The goal of this study is to propose the first direct comparison of Ga-68-DOTATATE PET/CT or PET/MR and Ga-68-DOTATOC PET/CT in patients with meningioma.

开始日期2024-03-01

申办/合作机构

Weill Medical College of Cornell University

[+1]

CTR20240013 / Recruiting临床3期

评价镓[68Ga]多特安肽注射液 PET/CT 对神经内分泌瘤（NETs）的诊断效能、药代动力学和安全性及比较镥[177Lu]氧奥曲肽注射液与长效奥曲肽在不可切除或转移性、进展性、分化良好（G1 和 G2）且生长抑素受体阳性的成人胃肠胰神经内分泌瘤患者中的安全性和有效性的诊疗一体化的Ⅲ期临床研究

主要目的：基于相对于真实性标准的受试者水平的灵敏度和特异度，评价镓[68Ga]多特安肽注射液 PET/CT 对 NETs 的诊断效能。次要目的：评价镓[68Ga]多特安肽注射液作为 PET/CT 检查的示踪剂在中国人群中的安全性；评价镓[68Ga]多特安肽注射液作为 PET/CT 检查的示踪剂在中国人群中的药代动力学（PK）及辐射剂量学。

开始日期2024-01-05

申办/合作机构

原子高科股份有限公司

NCT05880394 / Active, not recruiting临床2期IIT

Somatostatin Receptor Imaging Study of Estrogen Receptor Positive (ER+) Metastatic Breast Cancer

This will be a Phase 2 clinical trial to assess somatostatin receptor (SSTR) expression in Stage IV estrogen receptor positive (ER+) breast cancer using Gallium-68 DOTATATE or Copper-64 DOTATATE PET/CT.

开始日期2023-01-10

申办/合作机构

Hoag Memorial Hospital Presbyterian, Inc.

100 项与镓[68Ga]多特安肽相关的临床结果

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100 项与镓[68Ga]多特安肽相关的转化医学

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100 项与镓[68Ga]多特安肽相关的专利（医药）

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175

项与镓[68Ga]多特安肽相关的文献（医药）

2024-03-01·Applied Radiation and Isotopes

Performance evaluation of Gallium-68 radiopharmaceuticals production using liquid target PETtrace 800 cyclotron

Article

作者: Mahamood, Mazurin ; Halib, Dzulieza ; Adawiyah, Rabiatul ; Ashhar, Zarif ; Aziz, Firdaus ; Mat Ail, Noratikah ; Md Safee, Zaitulhusna ; Jamal Harizan, Muhammad Ali Hazizi ; Ahmad Fadzil, Muhammad Fakhrurazi ; Abd Hamid, Mohd Hamdi Noor ; Ibarhim, Ummi Habibah ; Razali, Nor Idayu ; Said, Mohamad Aminudin ; Alek Amran, Arieffuddin ; Nik Afinde, Nik Muhammad Fitri

Due to increased demand, cyclotron has an expanding role in producing Gallium-68 (⁶⁸Ga) radiopharmaceuticals using solid and liquid targets. Though the liquid target produces lower end-of-bombardment activity compared to the solid target, our study presents the performance of ⁶⁸Ga radiopharmaceuticals production using the liquid target by evaluating the end-of-bombardment activity and the end-of-purification activity of [⁶⁸Ga]GaCl₃. We also present the effect of increasing irradiation time, which significantly improves the end-of-synthesis yield. From the result obtained, the end-of-bombardment activity produced was 4.48 GBq, and the [⁶⁸Ga]GaCl₃ end-of-purification activity produced was 2.51 GBq with below-limit metallic impurities. Increasing the irradiation time showed a significant increase in the end-of-synthesis activity from 1.33 GBq to 1.95 GBq for [⁶⁸Ga]Ga-PSMA-11 and from 1.13 GBq to 1.74 GBq for [⁶⁸Ga]Ga-DOTA-TATE. Based on the improvements made, the liquid target production of ⁶⁸Ga radiopharmaceuticals is feasible and reproducible to accommodate up to 5 patients per production. In addition, this work also discusses the issues encountered, together with the possible corrective and preventative measures.

European Journal of Nuclear Medicine and Molecular Imaging

Head-to-head comparison between [68Ga]Ga-DOTA-NOC and [18F]DOPA PET/CT in a diverse cohort of patients with pheochromocytomas and paragangliomas

Article

作者: Liao, Zhihong ; He, Qiao ; Zhang, Bing ; Zhang, Zhengkun ; Zhang, Xiangsong ; Zhang, Yuying ; Zhang, Linqi ; Zha, Zhihao ; Long, Yali

PURPOSE:

To compare the detection ability of ⁶⁸Ga-labelled DOTA-l-Nal3-octreotide ([⁶⁸Ga]Ga-DOTA-NOC) and 6-[¹⁸F]fluoro-L-3,4-dihydroxyphenylalanine ([¹⁸F]DOPA) in patients with phaeochromocytomas and paragangliomas (PPGLs) of different origins and gene mutations, such as germline succinate dehydrogenase complex genes (SDHx).

METHODS:

Eighty-five patients with histopathologically confirmed PPGLs who underwent both [⁶⁸Ga]Ga-DOTA-NOC and [¹⁸F]DOPA PET/CT from March 2017 to June 2023 were enrolled in this retrospective study. For comparative analyses, PPGLs were classified as phaeochromocytoma (PCC), sympathetic paraganglioma (sPGL), and head/neck paraganglioma (HNPGL). Detection rates were analyzed on per-patient and per-lesion bases and compared using the Chi-square/Fischer's exact test.

RESULTS:

Among 85 patients with PPGLs (48 males; 43 years ± 17 [SD]), the patient-based detection rates of [⁶⁸Ga]Ga-DOTA-NOC and [¹⁸F]DOPA PET/CT were 87.1% (74/85) and 89.4% (76/85), respectively (p = 0.634), and the lesion-based detection rates were 80.8% (479/593) and 71.2% (422/593), respectively (p < 0.001). Only one patient with a recurrent PCC presented double-negative imaging, while 66 patients exhibited double-positive imaging. The remaining patients were either [⁶⁸Ga]Ga-DOTA-NOC-negative/[¹⁸F]DOPA-positive (n = 10) or [⁶⁸Ga]Ga-DOTA-NOC-positive/[¹⁸F]DOPA-negative (n = 8). In subgroup analyses, [⁶⁸Ga]Ga-DOTA-NOC PET/CT detected significantly more metastases of sPGL (91.1%, 236/259) and SDHx-related PPGL (89.6%, 86/96) than [¹⁸F]DOPA PET/CT (48.6%[126/259] and 50.0%[48/96], respectively; both p < 0.001). However, [¹⁸F]DOPA showed significantly higher detection rates of PCC in both primary/recurrent and metastatic lesions (94.3%[50/53] vs. 62.3%[33/53] and 87.9%[174/198] vs. 69.2%[137/198], respectively; both p < 0.001). Regarding metastases in different organs, [⁶⁸Ga]Ga-DOTA-NOC PET/CT detected more lesions than [¹⁸F]DOPA PET/CT in bone (96.2%[176/183] vs. 66.1%[121/183]; p < 0.001) and lymph nodes (82.0%[73/89] vs. 53.9%[48/89]; p < 0.001) but less lesions in peritoneum (20%[4/20] vs. 100%[20/20]; p < 0.001).

CONCLUSION:

[⁶⁸Ga]Ga-DOTA-NOC and [¹⁸F]DOPA are complementary in diagnosing PPGL under the appropriate clinical setting. [⁶⁸Ga]Ga-DOTA-NOC should be considered as the ideal first-line tracer for detecting metastases of sPGL and SDHx-related tumours, whereas [¹⁸F]DOPA may be the optimal tracer for evaluating non-SDHx-related PCC, especially in detecting primary lesions and monitoring recurrence.

2024-01-01·Journal of Nuclear Medicine

Preclinical Evaluation of Minigastrin Analogs and Proof-of-Concept [⁶⁸Ga]Ga-DOTA-CCK-66 PET/CT in 2 Patients with Medullary Thyroid Cancer

Article

作者: Lapa, Constantin ; Bundschuh, Ralph A ; Beck, Roswitha ; Viering, Oliver ; Dierks, Alexander ; Kircher, Malte ; Pfob, Christian H ; Günther, Thomas ; Wienand, Georgine ; Holzleitner, Nadine ; Wester, Hans-Jürgen

Because of the need for radiolabeled theranostics for the detection and treatment of medullary thyroid cancer (MTC), and the yet unresolved stability issues of minigastrin analogs targeting the cholecystokinin-2 receptor (CCK-2R), our aim was to address in vivo stability, our motivation being to develop and evaluate DOTA-CCK-66 (DOTA-γ-glu-PEG₃-Trp-(N-Me)Nle-Asp-1-Nal-NH₂, PEG: polyethylene glycol) and DOTA-CCK-66.2 (DOTA-glu-PEG₃-Trp-(N-Me)Nle-Asp-1-Nal-NH₂), both derived from DOTA-MGS5 (DOTA-glu-Ala-Tyr-Gly-Trp-(N-Me)Nle-Asp-1-Nal-NH₂), and clinically translate [⁶⁸Ga]Ga-DOTA-CCK-66. Methods: ⁶⁴Cu and ⁶⁷Ga labeling of DOTA-CCK-66, DOTA-CCK-66.2, and DOTA-MGS5 was performed at 90°C within 15 min (1.0 M NaOAc buffer, pH 5.5, and 2.5 M 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid buffer, respectively). ¹⁷⁷Lu labeling of these 3 compounds was performed at 90°C within 15 min (1.0 M NaOAc buffer, pH 5.5, 0.1 M sodium ascorbate). CCK-2R affinity of ^natGa/^natCu/^natLu-labeled DOTA-CCK-66, DOTA-CCK-66.2, and DOTA-MGS5 was examined on AR42J cells. The in vivo stability of ¹⁷⁷Lu-labeled DOTA-CCK-66 and DOTA-MGS5 was examined at 30 min after injection in CB17-SCID mice. Biodistribution studies at 1 h ([⁶⁷Ga]Ga-DOTA-CCK-66) and 24 h ([¹⁷⁷Lu]Lu-DOTA-CCK-66/DOTA-MGS5) after injection were performed on AR42J tumor-bearing CB17-SCID mice. In a translation to the human setting, [⁶⁸Ga]Ga-DOTA-CCK-66 was administered and whole-body PET/CT was acquired at 120 min after injection in 2 MTC patients. Results: Irrespective of the metal or radiometal used (copper, gallium, lutetium), high CCK-2R affinity (half-maximal inhibitory concentration, 3.6-6.0 nM) and favorable lipophilicity were determined. In vivo, increased numbers of intact peptide were found for [¹⁷⁷Lu]Lu-DOTA-CCK-66 compared with [¹⁷⁷Lu]Lu-DOTA-MGS5 in murine urine (23.7% ± 9.2% vs. 77.8% ± 2.3%). Overall tumor-to-background ratios were similar for both ¹⁷⁷Lu-labeled analogs. [⁶⁷Ga]Ga-DOTA-CCK-66 exhibited accumulation (percentage injected dose per gram) that was high in tumor (19.4 ± 3.5) and low in off-target areas (blood, 0.61 ± 0.07; liver, 0.31 ± 0.02; pancreas, 0.23 ± 0.07; stomach, 1.81 ± 0.19; kidney, 2.51 ± 0.49) at 1 h after injection. PET/CT examination in 2 MTC patients applying [⁶⁸Ga]Ga-DOTA-CCK-66 confirmed multiple metastases. Conclusion: Because of the high in vivo stability and favorable overall preclinical performance of [^nat/67Ga]Ga-/[^nat/177Lu]Lu-DOTA-CCK-66, a proof-of-concept clinical investigation of [⁶⁸Ga]Ga-DOTA-CCK-66 was completed. As several lesions could be identified and excellent biodistribution patterns were observed, further patient studies applying [⁶⁸Ga]Ga- and [¹⁷⁷Lu]Lu-DOTA-CCK-66 are warranted.

项与镓[68Ga]多特安肽相关的新闻（医药）

2024-04-16

·PRNewswire

Evergreen Theragnostics Completes $26M Capital Raise to Advance Novel Radiopharmaceutical Pipeline into the Clinic, Prepare for First Commercial Product Launch, and Expand Industry-Leading CDMO Services

SPRINGFIELD, N.J., April 16, 2024 /PRNewswire/ -- Evergreen Theragnostics, Inc., a clinical-stage radiopharmaceutical company, today announced the successful completion of a $26M capital raise supported both by existing shareholders and new institutional investors, Petrichor and LIFTT. The financing advances Evergreen's novel discovery pipeline into clinical trials, supports commercialization of its diagnostic agent, and further expands CDMO capabilities to meet growing client demand. "We have been advancing our discovery pipeline and are excited to take the next step in development," commented James Cook, CEO. "As we continue to work with the FDA on approval of our Ga-68 DOTATOC diagnostic kit, this new funding will enable us to rapidly progress our novel theragnostic pair, EVG-321, into clinical trials. In addition, our CDMO business is continuing to build momentum as we bring on new customers and expand our efforts with existing ones. We appreciate the trust given to us by our existing and new shareholders in advancing our priorities." "We have tracked Evergreen since the company's inception and are excited to partner with James and his team as they bring best- and first-in-class candidates into the clinic, broaden their top-tier radiopharma drug discovery efforts, prepare for commercial launch of their diagnostic product, and further capitalize on the highly specialized expertise required to build and run a radiopharma CDMO," said Patrick Lally, Partner at Petrichor. Stefano Buono, chairman of LIFTT and founder and former CEO of Advanced Accelerator Applications (AAA) noted, "the radioligand therapy industry is advancing rapidly. Our investment in Evergreen Theragnostics deepens our commitment to this exciting area with a company that is well-positioned to succeed." Evergreen has established a lean and experienced team of scientific, medical, commercial, and operational leaders and employees to continue to develop our capabilities. Over the next months, Evergreen will continue to plan for the launch of our diagnostic agent Octevy™, subject to approval by the FDA. Evergreen Discovery also intends to begin registration enabling therapeutic and diagnostic clinical trials for Lutetium-177 (177Lu) EVG-321 and Gallium-68 (68Ga) EVG-321, a novel radiopharmaceutical theragnostic pair, which, if successful, could offer new hope to patients with small cell lung cancer. About Evergreen Theragnostics, Inc. Evergreen Theragnostics is focused on improving the available options for cancer patients using radiopharmaceuticals. The company is engaged in Contract Development and Manufacturing (CDMO) services as well as drug discovery and commercialization of proprietary products. Evergreen is headquartered in Springfield, NJ in a state-of-the-art GMP radiopharmaceutical facility. The company was founded in 2019 by a team that brings a strong track record in theragnostic radiopharmaceutical manufacturing and commercialization. For more information, please visit . About Petrichor Petrichor partners with world-class healthcare managers and businesses to provide customized investment structures and support. The Petrichor team has completed over 125 investments representing more than $6 billion in invested capital and has held over 55 board seats. Petrichor maintains a deep in-house understanding of healthcare products and services, including scientific, technical, and commercial expertise. This healthcare expertise, together with a breadth of experience investing across sectors, geographies, and capital structures, provides a unique combination to help build successful companies. For more information on Petrichor, please see or contact the firm at [email protected]. About LIFTT LIFTT is an Italian Venture Capital operating in every industry with a focus on deep-tech. To date it has raised €103,7M and completed 50 investments in innovative start-ups. While generating value for its shareholders, LIFTT supports the creation of businesses, development, employment, and economic growth, through the implementation of an ethical and transparent governance model. To learn more, please visit For further information, please contact: James Cook President & CEO [email protected] SOURCE Evergreen Theragnostics, Inc.

2024-04-11

·BioSpace

Telix Pharmaceuticals Limited completes the acquisition of ARTMS, Inc.

BURNABY, British Columbia--(BUSINESS WIRE)-- ARTMS Products Inc. (ARTMS) is pleased to announce that the acquisition by Telix Pharmaceuticals Limited (Telix) has been completed. This acquisition further enhances the vertical integration of Telix’s supply chain and manufacturing by providing a greater level of supply chain and regulatory control over the production of key isotopes. ARTMS will support the high efficiency, large-scale and cost-effective production of commercially important medical isotopes for Telix’s portfolio of products, such as zirconium-89 (89Zr), gallium-68 (68Ga), technetium‐99m (99mTc) and copper-64 (64Cu), and will continue to partner with additional radiopharmaceutical companies to ensure that these critical isotopes are available on demand for patients. In addition, ARTMS’ portfolio of advanced cyclotron technologies has immediate application and differentiation for Telix in the production of future commercially important alpha-emitting, therapeutic isotopes, including actinium-225 (225Ac) and astatine-211 (211At). The history of ARTMS is rooted in a Canadian government funded project focused on solid target production of 99mTc. After that project was successfully completed, the innovation continued and resulted in a full suite of PET products. In 2017, ARTMS Inc. was formed with support and seed funding from Quark Venture, through their Global Health Sciences Fund (GHS) and founding institutions TRIUMF, BC Cancer, Lawson Health Research Institute and the Center for Probe Development. In May of 2020, ARTMS completed a $20M USD Series A fundraising that included GHS and welcomed Deerfield Management to the ARTMS family. In the subsequent years ARTMS has played a critical role in alternative production of medical isotopes with a focus on accelerating the production capabilities of the world’s most commonly installed cyclotrons. The collaboration between ARTMS’ unparalleled team, its investors and founding members has resulted in a truly differentiated organization. Solomon Partners Securities LLC acted as financial advisor and Norton Rose Fulbright Canada LLP acted as legal advisor to ARTMS during the negotiations and due diligence process related to the acquisition by Telix. About ARTMS, Based in Burnaby, British Columbia, Canada, ARTMS Inc. is the global leader in the development of novel technologies and products which enable the high-quality and high-yield production of the world’s most-used diagnostic imaging isotopes. ARTMS’ flagship product, the QUANTM Irradiation System (QISTM), enables decentralized, cost-effective, large-scale production of important medical isotopes such as gallium-68 (68Ga), zirconium-89 (89Zr), technetium‐99m (99mTc) and copper-64 (64Cu) using pharmaceutical distributor and hospital-based medical cyclotrons, empowering users to control their supply chain. ARTMS commercializes these award-winning and proprietary Canadian inventions on a global basis and has the prospect of revolutionizing the nuclear medicine industry. For more information on the QUANTM Irradiation System™ and ARTMS, please follow us on Twitter/X @ARTMS_Inc/X and LinkedIn and visit About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. 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). Visit 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.

并购

2024-04-05

·BiG生物创新社

核药接住了泼天的富贵：过去5年的交易、投资、市场格局

作者｜文心第二代放射性药物在肿瘤学领域的商业成功重新点燃了人们对这种治疗模式的兴趣，引起该领域公司的交易激增，风险融资增加。鉴于这一新兴的行业兴趣，Brianne Sullivan等人在Nature发文“The radiopharmaceutical renaissance: radiating hope in cancer therapy”。据此，本文评估了过去5年放射性药物领域的交易和投资格局，涵盖了治疗、诊断和诊断加治疗药物。 01 一代核药历经曲折，二代核药终获成功！系统放射性药物作为癌症的治疗方法首次应用于20世纪40年代，当时医生使用放射性碘治疗甲状腺癌症。鉴于早期放射治疗缺乏效力，以及由于缺乏特异性而产生的副作用，后来的药物经过发展，由科学家通过将放射性同位素与靶向部分（如肿瘤特异性小分子、肽或抗体）连接起来，开发出了更安全、更有效的药物。商业上可用的抗体放射治疗药物的出现始于本世纪初，2002年和2003年分别批准了Zevalin（ibritumomab tiuxetan；现在由Acrotech Biopharma销售）和Bexxar（tositumomab and iodine-131 [I-131] tositumomab；由葛兰素史克公司开发）用于治疗非霍奇金淋巴瘤。尽管疗效显著，医生热情高涨，但几个关键挑战——包括生产和处理所需的专用设施、设备和专业知识——限制了它们的商业成功。Zevalin和Bexxar在上市后的十多年里销量一直很低，导致Zevalin的所有权多次变更，Bexxar被从市场上撤下。而第二代放射性药物Xofigo（radium-223 [Ra-223] dichloride；拜耳，2013年批准）、Luthathera（lutetium-177 [Lu-177] dotatate；Advanced Accelerator Applications，2018年批准）和Pluvicto（lutetium-177 [Lu-177] vipivotide tetraxetan；诺华，2022年批准）已在商业上取得成功。XofigoXofigo是唯一批准的α粒子靶向疗法，该药是一款可发射α粒子的放射活性治疗药物。来自关键III期ALSYMPCA研究的数据证实：在治疗伴症状性骨转移且无已知内脏转移的转移性去势抵抗性前列腺癌患者时，与安慰剂相比，Xofigo可提供三重获益：显著延长生存期、推迟首次症状性骨骼事件（SSE）的发生时间、改善生活质量。此外，Xofigo还具有良好的安全性。LuthatheraLuthathera是一种放射性配体疗法，该药物去年9月25日III期NETTER-2试验达到了主要终点。与单独使用大剂量长效奥曲肽相比，Lutathera联合长效奥曲肽一线治疗新诊断为体泌素受体阳性、2级和3级晚期胃肠胰神经内分泌肿瘤（GEP-NET）患者的无进展生存期（PFS）实现明显改善。PluvictoPluvicto被批准用于治疗转移性去势耐受性前列腺癌症，它已经步入了成为重磅药物的行列，据诺华公司报告，2023年，pluvicto销售额9.8亿美元，同比增长高达261%。与现有的治疗相比，疗效的提高，包括放射肿瘤学家在内的肿瘤学实践的发展，以及稳定性和安全性提高的放射性同位素的使用，都为该领域注入了活力。 02 “诊疗一体化”是核药发展的大趋势此外，放射性药物的使用范围逐渐从治疗领域扩展到诊断领域。含有放射性成分的诊断剂在特定器官、组织或细胞中积聚，能够检测异常或功能变化，长期以来一直用于评估肿瘤、神经系统疾病、炎症性疾病和感染。最近，诊断治疗放射性药物的开发得到了大力推动，这种药物结合了诊断和治疗特性，支持“发现即治疗”的方法。诊断成分用于可视化和评估疾病或病症，然后使用相同或互补的放射性药物用于治疗目的。以个性化方式将诊断和治疗相结合的能力，为改善患者预后、优化治疗策略和推进精准医学方法带来了巨大的希望。 03 过去5年，核药共交易86笔在过去5年里，放射性药物领域共进行了86笔战略交易，其中大多数是合作/共同开发（n=26）和基于授权（n=26）的协议。2018年至2021年，交易格局相对稳定。然而，在2022年，交易数量比2021年增加了近两倍（分别为n=25和n=9；图1a）。值得注意的是，在临床前阶段（n=20）达成的交易数量最多，主要是由具有现有核医学能力和专业知识的公司（如Fusion Pharmaceuticals和Novartis）推动的，这些公司寻求扩大其放射性药物管线。许多交易也发生在2期临床阶段（n=18）；主要涉及基于授权和收购的诊断放射性药物交易（图1a）。图注：2018-2023年放射性药物领域生物制药公司的交易分布。a，每年按阶段划分的交易数量。该领域的活跃整合者包括大型全球生物制药公司（如诺华和拜耳）和专门的核医学公司（如Fusion Pharmaceuticals和Curium Pharma），交易活动涉及诊断、治疗和治疗加治疗药物。诊断放射性药物在该领域的交易总数中占据相当大的比例（约41%），其次是诊断治疗药物（约32%）和治疗药物（约27%；图1b）。肿瘤学在诊断治疗药物交易领域占据主导地位（分别占交易的93%和100%）；诊断领域的大部分交易在神经学领域（54%），其次是肿瘤学（31%）。图注：2018-2023年放射性药物领域生物制药公司的交易分布。b，每种形式的按适应症划分的交易数量。数据来源：Cortellis。*截至2023年10月3日。在分析期间，有17笔交易在宣布时披露了财务条款（约20%）。在所有开发阶段和模式中，商业交易的平均潜在总价值为8.34亿美元（前期2.84亿美元，里程碑5.5亿美元）（图2a）。与诊断资产的平均总交易价值（3900万美元；n=4）相比，诊断治疗（n=4）和治疗（n=9）资产的潜在交易价值分别高达7.29亿美元和10.26亿美元。诊断治疗资产的平均前期交易价值是治疗资产的2倍，这可能是由于前者的临床和监管风险较低。图注：2018-2023年放射性药物领域生物制药公司的交易价值。a按方式分类的交易价值。在考虑资产到期时的交易价值时，随着技术在临床阶段的进展，临床阶段资产的价值不断增加，尽管与早期临床资产相比，发现阶段交易的总交易价值更高（图2b）。在发现阶段达成的交易中，大部分（97%）的价值在于里程碑付款，反映了这些基于合作的交易在放射性药物疗法的发现、开发和商业化方面的高风险、高回报性质。图注：2018-2023年放射性药物领域生物制药公司的交易价值。b，按阶段分类的交易价值。数据来源：Cortellis。*截至2023年10月3日。商业阶段的交易主要是并购——收购近期获得美国食品和药物管理局（FDA）批准的公司。值得注意的是，诺华公司在2018年支付了39亿美元的预付款，收购了Advanced Accelerator Applications公司，紧随其后的是FDA批准该公司的神经内分泌肿瘤（NET）诊断产品Netspot（镓[ga-68] dotatate试剂盒），几乎与FDA批准诺华的治疗性产品Lutathera的时间相吻合。 04 核药公司融资数量稳步增加，集中于肿瘤领域自2018年以来，放射性药物领域发生的融资数量（n=54）一直在稳步增加，主要集中在癌症适应症（n=45；图3）。最活跃的融资集中在诊断加治疗（50%），其次是治疗（34%）和诊断（16%），大多数融资发生在早期，分别为A系列（56%）和B系列（32%）。随着兴趣和临床开发的不断提高，融资水平也在不断提高；2023年前三季度，九次融资的平均融资额为5100万美元，约为2018年全年四次融资2600万美元的2倍（图3）。图注：2018-2023年放射性药物领域源自私募融资的风险投资。*融资从A轮到D轮。数据来源：Pitchbook。*截至2023年10月3日。 05 上市公司交易收购热情不减虽然围绕放射性药物的热情导致了交易的增加，但从2023年初开始在美国主要交易所（纽约证券交易所或纳斯达克）上市的五家放射性药物公司（Fusion Pharmaceuticals、Lantheus Medical Imaging、POINT Biopharma、Perspective Therapeutics和Actinium Pharmaceuticals）的表现喜忧参半。从年初到2023年10月3日，他们的表现从POINT Biopharma股价上涨71%到Actinium Pharmaceuticals股价下跌43%不等。五家公司中，位于中位数的公司Perspective Therapeutics的股价上涨了11%，远高于纳斯达克生物技术指数的增长幅度，该指数在同一时期内下跌了7%。公共放射性药物公司平均表现积极的一个可能原因是私人市场模式带来的兴奋情绪蔓延到了公共市场。支持这一理论的是RayzeBio的首次公开募股（IPO），RayzeBio是一家放射性药物治疗公司，拥有一项主要资产，即用于治疗胃肠胰腺神经内分泌肿瘤的临床3期开发阶段的锕-225（Ac-225）dotatate。该公司在2023年9月15日在纳斯达克上市时筹集了3.58亿美元，上市后估值接近10亿美元。这是迄今为止年度第二大生物技术IPO，仅次于Acelyrin募集的5.4亿美元，是2023年医疗保健IPO平均规模的约2.9倍。2023年12月26日，RayzeBio与百时美施贵宝签署了最终合并协议，以41亿美元的价格被收购。RayzeBio股价当时溢价134%。一天后，礼来公司宣布以14亿美元的价格收购POINT Biopharma，该价格比POINT Biopharma在2023年10月3日宣布收购前一天的收盘价溢价87%。大型制药公司愿意为放射性制药公司支付高额溢价，进一步表明了该领域日益增长的兴趣。写在最后随着大量投资涌入早期放射性药物公司，作者预计随着这些新技术的成熟，制药公司将继续进行授权和并购活动。此外，随着对个性化医疗的日益重视，诊断加治疗的模式可能会继续受到人们的青睐；实际上，在上文的分析中，治疗诊断在考虑的模式中获得了最大的前期价值。放射性药物在肿瘤学以外的领域的使用可能会吸引更多的公司和风险投资商。由于放射性药物在可视化大脑和其他中央神经系统部分方面的独特能力，神经学在诊断交易中处于领先地位。总体而言，随着交易的继续进行，放射性药物领域充满了期待和期望。参考资料：The radiopharmaceutical renaissance: radiating hope in cancer therapy共建Biomedical创新生态圈！如何加入BiG会员？

放射疗法临床3期

100 项与镓[68Ga]多特安肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

适应症	最高研发状态	国家/地区	公司
神经内分泌肿瘤	批准上市	美国更多	Advanced Accelerator Applications USA, Inc. 更多
胃肠胰神经内分泌肿瘤	临床3期	中国更多	原子高科股份有限公司更多
转移性乳腺癌	临床2期	美国更多	Hoag Memorial Hospital Presbyterian, Inc. 更多
ER阳性乳腺癌	临床2期	美国更多	Rayzebio, Inc.初创企业更多

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临床结果

适应症

分期

评价

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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


ASCO_GI2023	N/A	APUD瘤	424	Ga68-DOTATE (Patients with well-differentiated NETs of GI and pancreatic origin)	齋衊遞鹹艱鹹築鹽艱製(築糧鬱襯觸鏇襯艱廠醖) = 觸膚淵醖願廠蓋範壓選醖繭積觸蓋簾選製壓襯 (製襯鬱築願顧淵衊鏇襯 ) 更多	-	2023-01-24
ASCO_GI2023	N/A	APUD瘤	424	Ga68-DOTATE (Patients with lung carcinoid)	鑰獵構築積觸鬱獵鹽壓(艱願構淵膚鹹鏇憲齋蓋) = 衊糧夢鏇糧鹽鏇積築觸壓鑰蓋醖鹽襯鹹淵選齋 (膚觸蓋鏇範顧壓衊蓋壓 )	-	2023-01-24
NCT03549598 (CTgov)	临床4期	心脏结节病	15	13NH3 PET/CT scan+18FDG PET/CT scan+68Ga-DOTATATE PET/CT	範願鑰構窪齋繭夢築蓋(顧鹽鑰選鑰壓鏇鏇製淵) = 淵夢繭艱鬱獵積顧廠壓簾鑰淵願窪繭蓋醖淵憲 (鑰顧構衊齋壓觸繭鬱餘, 網選鑰蓋構夢醖鑰淵醖 ~ 獵膚艱製範艱鬱遞鏇淵) 更多	-	2020-10-20
NCT02546388 (CTgov)	N/A	心脏结节病	17	Gallium-68 DOTATATE (Gallium-68 DOTATATE)	憲糧鑰蓋願遞衊遞衊構(窪餘積艱淵鹹顧鬱鬱顧) = 觸獵艱餘顧願醖壓獵蓋鹹膚壓獵繭遞窪醖願構 (糧簾鹽範獵選醖糧積選, 鑰蓋壓鏇遞鑰構淵窪鑰 ~ 製艱淵膚遞膚遞憲夢鏇) 更多	-	2020-03-25
NCT02546388 (CTgov)	N/A	心脏结节病	17	Indium-111 Pentreotide (Indium-111 Pentreotide (OctreoScan))	憲糧鑰蓋願遞衊遞衊構(窪餘積艱淵鹹顧鬱鬱顧) = 憲膚觸夢築製憲積鹽鏇鹹膚壓獵繭遞窪醖願構 (糧簾鹽範獵選醖糧積選, 餘觸壓遞網鬱構鹹艱願 ~ 鏇獵蓋選窪顧膚齋願獵) 更多	-	2020-03-25
NCT01967537 (CTgov)	临床2期	希佩尔·林道综合征 \| 神经内分泌肿瘤	341	Radio-guided surgery+68Gallium DOTATATE	衊獵夢艱築獵繭選醖網(顧廠選願憲鹽艱觸衊膚) = 範簾窪齋築範鏇築廠構構艱憲鏇餘鹽齋蓋糧糧 (憲艱繭鹽醖夢製獵觸齋, 糧膚選襯膚糧鬱壓製願 ~ 願繭憲憲淵壓餘遞築蓋) 更多	-	2019-04-02
ASCO_GI2019	N/A	神经内分泌肿瘤	101	Ga-68 Dotatate PET/CT	齋選積構餘蓋選糧製遞(獵積選網網淵衊艱鏇艱) = 鬱憲窪窪簾壓糧觸廠簾襯膚衊觸鬱選遞選憲鹹 (淵鑰膚願觸積鬱餘鬱衊 )	积极	2019-01-29