DCIS (ductal carcinoma in situ) is a common pre-stage for breast cancer. The goal of this clinical trial is to learn if FAPI-PET/MRI (an imaging technique with a weakly radioactive drug) helps to diagnose hidden invasive breast cancer in participants with DCIS. The main question it aims to answer is:
How good can FAPI-PET/MRI diagnose hidden invasive breast cancer in DCIS?
Researchers will compare FAPI-PET/MRI results to tissue samples obtained from surgery treatment to see if the FAPI-PET/MRI images show invasive breast cancer certainly.
Participants will
* receive the radioactive drug and lie in an imaging device for 45 minutes including a break
* visit the clinic once again for a checkup and test

开始日期2024-09-10

申办/合作机构

Universität Leipzig

NCT05898854 / Recruiting临床2期IIT

[68Ga]Ga-FAPI PET/CT: The Dagnostic Accuracy for Primary Staging and Re-staging After Chemotherapy in Patients With Gastric and Gastro-esophageal Junctional Cancer

Twenty (n=20) patients with gastric cancer or gastro-esophageal junctional cancer will undergo FAPI PET/CTs in addition to routing diagnostic workup (including FDG PET/CT) at primary staging and restaging.
The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT) using histopathology as reference standard, and the diagnostic accuracy will be determined. FAP-immunohistochemistry will be conducted in surgical specimens. FAPI PET/CT's impact on patient management and the prognostic value of FAPI PET/CT will be evaluated.

开始日期2024-02-15

申办/合作机构

Aalborg University Hospital

NCT05903807 / Recruiting临床2期IIT

[68Ga]Ga-FAPI-46 PET/CT: The Diagnostic Accuracy for Primary Staging and Re-staging of Patients With Ovarian Cancer

Fifty (n=50) patients with newly diagnosed ovarian cancer will undergo FAPI PET/CTs in addition to routine diagnostic workup (including FDG PET/CT) at primary staging and restaging.
The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT) using histopathology as reference standard, and the diagnostic accuracy will be determined. FAP-immunohistochemistry will be conducted in surgical specimens. FAPI PET/CT's impact on patient management and the prognostic value of FAPI PET/CT will be evaluated.

开始日期2023-11-17

申办/合作机构

Aalborg University Hospital

100 项与 [68Ga]FAPI-46 相关的临床结果

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100 项与 [68Ga]FAPI-46 相关的转化医学

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100 项与 [68Ga]FAPI-46 相关的专利（医药）

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项与 [68Ga]FAPI-46 相关的文献（医药）

2024-07-01·Molecular Pharmaceutics

Enhanced Detection of Early Pulmonary Fibrosis Disease Using ⁶⁸Ga-FAPI-LM3 PET

Article

作者: Chen, Jianhao ; Chen, Haojun ; Sun, Long ; Lin, Qin ; Zhao, Liang ; Pang, Yizhen ; Zhou, Yangfan ; Luo, Doudou ; Dai, Yaqing ; Su, Guoqiang ; Wu, Hua

Early detection of pulmonary fibrosis is a critical yet insufficiently met clinical necessity. This study evaluated the effectiveness of FAPI-LM3, a ⁶⁸Ga-radiolabeled heterobivalent molecular probe that targets fibroblast activating protein (FAP) and somatostatin receptor 2 (SSTR2), in the early detection of pulmonary fibrosis, leveraging its potential for early disease identification. A bleomycin-induced early pulmonary fibrosis model was established in C57BL/6 mice for 7 days. FAP and SSTR2 expression levels were quantitatively assessed in human idiopathic pulmonary fibrosis lung tissue samples and bleomycin-treated mouse lung tissues by using western blotting, real-time quantitative PCR (RT-qPCR), and immunofluorescence techniques. The diagnostic performance of FAPI-LM3 was investigated by synthesizing monomeric radiotracers ⁶⁸Ga-FAPI-46 and ⁶⁸Ga-DOTA-LM3 alongside the heterobivalent probe ⁶⁸Ga-FAPI-LM3. These imaging radiopharmaceuticals were used in small-animal PET to compare their uptake in fibrotic and normal lung tissues. Results indicated significant upregulation of FAP and SSTR2 at both RNA and protein levels in fibrotic lung tissues compared with that in normal controls. PET imaging demonstrated significantly enhanced uptake of the ⁶⁸Ga-FAPI-LM3 probe in fibrotic lung tissues, with superior visual effects compared to monomeric tracers. At 60 min postinjection, early stage fibrotic tissues (day 7) demonstrated low-to-medium uptake of monomeric probes, including ⁶⁸Ga-DOTA-LM3 (0.45 ± 0.04% ID/g) and ⁶⁸Ga-FAPI-46 (0.78 ± 0.09% ID/g), whereas the uptake of the heterobivalent probe ⁶⁸Ga-FAPI-LM3 (1.90 ± 0.10% ID/g) was significantly higher in fibrotic lesions than in normal lung tissue. Blockade experiments confirmed the specificity of ⁶⁸Ga-FAPI-LM3 uptake, which was attributed to synergistic targeting of FAP and SSTR2. This study demonstrates the potential of ⁶⁸Ga-FAPI-LM3 for early pulmonary fibrosis detection via molecular imaging, offering significant benefits over monomeric tracers ⁶⁸Ga-FAPI-46 and ⁶⁸Ga-DOTA-LM3. This strategy offers new possibilities for noninvasive and precise early detection of pulmonary fibrosis.

2024-04-01·Annals of Nuclear Medicine

Development and application of a fully automatic multi-function cassette module Mortenon M1 for radiopharmaceutical synthesis

Article

作者: Yu, Shan-You ; Zheng, Qi-Huang ; Eng, Wai-Si ; Lv, Xuan ; Yan, Cheng-Long ; Cui, Fang-Bo

INTRODUCTIONFunctions of existing automatic module systems for synthesis of radiopharmaceuticals mainly focus on the radiolabeling of small molecules. There are few modules which have achieved full-automatic radiolabeling of non-metallic and metallic nuclides on small molecules, peptides, and antibody drugs. This study aimed to develop and test a full-automatic multifunctional module system for the safe, stable, and efficient production of radiopharmaceuticals.METHODSAccording to characteristics of labeling process of radioactive drugs, using UG and Solidworks softwares, full-automatic cassette-based synthesis module system Mortenon M1 for synthesis of radiopharmaceuticals with various radionuclides, was designed and tested. Mortenon M1 has at least three significant highlights: the cassettes are disposable, and there is no need of manual cleaning; the synthesis method program is flexible and can be edited freely by users according to special needs; this module system is suitable for radiolabeling of both small-molecule and macromolecular drugs, with potentially various radionuclides including ¹⁸F, ⁶⁴Cu, ⁶⁸Ga, ⁸⁹Zr, ¹⁷⁷Lu, etc. By program control methods for certain drugs, Mortenon M1 was used for radiolabeling of both small-molecule drugs such as [⁶⁸Ga]-FAPI-46 and macromolecular drugs such as [⁸⁹Zr]-TROP2 antibody. Quality control assays for product purity were performed with radio-iTLC and radio-HPLC, and the radiotracers were confirmed for application in microPET imaging in xenograft tumor-bearing mouse models.RESULTSFunctional tests for Mortenon M1 module system were conducted, with [⁶⁸Ga]-FAPI-46 and [⁸⁹Zr]-TROP2 antibody as goal synthetic products, and it displayed that with the cassette modules, the preset goals could be achieved successfully. The radiolabeling synthesis yield was good ([⁶⁸Ga]-FAPI-46, 70.63% ± 2.85%, n = 10; [⁸⁹Zr]-TROP2, 82.31% ± 3.92%, n = 10), and the radiochemical purity via radio-iTLC assay of the radiolabeled products was above 99% after purification. MicroPET imaging results showed that the radiolabeled tracers had reasonable radioactive distribution in MDA-MB-231 and SNU-620 xenograft tumor-bearing mice, and the tumor targeted radiouptake was satisfactory for diagnosis.CONCLUSIONThis study demonstrated that the full-automatic module system Mortenon M1 is efficient for radiolabeling synthesis of both small-molecule and macromolecular substrates. It may be helpful to reduce radiation exposure for safety, provide qualified radiolabeled products and reliable PET diagnosis, and ensure stable production and supply of radiopharmaceuticals.

2023-03-01·Journal of Nuclear Medicine

PET Imaging of Fibroblast Activation Protein in Various Types of Cancer Using⁶⁸Ga-FAP-2286: Comparison with¹⁸F-FDG and⁶⁸Ga-FAPI-46 in a Single-Center, Prospective Study

Article

作者: Meng, Tinghua ; Zhang, Jingjing ; Pang, Yizhen ; Zhao, Liang ; Xu, Weizhi ; Lin, Qin ; Chen, Xiaoyuan ; Chen, Haojun ; Sun, Long ; Wu, Hua

PET imaging that targets fibroblast activation protein (FAP) on the surface of cancer-associated fibroblasts has yielded promising tumor diagnostic results. FAP-2286 contains cyclic peptides as FAP-binding motifs to optimize tumor retention compared with the small-molecule FAP inhibitor (FAPI) series (FAPI-04/46). The aim of this study was to evaluate the diagnostic accuracy of ⁶⁸Ga-FAP-2286 to detect primary and metastatic lesions in patients with various types of cancer, compared with ¹⁸F-FDG and ⁶⁸Ga-FAP-2286. Methods: Sixty-four patients with 15 types of cancer underwent ⁶⁸Ga-FAP-2286 PET/CT for initial assessment or detection of recurrence. For comparison, 63 patients underwent paired ⁶⁸Ga-FAP-2286 and ¹⁸F-FDG PET/CT and 19 patients underwent paired ⁶⁸Ga-FAP-2286 and ⁶⁸Ga-FAPI-46 PET/CT. Lesion uptake was quantified as SUV_max and tumor-to-background ratio. The Wilcoxon matched-pairs signed-rank test was used to compare SUV_max between PET modalities, and the McNemar test was used to compare lesion detectability. Results: Uptake of ⁶⁸Ga-FAP-2286 was significantly higher than that of ¹⁸F-FDG in primary tumors (median SUV_max, 11.1 vs. 6.9; P < 0.001), lymph node metastases (median SUV_max, 10.6 vs. 6.2; P < 0.001), and distant metastases, resulting in improved image contrast and lesion detectability. All primary tumors (46/46) were clearly visualized by ⁶⁸Ga-FAP-2286 PET/CT, whereas 9 of the 46 lesions could not be visualized by ¹⁸F-FDG PET/CT. The lesion detection rate of ⁶⁸Ga-FAP-2286 PET/CT was superior to that of ¹⁸F-FDG PET/CT for involved lymph nodes (98% [105/107] vs. 85% [91/107], P = 0.001) and bone and visceral metastases (95% [162/171] vs. 67% [114/171], P < 0.001). ⁶⁸Ga-FAP-2286 yielded tumor uptake and lesion detection rates similar to those of ⁶⁸Ga-FAPI-46 in a subcohort of 19 patients. Conclusion: ⁶⁸Ga-FAP-2286 is a promising FAP-inhibitor derivative for safe cancer diagnosis, staging, and restaging. It may be a better alternative to ¹⁸F-FDG for the cancer types that exhibit low-to-moderate uptake of ¹⁸F-FDG, which include gastric, pancreatic, and hepatic cancers. In addition, ⁶⁸Ga-FAP-2286 and ⁶⁸Ga-FAPI-46 yielded comparable clinical results.

项与 [68Ga]FAPI-46 相关的新闻（医药）

2024-05-10

·创鉴汇

36家创新药公司融资过亿！

▎药明康德内容团队编辑今年4月份，全球范围内有众多医药公司获得融资，这些资金在新一年将继续被用于创新医药技术发展。据创鉴汇不完全统计，4月共有68家生物医药公司获得融资，已披露融资总额超252亿元，36家公司融资过亿元。其中，值得关注的数据包括：细胞基因疗法受关注：所有融资事件中，11家获融资的公司开发细胞基因疗法，涉及实体瘤同种异体细胞疗法、溶瘤病毒疗法、新一代基因编辑工具等。抗肿瘤药物仍为主要药物关注方向：68家获融资公司中，过半数公司研发疾病领域方向包含抗肿瘤领域，其中，值得关注的公司有抗体药物研发公司TORL BioTherapeutics、共价变构剂药物开发公司Alterome Therapeutics及肿瘤放射性诊疗药物开发公司蓝纳成等。中国获融资公司集中于长江三角洲地区：4月获融资的20家中国公司中，有7家来自上海，3家来自江苏，3家来自浙江。# 德昇济医药完成6200万美元A+轮融资4月8日，德昇济医药宣布完成由欧洲生命科学投资企业Medicxi主导的6200万美元A+轮融资。德昇济医药是一家面向全球、临床阶段的生物技术公司，专注于肿瘤及免疫精准治疗药物的研发及商业化。根据德昇济医药新闻稿，本轮融资资金将用于加速德昇济医药产品管线在临床前和临床阶段的开发，特别是推动首款产品D3S-001的全球临床试验。D3S-001是新一代小分子KRAS G12C抑制剂。目前，D3S-001正在进行全球2期临床开发，适应症包括非小细胞肺癌、结直肠癌和胰腺癌。# 英派药业完成4亿元人民币D+轮融资4月19日，英派药业（IMPACT Therapeutics）宣布完成4亿元人民币D+轮融资。该公司以DNA损伤修复通路（DDR）自主研发产品为基础，构建了广泛的DDR产品组合，并且正在逐步拓展到更多的全新的"合成致死"靶点。目前英派药业研发管线包括PARP抑制剂塞纳帕利、WEE1抑制剂IMP7068、ATR抑制剂IMP9064、PARP1选择性抑制剂IMP1734以及多个其他DDR靶点抑制剂。其中，塞纳帕利已于2023年在中国递交新药上市申请，用于FIGO III-IV期上皮性卵巢癌、输卵管癌或原发性腹膜癌患者对一线含铂化疗达到完全或部分缓解后的维持治疗。# 蓝纳成完成3亿元B+轮融资4月25日，东诚药业宣布，其控股子公司烟台蓝纳成生物技术有限公司（简称蓝纳成）以增资扩股方式拟引入投资者。蓝纳成创立于2021年，由东诚药业与国际分子影像及纳米医学领域专家陈小元教授联合创立，专注于全球创新的1类诊疗一体化创新肿瘤核药研发平台的打造，致力于为肿瘤患者提供更加精准和有效的治疗方案，并推动核医学在全球的发展。目前，蓝纳成多个用于癌症的1类诊疗一体化创新药物已经进入临床试验阶段。其中包括靶向前列腺特异性膜抗原（PSMA）的放射性体内治疗药物177Lu-LNC1003注射液、用于前列腺癌诊断的1类创新核药氟[18F]思睿肽注射液、伴随诊断试剂68Ga-FAPI-46注射液、靶向FAP的放射性体内诊断药物氟[18F]纤抑素注射液、靶向FAP的放射性体内治疗药物177Lu-LNC1004注射液等等。# 滨会生物完成数亿元C轮融资4月22日，滨会生物宣布完成数亿元C轮融资。滨会生物是一家溶瘤病毒创新药研发企业，以溶瘤病毒（oHSV2）免疫治疗和孤儿药开发为特色，多平台协同开发1类生物新药。公司已建立病毒载体、核酸药物、蛋白药物及细胞治疗四大核心技术平台，核心产品BS001注射液是被中国CDE纳入突破性治疗品种的溶瘤病毒候选药物，并获得美国FDA孤儿药认定、被授予快速通道资格，在黑色素瘤、脑胶质瘤等适应症的临床试验中取得良好的安全性和突出的有效性数据。据悉，本轮融资将用于推进滨会生物临床研究、注册申报以及团队建设。# 跃赛生物完成超亿元A轮融资4月3日，跃赛生物宣布完成超亿元A轮融资。根据跃赛生物官方新闻稿，此次融资资金将用于加速推进公司的在研管线与临床试验进程，进一步深化创新细胞治疗药物的规模化开发和产业化建设。跃赛生物成立于2021年，致力于开发新一代基于人多能干细胞技术的细胞治疗药物，其在研管线覆盖了帕金森病和其他神经退行性疾病。近年来，跃赛生物取得了重大进展，预计在2024年完成IND临床试验申请，并计划于2025年初开始试验入组。该公司的多项研发成果已发表于Nature Methods、Cell Stem Cell等国际权威学术期刊。# Obsidian Therapeutics完成超1.6亿美元融资4月4日，Obsidian Therapeutics宣布完成超额1.605亿美元C轮融资。融资所得将用于推进Obsidian主打项目肿瘤浸润淋巴细胞（TIL）疗法OBX-115的开发。Obsidian致力于开创工程化的细胞和基因疗法，其OBX-115已进入治疗黑色素瘤与非小细胞肺癌（NSCLC）的1/2期临床试验。OBX-115是一种新型工程化的TIL疗法，该TIL具有表达于细胞膜上受调节的白介素-15（IL-15）蛋白，因此患者在接受OBX-115治疗时不需要同时接受高剂量的白介素-2（IL-2）治疗。# Nvelop Therapeutics完成1亿美元种子轮融资4月9日，Nvelop Therapeutics宣布正式启动，以开发针对广泛疾病的下一代基因药物。该公司基于病毒样蛋白颗粒（VLPs）的独有递送平台有潜力高效和细胞特异性地递送广泛的治疗性载荷。该公司已完成1亿美元的种子轮融资。Nvelop的模块化平台基于两种已经经过体内验证的递送方法。这些方法是基于基因编辑先驱刘如谦博士和Keith Joung博士实验室的研究。这些方法有望解决目前递送平台的局限性，实现基因药物的潜力。# Corner Therapeutics完成5400万美元融资4月19日，Corner Therapeutics宣布已完成5400万美元的A轮融资，用于研发能够终身保护人体免受癌症和传染病侵害的疫苗。Corner公司的技术让免疫系统能够生成对抗疾病，并长久生存的T细胞。Corner的技术专注于释放人体树突状细胞（DCs）的免疫调节能力，以提供终身的疾病保护。在临床前研究中，Corner的方法已被证明能够诱导对癌症和感染的保护性免疫——特别是在老年人或免疫力低下的受试者中效果显著。去年11月，mBio发表的研究证实，Corner的催化佐剂平台能够增强脂质纳米颗粒疫苗的免疫原性。2022年，Nature Reviews Immunology发表了由Corner的科学联合创始人Jonathan Kagan博士主导研究的文章，概述了超激活的DCs如何刺激抗肿瘤的细胞免疫。# TORL BioTherapeutics完成1.58亿美元融资4月10日，TORL BioTherapeutics宣布完成了超额的1.58亿美元B2轮融资，获得的资金将用于推动该公司研发管线中的多款潜在“first-in-class”和“best-in-class”抗体偶联药物（ADC）的临床开发。该公司的主打在研疗法TORL-1-23是一款靶向CLDN 6的潜在“first-in-class” ADC，目前正在1期临床试验中接受评估，预计在今年下半年启动2期临床试验。这一临床试验旨在支持TORL-1-23的监管审评和潜在批准。读者们请星标⭐创鉴汇，第一时间收到推送免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转发/复制至其他平台。转发授权请在「创鉴汇」微信公众号留言联系我们。更多数据内容推荐点击“在看”，分享创鉴汇健康新动态

基因疗法临床2期免疫疗法细胞疗法

2024-04-29

·创鉴汇

超10亿美元融资！AI药物新锐众星云集；16家创新药公司获融资 | 一周融资

▎药明康德内容团队编辑据创鉴汇不完全统计，上周（4月22日至4月28日）全球大健康领域共披露融资事件34起，总额近130亿元。按照金额划分，亿元及以上融资18起。按照已披露的融资轮次划分，早期融资（B轮以前）20起，中后期融资（B轮及以后）9起。生物医药领域共16家公司获融资，涉及药物类型包含抗体偶联物、小分子靶向药、放射性疗法等。#01Xaira Therapeutics获得超10亿美元融资关键词：AI药物最新融资：超10亿美元本轮投资机构：ARCH Venture Partners、Byers Capital、Foresite Capital、F-Prime Capital、红杉资本等4月23日，Xaira Therapeutics宣布正式启动，该公司目标是通过全方位应用新兴的人工智能（AI）技术，重新定义药物发现和开发的方式。Xaira由ARCH Venture Partners和Foresite Labs共同孵化，获得启动融资金额超过10亿美元。该公司开发主要涵盖三大核心领域：先进的机器学习研究、大规模数据生成以及强大的疗法开发能力。据行业媒体Endpoints News报道，这是今年以来获得潜在最高融资款项的初创公司之一。值得一提的是，Xaira公司众星云集，除了人工智能驱动的蛋白质折叠和设计先驱David Baker教授为该公司的共同创始人之一外，前基因泰克（Genentech）首席科学官Marc Tessier-Lavigne博士也加入团队担任首席执行官。Tessier-Lavigne博士同时也是洛克菲勒和斯坦福大学的前校长。#02Endeavor BioMedicines完成1.325亿美元C轮融资关键词：抗体偶联药物、小分子药物最新融资：1.325亿美元C轮本轮投资机构：AyurMaya、Eckuity Capital、富达、汇桥资本、Invus等4月24日，Endeavor BioMedicines宣布完成1.325亿美元C轮融资。获得的资金将用于推动其主打在研疗法ENV-101的临床开发，这款小分子疗法旨在治疗特发性肺纤维化（IPF）和进行性肺纤维化（PPF）。此外，这笔资金还将支持ENV-501的临床概念验证研究，ENV-501是一种针对人表皮生长因子3（HER3）阳性实体瘤的抗体偶联药物（ADC）。Endeavor BioMedicines是一家临床阶段的生物技术公司，致力于开发针对肺纤维化疾病和肿瘤的药物。#03SynOx Therapeutics完成7500万美元B轮融资关键词：抗体药物最新融资：7500万美元B轮本轮投资机构：Bioqube Ventures、Forbion、HealthCap4月22日，SynOx Therapeutics公司宣布完成7500万美元的B轮融资，获得的资金将用于推动其靶向CSF-1受体的潜在“best-in-class”抗体疗法emactuzumab的3期临床试验和后续开发，用于治疗腱鞘巨细胞瘤（TGCT）。Emactuzumab通过抑制CSF-1受体介导的信号通路，促进T细胞浸润和抗癌免疫反应。此前的临床试验数据显示，emactuzumab达到71%的客观缓解率（ORR），可快速缩小肿瘤并且疗效持久，显著改善患者功能性指标。#04蓝纳成完成B+轮3亿元融资关键词：放射性疗法最新融资：B+轮3亿元本轮投资机构：奥华清洁能源、龙信投资、前海方舟、深圳市创新投资集团、烟台财金控股4月24日，蓝纳成完成B+轮融资金额3亿元。此次融资将用于加快产品商业化及整合上市流程。蓝纳成创立于2021年，由东诚药业与国际分子影像及纳米医学领域专家陈小元教授联合创立，专注于全球创新的1类诊疗一体化创新肿瘤核药研发平台的打造，致力于为肿瘤患者提供更加精准和有效的治疗方案，并推动核医学在全球的发展。目前，蓝纳成多个用于癌症的1类诊疗一体化创新药物已经进入临床试验阶段。其中包括靶向前列腺特异性膜抗原（PSMA）的放射性体内治疗药物177Lu-LNC1003注射液、用于前列腺癌诊断的1类创新核药氟[18F]思睿肽注射液、伴随诊断试剂68Ga-FAPI-46注射液、靶向FAP的放射性体内诊断药物氟[18F]纤抑素注射液、靶向FAP的放射性体内治疗药物177Lu-LNC1004注射液等等。#05熙源安健完成超亿元融资关键词：小分子药物最新融资：超亿元Pre-A和Pre-A+轮本轮投资机构：博远资本、启明创投、顺禧基金、闻耐医药、中燃弈境等4月23日，熙源安健宣布完成超亿元Pre-A和Pre-A+融资。熙源安健是一家专注于疼痛管理领域创新性治疗药物开发的生物医药公司，本轮所融资金将用于其产品管线在临床前和临床阶段的开发，特别是加速其自主研发并进入临床的CGRP类小分子药物BR005项目的临床试验进度。熙源安健专注于开发针对严重慢性疼痛病症的创新型、高特异性的镇痛疗法，尤其重视解决头面部疼痛、肌肉骨骼疼痛和神经性疼痛等临床长期未满足需求。其中，BR005是由熙源安健研发的小分子CGRP受体拮抗剂。该产品已经在中国获批临床，拟用于治疗成人有先兆或无先兆急性偏头痛，目前1期临床研究已完成首例受试者入组。读者们请星标⭐创鉴汇，第一时间收到推送免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转发/复制至其他平台。转发授权请在「创鉴汇」微信公众号留言联系我们。更多数据内容推荐点击“在看”，分享创鉴汇健康新动态

临床3期抗体药物偶联物放射疗法引进/卖出

2024-04-25

·医药观澜

开发抗肿瘤核药，东诚药业子公司完成3亿元B+轮融资！

▎药明康德内容团队报道刚刚，东诚药业宣布，其控股子公司烟台蓝纳成生物技术有限公司（简称蓝纳成）以增资扩股方式拟引入投资者。本次投资由深创投领投，前海方舟、烟台财经、龙信投资、奥华清洁能源跟投，完成B+轮融资金额3亿元。按照蓝纳成发展规划，该公司将适时开展IPO融资上市。蓝纳成创立于2021年，由东诚药业与国际分子影像及纳米医学领域专家陈小元教授联合创立，专注于全球创新的1类诊疗一体化创新肿瘤核药研发平台的打造，致力于为肿瘤患者提供更加精准和有效的治疗方案，并推动核医学在全球的发展。公开资料显示，蓝纳成自成立以来，已经搭建了较为完备的核素诊疗管线，靶向药物涵盖小分子、多肽及抗体，产品涉及前列腺癌、实体瘤、脑胶质瘤、神经内分泌瘤等多个领域。包括成纤维细胞活化蛋白（FAP）相关的产品等，在研的多个诊疗一体化创新核药已陆续在中美申报，并已在全球同步开展临床研究。▲蓝纳成在研管线（截图来源：蓝纳成官网）目前，蓝纳成多个用于癌症的1类诊疗一体化创新药物已经进入临床试验阶段。其中包括靶向前列腺特异性膜抗原（PSMA）的放射性体内治疗药物177Lu-LNC1003注射液、用于前列腺癌诊断的1类创新核药氟[18F]思睿肽注射液、伴随诊断试剂68Ga-FAPI-46注射液、靶向FAP的放射性体内诊断药物氟[18F]纤抑素注射液、靶向FAP的放射性体内治疗药物177Lu-LNC1004注射液等等。参考资料：[1]蓝纳成完成B+轮3亿元融资！.Retrieved Apr 25 , 2024. From https://mp.weixin.qq.com/s/CxlCCKdri38HH5H9QJrExw[2]蓝纳成官网. From https://www.dc-lnc.com/pro1/本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转发授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

诊断试剂IPO放射疗法

100 项与 [68Ga]FAPI-46 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
卵巢癌	临床2期	丹麦	Aalborg University Hospital	2024-06-07
溃疡性结肠炎	临床2期	荷兰	Academic Medical Center University of Amsterdam	2023-08-31
克罗恩病	临床2期	荷兰	Academic Medical Center University of Amsterdam	2023-08-31
纤维化	临床2期	荷兰	Academic Medical Center University of Amsterdam	2023-08-31
胃食管交界处癌	临床2期	-	Aalborg University Hospital	2023-06-12
腺瘤性结肠息肉病	临床2期	美国	Sofie Biosciences, Inc.	2022-05-02
胰腺导管腺癌	临床2期	美国	Sofie Biosciences, Inc.	2022-05-02
胆管癌	临床1期	美国	Jonsson Comprehensive Cancer Center	2020-08-27
胸膜肿瘤	临床1期	美国	Jonsson Comprehensive Cancer Center	2020-08-27
睾丸肿瘤	临床1期	美国	Jonsson Comprehensive Cancer Center	2020-08-27

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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


SNMMI2023	N/A	-	-	68Ga-FAPI-46	觸鬱選襯糧鬱簾繭齋顧(繭壓願鹽鑰艱構鑰鏇鹹) = 製鹽顧顧範廠遞範廠淵簾顧壓鬱夢鏇艱選糧壓 (窪鏇壓願繭鬱衊衊艱膚 )	-	2023-08-28
SNMMI2023	N/A	-	-	68Ga-FAPI-4618F-FDGPI-46 (18F-FDG-PET)	積糧觸築糧醖齋範獵齋(鏇憲鬱廠獵築積選襯選) = the average 68Ga-FAPI-46/18-FDG average ratio was higher in LC than in benign lesions (3.64 +/- 1.59 versus 1.89 +/- 0.32) 繭淵壓選鏇餘憲夢鑰夢 (襯獵醖廠簾顧憲構積餘 ) 更多	-	2023-08-28
SNMMI2023	N/A	-	-	[68Ga]Ga-FAPI-46	選壓蓋鹹鹽齋醖蓋願壓(蓋憲餘簾齋範鏇鹽憲糧) = 醖艱鹹艱夢構膚襯繭簾襯鬱簾壓範築壓壓窪築 (餘鬱窪糧網鬱積願獵餘 ) 更多	-	2023-08-28
SNMMI2023	临床2期	腺瘤性结肠息肉病 FAP expression	91	68Ga-FAPI-4618F-FDGPI-46 (18F-FDG PET/CT)	鏇窪網鬱簾廠艱繭鑰鑰(鏇顧鏇範構醖壓蓋膚鑰) = 築憲範鹹簾築獵襯餘觸淵選獵壓艱顧鏇壓鏇淵 (窪膚鏇網膚憲醖遞壓鏇 )	积极	2023-08-28