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）

2025-02-01·Expert Review of Anticancer Therapy

Girentuximab imaging in renal cancer: diamond in the rough or just ZIRCON?

Review

作者: Urso, Luca ; Evangelista, Laura ; D’Angelillo, Rolando Maria ; Filippi, Luca

Small renal masses (SRM), especially those under 7 cm pose significant diagnostic challenges when using conventional imaging (CT/MRI). PET/CT with [⁸⁹Zr]Zr-girentuximab offers a promising alternative in this setting by enabling molecular-level imaging. The ZIRCON trial, a phase 3 multicenter study, evaluated the diagnostic accuracy of [⁸⁹Zr]Zr-girentuximab PET/CT in detecting clear cell renal cell carcinoma (ccRCC) in SRM. A total of 300 patients with indeterminate renal masses received a single intravenous dose of [⁸⁹Zr]Zr-girentuximab, followed by PET/CT imaging 5 days post-injection. Generally, sensitivity and specificity for ccRCC detection were 85.5% and 87.0%, respectively. However, smaller masses (maximum diameter: ≤4 cm) demonstrated strong diagnostic performance, with mean sensitivity and specificity of 85% and 89.5%, respectively. PET positivity was observed exclusively in malignant lesions. Nevertheless, both benign and malignant non-ccRCC tumors are 'cold' at [⁸⁹Zr]Zr-girentuximab, thus differential diagnosis remains an unresolved issue. Despite its strengths, the trial highlights limitations: restricted imaging scope to the abdomen, lack of a cost-effectiveness analysis, concerns over radiation exposure given zirconium-89's 78.4-h half-life, and the daily scheduling of the examination. Only further studies and time will reveal whether the ZIRCON trial's findings will shine like a diamond or remain akin to zircon - brilliant but constrained in value.

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·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）

2025-03-14

·Endpoints

Altimmune to put its incretin into addiction trials; Tarsus aims to raise $125M

Plus, news about Heidelberg, Accropeutics, Allarity Therapeutics, Cadrenal and Inovio: Altimmune to test its incretin in addiction : Following the path set by Novo Nordisk last week , Altimmune said Thursday at its R&D Day that it plans to begin trials of its injectable GLP-1/glucagon agonist pemvidutide in alcohol use disorder as well as alcoholic liver disease. Stifel analysts wrote in a note on Thursday that Altimmune has animal data that suggest pemvidutide could reduce daily alcohol intake by around half. They also cautioned that additional data would be needed to validate the hypothesis. — Elizabeth Cairns Tarsus Pharmaceuticals’ expected $125 million stock sale: The drugmaker said the funds from the public offering will be used to support the US commercialization of Xdemvy, eye drops for irritation caused by tiny mites. Tarsus also said the funds will be used to advance its experimental ocular rosacea and lyme disease drugs. — Lei Lei Wu Heidelberg amends royalty deal: The company signed an agreement with HealthCare Royalty a year ago to provide royalties to Zircaix, or TLX250-CDx, an imaging agent for some kidney cancers. While the total value of the milestones remains the same at $90 million, the companies changed the deal so that Heidelberg will receive $20 million immediately rather than get $15 million as a sales milestone. They also reduced the FDA approval milestone to $70 million from $75 million. (That milestone will be further reduced if approval comes after 2025.) Heidelberg licensed the drug to Telix in 2017, and a rolling FDA submission was initiated in 2023. — Max Gelman Accropeutics raises $12M to fund IBD asset : The Series B-plus round was led by Shenzhen Capital Group and is set to extend the biotech’s cash runway into the second half of next year. The proceeds will be used for the ongoing Phase 1b trial of Accropeutics’ RIPK2 inhibitor, known as AC-101, in ulcerative colitis. Accropeutics also has a mid-stage TYK2/JAK1 inhibitor in development for psoriasis and a RIPK1 inhibitor for graft-versus-host disease. — Elizabeth Cairns Allarity Therapeutics settles with SEC: The company will pay $2.5 million to the Securities and Exchange Commission after the regulator alleged Allarity executives concealed from investors that the FDA had recommended against approving dovitinib, an experimental cancer therapy. The company did not admit or deny the allegations. — Jaimy Lee Cadrenal is still seeking a partner for tecarfarin: It wants help advancing the oral vitamin K antagonist into a pivotal trial for patients with left ventricular assist devices and other rare cardiovascular conditions. — Jaimy Lee Inovio’s DNA therapy is durable in early trial : The company said Thursday that a Phase 1 trial proves the concept of its so-called DMAbs. The DNA plasmids encoding antibodies derived from Evusheld, AstraZeneca’s Covid-19 prophylactic, were given to patients and were translated into the proteins by the patient’s own cells. All subjects who reached week 72 had biologically relevant levels of the antibodies, according to Inovio, and the expressed DMAbs bound to the SARS-CoV-2 spike protein confirmed functional activity. However, the company did not say whether the approach prevented infections . — Elizabeth Cairns

临床1期临床结果

2025-03-13

·抗体圈

核药一哥发威！收入井喷领跑千亿蓝海市场

核药领域正在进入收获期。全球核药龙头捷报频传——诺华的两款核药2024年销售收入首次突破20亿美元；远大医药（0512.HK）交出的2024年答卷同样让人眼前一亮。 3月12日，远大医药发布2024年年度业绩，公司实现收入约116.45亿港元，剔除汇率同比增长12.8%；归母净利润约24.68亿港元，剔除汇率同比增长34%；得益于去年良好的业绩表现，公司拟派息每股0.26港元，合计超9.1亿港元。这份成绩单发布后的首个交易日就获得了市场资金的强烈认可，远大医药股价一度大涨超过21%，最终当日收涨19.66%。远大医药作为全球仅有的四家在肿瘤治疗方面成功实现创新核药商业化应用的创新制药企业之一，如今以易甘泰®钇[90Y]为首的核药板块已经成为公司收入增长最快的“尖兵”之一。同时，公司的全球化程度和核药管线数量在国际领先，目前拥有3款产品处在临床三期阶段，且核药产品储备数量已超过20个，未来像易甘泰®钇[90Y]这样的爆品，远大医药有望陆续推出。立足当下，2025年将是远大医药业绩爆发的元年，公司凭借着“自研+合作引进+并购布局”多轮驱动投入转型创新的模式，2024年已经实现63项重大的里程碑，在年内新增14款商业化产品的同时，我们同时也看到公司的核药、五官科、呼吸等板块中的数款创新产品正在快步迈入商业化放量的新阶段，不仅将带动公司的收入规模快速增长，并且将公司整体的盈利结构和质量进一步优化提升。远大医药即将迎来属于自己的股价和业绩的“戴维斯双击”时刻。 01 核药重磅炸弹时代来临核药的重磅炸弹时代来临，远大医药将率先并充分受益。 2024年诺华两款核药收入达到21.16亿美元，其中Pluvicto实现销售13.92亿美元（同比增长42%），首次进入“10亿美元分子俱乐部”，而Lutathera得益于适应症范围的扩大（纳入了12岁及以上SSTR+胃肠胰神经内分泌肿瘤儿童患者），实现7.24亿美元（同比增长20%），在2-3年内也将进入10亿美元分子行列。基于两款核药Pluvicto和Lutathera各自在前列腺癌、胃肠胰神经内分泌瘤领域展现出的强大治疗潜力和广阔的市场空间，近年来MNC和国际资本大力布局核药资产以“占位”下一个重磅炸弹，仅2024年MNC便完成了3笔核药并购交易，包括阿斯利康20亿美元收购Fusion Pharmaceuticals、BMS以41亿美元收购RayzeBio、诺华以10亿美元预付款+7.5亿美元里程碑收购Mariana Oncology。远大医药在国内的强劲商业化表现，也正在兑现核药在全球市场所展现出的潜力。 2024年，远大医药核药板块实现收入约5.89亿港元，剔除汇率同比大幅增长近176.6%，其中易甘泰®钇[90Y]微球注射液自2022年国内获批上市后快速放量，已累计治疗近2000例患者，目前其正式手术已在国内22个省市的50余家医院展开。易甘泰®钇[90Y]的快速放量，不仅基于远大医药出色的商业化，并且离不开核药自身治疗机制优势和优异的疗效解决临床未满足需求。诺华的Pluvicto填补了PSMA阳性转移性去势抵抗性前列腺癌（mCRPC）治疗的临床空白，并在上市之初一度因产能问题导致供不应求。易甘泰®钇[90Y]在原发性肝癌和结肠癌肝转移领域为大量用药选择有限的患者提供了全新治疗选择，能够实现肝癌降期并帮助患者实现临床治愈，这是过去传统的治疗手段无法做到的。易甘泰®钇[90Y]国内商业化以来已累计治疗近2000例患者，目前已有40余名患者顺利实现肝癌肿瘤降期转化并实施了肝癌切除手术，10余名患者通过桥接治疗成功实施肝移植，实现临床治愈。易甘泰®钇[90Y]之外，随着远大医药与合作伙伴的快速临床推进，公司处于后期临床产品线正持续丰富，截至目前公司有3款核素偶联药物（RDC）处于临床三期，分别是前列腺癌诊断核药TLX591-CDx、透明细胞肾细胞癌诊断核药TLX250-CDx和胃肠胰神经内分泌瘤治疗性核药ITM-11，这也使得远大医药成为国内拥有最多三期临床创新核药管线的公司之一，足见公司在核药领域的深耕程度和布局的前瞻性。这三款核药管线中TLX591-CDx、TLX250-CDx两款管线源自于与Telix的合作，而Telix在海外的表现已经充分证明了市场对其的认可和潜在巨大产品价值。 2024年，Telix总收入实现7.83亿澳元（约合4.87亿美元），同比增长56%；净利润约4990万澳元（约合0.31亿美元），同比增长860%。Telix业绩的高速增长的源于Illuccix®（即TLX591-CDx ）的持续放量，自2022年Illuccix®获批以来，其在美国展现出强劲的放量表现。这种强劲的放量表现，不仅仅是得益于Pluvicto的快速爆量，更在于产品的高灵敏度和特异性，其不仅能够检测到90%以上原发性和转移性前列腺癌细胞表面的PSMA阳性病变，可用于检测基于血清PSA水平升高的复发前列腺癌患者，这促使Illuccix®在美国诊断性核药的竞争中更获得医生青睐。自Illuccix®商业化放量以来，Telix的股价累计涨幅已经超过了500%。Telix管理层在最新的交流中也给出了2025年的业绩指引：公司收入将达到11.8~12.3亿澳元（同比增长50.6~57.05%），并计划继续增加研发投入，预计同比增长20~25%。除此之外，Telix准备在2025年推出三款新产品 TLX007-CDx (Gozellix®)、TLX101-CDx(Pixclara®) 和 TLX250-CDx (Zircaix®)，这对于远大医药来说显然是好消息，随着合作产品在美国实现商业化，国内管线可以通过桥接临床实现进度加速。值得一提的是TLX250-CDx，目前透明细胞肾细胞癌（ccRCC）临床常用诊断方法CT或MRI提示存在肾脏肿块但无法判断是否为ccRCC的患者，TLX250-CDx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FDA要求的预设阈值，其有望成为ccRCC全新临床诊断标准。另外，TLX250-CDx并不局限于ccRCC，目前用于三阴性乳腺癌（TNBC）、非肌层浸润性膀胱癌（NMIBC）以及尿路上皮癌（UC）的多项适应症临床研究也在全球同步推进中。在全球热门SSTR靶向核药布局方向，远大医药选择重点推进的治疗性核药ITM-11是一款潜在的同类最佳产品，这是一款将无载体177Lu与生长抑素类似物结合的RDC，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。远大医药不仅核药商业化拔得头筹，并且其核药诊疗一体化大平台已经逐渐成型，实现了自研&合作技术平台（20款储备管线）、温江研发生产基地、商业化平台的布局兑现，核药板块后劲很足。 02 新爆点：创新眼药攻势如潮经历了数年的深耕与布局，2024年可谓是远大医药创新眼药的蓄力之年，未来几年眼科创新药物显然将成为公司的全新爆点。过去，远大医药的五官科板块已经为公司在眼科商业化层面打下了坚实基础，已商业化的品种包括：国家保护独家品种的和血明目片（治疗眼底疾病）、治疗干眼症一线用药的人工泪液瑞珠等，这些均为畅销的大品种。公司在多年的合作与沉淀后，已经构建起了一个丰富而具有差异化的创新眼药管线平台，从覆盖的疾病广度包括像屈光不正、干眼症这样的眼科大适应症，从差异化和未满足临床需求又可以覆盖到像蠕形螨睑缘炎、翼状胬肉这样的缺乏明确对症治疗药物的领域。 2024年至今，远大医药在创新眼药领域发生了许多重磅的里程碑事件，包括白内障术后抗炎镇痛创新药GPN00833完成国内三期临床研究并达到临床终点、从箕星药业引入OC-01和OC-02鼻喷雾剂两款干眼症药物的大中华区权益，以及蠕形螨睑缘炎创新眼药GPN01768的NDA获得CDE受理等，这几款创新药物未来的商业化放量都将给远大医药的眼药板块甚至公司整体业绩带来巨大的弹性。博研咨询数据显示，2023年国内治疗药物市场高达120亿元，同比增长15%。其中，人工泪液在国内干眼症治疗市场中的占比超过50%。值得注意的是，当前市面上的人工泪液仅可模拟泪膜的一种或多种成分，难以真正对天然泪液进行替代。远大医药已经商业化的OC-01（酒石酸伐尼克兰）是一种不含防腐剂鼻喷雾剂，其不同于人工泪液的眼表给药方式而采用创新的经鼻给药方式，其有效成份伐尼克兰通过结合烟碱型乙酰胆碱 (nACh) 使其活化，三叉神经副交感神经通路（控制泪膜自稳态）被激活，导致基础泪液分泌增加，从而达到治疗干眼的目的。相比长期使用人工泪液可能产生的药物依赖、引发结膜炎和眼角膜损伤等安全性风险，OC-01拥有更高的选择性和安全性，其市场潜力非常可观。鉴于玻璃酸钠滴眼液、环孢素滴眼液在国内2023年销售规模均超过10亿元，OC-01凭借创新药属性和全新作用机制有望快速突破这一门槛。远大医药前不久在三期临床取得成功的GPN00833是一款抗炎镇痛类激素纳米混悬滴眼液，目前激素眼用制剂是白内障手术后抗炎镇痛最常用且最有效的药物之一，可以快速有效控制眼科术后的感染、减轻患者眼部炎症和促进伤口愈合，现有眼科术后围手术期激素眼用制剂（多为糖皮质激素，如地塞米松、泼尼松龙）普遍存在安全性风险较高的问题。 GPN00833利用独特的纳米制剂工艺解决了激素类产品低水溶性导致的生物利用度低及安全性风险，并在国内两项三期研究中其展现出可持久地清除眼部炎症和治愈眼部疼痛的疗效，同时安全性与安慰剂相似，有望对现有激素眼用制剂进行迭代。博研咨询数据显示，2023年国内泼尼松龙滴眼液（专利期已过、单价35元/支）在8亿元左右。GPN00833作为安全性、有效性更优的迭代创新药，市场竞争格局更优、具备创新溢价，未来销售峰值超越泼尼松龙滴眼液只是时间问题。处于NDA审评阶段的GPN01768（Xdemvy）是一种非竞争性γ-氨基丁酸氯离子通道（GABA-Cl）拮抗剂，用于治疗蠕形螨睑缘炎。蠕形螨睑缘炎是一种容易复发的疾病，影响的人群数量庞大，在中国和美国影响人群分别为4000万人和2500万人，在GPN01768获批之前全球尚未有针对蠕形螨睑缘炎的药物上市，临床空白巨大。 GPN01768在中国和美国的临床充分证明了自身对症杀螨的强大有效性和安全性，尤其国内三期临床研究LIBRA的顶线数据结果显示，GPN01768治疗蠕形螨睑缘炎患者的螨虫根除率具有统计学显著性（p<0.001），关键临床的大多数不良事件轻微可控，未出现治疗相关的停药。 GPN01768早在2023年7月在美国实现商业化，上市以来快速放量，2024年实现销售1.8亿美元，美银美林BofA更是预测GPN01768的峰值销售额将高达11亿美元。基于该药在美国上市以来的快速放量趋势、国内患者人群基数大于美国，其在国内的销售峰值潜力显然在10亿元之上。集合上述分析，远大医药这三款商业化阶段创新眼药产品再加上治疗翼状胬肉的GPN00153（CBT-001）合计有着超越50亿国内销售的潜力，而这些差异化品种的合作引进，仅仅也只是公司前瞻性布局眼光和差异化品种战略的冰山一角的早期兑现，随着这些品种的商业化放量能力逐步验证以及公司自研产品的发力，远大医药的创新眼药板块成长性将会越来越强。 03 两大板块核心优势继续强化远大医药布局特点是较快的并购节奏和明确指向补强，重点在于提升呼吸及危重症板块丰度，以及强化公司在心脑血管急救板块的竞争力。呼吸、心脑血管这两大领域均为致死风险极高的疾病领域，临床未满足需求多，药物开发市场空间大。 2024年远大医药呼吸及危重症板块的表现突出，实现营收17.09亿港元，同比增长26.9%，展现了十足的成长力。这种稳定的成长力来源于公司深厚的积累，目前公司手握切诺®（黏液溶解促排剂）、恩卓润®和恩明润®（改善中重度哮喘）等稳定贡献现金流的品种，还有诸如Ryaltris®这样的创新品种正在蓄势待发。在该领域，远大医药2024年完成了对百济制药的全资并购，在获得百济制药技术领先鼻喷制剂平台的同时，通过纳入该公司管线资产，形成了一套面向轻、中、重度过敏性鼻炎患者的吸入制剂药物产品组合。远大医药治疗过敏性鼻炎鼻喷剂Ryaltris®正等待CDE的上市批准，作为国内第一个创新复方鼻喷剂其填补了一线对症治疗经治中重度过敏性鼻炎患者的临床空白。公司通过并购百济制药获得了一线过敏性鼻炎鼻喷剂用药（丙酸氟替卡松鼻喷雾剂、糠酸莫米松鼻喷雾剂、布地奈德鼻喷雾剂），这一产品组合未来要分享的是国内过敏性鼻炎百亿的用药市场，并购带来的化学反应不可估量。另外，远大医药针对未满足临床需求如重症治疗监护、呼吸窘迫综合征、脓毒症等领域开发了拥有自主知识产权的“全球新”药物，如脓毒症创新药STC3141已完成国内二期临床患者入组并给药、脓毒症创新药APAD已完成了国内一期临床并顺利达成临床终点。在心脑血管急救板块，远大医药近年来品种数量正在快速扩充（心脑血管急救板块从2022H1的24个品种到2024年的30个品种），产品管线数量位居行业前列，覆盖血压控制、血管活性药、心肌代谢、心衰、抗凝等领域，后劲充足。 2024年，远大医药该板块力美通®依普利酮片成功进入国家医保目录，进一步促进了产品可及性的提升。同时，公司通过布局天津田边合心爽®、合贝爽®这样的畅销心脑血管急救药物（临床上治疗冠状动脉痉挛心绞痛的首选药物）迅速切入如如糖尿病、胃肠道疾病等慢性疾病赛道，同时获得天津天边的制剂产能加速公司原料制剂一体化，提升公司的盈利能力。另外，远大医药同年收购了多普泰，其核心产品脉血康系列药物（销售规模在5亿元）及其他产品与公司现有产品组合也形成了良好的协同效应。随着远大医药的创新急救产品Jext®在大湾区获批上市，叠加这两大并购资产的注入，未来几年将成为公司全新增长动力，带来一揽子有充分竞争力的产品，为板块业绩成长提供坚实保障。从对远大医药的呼吸及危重症、心脑血管急救这两大优势板块布局分析不难看出，公司在过去的投入及积累了大量的现金牛产品，已经逐渐放量成为各板块业绩的稳定内生增长动力；而公司通过自研、引入具备差异化的创新产品，同时辅以补强指向明确的资产并购，使得公司在呼吸、心脑血管这两大板块未来不缺乏“强大的发动机”，这显然能够双轮驱动公司板块以及整体业绩快速提升。结语：历经多年的投入、前瞻性的布局眼光和强大商业化并购整合能力，远大医药的核药、眼药、呼吸和心脑血管等几大板块正在快速步入创新布局兑现期。核药板块易甘泰®钇[90Y]有望进一步放量冲击10亿单品，成都温江甲级核素研发生产基地将在2025年建成形成集研发、生产、运营为一体的全产业链版图；呼吸及危重症板块，STC3141国内脓毒症二期有望在上半年取得初步成药性数据；五官科板块，新一代干眼症药物商业化加速放量，多款创新眼药将迎来重大里程碑；另外，心脑血管精准介入、生物科技板块，公司也在丰富产品技术布局和积极拓展商业化链路，为公司增长贡献稳健增量。可以预见的是，远大医药2024年交出的这一份出色的业绩答卷也仅仅是这艘巨轮加速行驶的预兆，而更多的惊喜和爆发式成长或许还在后头，我们或许能见证一家传统Pharma转型创新成功的涅槃过程。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。

并购临床3期财报申请上市

2025-03-13

·heidelberg-pharma.com

PR: Heidelberg Pharma Amends Royalty Financing with HealthCare Royalty

HealthCare Royalty and Heidelberg Pharma amend royalty financing agreement to provide for USD 20 million payment Heidelberg Pharma extends cash runway into 2027 Ladenburg, Germany, 13 March 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech Company developing innovative Antibody Drug Conjugates (ADCs), and HealthCare Royalty (HCRx) today announced that they have signed an amendment to the royalty financing agreement entered into in March 2024. The March 2024 royalty financing agreement and current amendment cover the partial monetization of Heidelberg Pharma’s future royalties on the worldwide sales of TLX250-CDx, a radiopharmaceutical Positron Emission Tomography (PET) imaging agent for the diagnosis and characterization of clear cell renal cancer. An upfront payment of USD 25 million was already made to Heidelberg Pharma in March 2024. Key terms of the amended agreement between Heidelberg Pharma and HCRx are as follows: Heidelberg Pharma will receive a payment of USD 20 million upon signature. The USD 15 million sales-based milestone for year 2025 is eliminated. The originally agreed USD 75 million payment upon FDA approval of TLX250-CDx will be reduced to USD 70 million, with further reductions if FDA approval occurs after the end of 2025. The second tier of the two-tier escalating cap on cumulative royalties sold to HCRx has increased. When the escalating cap has been reached, royalty payments will return to Heidelberg Pharma and HCRx will receive a low single digit royalty tail percentage thereof. Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, commented: “The amendment with HCRx provides us with non-dilutive financing and will significantly increase our cash reach. Due to the delay in FDA approval of TLX250-CDx, the agreed sales-based milestone payment would have been difficult to achieve and has now instead been converted into another payment. We are very pleased that our development and commercialization partner Telix has received positive feedback from the FDA on its Biologics License Application and has been granted priority review. We expect an approval decision and the next significant milestone payment by the end of August.” Based on the agreement with HCRx and expected incremental payments of USD 90 million to Heidelberg Pharma, the company anticipates an extended cash runway into 2027. About TLX250-CDx TLX250-CDx is a radiolabeled form of the antibody girentuximab which binds to the tumor-specific antigen CAIX on clear cell renal cell carcinomas. TLX250-CDx also has potential as a PET diagnostic imaging agent for other tumor types. Heidelberg Pharma developed the antibody up to a first completed Phase III clinical trial prior to licensing it to Telix Pharmaceuticals Limited (Telix), an Australian company based in Melbourne, Australia, in 2017. About Heidelberg Pharma Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells. Heidelberg Pharma uses several compounds and has built up an ADC toolbox that overcomes tumor resistance via numerous pathways and addresses different types of cancer using various antibodies. The goal is to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors. Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology. The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com. ATAC® is a registered trademark of Heidelberg Pharma Research GmbH. ITAC™, ETAC™ are pending trademark applications of Heidelberg Pharma Research GmbH. About Healthcare Royalty HealthCare Royalty (HCRx) is a leading royalty acquisition company focused on commercial or near-commercial biopharmaceutical products. With offices in Stamford, Conn., San Francisco, Boston, London and Miami, HCRx has invested $5+ billion in over 90 biopharmaceutical products since inception. For more information, visit https://www.hcrx.com. HEALTHCARE ROYALTY® and HCRx® are registered trademarks of HealthCare Royalty Management, LLC.

临床3期抗体药物偶联物并购

100 项与锆[89Zr]吉伦妥昔单抗相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
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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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


SNMMI2024	N/A	辐射损伤	-	89Zr-girentuximab	艱鏇遞餘鑰網膚餘積鏇(艱簾繭遞糧蓋艱壓窪積) = 鏇窪鑰壓醖壓夢膚鑰鹽鏇選鏇顧繭遞壓鬱製糧 (觸窪鬱夢餘淵願艱壓廠 )	-	2024-06-09
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	觸鹽繭鬱壓壓構鏇選衊(鹹顧鏇壓築選獵醖窪夢) = in the breast, skin, adrenal gland and brain was 100% 窪廠鬱簾糧膚鹹選醖構 (範獵遞範壓製顧顧製繭 ) 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	遞餘鏇蓋衊艱齋齋壓構(積鬱製選糧選夢齋襯鏇) = 艱鬱簾獵選艱顧繭壓糧壓憲襯構艱蓋鹽網膚膚 (顧鹹鑰鑰範鑰艱觸蓋鑰, 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	壓壓製壓鏇構願膚餘淵(獵膚網積觸糧顧繭遞壓) = 糧鏇鬱願繭夢醖齋顧築鹽壓獵築顧網廠衊齋繭 (蓋顧廠蓋餘鬱艱夢膚顧 ) 更多	积极	2022-11-06