This phase II trial investigates how well 177Lu-DOTATATE works in treating patients with breast cancer that is stage IV or has come back (recurrent). 177Lu-DOTATATE may shrink or destroy the tumor or circulating breast cancer stem cells if they show evidence of the SSTR2. 177Lu-DOTATATE is a targeted therapy that uses DOTATATE, linked to a radioactive agent called 177Lu. DOTATATE attaches to tumor cells with SSTR2 and delivers 177Lu to kill them. Giving 177Lu-DOTATATE may help decrease the number and size of tumors and the number of circulating cancer stem cells in patient's blood for the treatment of patients with breast cancer positive for SSTR2.

开始日期2025-01-01

申办/合作机构

OHSU Knight Cancer Institute

[+3]

NCT06607692 / Recruiting临床2期IIT

Single-arm Open-label Phase II Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined with the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed)

Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)

开始日期2024-10-01

申办/合作机构-

NCT05687123 / Recruiting临床1期IIT

A Phase I Dose Escalation-Expansion Trial of Sunitinib Malate Plus Lutetium Lu 177 Dotatate (Lutathera) in Somatostatin Receptor Positive Pancreatic Neuroendocrine Tumors

This phase I trial tests the safety, side effects, and best dose of sunitinib malate in combination with lutetium Lu 177 dotatate in treating patients with pancreatic neuroendocrine tumors. Sunitinib malate is in a class of medications called kinase inhibitors and a form of targeted therapy that blocks the action of abnormal proteins called VEGFRs that signal tumor cells to multiply. This helps stop or slow the spread of tumor cells. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. It is also a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as somatostatin receptors, so that radiation can be delivered directly to the tumor cells and kill them. Giving sunitinib malate and lutetium Lu 177 dotatate in combination may be safer and more effective in treating pancreatic neuroendocrine tumors than giving either drug alone.

开始日期2024-08-14

申办/合作机构

National Cancer Institute

100 项与 (177镥)镥氧奥曲肽相关的临床结果

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100 项与 (177镥)镥氧奥曲肽相关的转化医学

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100 项与 (177镥)镥氧奥曲肽相关的专利（医药）

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1,057

项与 (177镥)镥氧奥曲肽相关的文献（医药）

2025-01-01·SURGERY

Surgery enhances the effectiveness of peptide receptor radionuclide therapy in metastatic gastroenteropancreatic neuroendocrine tumors

Article

作者: Gujarathi, Rushabh ; Vaghaiwalla, Tanaz ; Liao, Chih-Yi ; Keutgen, Xavier M. ; Tobias, Joseph ; Abou Azar, Sara ; Keutgen, Xavier M ; Nordgren, Rachel ; Feinberg, Nicholas ; Millis, J. Michael ; Millis, J Michael

BACKGROUND:

With the advent of peptide receptor radionuclide therapy, the timing and sequence of surgery in the treatment of metastatic gastroenteropancreatic neuroendocrine tumors merits further study. We hypothesized that surgery before peptide receptor radionuclide therapy might enhance its effectiveness in patients with metastatic gastroenteropancreatic neuroendocrine tumors.

METHODS:

Eighty-nine patients with metastatic well-differentiated gastroenteropancreatic neuroendocrine tumors treated with ¹⁷⁷Lutetium-dotatate peptide receptor radionuclide therapy between 2018 and 2023 were included. Fifty-six patients underwent surgery (primary tumor resection and/or liver debulking) before peptide receptor radionuclide therapy and 33 patients did not. Primary outcome was progression-free survival according to Response Evaluation Criteria in Solid Tumors. Pretreatment dotatate positron emission tomography/computed tomography was used to calculate tumor volumes.

RESULTS:

The surgery and no-surgery groups were well-matched. Median progression-free survival after peptide receptor radionuclide therapy was 15.6 months (interquartile range, 9.1-22.7 months) in the no-surgery group compared with 26.1 months (interquartile range, 12.7-38.1 months) in the surgery group (P = .04). On subgroup analysis, median progression-free survival was 18.1 months (interquartile range, 11.9-38.4 months) in patients who underwent primary tumor resection only compared with 26.2 months (interquartile range, 14.0-38.1 months) in patients who underwent liver debulking (P = .04). Tumor volume was lowest in patients who underwent liver debulking (median 146.07 mL³) compared with no surgery (median 626.42 mL³) (P = .001). On univariable analysis, a tumor volume <138.8 mL³ was associated with longer progression-free survival (hazard ratio, 2.03; 95% confidence interval, 0.95-4.34, P = .05), with a median progression-free survival of 38.1 months (interquartile range, 16.9-41.3 months) compared with 17.8 months (interquartile range, 10.8-28.7 months).

CONCLUSION:

Surgery may enhance the effectiveness of ¹⁷⁷Lutetium-dotatate in the treatment of metastatic well-differentiated gastroenteropancreatic neuroendocrine tumors. This positive effect may be the result of a lower tumor volume in patients after surgery. Our findings fortify the concept of using surgical debulking to improve systemic therapies such as peptide receptor radionuclide therapy.

2025-01-01·CLINICAL NUCLEAR MEDICINE

A False-Negative 123I-MIBG SPECT/CT With True-Positive 68Ga-DOTATATE PET/CT in a Patient With Neuroblastoma Following 177Lu-DOTATATE Therapy

Article

作者: Lu, Xia ; Yang, Jigang ; Wang, Wei ; Li, Siqi ; Xu, Yanfeng

Abstract:

A 10-year-old girl with high-risk neuroblastoma underwent 123I-MIBG SPECT/CT and 68Ga-DOTATE PET/CT, which both showed multiple bone metastases. However, following 177Lu-DOTATATE therapy, only 68Ga-DOTATATE PET/CT identified residual lesions with negative 123I-MIBG SPECT/CT results. The case emphasized the complementary role of 68Ga-DOTATATE PET/CT and 123I-MIBG SPECT/CT after 177Lu-DOTATATE therapy.

2024-12-01·NUCLEAR MEDICINE COMMUNICATIONS

SeHCAT retention measurements may be compromised by traces of 177Lu/177mLu more than 90 days after 177Lu-DOTATATE was administered

Article

作者: Meades, Richard ; Willson, Tamar

[75Se]tauroselcholic acid (SeHCAT) retention measurement provides a noninvasive test for bile acid diarrhea (BAD); however, it is sensitive to the presence of other radionuclides. Two SeHCAT patients at the Royal Free Hospital (RFH) had significant discrepancies between the lower photopeak (111–159 keV) and central photopeak (242–296 keV) windows, indicating contamination with a radionuclide other than 75Selenium. These patients had received lutetium-177 oxodotreotide (177Lu-DOTATATE) therapy 98 and 151 days before their SeHCAT tests. Traces of 177Lu may be retained longer than typically modeled, along with the contaminant 177mLu. This work includes a retrospective audit to examine the prevalence of SeHCAT tests being affected by 177Lu and phantom measurements to investigate the potential impact. Of 579 patients who received 177Lu-DOTATATE therapy at our center, 11 subsequently attended for a SeHCAT test. The two previously identified patients may have had compromised SeHCAT results; however, the other patients had longer intervals between their therapy and test, and their tests are believed to be valid. Spectra were acquired from a phantom containing either a SeHCAT capsule or a mixture of 177Lu/177mLu representative of a patient >90 days after their treatment. The SeHCAT spectrum was scaled to produce simulated day-7 spectra, and the SeHCAT retention that would have been calculated if 177Lu/177mLu were present was determined. All SeHCAT measurement windows are affected by the 177Lu/177mLu, producing clinically significant errors. Patients requiring SeHCAT testing should be asked whether they have ever received 177Lu-DOTATATE. Patient-specific background measurements may be useful for checking for significant levels of other radionuclides.

434

项与 (177镥)镥氧奥曲肽相关的新闻（医药）

2024-12-31

·汇聚南药

2024年关注的生物医药十大关键词回顾

关键词一：NewCo 点评：境内Biotech产品出海的“新”探索 NewCo模式是指，境内Biotech提供管线（获得许可费+股权），境外机构提供资金（负责经营管理），设立一家新的独立公司（即“NewCo”）推进管线的开发和商业化等事宜，并在未来独立IPO或被并购。 Newco模式今年作为国内资本市场的热词，源起于国内医药“一哥”恒瑞医药GLP-1产品的出海。2024年5月，恒瑞医药将其GLP-1类创新药产品组合HRS-7535（口服小分子GLP-1受体激动剂，针对II型糖尿病和减重，国内已进入Ⅱ期临床）、HRS9531（GLP-1/GIP双靶点激动剂，针对超重/肥胖，国内已进入Ⅱ期临床）和HRS-4729（肠促胰岛素产品，正进行临床前开发）的除大中华区以外的全球范围内开发、生产和商业化的权利独家许可给美国Hercules。Hercules是由Bain Capital联合Atlas Ventures、RTW capital、Lyra capital共同投资4亿美元于2024年5月成立于美国特拉华州的Biotech公司。在该起案例中，恒瑞医药除了常规的license out条款外，还将获得美国Hercules公司19.99%的股权。除了恒瑞医药以外，2024年已有多起NewCo案例，例如康诺亚与Belenos Biosciences、嘉和生物与TRC 2004、维立志博与Oblenio Bio等。关键词二：并购重组点评：并购重组的“暖风” 2024年，国务院发布《国务院关于加强监管防范风险推动资本市场高质量发展的若干意见》（简称“新国九条”）、证监会发布《关于深化科创板改革服务科技创新和新质生产力发展的八条措施》（简称“科创板八条”）及《关于深化上市公司并购重组市场改革的意见》（简称“并购六条”）等一系列支持鼓励上市公司进行并购重组的政策，让并购重组成为2024年的热门趋势。据财联社创投通数据显示，截至2024年12月15日，2024年以“A股上市公司”为参与主体的并购事件高达2200多起，生物医药行业的并购事件数量位列第三。2024年期间不乏重磅交易，例如迈瑞医疗以25%的溢价以66.52亿元并购惠泰医疗，股价涨幅榜“当红辣子鸡”浩欧博通过并购重组顺利易主，也有海尔生物吸收并购上海莱士这样的“蛇吞象”并购。关键词三：细胞疗法点评：细胞疗法迎来“实”质性进展 2024年，细胞疗法领域取得了显著的进展，特别是在实体瘤的治疗上显示了突破性的成果。 2024年2月16日，Iovance Biotechnology的AMTAGVITM（lifileucel）成为全球首款上市的肿瘤浸润淋巴细胞（TIL）疗法，用于治疗PD-1抗体治疗后进展的黑色素瘤。这一批准标志着TIL疗法开始迈进实体瘤时代。 2024年8月1日，Adaptimmune Sciences的Tecelra®（Afamitrisgene autoleucel）成为全球首个获批上市的TCR-T疗法，用于治疗无法切除或转移性的滑膜肉瘤成人患者，也是十多年来针对滑膜肉瘤的首个新型治疗选择。 2024年12月19日，Mesoblast公司开发的Ryoncil（remestemcel）获批上市，成为FDA首个获批的间充质基质细胞（MSC）疗法，用于治疗2个月及以上儿童患者的类固醇难治性急性移植物抗宿主病（SR-aGVHD）。关键词四：AI for science 点评：AI破解“大自然折纸术” 瑞典皇家科学院2024年10月9日宣布，将2024年诺贝尔化学奖一半授予大卫·贝克（David Baker），以表彰其在计算蛋白质设计方面的贡献；另一半则共同授予德米斯·哈萨比斯（Demis Hassabis）和约翰·詹珀（John M. Jumper），以表彰他们在蛋白质结构预测方面的成就。蛋白质是生命的基石，是生命中精巧的化学工具。David Baker成功地完成了一项几乎不可能完成的任务—构建全新的蛋白质，Demis Hassabis和John M. Jumper开发了一种人工智能（AI）模型，解决了一个50年未解的问题—预测蛋白质的复杂结构。关键词五：TCE 点评：抗体药物的下一个爆发点 T细胞衔接器（TCE）疗法是一种肿瘤免疫疗法，TCE作为双抗能同时结合肿瘤相关抗原（TAA）和T细胞上CD3，将肿瘤细胞与抗肿瘤T细胞相连，以触发T细胞杀伤肿瘤。很长一段时间，TCE的应用都局限在血液瘤领域，临床价值有限，直到近年才在实体瘤与自免疾病领域实现突破。2024年5月16日，美国FDA加速批准Tarlatamab（DLL3/CD3双抗），用于在铂类化疗后疾病进展的广泛期小细胞肺癌（ES-SCLC）。 2024年8月9日，默沙东宣布以引进同润生物的一款CD3/CD19 TCE双抗，首付款7亿美元，同润生物还有资格获得高达6亿美元的里程碑付款。此外，恩沐生物与葛兰素史克也完成3亿美元预付款的三靶点TCE合作，嘉和生物、岸迈生物、维立志博三家的TCE产品则以Newco形式实现出海。国内入局的药企，大部分已跳过内卷的血液瘤领域，直接将TCE双抗的目标瞄准在实体瘤领域，甚至是自免领域，这也是被海外药企青睐的重要原因。关键词六：核药点评：核药赛道风口已至核药，又称放射性药物，是通过放射性同位素衰变产生的射线来进行疾病诊断和治疗的一种药物。与其他癌症疗法相比，放射性药物有其独特的优势。这类药物通过“粉碎”DNA达到杀伤肿瘤细胞的目的，这种作用机制最大限度地减少了耐药性，并带来了丰富的联合治疗机会，特别是与免疫疗法的联合。诺华两款明星靶向放射性药物—Lutathera（2024年上半年销售额3.44亿美元）和Pluvicto（2024年上半年销售额6.55亿美元）优秀的疗效数据及强力的市场表现，触发了这一赛道多起数十亿美元的Biotech收购。在诺华引领的核药风口下，诸多MNC也纷纷入局，礼来、百时美施贵宝、阿斯利康以超高溢价抢购明星标的核药Biotech，强生、默沙东、赛诺菲等也以BD合作的方式进行快速布局。国内多家Biotech也都在2024年完成超亿元的股权融资，包括法伯新天、通瑞生物、蓝纳成、纽瑞特、米度生物、辐联科技等。关键词七：PD-(L)1/VEGFR 点评：再掀免疫治疗热潮免疫疫检查点抑制剂PD-(L)1单抗开启癌症治疗新时代，促进多个大单品的诞生，包括默沙东的K药和百时美施贵宝的O药，K药在2023年全球销售额高达250亿美元。为突破单一免疫疗法的局限性，中国Biotech在全球掀起了以PD-(L)1为骨架的双靶二代免疫治疗药物开发热潮。康方生物的全球首创PD-1/VEGF双特异性抗体新药依沃西单抗注射液（AK112）于2024年5月获批上市，该药物在一线治疗PD-L1阳性非小细胞肺癌的临床研究中表现出显著疗效，成为全球首个在头对头III期临床研究中证明疗效优于K药的药物。2024年11月13日，普米斯宣布与BioNTech达成股权收购协议，BioNTech将以8亿美元预付款收购普米斯100%已发行股本，双方此前已经针对PD-L1/VEGF双抗PM8002开展合作。2024年11月14日，默沙东宣布与礼新医药达成全球独家许可，获得礼新医药PD-1/VEGF双抗LM-299的全球开发、生产和商业化独家许可，礼新医药将获得5.88亿美元的首付款和最高27亿美元的里程碑付款。此外，Instil Bio公司也与宜明昂科就PD-L1/VEGF双抗IMM251达成BD合作。PD-(L)1/VEGF双抗能否接棒PD-1单抗，值得期待。关键词八：CNS 点评：熬过黑暗终将迎来光明中枢神经系统（CNS）疾病包括发育性神经系统疾病（如亨廷顿病、多发性硬化症、肌萎缩性脊髓侧索硬化症等）、精神性神经系统疾病（包括精神分裂、双向障碍、抑郁、癫痫等）以及退行性神经系统疾病（包括阿尔茨海默症、帕金森症等）。过去这一年，CNS领域大爆发，精神分裂症迎来破冰，阿尔兹海默症再迎重磅新药。2024年9月26日，Karuna研发的KarXT获得FDA批准上市，这是35年来首款精神分裂症新药的问世，去年底百时美施贵宝也以140亿美元收购Karuna。2024年7月2日，FDA已批准donanemab单抗用于治疗早期阿尔茨海默病的成年患者。CNS领域正成为前沿Biotech和MNC的兵家必争之地，今年该阶段一个接一个里程碑的突破，也将会在接下来几年的商业化的竞争上体现的更加淋漓尽致。关键词九：外商独资医院开放试点点评：看病就医迎来更多选择 2024年9月8日，商务部、国家卫生健康委、国家药监局发布《关于在医疗领域开展扩大开放试点工作的通知》（以下简称《通知》），拟在医疗领域开展扩大开放试点工作，拟允许在北京、天津、上海、南京、苏州、福州、广州、深圳和海南全岛设立外商独资医院（中医类除外，不含并购公立医院）。 2024年11月29日，更具体的工作方案出炉，国家卫生健康委、商务部、国家中医药局、国家疾控局四部门公布《独资医院领域扩大开放试点工作方案》（简称“《工作方案》”）。《工作方案》明确提出允许在北京、天津、上海、南京、苏州、福州、广州、深圳和海南全岛设立外商独资医院（中医类除外，不含并购公立医院），其中医院类别为综合医院、专科医院、康复医院，允许医院按规定聘用外国医师、港澳台医师、港澳其他卫生专业技术人员短期执业。发布《通知》及《工作方案》后，市场很快就有回应。2024年12月16日，天津市向天津鹏瑞利医院颁发第一张外商独资三级综合医院医疗机构执业许可证。关键词十：三明医改点评：统筹“三医联动” 三明医改是中国福建省三明市自2012年开始实施的一系列医疗改革措施,旨在解决医疗费用快速增长、医保基金面临被击穿等问题。改革以医疗、医保、医药“三医”联动为核心，推动医疗体系多层次全面改革。三明医改以三医联动为基础，在政府、医保、医疗机构、医药品流通几个核心层面实现同步联动改革，强化政府的领导、保障、监督、管理责任；坚持公立医疗机构的硬件投入靠政府，软件和日常管理靠医院自身，降低医疗成本和提高运行效率靠体制机制创新，深化医药卫生体制改革，实现百姓可以接受、财政可以承担、基金可以运行、医院可以持续的目标。国家卫生健康委体改司司长杨建立在2024年8月30日的新闻发布会上强调：三明医改的成功经验将被视为国家深化医改的典范。计划在未来五年内，每年选择2-3个地区作为重点推广区域，逐步实现全国范围内的覆盖。喜欢我们文章的朋友点个“在看”和“赞”吧，不然微信推送规则改变，有可能每天都会错过我们哦~ 免责声明 “汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。信息来源：康橙投资往期推荐本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。

并购细胞疗法免疫疗法临床3期临床2期

2024-12-27

·Endpoints

Novartis ends Phase 1 radiopharma trial; Solve Therapeutics pursues $75M round

Novartis ends a radiopharma trial with PeptiDream : The Swiss drug giant terminated a Phase 1 trial of [177Lu]Lu-FF58 in patients with selected advanced solid tumors, a spokesperson confirmed to Endpoints News . The spokesperson cited “careful evaluation of available clinical data” as the reason and noted it “was not based on safety concerns.” All patients have either discontinued treatment or completed safety follow-up, the spokesperson added. The asset is part of Novartis’ collaboration with PeptiDream . A PeptiDream spokesperson didn’t respond to a request for comment. The Novartis spokesperson didn’t comment on the future of the candidate. Radiopharma has become a key focus for Novartis, which markets Pluvicto and Lutathera and has inked multiple deals in the space . — Kyle LaHucik Solve Therapeutics eyes $75 million funding round: The Belmont, CA-based ADC biotech, led by former VelosBio CEO Dave Johnson, has raised $50 million so far in a $75 million equity round, according to an SEC filing on Thursday. Johnson declined to comment. He sold VelosBio to Merck for $2.75 billion in cash in 2020. About a year later, Solve raised a $126 million Series A from Matrix, Decheng Capital, General Atlantic and Surveyor Capital, according to Johnson’s LinkedIn page . The company acquired Cereius, a radiodiagnostics and radiotherapeutics spinout from Duke University, in 2023. — Kyle LaHucik Veru sold off some non-essential assets: The company announced Tuesday that it’s selling its FC2 Female Condom business to a New York investment firm called Riva Ridge Capital Management for $18 million. The deal lets Veru focus on its obesity program called enobosarm, which is expected to read out topline Phase 2b data in January. — Max Gelman Ideaya Biosciences makes an ADC deal with Hengrui Pharma : The South San Francisco biotech will pay $75 million upfront and up to $1.04 billion in total, for ex-China access to Hengrui’s DLL3-targeting ADC called SHR-4849. The candidate, with a Topo-I payload, could be combined with Ideaya’s PARG inhibitor, which is called IDE161 . The drug is in Phase 1 in solid tumors in China, and Ideaya plans to ask for FDA trial clearance in the first half of next year. — Kyle LaHucik Amylyx expands GLP-1 work with a new Gubra collaboration: The neurodegenerative biotech said Monday it is paying a “small upfront fee” plus research payments, with more than $50 million in milestones available to Gubra to identify a novel long-acting GLP-1 drug. Amylyx will have the option to lead future development if a candidate is found. — Max Bayer Good news for Novartis ’ intrathecal Zolgensma: The treatment succeeded in a Phase 3 trial in patients with spinal muscular atrophy (SMA) type 2 between the ages of 2 and 18 who can sit but have never walked independently. Patients given the gene therapy had increased scores on a rating scale of motor ability and disease progression compared with sham control. Further data and regulatory submissions are expected to come in 2025. An approval would extend Zolgensma’s reach; it is currently only approved in SMA patients aged younger than 2. — Elizabeth Cairns Immedica Pharma announces plans to buy Marinus Pharmaceuticals : The Swedish rare disease company agreed to acquire Marinus for an enterprise value of about $151 million . Marinus’ shares $MRNS were up about 42% to 52 cents apiece in early trading on Monday, nearly matching the offer of 55 cents per share. Marinus markets the rare seizure drug Ztalmy. The medicine, also known as ganaxolone, recently failed a late-stage trial, leading the company to again lay off employees . Also on Monday, Orion and Marinus mutually terminated a marketing and distribution pact for ganaxolone in Europe. — Kyle LaHucik Johnson & Johnson is partnering with the Japanese company Kaken on a STAT6 program. J&J will get the rights to KP-723, an oral STAT6 inhibitor still in preclinical testing, and take over development after Kaken completes Phase 1 studies. Kaken gets $30 million upfront and up to $1.2 billion. — Max Gelman Kronos Bio and Roche ended their R&D alliance following Kronos’ significant downsizing, according to SEC documents. The biotech elected to end development on a CDK9 inhibitor called istisociclib last month, resulting in layoffs of about 83% and the departure of CEO Norbert Bischofberger. Kronos and Roche had partnered in 2023 on a different program for $20 million upfront and $554 million in milestones. — Max Gelman AusperBio raised a $73 million Series B round led by HanKang Capital, the proceeds of which will fund mid-stage development of its lead candidate AHB-137. The antisense oligonucleotide, intended as a functional cure for hepatitis B, is in a Phase 2 trial in China that could be reported next year. The company said the new financing will also enable global trials of AHB-137, as well as expansion of its therapeutic pipeline, manufacturing and operational capabilities. — Elizabeth Cairns A few months after announcing a strategic review , London-based Achilles Therapeutics is offloading data and samples from its non-small cell lung cancer study to AstraZeneca for $12 million. The UK pharma will also get access to a platform and network of tumor samples from nearly 300 cancer patients. — Kyle LaHucik AstraZeneca and Daiichi Sankyo have withdrawn their European Medicines Agency application for the ADC datopotamab deruxtecan in lung cancer. While AstraZeneca has positioned the drug as a successor to Enhertu, the company said in May that a lung cancer trial failed to reach its overall survival goal. — Max Gelman China’s CASI Pharmaceuticals said in a securities filing that its experimental drug CID-103 has been put on a clinical hold by the FDA. The drug is an anti-CD38 antibody that’s being studied to prevent the rejection of transplanted kidneys. The company said it plans to respond to the FDA. — Drew Armstrong Assembly Biosciences reported interim Phase 1b data for its hepatitis B antiviral program ABI-4334. In patients who were predominantly hepatitis B e antigen (HBeAg) negative, ABI-4334 induced a 99.9% average decline of hepatitis B virus DNA (a 2.9 log10 reduction). Among those with detectable virus RNA at baseline, there was an average decline of 99.7% (2.5 log10). Assembly said there were “limited changes in viral antigens” due to the nature of the 28-day study. The company is partnered with Gilead on a trio of antivirals, including ABI-4334. — Max Gelman

临床2期临床1期临床3期并购临床结果

2024-12-15

·E药经理人

2024-2030年RDC核药行业深度调研及发展战略咨询报告

随着全球核药技术的不断发展，治疗型核药快速发展全球 RDC 药物加速开发与商业化落地。目前全球已有11款RDC 药物获批上市，其中9款药物用于诊断，2款药物用于治疗，上市的RDC 药物靶点集中于前列腺特异性膜抗原(PSMA)和生长抑素受体(SSTR)。特别是 2018 年和 2022 年诺华的两款重磅 RDC 产品(Lutathera、Pluvicto)获批上市后展现的优异疗效以及快速的商业化放量，吸引全球更多的MNC将资源投入治疗用核药的开发上。2023年Pluvicto的销售额约为9.21亿美元，2024 上半年该药销售额已超过5亿美元，预计全年销售额将超过 10 亿美元。从长远来看，2026年全球核药市场规模有望超百亿美元目前诊断类核药占比近七成。自2013年起全球核药市场规模快速扩容，十年间的 CAGR 约为6%，据Nature(自然杂志)披露 2026 年全球核药市场规模有望达120 亿美元，而据Evaluate 预测，到2028 年全球治疗型放射性药物的年销售额预计将超过 60 亿美元，治疗用核药市场规模占核药整体市场比重有望快速提升。而据中国核安全局数据显示，预计2025 年，国内放射性药物市场规模将达到93 亿元人民币，到 2030年，市场规模将进一步增加至260 亿元人民币。那么，在RDC核药当前形势下，我们该如何把握和抓住RDC 核药的发展机遇和前景趋势呢? 识别二维码▼查看完整版报告《2024-2030 年 RDC 核药行业深度调研及发展战略咨询报告》正是在这一背景下应运而生，旨在通过全面、深入的分析，为业界提供一份关于 RDC 核药行业未来发展趋势的权威指南。本报告基于广泛的市场调研、专家访谈、政策解读以及技术创新追踪，力求从多角度、多层次揭示 RDC 核药行业的现状、挑战与机遇。识别二维码进群▼了解更多报告一审| 黄佳二审| 李芳晨三审| 李静芝

放射疗法上市批准

100 项与 (177镥)镥氧奥曲肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	V10XX04	DB13985

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
神经内分泌肿瘤	加拿大	Advanced Accelerator Applications USA, Inc.	2019-01-09
胃肠胰神经内分泌肿瘤	美国	Advanced Accelerator Applications USA, Inc.	2018-01-26
SSTR阳性胃肠胰神经内分泌肿瘤	欧盟	Advanced Accelerator Applications SA	2017-09-26
SSTR阳性胃肠胰神经内分泌肿瘤	冰岛	Advanced Accelerator Applications SA	2017-09-26
SSTR阳性胃肠胰神经内分泌肿瘤	列支敦士登	Advanced Accelerator Applications SA	2017-09-26
SSTR阳性胃肠胰神经内分泌肿瘤	挪威	Advanced Accelerator Applications SA	2017-09-26

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
晚期神经内分泌肿瘤	临床3期	中国	北京先通国际医药科技股份有限公司	2024-06-01
晚期胰腺神经内分泌肿瘤	临床3期	中国	江苏恒瑞医药股份有限公司	2023-07-06
大肠类癌	临床3期	美国	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	比利时	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	法国	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	德国	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	意大利	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	葡萄牙	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	西班牙	Advanced Accelerator Applications SA	2012-09-06
大肠类癌	临床3期	英国	Advanced Accelerator Applications SA	2012-09-06

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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


NCT03972488 (NETTER-2, CTgov)	临床3期	胃肠胰神经内分泌肿瘤	226	30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot)+2.5% Lys-Arg sterile amino acid solution+Lutathera (Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm))	艱齋鏇艱願築鏇築齋鹹(夢鏇鏇餘簾鏇鬱網艱遞) = 淵鹹窪鹽淵醖範齋顧餘鏇鬱衊簾築鏇鑰襯憲積 (選繭觸選壓齋簾範積觸, 構觸齋積鏇鏇餘淵鹹遞 ~ 膚鏇鬱膚淵餘夢壓鹹選) 更多	-	2024-10-10
				High dose 60 mg octreotide long-acting repeatable (Octreotide LAR 60 mg (Control Arm))	艱齋鏇艱願築鏇築齋鹹(夢鏇鏇餘簾鏇鬱網艱遞) = 遞簾鏇遞觸選襯願襯顧鏇鬱衊簾築鏇鑰襯憲積 (選繭觸選壓齋簾範積觸, 鹽製顧鹹餘願鏇簾簾鏇 ~ 顧選選鬱積蓋鹽襯網艱) 更多
Biospace 人工标引	临床2期	脑膜瘤	20	Lutathera	壓網鏇積襯壓遞壓鬱積(顧繭鑰鹽淵夢齋鏇鹹齋) = 餘鹹廠範廠糧窪夢簾鏇膚齋醖艱齋窪積窪築範 (獵構艱獵顧餘窪鏇膚膚 ) 更多	积极	2024-09-30
NCT04086485 (EANM2024)	临床1/2期	神经内分泌肿瘤 SSTR	11	Lu-177-DOTATATE + Olaparib	壓鏇願製窪蓋製夢鑰襯(遞鏇壓觸夢繭襯遞襯齋) = 範鹹夢淵壓網襯鹽蓋夢膚齋齋網製醖憲鏇夢製 (齋淵簾襯憲窪廠鹹簾簾, 0.77 ~ 248.85)	积极	2024-09-27
EANM2024	N/A	胃肠道肿瘤	36	[177Lu]Lu-DOTA-TATE (Ileal NET)	簾窪齋窪鏇鹽膚選壓積(窪願選範鑰夢餘顧選簾) = 衊淵構襯範積選鑰夢壓齋鹽夢廠獵網築鏇積餘 (觸積繭淵顧觸遞糧鏇觸 ) 更多	积极	2024-09-27
EANM2024	N/A	神经内分泌肿瘤	-	[177Lu]- DOTA-TATE	構獵願繭觸鏇鏇範襯蓋(憲觸蓋積鹽襯膚淵壓齋) = RR-PRRT-associated AEs (grade 3-4) included thrombocytopenia (12.9%), lymphopenia (9.7%), anemia (6.5%), and leukopenia (3.2%). Importantly, no nephrotoxicity was observed during RR-PRRT. 壓膚鬱憲簾艱艱遞範憲 (遞願獵鹽窪襯襯憲積繭 )	积极	2024-09-27
NCT04086485 (Phase 1 Trial of Lu-177-DOTATATE in Combination with Olaparib, EANM2024)	临床1/2期	SSTR阳性胃肠胰神经内分泌肿瘤 SSTR+	11	Lu-177-DOTATATE 200 mCi	淵觸醖選衊簾顧壓積網(簾選顧艱憲獵繭選鬱齋) = 廠鹹窪顧齋觸遞壓築選窪膚壓製餘鏇鑰積淵醖 (製衊糧鏇鑰範鬱鏇構網 ) 更多	积极	2024-09-27
				Olaparib 50mg	淵觸醖選衊簾顧壓積網(簾選顧艱憲獵繭選鬱齋) = 夢鬱壓獵餘蓋鏇鹽窪鹽窪膚壓製餘鏇鑰積淵醖 (製衊糧鏇鑰範鬱鏇構網 ) 更多
EANM2024	N/A	神经母细胞瘤	23	Lu-177 DOTATATE	選鏇廠鬱築繭憲醖艱鹽(鬱積鹽鹽選範觸繭簾構) = 鏇網鹽築鏇糧壓築夢鹹淵構簾積鑰淵壓範範鏇 (遞鬱選觸鏇獵選糧獵淵 ) 更多	积极	2024-09-27
Lu-177 DOTATATE (EANM2024)	N/A	副神经节瘤 \| 嗜铬细胞瘤 increased somatostatin receptor (SSTR) expression	26	2-4 courses of Lu-177 DOTATATE	鏇積繭衊糧蓋鑰窪鏇範(範淵艱網襯襯製鏇衊鹽) = 壓襯獵艱壓鏇鏇壓憲齋顧構鬱觸構餘廠鹹觸簾 (蓋齋淵壓膚網積艱構淵 ) 更多	积极	2024-09-27
				≥5 courses of Lu-177 DOTATATE	鏇獵鹹醖積簾醖願膚鏇(憲衊齋築製製繭鏇積獵) = 衊膚艱獵廠觸願顧膚獵顧鬱餘艱築觸顧鏇鹽網 (糧顧餘艱築淵鏇糧鬱積 ) 更多
ESMO2024	N/A	-	-	90Y DOTA-TATE	夢醖齋壓簾鏇遞鏇襯簾(獵鏇膚憲糧醖憲構鹽襯) = 艱積鑰願蓋選積積積夢簾構願繭觸艱鏇齋鑰鹹 (糧鹹製鹹製範築齋憲簾, 40 ~ 100.4) 更多	-	2024-09-16
				177Lu DOTA-TATE	夢醖齋壓簾鏇遞鏇襯簾(獵鏇膚憲糧醖憲構鹽襯) = 願範鏇製積艱網構艱顧簾構願繭觸艱鏇齋鑰鹹 (糧鹹製鹹製範築齋憲簾, 40 ~ 100.4) 更多
NCT03972488 (ESMO2024)	临床3期	胃肠胰神经内分泌肿瘤	-	[177Lu]Lu-DOTA-TATE + octreotide 30 mg long-acting release (LAR)	簾艱構簾壓窪憲願網簾(糧鹽鏇網夢衊衊鬱憲遞): OR = 10.43 (95% CI, 3.98 ~ 27.29), P-Value = <0.1 更多	-	2024-09-13
				octreotide 60 mg LAR