A multicentre, open-label, Phase I study investigating the safety, tolerability, and efficacy of 177Lu-SSO110 with 68Ga-SSO120 companion imaging in participants with extensive stage small cell lung cancer (ES-SCLC) who are on maintenance treatment with atezolizumab

开始日期2023-06-30

申办/合作机构-

EUCTR2020-003640-88-AT / Unknown status临床1/2期

A Multicentre Surveillance Study to Evaluate the Long-term Safety in Participants who Have Been Previously Treated with 177Lu-IPN01072 in an Ipsen-sponsored Clinical Study

开始日期2022-01-26

申办/合作机构

Ariceum Therapeutics GmbH初创企业

NCT04997317 / Recruiting早期临床1期IIT

Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-Satoreotide (PROMENADE-Study)

Meningiomas are known to be the most frequent intracranial neoplasms and account for approx. 25-33% of all intracranial tumours.Targeted radionuclide therapy with radiolabelled somatostatin analogues, also called Peptide Receptor Radionuclide Therapy (PRRT), has proven to be an effective treatment in metastatic intestinal neuroendocrine tumours and is currently used in advanced, recurrent or progressive meningiomas with promising results. In this study, the therapeutic index of a standard and newly developed radiolabelled somatostatin antagonist will be evaluated and compared in PRRT. In a second step, safety and efficacy of the latter will be assessed.

开始日期2021-04-21

申办/合作机构

Universitätsspital Basel

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100 项与 177Lu-Satoreotide tetraxetan 相关的临床结果

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100 项与 177Lu-Satoreotide tetraxetan 相关的专利（医药）

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项与 177Lu-Satoreotide tetraxetan 相关的文献（医药）

2023-12-01·European journal of nuclear medicine and molecular imaging

A phase I/II study of the safety and efficacy of [177Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours

Article

作者: Navalkissoor, Shaunak ; Pennestri, Daniele ; Ansquer, Catherine ; Haug, Alexander ; Hicks, Rodney J ; Lenzo, Nat P ; Volteau, Magali ; Nicolas, Guillaume P ; Lassmann, Michael ; Grønbæk, Henning ; Wild, Damian ; Pais, Ben ; McEwan, Alexander ; Beauregard, Jean-Mathieu

Abstract:

Purpose:

We present the results of an open-label, phase I/II study evaluating the safety and efficacy of the novel somatostatin receptor (SSTR) antagonist [177Lu]Lu-satoreotide tetraxetan in 40 patients with previously treated, progressive neuroendocrine tumours (NETs), in which dosimetry was used to guide maximum administered activity.

Methods:

This study was conducted in two parts. Part A consisted of 15 patients who completed three cycles of [177Lu]Lu-satoreotide tetraxetan at a fixed administered activity and peptide amount per cycle (4.5 GBq/300 µg). Part B, which included 25 patients who received one to five cycles of [177Lu]Lu-satoreotide tetraxetan, evaluated different administered activities (4.5 or 6.0 GBq/cycle) and peptide amounts (300, 700, or 1300 μg/cycle), limited to a cumulative absorbed radiation dose of 23 Gy to the kidneys and 1.5 Gy to the bone marrow.

Results:

Median cumulative administered activity of [177Lu]Lu-satoreotide tetraxetan was 13.0 GBq over three cycles (13.1 GBq in part A and 12.9 GBq in part B). Overall, 17 (42.5%) patients experienced grade ≥ 3 treatment‑related adverse events; the most common were lymphopenia, thrombocytopenia, and neutropenia. No grade 3/4 nephrotoxicity was observed. Two patients developed myeloid neoplasms considered treatment related by the investigator. Disease control rate for part A and part B was 94.7% (95% confidence interval [CI]: 82.3–99.4), and overall response rate was 21.1% (95% CI: 9.6–37.3).

Conclusion:

[177Lu]Lu-satoreotide tetraxetan, administered at a median cumulative activity of 13.0 GBq over three cycles, has an acceptable safety profile with a promising clinical response in patients with progressive, SSTR-positive NETs. A 5-year long-term follow-up study is ongoing.

Trial registration:

ClinicalTrials.gov, NCT02592707. Registered October 30, 2015.

2023-06-30·EJNMMI radiopharmacy and chemistry

First preclinical evaluation of [²²⁵Ac]Ac-DOTA-JR11 and comparison with [¹⁷⁷Lu]Lu-DOTA-JR11, alpha versus beta radionuclide therapy of NETs.

Article

作者: Beekman, Savanne ; Bruchertseifer, Frank ; de Ridder, Corrina ; Denkova, Antonia ; Handula, Maryana ; Morgenstern, Alfred ; Konijnenberg, Mark ; de Blois, Erik ; Seimbille, Yann ; Stuurman, Debra

BACKGROUND:

The [¹⁷⁷Lu]Lu-DOTA-TATE mediated peptide receptor radionuclide therapy (PRRT) of neuroendocrine tumors (NETs) is sometimes leading to treatment resistance and disease recurrence. An interesting alternative could be the somatostatin antagonist, [¹⁷⁷Lu]Lu-DOTA-JR11, that demonstrated better biodistribution profile and higher tumor uptake than [¹⁷⁷Lu]Lu-DOTA-TATE. Furthermore, treatment with alpha emitters showed improvement of the therapeutic index of PRRT due to the high LET offered by the alpha particles compared to beta emitters. Therefore, [²²⁵Ac]Ac-DOTA-JR11 can be a potential candidate to improve the treatment of NETs (Graphical abstract). DOTA-JR11 was radiolabeled with [²²⁵Ac]Ac(NO₃)₃ and [¹⁷⁷Lu]LuCl₃. Stability studies were performed in phosphate buffered saline (PBS) and mouse serum. In vitro competitive binding assay has been carried out in U2OS-SSTR2 + cells for ^natLa-DOTA-JR11, ^natLu-DOTA-JR11 and DOTA-JR11. Ex vivo biodistribution studies were performed in mice inoculated with H69 cells at 4, 24, 48 and 72 h after injection of [²²⁵Ac]Ac-DOTA-JR11. A blocking group was included to verify uptake specificity. Dosimetry of selected organs was determined for [²²⁵Ac]Ac-DOTA-JR11 and [¹⁷⁷Lu]Lu-DOTA-JR11.

RESULTS:

[²²⁵Ac]Ac-DOTA-JR11 has been successfully prepared and obtained in high radiochemical yield (RCY; 95%) and radiochemical purity (RCP; 94%). [²²⁵Ac]Ac-DOTA-JR11 showed reasonably good stability in PBS (77% intact radiopeptide at 24 h after incubation) and in mouse serum (~ 81% intact radiopeptide 24 h after incubation). [¹⁷⁷Lu]Lu-DOTA-JR11 demonstrated excellent stability in both media (> 93%) up to 24 h post incubation. Competitive binding assay revealed that complexation of DOTA-JR11 with ^natLa and ^natLu did not affect its binding affinity to SSTR2. Similar biodistribution profiles were observed for both radiopeptides, however, higher uptake was noticed in the kidneys, liver and bone for [²²⁵Ac]Ac-DOTA-JR11 than [¹⁷⁷Lu]Lu-DOTA-JR11.

CONCLUSION:

[²²⁵Ac]Ac-DOTA-JR11 showed a higher absorbed dose in the kidneys compared to [¹⁷⁷Lu]Lu-DOTA-JR11, which may limit further studies with this radiopeptide. However, several strategies can be explored to reduce nephrotoxicity and offer opportunities for future clinical investigations with [²²⁵Ac]Ac-DOTA-JR11.

2021-12-01·Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology3区 · 医学

Imaging inflammation in atherosclerotic plaques, targeting SST2 with [111In]In-DOTA-JR11

3区 · 医学

Article

作者: van der Steen, Antonius F W ; van der Heiden, Kim ; de Jong, Marion ; Krenning, Boudewijn J ; Meester, Eric J ; Bernsen, Monique R ; de Blois, Erik

Abstract:

Background:

Imaging Somatostatin Subtype Receptor 2 (SST2) expressing macrophages by [DOTA,Tyr3]-octreotate (DOTATATE) has proven successful for plaque detection. DOTA-JR11 is a SST2 targeting ligand with a five times higher tumor uptake than DOTATATE, and holds promise to improve plaque imaging. The aim of this study was to evaluate the potential of DOTA-JR11 for plaque detection.

Methods and Results:

Atherosclerotic ApoE−/− mice (n = 22) fed an atherogenic diet were imaged by SPECT/CT two hours post injection of [111In]In-DOTA-JR11 (~ 200 pmol, ~ 50 MBq). In vivo plaque uptake of [111In]In-DOTA-JR11 was visible in all mice, with a target-to-background-ratio (TBR) of 2.23 ± 0.35. Post-mortem scans after thymectomy and ex vivo scans of the arteries after excision of the arteries confirmed plaque uptake of the radioligand with TBRs of 2.46 ± 0.52 and 3.43 ± 1.45 respectively. Oil red O lipid-staining and ex vivo autoradiography of excised arteries showed [111In]In-DOTA-JR11 uptake at plaque locations. Histological processing showed CD68 (macrophages) and SST2 expressing cells in plaques. SPECT/CT, in vitro autoradiography and immunohistochemistry performed on slices of a human carotid endarterectomy sample showed [111In]In-DOTA-JR11 uptake at plaque locations containing CD68 and SST2 expressing cells.

Conclusions:

The results of this study indicate DOTA-JR11 as a promising ligand for visualization of atherosclerotic plaque inflammation.

项与 177Lu-Satoreotide tetraxetan 相关的新闻（医药）

2024-06-10

·PRNewswire

Ariceum Therapeutics to Present Outstanding New Preclinical Data at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting 2024

SST2 antagonist, 225Ac-SSO110 (satoreotide), is multiple times more potent than SST2 agonist, 225Ac-DOTATATE Satoreotide demonstrated durable complete response in standard murine xenograft models of Small Cell Lung Cancer in animal models, versus tumor growth delay with 225Ac-DOTATATE BERLIN, June 10, 2024 /PRNewswire/ -- Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announces that it will be presenting a poster demonstrating the efficacy of its somatostatin receptor 2 (SST2) antagonist, SS0110 (satoreotide), relative to SST2-targeting agonists, at this year's Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting being held 8-11 June 2024 in Toronto, Canada. The poster presentation entitled '[225Ac]Ac-SSO110 and [177Lu]Lu-SSO110 demonstrate significantly better efficacy than [225Ac]Ac-DOTA-TATE in the treatment of SST2-positive tumor xenografts' compares satoreotide with the SST2 agonist, 225Ac-DOTATATE, and reveals that single doses of 20 MBq 177Lu-satoreotide or 30 kBq 225Ac-satoreotide induce significantly better efficacy than a single dose of 30 kBq 225Ac-DOTATATE. Most remarkably, 30 kBq 225Ac-satoreotide induced complete tumor regression in the NCI-H69 model, something not observed with the same or higher doses of 225Ac-DOTATATE. These data highlight the significantly higher tumor uptake and longer tumor retention leading to a higher tumor to background and tumor to kidney ratios of satoreotide which translates into higher pre-clinical efficacy than SST2-targeting agonists when labelled with isotopes, 225Ac-satoreotide and 177Lu-satoreotide. This demonstrates the potential for satoreotide to clinically outperform SST2-targeting agonists and strongly supports its further clinical development for the treatment of SST2 positive tumors such as Small Cell Lung Cancer (SCLC) and Merkel Cell Carcinoma (MCC). Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: "With this significant data we demonstrate that satoreotide has the potential to be a game changer for the treatment of SCLC and MCC. Satoreotide is multiple times more potent than DOTATATE, irrespective of the isotope, and this confirms the superiority of SST2 antagonist over agonist. We look forward to presenting our findings at this year's SNMMI meeting." Details of the poster presentation are as follow: Title: [225Ac]Ac-SSO110 and [177Lu]Lu-SSO110 demonstrate significantly better efficacy than [225Ac]Ac-DOTA-TATE in the treatment of SST2-positive tumor xenografts Authors: Anika Jaekel, Prachi Desai, Germo Gericke, Manuel Sturzbecher-Hoehne, Dennis Mewis & Manfred Rüdiger Presenter: Anika Jaekel, Senior Director, Head of Translational Biology and Non-Clinical Pharmacology at Ariceum Therapeutics Session: MTA07 POPs/Meet the Author: Oncology, Basic & Translational 2 Session Date and Time: Monday, June 10, 2024, 10:00 - 11:15 DST Abstract ID: 242038 About Ariceum Therapeutics Ariceum Therapeutics (Ariceum) is a private, clinical stage radiopharmaceutical company focused on the diagnosis and precision treatment of certain neuroendocrine and other aggressive, hard-to-treat cancers. The name Ariceum is an anagram of 'Marie Curie' whose discovery of radium and polonium have been huge contributions to finding treatments for cancer. Ariceum's lead targeted systemic radiopharmaceutical product, 177Lu-satoreotide tetraxetan ("Satoreotide"), is an antagonist of the somatostatin type 2 (SSTR2) receptor which is overexpressed in neuroendocrine tumours (NETs) and some aggressive cancers such as small cell lung cancer (SCLC), or Merkel Cell Carcinoma, all of which have few treatment options and poor prognosis. Satoreotide is being developed as a 'theranostic' pair for the combined diagnosis and targeted radionuclide treatment of these tumours. Ariceum is also developing a radiolabelled PARP-inhibitor (ATT001), which is slated to enter clinical development in 2024. ATT001 was part of the acquisition of Theragnostics Ltd which was closed in June 2023. Ariceum Therapeutics, launched in 2021, acquired all rights to Satoreotide from Ipsen. Ipsen remains a shareholder in the Company. Ariceum is headquartered in Berlin, with operations in Germany, Switzerland, Australia, United Kingdom and United States of America and with activities currently across the globe. Ariceum is led by a highly experienced management team and supported by specialist investors including EQT Life Sciences (formerly LSP), HealthCap, Pureos Bioventures, Andera Partners and Earlybird Venture Capital. For further information, please visit . About SNMMI The Society of Nuclear Medicine and Molecular Imaging (SNMMI), headquartered in Reston, VA, is a nonprofit scientific and professional organization that promotes the science, technology and practical application of nuclear medicine and molecular imaging. SOURCE Ariceum Therapeutics

并购寡核苷酸

2024-06-07

·BioSpace

Y-mAbs Announces Preclinical GD2-SADA Data to be Presented at 2024 SNMMI Annual Meeting

NEW YORK, June 07, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced that preclinical GD2-SADA data will be presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2024 Annual Meeting taking place June 8 – 11, 2024, in Toronto, Canada. The poster titled “High-affinity and specific binding between DOTA-chelated lanthanides and GD2-SADA, a self-assembling and disassembling bispecific fusion protein for pre-targeted” (poster #241436) characterizes the binding properties of GD2-SADA, a Self-Assembling and DisAssembling (“SADA”) bispecific fusion protein used in a two-step approach to pre-targeted radioimmunotherapy (“PRIT”). Building on previous studies, the analysis demonstrates real-time, high-affinity binding interactions between the GD2-SADA protein and several “caged” lanthanide metals with diagnostic and therapeutic applications. “The results reinforce the potential clinical utility of GD2-SADA in the diagnosis and treatment of GD2-expressing tumors, and the strength of our radiochemistry program,” said Johannes Nagel, Ph.D., lead author. “Based on the totality of our preclinical data, we are continuing to advance our GD2-SADA program through Phase 1 clinical development.” Researchers at Memorial Sloan Kettering Cancer Center (“MSK”), including Dr. Nai-Kong V. Cheung, M.D., Ph.D., developed the SADA technology for radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs. Dr. Cheung has intellectual property rights and interests in the technology, and as a result of this licensing arrangement, MSK has institutional financial interests in the technology and in Y-mAbs. About Y-mAbs Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, radioimmunotherapy, and antibody-based therapeutic cancer products. The Company’s technologies include its investigational Self-Assembly DisAssembly (“SADA”) Pretargeted Radioimmunotherapy Platform (“PRIT”) and bispecific antibodies generated using the Y-BiClone platform. The Company’s broad and advanced product pipeline includes the anti-GD2 therapy DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after a partial response, minor response, or stable disease to prior therapy. About GD2-SADA PRIT GD2-SADA is a bispecific fusion protein that tightly binds to the glycolipid GD2 and Lutetium 177 (Lu 177)-DOTA, a chelated or “caged” radionuclide. In the first step of pre-targeted radiotherapy, non-radiolabeled GD2-SADA tetramers are infused and bind to GD2-expressing solid tumors, while unbound GD2-SADA protein disassembles into low molecular weight monomers that are removed by the kidney. The second infusion delivers the “radioactive payload,” which binds directly to GD2-SADA on tumor cells for localized irradiation. GD2-SADA PRIT with Lutetium 177-DOTA is currently being investigated in adults and adolescents in Trial 1001 (NCT05130255). Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, statements about our business model, including financial outlook for 2024 and beyond, including estimated operating expenses, cash burn and DANYELZA product revenue and sufficiency of cash resources and related assumptions; implied and express statements regarding the future of the Company’s business, including with respect to expansion and its goals; the Company’s plans and strategies, development, commercialization and product distribution plans, including potential partnerships; expectations with respect to the Company’s products and product candidates, including potential territory and label expansion of DANYELZA and the potential market opportunity related thereto and potential benefits thereof, and the potential of the SADA Technology and potential benefits and applications thereof; statements with respect to DANYELZA as a growing commercial product and SADA as a differentiated radioimmunotherapy platform positioning the Company on a path to potentially transform the treatment paradigm for a variety of cancers and improve patients’ lives; expectations relating to key anticipated development milestones, including potential expansion of international commercialization efforts with respect to DANYELZA development efforts and the SADA Technology, including potential indications and applications, and the timing thereof; expectations with respect to current and future clinical and pre-clinical studies and the Company’s research and development programs, including with respect to timing and results; expectations related to the timing of the initiation and completion of regulatory submissions; additional product candidates and technologies; expectations regarding collaborations or strategic partnerships and the potential benefits thereof; expectations related to the use of cash and cash equivalents, and the need for, timing and amount of any future financing transaction; expectations with respect to the Company’s future financial performance; and other statements that are not historical facts. Words such as ‘‘anticipate,’’ ‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ “hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ “will”, ‘‘would’’, “guidance,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company’s financial condition and need for additional capital; the risks that actual results of the Company’s restructuring plan and revised business plan will not be as expected; risks associated with the Company’s development work; cost and success of the Company’s product development activities and clinical trials; the risks of delay in the timing of the Company’s regulatory submissions or failure to receive approval of its drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of product candidates; development of sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for products; the risks related to the Company’s dependence on third parties including for conduct of clinical testing and product manufacture; the Company’s inability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of the Company’s intellectual property rights; risks related to employee matters and managing growth; risks related to the Company’s common stock, risks associated with macroeconomic conditions, including the conflict between Russia and Ukraine and sanctions related thereto, the state of war between Israel and Hamas and the related risk of a larger regional conflict, inflation, increased interest rates, uncertain global credit and capital markets and disruptions in banking systems; and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 and future filings and reports by the Company. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. DANYELZA®, OMBLASTYS® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc. Investor Contact: Courtney Dugan VP, Head of Investor Relations cdu@ymabs.com

免疫疗法引进/卖出上市批准

2024-05-20

·信狐药迅

博志研新止咳祛痰改良新BCM347口溶膜提交上市申请| 新受理（5.13-5.19）

本周药品注册受理数据，分门别类呈现，一目了然。(5.13-5.19）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号BCM347口溶膜博志研新泰州药物技术有限公司2.2CXHS2400043BCM347口溶膜博志研新泰州药物技术有限公司2.2CXHS2400042新药临床申请药品名称企业注册分类受理号ZL-82片成都赜灵生物医药科技有限公司1CXHL2400510ZL-82片成都赜灵生物医药科技有限公司1CXHL2400509ZL-82片成都赜灵生物医药科技有限公司1CXHL2400508NTQ5082胶囊南京正大天晴制药有限公司1CXHL2400499NTQ5082胶囊南京正大天晴制药有限公司1CXHL2400498KY-001上海栖臻医药科技有限公司1CXHL2400507KY-001上海栖臻医药科技有限公司1CXHL2400506CS060304片凯思凯迪(上海)医药科技有限公司1CXHL2400496CS060304片凯思凯迪(上海)医药科技有限公司1CXHL2400495CS060304片凯思凯迪(上海)医药科技有限公司1CXHL2400494CS060304片凯思凯迪(上海)医药科技有限公司1CXHL2400493CPU-216片中国药科大学1CXHL2400497HSK39004吸入混悬液西藏海思科制药有限公司1CXHL2400489HSK39004吸入混悬液西藏海思科制药有限公司1CXHL2400488HTMC0658片上海壹典医药科技开发有限公司1CXHL2400485HTMC0658片上海壹典医药科技开发有限公司1CXHL2400484ABSK043胶囊上海和誉生物医药科技有限公司1CXHL2400483ABSK061胶囊上海和誉生物医药科技有限公司1CXHL2400482ABSK061胶囊上海和誉生物医药科技有限公司1CXHL2400481ABSK061胶囊上海和誉生物医药科技有限公司1CXHL2400480APH01727片广州一品红制药有限公司1CXHL2400478APH01727片广州一品红制药有限公司1CXHL2400477APH01727片广州一品红制药有限公司1CXHL2400476APH01727片广州一品红制药有限公司1CXHL2400475APH01727片广州一品红制药有限公司1CXHL2400474注射用RFUS-250宜昌人福药业有限责任公司1CXHL2400491注射用RFUS-250宜昌人福药业有限责任公司1CXHL2400490APH01727片广州一品红制药有限公司1CXHL2400473D3S-001胶囊德昇济医药(无锡)有限公司1CXHL2400472D3S-001胶囊德昇济医药(无锡)有限公司1CXHL2400471HDM3010杭州中美华东制药有限公司2.1CXHL2400486SL001四川省三星堆制药有限公司2.2CXHL2400511利拉鲁肽注射液浙江和泽医药科技股份有限公司2.2CXHL2400487XZ126山东新时代药业有限公司2.2CXHL2400479恩那度司他片深圳信立泰药业股份有限公司2.4CXHL2400505恩那度司他片深圳信立泰药业股份有限公司2.4CXHL2400504恩那度司他片深圳信立泰药业股份有限公司2.4CXHL2400503恩那度司他片深圳信立泰药业股份有限公司2.4CXHL2400502恩那度司他片深圳信立泰药业股份有限公司2.4CXHL2400501恩那度司他片深圳信立泰药业股份有限公司2.4CXHL2400500甲磺酸伏美替尼片上海艾力斯医药科技股份有限公司2.4CXHL2400492重组带状疱疹疫苗(CHO细胞)远大赛威信生命科学(南京)有限公司1.3CXSL2400311重组带状疱疹疫苗(CHO细胞)远大赛威信生命科学(南京)有限公司1.3CXSL2400310PM1032注射液普米斯生物技术(珠海)有限公司1CXSL2400330IBI3004信达生物制药(苏州)有限公司1CXSL2400324注射用重组WNV-HCD86四川安可康生物医药有限公司1CXSL2400329注射用重组WNV-HCD86四川安可康生物医药有限公司1CXSL2400328注射用重组WNV-HCD86四川安可康生物医药有限公司1CXSL2400327注射用重组WNV-HCD86四川安可康生物医药有限公司1CXSL2400326注射用重组WNV-HCD86四川安可康生物医药有限公司1CXSL2400325VPD/FC01001 注射液微能生命科技集团有限公司1CXSL2400323IASO-782注射液上海驯鹿生物技术有限公司1CXSL2400322注射用SHR-A1921苏州盛迪亚生物医药有限公司1CXSL2400317RC148注射液荣昌生物制药(烟台)股份有限公司1CXSL2400320FS-8002注射液华普生物技术(河北)股份有限公司1CXSL2400319注射用RC88荣昌生物制药(烟台)股份有限公司1CXSL2400318注射用BA1302山东博安生物技术股份有限公司1CXSL2400321IBI3003信达生物制药(苏州)有限公司1CXSL2400313注射用YK012益科思特(北京)医药科技发展有限公司1CXSL2400312SCT650C 注射液神州细胞工程有限公司1CXSL2400316WGc-043 注射液成都威斯津生物医药科技有限公司1CXSL2400315WGc-043 注射液成都威斯津生物医药科技有限公司1CXSL2400314仿制药申请药品名称企业注册分类受理号葡萄糖酸钙氯化钠注射液石家庄四药有限公司3CYHS2401493乙酰半胱氨酸注射液湖南华纳大药厂股份有限公司3CYHS2401507乌苯美司胶囊西安万隆制药股份有限公司3CYHS2401505洛索洛芬钠口服溶液合肥诚志生物制药有限公司3CYHS2401502利格列汀二甲双胍缓释片湖北广辰药业有限公司3CYHS2401498利格列汀二甲双胍缓释片湖北广辰药业有限公司3CYHS2401497丁酸氯维地平注射用乳剂齐鲁制药(海南)有限公司3CYHS2401496复方聚乙二醇(3350)电解质散湖北莱康医疗技术有限公司3CYHS2401489布美他尼注射液四川奥邦古得药业有限公司3CYHS2401480盐酸纳美芬注射液海南爱科制药有限公司3CYHS2401479重酒石酸间羟胺注射液广州惠沣德生物技术有限公司3CYHS2401477二甲双胍格列本脲片通化万通药业股份有限公司3CYHS2401476二甲双胍格列本脲片通化万通药业股份有限公司3CYHS2401475二羟丙茶碱注射液峨眉山通惠制药有限公司3CYHS2401474帕拉米韦注射液浙江康吉尔药业有限公司3CYHS2401473己酮可可碱缓释片山东京卫制药有限公司3CYHS2401472氨磺必利注射液南京正科医药股份有限公司3CYHS2401488氨磺必利注射液南京正科医药股份有限公司3CYHS2401487法莫替丁注射液海南未见药业有限公司3CYHS2401455地奈德乳膏海南全盈药业有限公司3CYHS2401451环丝氨酸胶囊河北龙海药业有限公司3CYHS2401450盐酸甲氧氯普胺注射液江苏宝东医药科技有限公司3CYHS2401459盐酸去氧肾上腺素注射液云南龙海天然植物药业有限公司3CYHS2401452盐酸去氧肾上腺素注射液浙江博崤生物制药有限公司3CYHS2401460山梨醇甘露醇冲洗剂海南爱科制药有限公司3CYHS2401447复方聚乙二醇(3350)电解质散重庆希尔安药业有限公司3CYHS2401444法莫替丁注射液成都倍特药业股份有限公司3CYHS2401441坎地氢噻片北京福元医药股份有限公司3CYHS2401435洛索洛芬钠凝胶贴膏上海延安药业(湖北)有限公司4CYHS2401506盐酸氨溴索注射液江苏苏中药业集团生物制药有限公司4CYHS2401504他达拉非片烟台鲁银药业有限公司4CYHS2401503他达拉非片烟台鲁银药业有限公司4CYHS2401501他达拉非片烟台鲁银药业有限公司4CYHS2401500注射用头孢唑肟钠南京恩泰医药科技有限公司4CYHS2401499依折麦布阿托伐他汀钙片(I)晖致(海南)投资有限公司4CYHS2401495依折麦布阿托伐他汀钙片(II)晖致(海南)投资有限公司4CYHS2401494平衡盐溶液(供灌注用)海南爱科制药有限公司4CYHS2401492恩格列净片郑州韩都药业集团有限公司4CYHS2401491恩格列净片郑州韩都药业集团有限公司4CYHS2401490碳酸氢钠血滤置换液上海峰林生物科技有限公司4CYHS2401478利伐沙班干混悬剂南京海纳制药有限公司4CYHS2401486利伐沙班干混悬剂南京海纳制药有限公司4CYHS2401485地屈孕酮片浙江高跖医药科技股份有限公司4CYHS2401484富马酸伏诺拉生片合肥英太制药有限公司4CYHS2401483富马酸伏诺拉生片合肥英太制药有限公司4CYHS2401482左氧氟沙星滴眼液石家庄凯达生物工程有限公司4CYHS2401481盐酸艾司洛尔注射液中国大冢制药有限公司4CYHS2401471帕利哌酮缓释片合肥华方医药科技有限公司4CYHS2401470帕利哌酮缓释片合肥华方医药科技有限公司4CYHS2401469他克莫司缓释胶囊石药集团中诺药业(石家庄)有限公司4CYHS2401468他克莫司缓释胶囊石药集团中诺药业(石家庄)有限公司4CYHS2401467富马酸伏诺拉生片福建省宝诺医药研发有限公司4CYHS2401466洛索洛芬钠凝胶贴膏北京百奥药业有限责任公司4CYHS2401465间苯三酚注射液吉林振澳制药有限公司4CYHS2401454盐酸美金刚片四川尚锐生物医药有限公司4CYHS2401453复方氨基酸注射液(18AA-VII)四川太平洋药业有限责任公司4CYHS2401464盐酸莫西沙星滴眼液江苏福邦药业有限公司4CYHS2401463酒石酸溴莫尼定滴眼液浙江赛默制药有限公司4CYHS2401462聚乙烯醇滴眼液苏州欧康维视生物科技有限公司4CYHS2401461注射用磷酸特地唑胺江苏明圣康源药业有限公司4CYHS2401456瑞舒伐他汀钙片重庆药友制药有限责任公司4CYHS2401458瑞舒伐他汀钙片重庆药友制药有限责任公司4CYHS2401457盐酸曲唑酮缓释片山东京卫制药有限公司4CYHS2401449盐酸曲唑酮缓释片山东京卫制药有限公司4CYHS2401448苯磺顺阿曲库铵注射液本溪恒康制药有限公司4CYHS2401446苯磺顺阿曲库铵注射液本溪恒康制药有限公司4CYHS2401445二甲双胍恩格列净片(I)北京双鹭药业股份有限公司4CYHS2401443二甲双胍恩格列净片(V)北京双鹭药业股份有限公司4CYHS2401442氨氯地平阿托伐他汀钙片宁波大红鹰药业股份有限公司4CYHS2401440胞磷胆碱注射液山东化药医药科技有限公司4CYHS2401439胞磷胆碱注射液山东化药医药科技有限公司4CYHS2401438钆布醇注射液海南葫芦娃药业集团股份有限公司4CYHS2401437钆布醇注射液海南葫芦娃药业集团股份有限公司4CYHS2401436沙库巴曲缬沙坦钠片海南葫芦娃药业集团股份有限公司4CYHS2401434沙库巴曲缬沙坦钠片海南葫芦娃药业集团股份有限公司4CYHS2401433右酮洛芬氨丁三醇注射液北京百奥药业有限责任公司3CYHL2400098孟鲁司特钠口腔崩解片北京百奥药业有限责任公司3CYHL2400097孟鲁司特钠口腔崩解片北京百奥药业有限责任公司3CYHL2400096酒石酸阿福特罗雾化吸入用溶液海南葫芦娃药业集团股份有限公司3CYHL2400094右美沙芬安非他酮缓释片石药集团欧意药业有限公司3CYHL2400093甘露醇山梨醇注射液湖北欣泽霏药业有限公司3CYHL2400092沙美特罗替卡松吸入粉雾剂艾特美(苏州)医药科技有限公司4CYHL2400095四价流感病毒裂解疫苗深圳康泰生物制品股份有限公司3.3CXSL2400331进口申请药品名称企业注册分类受理号艾加莫德α注射液argenx BV2.2JXSS2400042本瑞利珠单抗注射液AstraZeneca AB3.1JXSS2400041地拉罗司颗粒Annora Pharma Private Limited5.2JYHS2400029地拉罗司颗粒Annora Pharma Private Limited5.2JYHS2400028熊去氧胆酸片Zydus Lifesciences Limited5.2JYHS2400027熊去氧胆酸片Zydus Lifesciences Limited5.2JYHS2400026甲磺酸贝舒地尔片Kadmon Pharmaceuticals, LLC2.4JXHL2400115Fezolinetant片Astellas Pharma Global Development, Inc.2.4JXHL2400114Upadacitinib片AbbVie Inc.2.4JXHL2400112Upadacitinib片AbbVie Inc.2.4JXHL2400111Upadacitinib片AbbVie Inc.2.4JXHL2400110镥(177Lu)vipivotide tetraxetan注射液Novartis Pharma AG2.4JXHL2400109镥(177Lu)vipivotide tetraxetan注射液Novartis Pharma AG2.4JXHL2400108用于制备放射性药物镓(68Ga)gozetotide注射液的药盒Novartis Europharm Limited5.1JXHL2400113Amlitelimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400093注射用M9140Merck Healthcare KGaA1JXSL2400096PF-06823859注射液Pfizer Inc.1JXSL2400092Dostarlimab注射液GlaxoSmithKline Research & Development Limited2.2JXSL2400095Dostarlimab注射液GlaxoSmithKline Research & Development Limited2.2JXSL2400094中药相关申请药品名称企业注册分类受理号二冬颗粒贵州威门药业股份有限公司3.1CXZS2400016JKN2303江西中医药大学1.2CXZL2400029JKN2303吸入溶液广西馨海药业科技有限公司1.2CXZL2400028JKN2303吸入溶液广西馨海药业科技有限公司1.2CXZL2400027JKN2303吸入溶液广西馨海药业科技有限公司1.2CXZL2400026JKN2303吸入溶液广西馨海药业科技有限公司1.2CXZL2400025不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市

100 项与 177Lu-Satoreotide tetraxetan 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16323

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
乳腺癌	临床2期	美国	Ipsen SA	2019-05-14
乳腺癌	临床2期	奥地利	Ipsen SA	2019-05-14
乳腺癌	临床2期	比利时	Ipsen SA	2019-05-14
乳腺癌	临床2期	法国	Ipsen SA	2019-05-14
乳腺癌	临床2期	德国	Ipsen SA	2019-05-14
乳腺癌	临床2期	瑞士	Ipsen SA	2019-05-14
乳腺癌	临床2期	英国	Ipsen SA	2019-05-14
小细胞肺癌	临床2期	美国	Ipsen SA	2019-05-14
小细胞肺癌	临床2期	奥地利	Ipsen SA	2019-05-14
小细胞肺癌	临床2期	比利时	Ipsen SA	2019-05-14

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02592707 (CTgov)	临床1/2期	Somatostatin Receptor-Positive Neuroendocrine Tumor	40	177Lu-IPN01072 (Part A: 177Lu-IPN01072 4.5 GBq)	餘願築鹹繭簾艱積築繭(膚壓顧遞夢鏇鏇襯鏇餘) = 鏇積衊鏇積網顧襯獵憲築觸遞鏇壓廠積遞鏇築 (艱夢衊醖餘顧網鏇鏇醖, 製鹹製鹽鬱衊憲鏇窪衊 ~ 艱鹹觸衊製願壓願淵鑰) 更多	-	2023-07-19
NCT02592707 (CTgov)	临床1/2期	Somatostatin Receptor-Positive Neuroendocrine Tumor	40	GBq+177Lu-IPN01072 (Part B Cohort 1: 177Lu-IPN01072 6 GBq)	餘願築鹹繭簾艱積築繭(膚壓顧遞夢鏇鏇襯鏇餘) = 鏇製構壓蓋觸齋繭製鏇築觸遞鏇壓廠積遞鏇築 (艱夢衊醖餘顧網鏇鏇醖, 願築網簾顧網鹽顧顧選 ~ 鹽糧齋觸廠艱獵艱蓋廠) 更多	-	2023-07-19
NCT02592707 (ESMO2020) 人工标引	临床1/2期	神经内分泌肿瘤	35	177Lu-satoreotide tetraxetan	憲鏇壓窪範蓋淵製衊窪(壓鹽襯膚觸鏇顧鹽膚選) = 34.3%[lymphopenia/decrease in lymphocyte counts in 6 (17.1%), thrombocytopenia/decrease in platelets count in 5 (14.3%), neutropenia in 2 (5.7%) and anemia in 1 (2.9%)]. No grade 3/4 renal toxicities were reported. 廠繭範簾簾獵構觸範簾 (願構築壓積選壓憲鬱觸 )	积极	2020-09-20
NCT02609737 (Pubmed \| Clin Cancer Res) 人工标引	临床1期	神经内分泌肿瘤	20	Lutetium-177 DOTA satoreotide	觸齋顧簾廠構淵鹹構衊(遞齋夢衊選鏇鏇廠顧築) = 鬱鹹糧蓋顧衊積憲鏇鹹衊廠願製齋顧醖積願憲 (餘選鹽齋醖餘構艱蓋鹹 ) 更多	积极	2019-12-01