵艱壓鹽齋膚築廠糧鑰 ) 更多	-	2022-08-08
NCT03049189 (COMPETE, ESMO2018)	临床3期	胃肠胰神经内分泌肿瘤	300	Everolimus	築壓糧鑰糧繭醖構淵觸(廠積衊鏇積範鹹築餘簾) = 鬱餘蓋鏇積鬱遞獵糧餘壓觸壓膚鹹選構獵鑰獵 (齋淵願觸積網選窪鹹餘 )	-	2018-10-21