A Confirmatory, Open-label, Single-arm, Multi-centre Study to Evaluate Safety, Tolerability and Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) to Non-invasively Detect Clear Cell Renal Cell Carcinoma (ccRCC) by Positron Emission Tomography/Computed Tomography (PET/CT) Imaging in Chinese Patients With Indeterminate Renal Masses (ZIRCON-CP Study)

89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma, and this Phase 3 bridging study in mainland Chinese patients is intended to support the successful ZIRCON data (ZIRCON Clinicaltrial.gov ID: NCT03849118)

开始日期2024-11-06

申办/合作机构

Telix Pharmaceuticals Ltd.

NCT06447103 / Recruiting临床2期IIT

89Zr-DFO-GmAb PET/CT vs Contrast-Enhanced CT for Detection of Recurrent Clear Cell Renal Cell Carcinoma After Surgery

This phase II trial compares the safety and effectiveness of 89Zr-DFO-GmAb positron emission tomography (PET)/computed tomography (CT) compared to contrast-enhanced CT after surgery in detecting clear cell renal cell cancer that has come back (recurrent). For some patients, the risk of recurrence after surgery remains high. Conventional CT methods, such as contrast-enhanced CT, may not detect small volume or micrometastatic disease. PET/CT with radiotracers, such as 89Zr-DFO-GmAb, may improve detection of tumor cells. Girentuximab (GmAb), a monoclonal antibody, is tagged with zirconium-89, a radioactive atom (which is also known as an isotope). The zirconium-89 (89Zr) isotope is attached to girentuximab with desferrioxamine (DFO) and this combined product is called 89Zr-DFO-girentuximab. 89Zr-DFO-girentuximab attaches itself to a protein on the surface of clear cell renal cell tumor cells called CAIX. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 89Zr-DFO-GmAb. Because some cancers, including clear cell renal cell cancer, take up 89Zr-DFO-GmAb it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Using contrast agents with CT scan to enhance the images (contrast-enhanced CT) is standard of care imaging. 89Zr-DFO-GmAb PET/CT may be safe and effective compared to contrast-enhanced CT in detecting recurrent clear cell renal cell cancer after surgery.

开始日期2024-08-06

申办/合作机构

Jonsson Comprehensive Cancer Center

[+1]

NCT05861778 / Completed临床1期

An Open-label, Phase I Study to Evaluate the Safety, Radiation Dosimetry and Pharmacokinetics of 89Zr-TLX250 PET/CT in Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma

The study is designed to evaluate the safety, tolerability, radiation dosimetry and pharmacokinetics 89Zr-TLX250 (also known as 89Zr-DFO-girentuximab) Positron Emission Tomography/Computed Tomography (PET/CT) in adult Chinese patients with indeterminate renal masses or Suspected Recurrent Renal Clear Cell Carcinoma

开始日期2023-06-26

申办/合作机构

Telix International Pty Ltd

[+1]

100 项与锆[89Zr]吉伦妥昔单抗相关的临床结果

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100 项与锆[89Zr]吉伦妥昔单抗相关的转化医学

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100 项与锆[89Zr]吉伦妥昔单抗相关的专利（医药）

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项与锆[89Zr]吉伦妥昔单抗相关的文献（医药）

2024-11-01·Med

[89Zr]Zr-girentuximab PET-CT imaging to diagnose, characterize, and differentiate clear-cell renal cell carcinoma

Article

作者: Agarwal, Neeraj ; Hage Chehade, Chadi ; Gebrael, Georges

In the phase 3 ZIRCON trial, [⁸⁹Zr]Zr-girentuximab positron emission tomography-computed tomography (PET-CT) detected the presence of clear-cell renal cell carcinoma (ccRCC) with a sensitivity of 86% and a specificity of 87% in patients with an indeterminate renal mass undergoing nephrectomy.¹ This imaging technique could be a promising tool that could revolutionize the management of small renal masses (SRMs) and ccRCC.

2024-10-01·EUROPEAN UROLOGY

Re: [89Zr]Zr-Girentuximab for PET–CT Imaging of Clear-cell Renal Cell Carcinoma: A Prospective, Open-label, Multicentre, Phase 3 Trial

Article

作者: Serni, Sergio ; Campi, Riccardo ; Pecoraro, Alessio ; Granata, Salvatore

A review.Girentuximab, a chimeric monoclonal antibody, targets carbonic anhydrase 9, a tumor-associated antigen that is highly expressed in ccRCC. Previous phase 1/2 trials showed the favorable safety profile of 89Zr-girentuximab and its potential impact on clin. decision-making.ZIRCON enrolled patients with an indeterminate cT1 renal mass suspicious for ccRCC who were scheduled for nephrectomy at 36 research hospitals and practices across nine countries over a 3-yr period (August 2019-July 2022).Patients received a single i.v. dose of 89Zr-girentuximab (37 MBq ±10%; 10 mg of girentuximab) at 5 d (±2 d) before abdominal PET/CT imaging.Viewed from this perspective, the ZIRCON trial is arguably a first effort towards change in real-world clin. practice.Several unknowns still need to be addressed, and further steps are needed to make this change happen.In summary, ZIRCON has identified exciting new frontiers in the field of RCC diagnosis.The trial results can inspire clinicians and scientists to move away from the dogma of ′′surgical biopsy′′ and embrace the paradigm of (noninvasive) renal mass characterization before treatment decisions, a well-established principle in modern oncol.The challenge for the scientific community is to design the next trials that should provide the evidence base to move the field forward.

2024-10-01·LANCET ONCOLOGY

[89Zr]Zr-girentuximab for PET–CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial

Article

作者: Scott, Andrew M ; Hayward, Colin R W ; Pandit-Taskar, Neeta ; Merkx, Robin ; Lee, Sze Ting ; Tauchmanova, Libuse ; Önal, Bülent ; van Praet, Charles ; Behrenbruch, Christian ; Schmidt, Karl ; Schuster, David M ; Pantuck, Allan J ; Mulders, Peter ; Allman, Phillip ; Bailly, Clement ; Aksoy, Tamer ; Shuch, Brian ; Master, Viraj ; Wheatcroft, Michael ; Fan, Alice C ; Morris, Michael A ; Bernhard, Jean-Christophe

BACKGROUND:

With limitations of conventional imaging and biopsy, accurate, non-invasive techniques to detect clear-cell renal cell carcinoma in patients with renal masses remain an unmet need. ⁸⁹Zr-labelled monoclonal antibody ([⁸⁹Zr]Zr-girentuximab) has high affinity for carbonic anhydrase 9, a tumour antigen highly expressed in clear-cell renal cell carcinoma. We aimed to evaluate [⁸⁹Zr]Zr-girentuximab PET-CT imaging for detection and characterisation of clear-cell renal cell carcinoma.

METHODS:

ZIRCON was a prospective, open-label, multicentre, phase 3 trial conducted at 36 research hospitals and practices across nine countries (the USA, Australia, Canada, the UK, Türkiye, Belgium, the Netherlands, Spain, and France). Patients aged 18 years or older with an indeterminate renal mass 7 cm or smaller (cT1) suspicious for clear-cell renal cell carcinoma and scheduled for nephrectomy received a single dose of [⁸⁹Zr]Zr-girentuximab (37 MBq ±10%; 10 mg girentuximab) intravenously followed by abdominal PET-CT imaging 5 days (±2 days) later. Surgery was performed no later than 90 days after administration of [⁸⁹Zr]Zr-girentuximab. Blinded central review, conducted by three independent readers, determined the histology from surgical samples. The coprimary endpoints, determined for each individual reader, were the sensitivity and specificity of [⁸⁹Zr]Zr-girentuximab PET-CT imaging to detect clear-cell renal cell carcinoma, with histopathological confirmation as standard of truth. Analyses were on the full analysis set of patients, defined as patients who had evaluable PET-CT imaging and a confirmed histopathological diagnosis. The trial is registered with ClinicalTrials.gov, NCT03849118, and EUDRA Clinical Trials Register, 2018-002773-21, and is closed to enrolment.

FINDINGS:

Between Aug 14, 2019, and July 8, 2022, 371 patients were screened for eligibility, 332 of whom were enrolled. 300 patients received [⁸⁹Zr]Zr-girentuximab (214 [71%] male and 86 [29%] female). 284 (95%) evaluable patients were included in the primary analysis. The mean sensitivity was 85·5% (95% CI 81·5-89·6) and mean specificity was 87·0% (81·0-93·1). No safety signals were observed. Most adverse events were not or were unlikely to be related to [⁸⁹Zr]Zr-girentuximab, with most (193 [74%] of 261 events) occurring during or after surgery. The most common grade 3 or worse adverse events were post-procedural haemorrhage (in six [2%] of 261 patients), urinary retention (three [1%]), and hypertension (three [1%]). In 25 (8%) of 300 patients, 52 serious adverse events were reported, of which 51 (98%) occurred after surgery. There were no treatment-related deaths.

INTERPRETATION:

Our results suggest that [⁸⁹Zr]Zr-girentuximab PET-CT has a favourable safety profile and is a highly accurate, non-invasive imaging modality for the detection and characterisation of clear-cell renal cell carcinoma, which has the potential to be practice changing.

FUNDING:

Telix Pharmaceuticals.

项与锆[89Zr]吉伦妥昔单抗相关的新闻（医药）

2025-01-02

·远大医药官微

远大医药全球创新温度敏感性栓塞剂在中国的注册性临床研究完成首例患者入组

GPN00289是一款获得国家药监局创新型医疗器械资质认定的温度敏感性栓塞材料； GPN00289具有温度响应且可塑高的特点，可随温度的变化发生液固相转变，对大小不同、形状各异的血管都能进行栓塞； GPN00289具有载药功能，除了可以与现有化疗药物进行联用外，还有望与远大医药全球创新的内放射性治疗药物易甘泰®钇[90Y]微球注射液进行联用。近日，远大医药(0512.HK)全球创新温度敏感性栓塞剂产品GPN00289在中国开展的用于原发性肝癌经动脉化疗栓塞的注册性临床研究完成了首例患者入组。该研究是一项前瞻性、多中心、随机、平行对照临床研究，旨在评估GPN00289用于原发性肝癌经动脉化疗栓塞的安全性和有效性。此次GPN00289的注册性临床研究完成首例患者入组是远大医药在核药抗肿瘤诊疗领域在肿瘤介入方向上的又一次重大的研发进展。已获创新型医疗器械资质认定关于GPN00289 GPN00289是一款获得国家药监局创新型医疗器械资质认定的温度敏感性栓塞材料，用于治疗富血管的良性及恶性肿瘤。该产品具有温度响应且可塑高的特点，可随温度的变化发生液固相转变，对大小不同、形状各异的血管都能进行栓塞。于常温下，该产品具有良好的流动性，通过微导管输送到病变组织的血管后，在人体温度下形成从末梢血管到主供血管的原位固化，可实现对病变组织末梢血管的完全栓塞，能有效防止侧支循环的形成，对动脉血流的阻断更完全、更持久有效，适用于各种富血管性实质脏器肿瘤，特别是肝脏富血管的良性及恶性肿瘤的栓塞治疗。同时，该产品具有可降解特性，可使得血管获得多次治疗机会，并减少持久栓塞造成的不良反应，安全性高，且可实时显影，满足手术精准操作需求。此外，GPN00289具有载药功能，除了可以与现有化疗药物进行联用外，还有望与远大医药全球创新的内放射性治疗药物易甘泰®钇[90Y]微球注射液进行联用，一方面，可以进一步提升对肝癌的治疗效果，另一方面，也有望拓展易甘泰®钇[90Y]微球注射液的潜在适应症。该产品于2024年7月进入注册性临床研究阶段。关于原发性肝癌原发性肝癌是全球第六大常见癌症和第三大癌症死亡原因。2022年全球新增原发性肝癌约87万例，新增原发性肝癌相关死亡约76万例，其中中国原发性肝癌新增病例约37万例（占比42.5%），新增死亡约32万例（占比42.1%），均居全球首位。目前，外科手术依旧是肝癌的根治性治疗手段，然而，由于中国肝癌高危人群早期诊断率低，导致70%～80%的患者在诊断时已经是中晚期，且绝大多数患者已不适合手术切除。临床上针对中晚期肝癌患者最经典的治疗手段是经导管动脉化疗栓塞术(TACE)，常规TACE主要分为以碘化油化疗药物乳剂为主的液体栓塞和以颗粒型栓塞剂为主的固体栓塞，固体栓塞栓塞效果好，但是进入末梢血管比较困难。而液体栓塞虽然能栓塞末梢血管，但在体内会被快速清除，不能缓释药物，这些缺陷会影响TACE在肝癌治疗中的效果。 GPN00289结合了液体栓塞和固体栓塞的优势，集载药和栓塞为一体，可弥补现有TACE治疗手段的缺陷。持续推进创新产品研发夯实全球核药领军地位肿瘤介入方向是远大医药核药抗肿瘤诊疗板块重点布局的战略方向之一，全球销售网络覆盖50多个国家和地区，并已联合远大医药联营公司Sirtex Medical Pty Limited搭建了具有国际一流水平的肿瘤介入技术平台。远大医药核心产品易甘泰®已于2022年1月获得药监局的上市许可。该产品为中国肝脏恶性肿瘤患者提供了一种全新且有效的治疗方式，提供转化治疗并进而进行手术切除的机会，实现临床治愈，弥补了结直肠癌肝转移局部治疗的空白，改善中国肝癌患者群体的远期治疗效果，标志中国肝脏恶性肿瘤领域迎来了全新国际化精准介入治疗方案。另一款核心产品创新液体栓塞剂LavaTM于2023年4月获得美国FDA上市批准，并于2023年10月在美国正式商业化。该产品是美国首款也是唯一一款获得美国FDA批准的用于治疗外周血管动脉出血的创新液体栓塞剂。此次GPN00289的临床进展将有望为远大医药在肿瘤介入方向上提供更加多样化的产品组合，进一步夯实远大医药核药抗肿瘤诊疗板块的综合实力。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远大医药在抗肿瘤领域重点打造的高端技术平台，目前远大医药已实现了研发、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，是远大医药全球化程度最高的板块之一。同时，远大医药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。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。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，远大医药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，持续夯实远大医药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：“远大医药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，充分发挥远大医药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 ▲喜提恩施医药行业首个 “金护照”！八峰药化荣获海关AEO高级认证 ▲ 远大医药心脑血管精准介入诊疗板块三款重磅产品获批上市 ▲ 远大医药全球创新的治疗蠕形螨睑缘炎产品上市许可申请获国家药监局受理 ↑↓ 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。

放射疗法临床申请

2024-12-30

·PipelineReview

Telix Files TLX250-CDx (Zircaix®) BLA for Kidney Cancer Imaging

MELBOURNE, Australia and INDIANAPOLIS, IN, USA I December 30, 2024 I Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX250-CDx (Zircaix® 1 , 89 Zr- girentuximab) kidney cancer imaging 2 . TLX250-CDx is an investigational PET 3 drug product for the non-invasive diagnosis and characterization of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. If approved, TLX250-CDx will be the first and only targeted PET agent specifically for kidney cancer to be commercially available in the U.S., further building on Telix’s successful urology imaging franchise. The FDA is expected to advise the PDUFA 4 goal date following the 60-day administrative review of the application. Kevin Richardson, Chief Executive Officer, Precision Medicine at Telix, stated, “We are pleased to be progressing the BLA for TLX250-CDx, which has been granted Breakthrough designation, and may therefore be eligible for priority review. Telix continues to target a full U.S. commercial launch in 2025 addressing a major unmet medical need for patients with suspected ccRCC.” About TLX250-CDx TLX250-CDx (Zircaix® 1 ) is an investigational PET agent that is under development for the diagnosis and characterization of ccRCC. Telix’s pivotal Phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118 ) evaluating TLX250-CDx in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% positive-predictive value for ccRCC across three independent radiology readers 5 . Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC. Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of diagnostic and therapeutic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX). Telix’s lead imaging product, gallium-68 ( 68 Ga) gozetotide injection (also known as 68 Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA) 6 , by the Australian Therapeutic Goods Administration (TGA) 7 , and by Health Canada 8 . No other Telix product has received a marketing authorization in any jurisdiction. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn . 1 Brand name subject to final regulatory approval. 2 Telix ASX disclosure 31 July 2024. The FDA requested additional data demonstrating adequate sterility assurance during dispensing of TLX250-CDx in the radiopharmacy production environment. 3 Positron emission tomography. 4 Prescription Drug User Fee Act. 5 Shuch et al. Lancet Oncol. 2024. Telix ASX disclosures 7 November 2022. 6 Telix ASX disclosure 20 December 2021. 7 Telix ASX disclosure 2 November 2021. 8 Telix ASX disclosure 14 October 2022. SOURCE: Telix Pharmaceuticals

临床3期临床结果上市批准优先审批突破性疗法

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

100 项与锆[89Zr]吉伦妥昔单抗相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
肾细胞癌	申请上市	美国	Telix Pharmaceuticals Ltd.	2023-12-18
尿路上皮癌	临床3期	-	Heidelberg Pharma Research GmbH	2023-05-30
肾肿瘤	临床3期	-	Heidelberg Pharma AG	-
肾透明细胞肉瘤	临床2期	美国	Telix Pharmaceuticals Ltd.	2024-08-06
胆管癌	临床2期	美国	Telix Pharmaceuticals Ltd.	2023-06-06
结直肠癌	临床2期	美国	Telix Pharmaceuticals Ltd.	2023-06-06
食管癌	临床2期	美国	Telix Pharmaceuticals Ltd.	2023-06-06
多形性胶质母细胞瘤	临床2期	美国	Telix Pharmaceuticals Ltd.	2023-06-06
肝细胞癌	临床2期	美国	Telix Pharmaceuticals Ltd.	2023-06-06
鼻咽癌	临床2期	美国	Telix Pharmaceuticals Ltd.	2023-06-06

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临床结果

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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


NCT04758780 (OPALESCENCE, PRNewswire) 人工标引	临床2期	三阴性乳腺癌 HER2 Negative \| PR Negative \| ER Negative	12	TLX250-CDx	鏇觸膚醖獵襯蓋築糧鹽(網廠膚齋糧範廠獵鏇襯) = in the breast, skin, adrenal gland and brain was 100% 壓選繭餘蓋遞鏇積襯鏇 (壓糧製選願蓋繭獵築鑰 ) 更多	积极	2023-12-06
NCT03849118 (ZIRCON, ASCO_GU2023) 人工标引	临床3期	肾细胞癌	284	89Zr-DFO-girentuximab	膚鏇顧淵鹹蓋鹽顧製膚(鏇糧獵構衊膚淵獵網餘) = 衊獵齋積繭構淵淵築構夢繭餘淵獵鑰艱簾遞壓 (憲齋獵襯積範夢鏇鏇鹹, 80 ~ 90) 达到更多	积极	2023-02-21
NCT03849118 (ZIRCON, PRNewswire) 人工标引	临床3期	肾肿瘤	284	Girentuximab-Zr-89	窪繭積製遞廠壓鬱鹽獵(鹹鏇鬱醖範網製製淵憲) = 醖窪積願願鏇範鹽顧選衊簾顧鑰遞鏇簾齋觸齋 (鹹齋襯糧壓繭製獵壓餘 ) 更多	积极	2022-11-06