Randomized controlled trial for the effect of HIF-PH inhibitor and epoetin beta pegol in renal anemia treatment of the peritoneal dialysis (PD) patients - Randomized controlled trial for the effect of HIF-PH inhibitor and epoetin beta pegol in renal anemia treatment of the peritoneal dialysis (PD) patients

开始日期2020-07-30

申办/合作机构

International University of Health & Welfare

TCTR20190718006 / Recruiting临床4期IIT

A RANDOMIZED, CONTROLLED, OPEN-LABEL, SINGLE-CENTER, PARALLEL GROUP STUDY TO ASSESS THE EFFECT OF MIRCERA ON DELAYING DIALYSIS IN ANEMIC PATIENTS WITH STAGE 5 CHRONIC KIDNEY DISEASE NOT ON DIALYSIS

开始日期2019-03-19

申办/合作机构-

NCT03427801 / CompletedN/AIIT

Effect of Erythropoiesis-Stimulating Agent Therapy in Patients Receiving Palliative Care of Chronic Kidney Disease

An observational study to evaluate the effect of erythropoiesis-stimulating agents in treating anaemia of renal disease among adult patients receive palliative care instead of dialysis.

开始日期2017-03-01

申办/合作机构

香港中文大学

100 项与甲氧聚二醇重组人促红素相关的临床结果

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100 项与甲氧聚二醇重组人促红素相关的转化医学

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100 项与甲氧聚二醇重组人促红素相关的专利（医药）

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241

项与甲氧聚二醇重组人促红素相关的文献（医药）

2024-03-01·Pediatric nephrology (Berlin, Germany)

Real-world evidence on the dosing and safety of C.E.R.A. in pediatric dialysis patients: findings from the International Pediatric Dialysis Network registries

Article

作者: Warady, Bradley A ; Rutten-Jacobs, Loes ; Schmitt, Claus Peter ; Yap, Hui-Kim ; Coccia, Paula A ; Reigner, Sylvie Meyer ; Studer, Milena ; Sander, Anja ; Schaefer, Franz ; Cano, Francisco ; Kohlhas, Laura ; Vondrak, Karel

Abstract:

Background:

This retrospective real-world study used data from two registries, International Pediatric Peritoneal Dialysis Network (IPPN) and International Pediatric Hemodialysis Network (IPHN), to characterize the efficacy and safety of continuous erythropoietin receptor activator (C.E.R.A.) in pediatric patients with chronic kidney disease (CKD) on peritoneal dialysis (PD) or hemodialysis (HD).

Methods:

IPPN and IPHN collect prospective data (baseline and every 6 months) from pediatric PD and HD centers worldwide. Demographics, clinical characteristics, dialysis information, treatment, laboratory parameters, number and causes of hospitalization events, and deaths were extracted for patients on C.E.R.A. treatment (IPPN: 2007–2021; IPHN: 2013–2021).

Results:

We analyzed 177 patients on PD (median age 10.6 years) and 52 patients on HD (median age 14.1 years) who had ≥ 1 observation while being treated with C.E.R.A. The median (interquartile range [IQR]) observation time under C.E.R.A. exposure was 6 (0–12.5) and 12 (0–18) months, respectively. Hemoglobin concentrations were stable over time; respective means (standard deviation) at last observation were 10.9 (1.7) g/dL and 10.4 (1.7) g/dL. Respective median (IQR) monthly C.E.R.A. doses at last observation were 3.5 (2.3–5.1) µg/kg, or 95 (62–145) µg/m2 and 2.1 (1.2–3.4) µg/kg, or 63 (40–98) µg/m2. Non-elective hospitalizations occurred in 102 (58%) PD and 32 (62%) HD patients. Seven deaths occurred (19.8 deaths per 1000 observation years).

Conclusions:

C.E.R.A. was associated with efficient maintenance of hemoglobin concentrations in pediatric patients with CKD on dialysis, and appeared to have a favorable safety profile. The current analysis revealed no safety signals.

Graphical abstract:

2023-12-01·Kidney international reports

Contemporary Practice of Anemia Treatment Among Dialysis Patients in the United States

Article

作者: Petersen, Jeffrey ; Eggert, William ; Weinhandl, Eric D ; Gilbertson, David T ; Hwang, Yunji

Introduction:

The treatment of anemia is a major activity in the care of patients undergoing maintenance hemodialysis (HD). The comparative effectiveness of new pharmacologic treatments, relative to erythropoiesis-stimulating agents (ESAs), should be anticipated on the bases of controlled trials and current practice. We describe the contemporary practice of anemia treatment in a national cohort of patients undergoing maintenance HD.

Methods:

We analyzed the United States Renal Data System (USRDS) data to identify adult patients undergoing in-facility HD in 2016 to 2019. Using the Consolidated Renal Operations in a Web-Enabled Network (CROWNWeb) dataset, we identified hemoglobin and ESA utilization (agent and cumulative dose) during each patient-month, as well as intravenous (IV) iron utilization, ferritin, and transferrin saturation. We compared ESA dosing during the study era to dosing in the Normal Hematocrit Cardiac Trial (NHCT), conducted in the 1990s. We assessed ESA hyporesponsiveness by estimating the prevalence of the following: (i) high erythropoietin resistance index (ERI) and (ii) either 3 or 6 consecutive months with hemoglobin <10 g/dl.

Results:

Nearly two-thirds of patient-months had hemoglobin of 10.0 to 11.9 g/dl. Mean ESA utilization was 76.7% per month, with increasing use of pegylated epoetin beta. ESA dosing was stable; epoetin alfa dosing was slightly lower than in the low-target arm of the NHCT. The prevalence of ESA hyporesponsiveness was 22.2% if defined by high ERI, but only 2.1% to 6.0% if defined by 3 to 6 consecutive months with hemoglobin <10 g/dl. Median transferrin saturation was 22.3% with high ERI and persistently low hemoglobin.

Conclusion:

Hemoglobin and ESA dosing distributions are stable, with epoetin alfa dosing below the low-target arm of the NHCT. Persistently low hemoglobin occurs infrequently and may reflect iron depletion.

2023-11-01·Panminerva medica4区 · 医学

Identification and functional characterization of two rare LDLR stop gain variants (p.C231* and p.R744*) in Saudi familial hypercholesterolemia patients

4区 · 医学

Article

作者: Almukadi, Haifa ; Bima, Abdulhadi I ; Altayar, Ahmed E ; Awan, Zuhier ; Almansouri, Majid ; Alharbi, Raneem S ; Kutbi, Hussam I ; Jamalalail, Bassam ; Banaganapalli, Babajan ; Al-Allaf, Faisal A ; Hegazy, Gehan A ; Shaik, Noor A ; Batran, Alhanuf

BACKGROUND:

Familial hypercholesterolemia (FH) is a globally underdiagnosed inherited metabolic disorder. Owing to limited published data from Arab world, this study was conducted with the aim of identifying the genetic and molecular basis of FH in highly consanguineous Saudi population.

METHODS:

We performed clinical screening, biochemical profiling, whole exome sequencing and variant segregation analysis of two Saudi FH families. Additionally, 500 normolipic individuals were screened to ensure the absence of FH variant in general Saudi population. Functional characterization of FH variants on secondary structure characteristics of RNA and protein molecules was performed using different bioinformatics modelling approaches.

RESULTS:

WES analysis identified two independent rare LDLR gene stop gain variants (p.C231* and p.R744*) consistent to the clinical presentation of FH patients from two different families. RNAfold analysis has shown that both variants were predicted to disturb the free energy dynamics of LDLR mRNA molecule and destabilize its folding pattern and function. PSIPRED based structural modelling analysis has suggested that both variants bring drastic changes disturbing the secondary structural elements of LDLR molecule. The p.C231* and p.R744* variants are responsible for partial or no protein product, thus they are class 1 variants causing loss of function (LoF) LDLR variants.

CONCLUSIONS:

This study highlights the effectiveness of the WES, sanger sequencing, and computational analysis in expanding FH variant spectrum in culturally distinct populations like Saudi Arabia. Genetic testing of FH patients is very essential in better clinical diagnosis, screening, treatment, and management and prevention of cardiovascular disease burden in the society.

项与甲氧聚二醇重组人促红素相关的新闻（医药）

2024-04-03

·Pharmaceutical Technology

EC approves Bristol Myers Squibb’s Reblozyl for first-line MDS treatment

The approval for Bristol Myers Squibb’s Reblozyl is applicable in all the EU member states. Katherine Welles / Shutterstock.com. The European Commission (EC) has granted expanded approval for Bristol Myers Squibb ‘s (BMS) Reblozyl (luspatercept) as a first-line treatment for adults with transfusion-dependent anaemia associated with very low, low and intermediate-risk myelodysplastic syndromes (MDS). The decision is applicable in all the member states of the European Union (EU). The EC’s expanded approval is based on the results from the open-label, randomised Phase III COMMANDS study. The trial assessed the efficacy and safety of Reblozyl compared to epoetin alfa, an erythropoiesis-stimulating agent, in treating anaemia due to MDS. It included subjects who needed red blood cell (RBC) transfusions and had not previously received erythropoiesis-stimulating agents. See Also: Alexion’s Voydeya gains FDA approval for extravascular haemolysis Novartis gets grant for treatment of cocaine use disorder using mavoglurant Reblozyl significantly outperformed epoetin alfa in achieving concurrent RBC transfusion independence and a rise in haemoglobin levels – the study’s primary endpoint. Safety results were in line with previous studies on MDS, with no significant differences in progression to acute myeloid leukaemia or total deaths between the study arms. This approval is the fourth indication authorised for Reblozyl in Europe, positioning it as a first-in-class treatment for people with disease-related anaemia and the first therapy to demonstrate superior efficacy versus epoetin alfa in lower-risk MDS (LR-MDS). Reblozyl is a product of a global collaboration and is co-promoted in North America by Merck (MSD), following its acquisition of Acceleron Pharma in November 2021. It has also been approved in the US and Japan for the first-line treatment of anaemia associated with LR-MDS. Bristol Myers Squibb European Markets senior vice-president and head Monica Shaw stated: “With this approval for Reblozyl as a first-line treatment for anaemia in adults with LR MDS, more patients in the EU will have the potential to become transfusion independent for longer periods compared to current options available. “This milestone underscores our ongoing commitment to developing new options for patients with disease-related anaemia.” Last month, the EC approved BMS’ Abecma (idecabtagene vicleucel; ide-cel) to treat adults with relapsed and refractory multiple myeloma .

上市批准临床3期临床结果

2024-03-28

·美通社

先健科技公布2023年度业绩：国际业务增长强劲，创新驱动稳健发展

深圳 2024年3月28日 /美通社/ -- 2024年3月28日，领先的心脑血管及外周血管介入医疗器械企业——先健科技公司（"本公司"或"先健科技"，股份代码：1302.HK）及其附属公司（统称"本集团"）公布截至2023年12月31日止年度（"报告期内"）经审核的综合业绩：国际业务增长强劲：本集团实现销售收入约人民币1,267.2百万元，同比增长约15.5%，其中海外市场销售额同比显著增长约36.0%，尤其欧洲市场强劲增长约52.9%；盈利能力稳定：本集团实现毛利约人民币995.6百万元，同比增长约13.9%；毛利率表现稳定，约为78.6%。剔除若干非经常性项目【 1 】，归母净利润约为人民币423.3百万元，归母净利润率约为33.4%；现金流充裕：截至2023年12月31日，本集团持有现金及现金等价物约为人民币979.3百万元，同比增长约17.5%，该增长主要由于经营活动产生的现金流增加。充裕的现金流为本集团的长期发展奠定了坚实基础。注释：【1】上述非经常性项目包括：1）因元心科技（深圳）有限公司B轮融资的估值大幅上升，其可赎回股份的公平值相应大幅增加，2023年按公平值计入损益的金融负债之公平值变动的亏损约为人民币213.8百万元；2）按公平值计入损益的金融资产所产生的其他收益及亏损，于2023年的收益约为人民币34.0百万元；3）以股份为基础的付款开支，于2023年合共约为人民币112.8百万元。国际业务增长强劲内地业务运营稳健 2023年，本集团直面多重挑战，持续聚焦全球未被满足的临床治疗需求，在"创新"和"国际化"双轮驱动发展战略的引领下，创新持续赋能本集团于国际市场的深入发展。于报告期内，本集团以丰富的创新产品组合和高质量的学术服务连接世界，并在品牌、专利、渠道、临床注册、全球化运营管理等方面的经验和优势的协同发展下，成功将销售渠道拓展至全球近120个国家和地区，产品于海外市场的渗透率不断深化，录得海外销售额同比显著增长约36.0%，尤其欧洲市场在高基数上强劲增长约52.9%。随着国际化战略的有效推进，本集团国际业务发展持续加速，来自海外市场的销售贡献占本集团总收入的比重于报告期内上升至约21.7% 。其中，亚洲（不包括中国内地）和欧洲是本集团最大的两个海外市场，于报告期内的销售额占本集团总收入比例跃升至约9.0%及约8.8%。中国内地市场是本集团的发展根基，亦是本集团目前最大的市场。本集团持续在中国内地市场推进核心发展战略，并根据国内行业的变化，积极探索并适时采取更加稳健和可持续的业务发展策略，不断加速新产品于中国内地市场的临床及上市进程。于报告期内录得销售额较去年同期增长约10.8%，占本集团总收入约78.3%。本集团的先天性心脏病封堵器、左心耳封堵器、主动脉覆膜支架和腔静脉滤器系列产品，创新迭代层级丰富，深入内地基层市场，多年来始终保持中国内地市场份额领先。核心业务稳步增长持续彰显发展韧性 NO.1 结构性心脏病业务：本集团结构性心脏病业务提供的产品主要包括左心耳封堵器及先天性心脏病封堵器，于报告期内录得销售收入约为人民币495.7百万元，较去年同期增长约25.6%。其中，销售左心耳封堵器产生的收入同比增长约32.0% ，该创新产品稳居全球市场国产品牌市场占有率第一；销售先天性心脏病封堵器产生的收入同比增长约23.1%，主要得益于本集团于全球市场通过差异化的产品策略满足不同的市场需求。本集团结构性心脏病业务产品组合多元化，并通过持续的技术创新和产品升级不断满足日益增长的治疗需求，从而进一步深化于全球市场的销售布局。 NO.2 外周血管病业务：本集团致力于为海内外患者提供技术领先的外周血管疾病系统性综合介入器械治疗方案，主要产品包括胸主动脉覆膜支架、腹主动脉覆膜支架、髂动脉分叉支架及腔静脉滤器。于报告期内，本集团外周血管病业务收入约为人民币707.1百万元，同比上升约9.7%。其中，销售覆膜支架产生的收入较去年同期增长约11.2%，销售腔静脉滤器产生的收入较去年同期下降约1.0%。上述两个系列产品多年保持中国内地市场龙头地位。本集团外周血管病业务在研及临床注册中产品可与现有产品有效协同，为患者提供整体解决方案，并将填补多项临床治疗空白，这将赋予本集团外周血管病业务强大且持久的全球市场竞争力。 NO.3 起搏电生理业务：本集团为国产首家拥有达到国际级技术及功能的植入式心脏起搏器完整产品组合的生产厂商，于报告期内录得销售收入约为人民币64.4百万元，同比增长约10.3%。本集团国产品牌的MRI兼容起搏器项目正在有条不紊的推进之中，将进一步丰富本集团起搏电生理业务的产品组合。创新蓄力持续发展自主研发的创新医疗器械产品不仅能够为本集团的可持续发展蓄积能量，亦可为本集团提供长久的市场竞争力。本集团目前在研及临床管线丰富，均具极高的创新含量和广阔的市场前景。这使我们有能力突破未来挑战，面向全球患者提供更优的疾病治疗方案。2023年，本集团研发投入为人民币约297.9百万元，较去年同期增长约42.9%，以持续加强本集团的技术创新能力，并加速新产品的研发及商业化进程。产品商业化有序推进 AcuMark™房间隔缺损测量球囊、外周血栓抽吸导管及Epione™穿刺手术导航定位系统获国家药品监督管理局（NMPA）批准上市； Aegisy™腔静脉滤器、AcuMark™房间隔缺损测量球囊、ZoeTrack™导丝、SeQure™管腔抓捕系统及Cera™血管塞系统成功转换获批CE MDR（欧盟医疗器械法规）认证； Ankura™ Chimney主动脉覆膜支架系统（包括Ankura™ Pro主动脉主体覆膜支架系统及Longuette™主动脉分支覆膜支架系统）、Futhrough™主动脉覆膜支架破膜系统、FemFlow™药物洗脱外周球囊导管、CeraFlex™无螺纹陶瓷膜房间隔缺损封堵器、远端通路导管套装、一次性负压吸引泵、颅内血栓抽吸导管及DiAcu™一次性内窥镜超声吸引活检针正在中国注册审批中； Ankura™ IIc大动脉覆膜支架系统及Ankura™ Chimney主动脉覆膜支架系统（包括Ankura™ Pro主动脉主体覆膜支架系统及Longuette™主动脉分支覆膜支架系统）正在欧盟CE认证中；胸腹主动脉覆膜支架系统（包括G-Branch™胸腹主动脉覆膜支架系统、SilverFlow™ PV外周血管覆膜支架系统及主动脉延长覆膜支架系统）及主动脉弓支架系统（包括Ankura™ Plus主动脉弓主体支架系统及CSkirt™主动脉弓分支支架系统）已在中国完成上市前临床入组，目前正在进行临床随访； CS主动脉弓部分支重建系统、X-Clip™经导管二尖瓣夹系统及X-Clip™可操控导引系统已成功完成于中国的首次植入人体（FIM）的临床研究； Cera™陶瓷膜卵圆孔未闭封堵器及Cinenses™肺减容回力圈系统目前于中国处于注册前临床入组阶段。铁基可吸收材料平台：资本助力快速发展 2023年9月，附属公司元心科技（深圳）有限公司（以下简称"元心科技"）顺利完成2亿余元B轮战略融资。B轮融资引入共青城华屹、广发乾和等多家战略投资者，A轮投资者IDG、上海抱泉等继续跟投，带来投后估值大幅提升173%。元心科技专注于医用生物可吸收金属材料产品的研究、开发、制造及销售，公司自主研发的、全球首创的铁基生物可吸收材料，在医疗领域具有广泛的应用空间和拓展潜力。首批三款产品分别针对治疗冠状动脉狭窄、膝下动脉狭窄及肺动脉狭窄，市场容量极大或临床需求亟待满足，具有广阔的市场前景。在资本的助力下，该三款创新产品于报告期内的临床及上市审批均有序推进，产品的临床数据优势明显。 IBS™可吸收药物洗脱冠脉支架系统已顺利完成FIM临床研究的五年期随访，II期及III期临床亦正在随访中，并已提交欧盟CE注册申请。该创新产品共三期临床累计植入1,100多例，手术成功率为100%，靶血管失败率和血栓发生率符合预期，均处于较低水平。 IBS Titan™可吸收药物洗脱外周支架系统的注册临床工作正稳步开展，已于欧洲成功完成首次临床入组并已提交欧盟CE注册申请。该产品已获得美国FDA"同情使用"批准并成功完成植入。全球唯一适用于儿童的铁基可吸收支架——IBS Angel™铁基可吸收支架系统已获得马来西亚注册证及欧盟CE MDR认证，亦在美国通过FDA"同情使用"批准植入多例。资本的助力将进一步加速本集团铁基生物可吸收材料平台上革命性创新产品的临床及上市进程，从而早日为全球患者带来前所未有的、安全有效的治疗方式，并将有效推动元心科技独立进行后续的资本化运作，进而提升本集团的整体价值。知识产权保驾护航本集团持续重视高质量的全球知识产权布局，截至2023年12月31日累计提交了2,147项有效专利申请，其中942项有效专利已获批准。通过持续的知识产权创新、应用、保护与管理，本集团已构建起领先的技术创新能力、前瞻的专利布局和完善的知识产权保护体系。创新能力获得业界高度认可 "DiAcu™一次性内窥镜超声吸引活检针"产品工业设计荣获德国红点奖； "结构性心脏病介入诊疗关键技术体系创新与推广应用"项目获北京市技术发明奖一等奖； "全主动脉腔内诊疗体系的构建与应用"获北京市科学技术进步奖二等奖； "LAmbre™左心耳封堵器系统"荣获2023年十大自主创新医疗器械产品。先健科技董事局主席兼首席执行官谢粤辉先生表示： "尽管2023年面临多重挑战，我们在研发创新、全球渠道拓展及产品销售等方面依旧稳步向前。在‘创新'和‘国际化'发展战略的双向驱动下，先健科技以原研创新产品穿越全球知识产权密林，深入覆盖全球近120个国家和地区，使我们业务的国际化程度于国内行业保持领先。我们坚信创新的长期效益将使公司有能力面对未来挑战，为突破性发展提供永续动能，并为我们不断拓展国际市场提供坚实保证。未来，我们将持续以创新激发我们在全球市场强大的业务活力和发展潜力。以审慎务实的态度、严谨高效的管理和扎实稳健的业务内核，推进现有业务于全球市场的快速发展。同时，我们还将积极寻求并把握新的发展机会，整合并强化内外部优势资源，多维度提升本集团的整体价值，以期早日实现我们在全球医疗健康领域的发展目标。" 关于先健科技：先健科技公司(股份代号：1302.HK)是业内领先的心脑血管和外周血管介入医疗器械企业，于1999年成立于中国深圳，为国家级高新技术企业，国家工信部第三批专精特新"小巨人"企业。公司在研、在售产品涵盖结构性心脏病、外周血管病、起搏电生理、呼吸介入、神经介入、肿瘤介入等领域，并拥有全球首创的铁基生物可吸收材料平台，在多个细分领域实现自主创新技术突破。截至2023年12月31日，公司已实现高质量专利布局2,147项，目前累计15款产品获国家药品监督管理局（NMPA）批准进入"创新医疗器械特别审查程序"。秉承"创新"和"国际化"发展战略，公司主要在售产品的市场份额长期处于国内领先地位，并在全球6个国家拥有子公司和办事处，销售网络覆盖全球近120个国家和地区，是国内少有的业务具高度国际化的三类介入医疗器械企业。

财报医药出海引进/卖出

2024-02-13

·Business Wire

Injectable Hematology Growth Factors Report 2024 - Evolution in Therapeutic Care - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Injectable Hematology Growth Factors Report" has been added to ResearchAndMarkets.com's offering. This report is a comprehensive evaluation and analysis of the technology, products, and participants providing the driving force behind this evolving segment of the healthcare sector. The study is designed to provide drug company decision-makers, drug delivery developers, device designers, healthcare marketers, and supply chain participants with a detailed understanding of the economics, technologies, and opportunities for injection devices designed for patient self-administration. Provider organization business managers, healthcare administrators, and investors will also benefit from this study. Evolution in Therapeutic Care Several recombinant hematologic growth factors or agonists for their receptors have been produced that are useful in treating anemia, neutropenia, and thrombocytopenia, particularly in patients with end-stage renal disease or aplastic anemia or who have received cancer chemotherapy or a hematopoietic cell transplant. The shift in as-supplied packaging from single and multi-use vials to prefilled injection devices will accelerate over the next five years as drug developers move to empower an increasing number of chronically ill patients. The powerful physiological effects of antibodies, hormones, and other biological drugs also increase the need for safety and compliance. What You Will Learn Provides detailed analysis of injectable hematology growth factors delivery and device strategies, and product development factors. Assesses key markets, market dynamics, and market demographics. Analyzes therapeutic demand drivers and evaluates injectable drug products in a number of key therapeutic segments. Provides market data and forecasts. Profiles market sector participants, their product development activities, business strategies, and corporate alliances and affiliations Assesses the importance of alliances and partnerships on drug product commercialization. Evaluates the impact of economic, technology, and regulatory factors Key Topics Covered: Hematology Market Dynamics Competitive Factors Proliferation of Biological Drugs Product Manufacturers Hematology Growth Factors Devices for Administering Injectable Growth Factors Device Selection - Stability and Material Issues Competitive Landscape Prefilled Syringes Pen Injectors Dual Chamber Pens Emerging Devices Injectable Hematology Growth Factors - Product Assessment Abseamed Accofil Aranesp Binocrit Biograstim Biopoin Epoetin Alfa Hexal Eporatio Filgrastim Hexal Fulphila Granix Grastofil Mircera NeoRecormon Neulasta Neupogen Nivestim Ratiograstim Retacrit Rolvedon Silapo Tevagrastim Udenyca (Coherus BioSciences) Zarzio Ziextenzo Market Assessment Anemia Hematopoietic Stem Cell Transplant Advanced Kidney Disease Neutropenia Predonation of Autologous Blood Company Profiles Companies Mentioned AbZ-Pharma Accord Healthcare Amgen Genentech Hexal AG Medice Arzneimittel Mylan International Novartis Pfizer Ratiopharm Rentscler Biotechnologie Roche Sandoz Stada Arzneimittel AG Teva Pharmaceuticals For more information about this report visit https://www.researchandmarkets.com/r/bktosb About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

ASH会议

100 项与甲氧聚二醇重组人促红素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	甲氧聚二醇重组人促红素	B03XA03	DB09107

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
贫血	中国	Roche Pharma (Schweiz) AG	2018-04-28
肾性贫血	日本	Chugai Pharmaceutical Co., Ltd.	2011-04-22
慢性肾衰竭贫血	欧盟	Roche Registration GmbH	2007-07-20
慢性肾衰竭贫血	冰岛	Roche Registration GmbH	2007-07-20
慢性肾衰竭贫血	列支敦士登	Roche Registration GmbH	2007-07-20
慢性肾衰竭贫血	挪威	Roche Registration GmbH	2007-07-20

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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
腹膜透析并发症	临床3期	日本	Chugai Pharmaceutical Co., Ltd.	2007-02-01
肾病	临床3期	日本	Chugai Pharmaceutical Co., Ltd.	2007-01-01
慢性肾病	临床3期	美国	Hoffmann-La Roche, Inc.	2004-02-01
慢性肾病	临床3期	加拿大	Hoffmann-La Roche, Inc.	2004-02-01
慢性肾病	临床3期	法国	Hoffmann-La Roche, Inc.	2004-02-01
慢性肾病	临床3期	德国	Hoffmann-La Roche, Inc.	2004-02-01
慢性肾病	临床3期	意大利	Hoffmann-La Roche, Inc.	2004-02-01
慢性肾病	临床3期	挪威	Hoffmann-La Roche, Inc.	2004-02-01
慢性肾病	临床3期	西班牙	Hoffmann-La Roche, Inc.	2004-02-01
慢性肾病	临床3期	瑞士	Hoffmann-La Roche, Inc.	2004-02-01

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临床结果

适应症

分期

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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


CROWNWeb (ASN2022)	N/A	维持 erythropoietin resistance index (ERI) \| hemoglobin (Hb) \| transferrin saturation (TSAT)	-	Epoetin alfa (EPO)	範選構簾齋衊壓簾願壓(襯簾繭壓夢鑰範膚窪憲) = 積範膚壓廠獵構蓋觸襯網構獵簾憲鏇醖蓋醖糧 (艱鑰襯襯觸衊獵選繭鏇 ) 更多	-	2022-11-03
				Darbepoetin alfa (DPO)	範選構簾齋衊壓簾願壓(襯簾繭壓夢鑰範膚窪憲) = 網齋選艱衊鏇範積壓獵網構獵簾憲鏇醖蓋醖糧 (艱鑰襯襯觸衊獵選繭鏇 ) 更多
NCT03552393 (SKIPPER, ERA2022)	临床2期	伴随慢性肾病的贫血维持	-	C.E.R.A. SC every 4 weeks	積衊鹽鏇憲鏇壓網範鑰(醖壓夢鹽鹽壓築製夢觸) = 鬱艱願範構糧醖製選齋願繭醖鹹築齋構願築壓 (顧積艱鬱夢憲顧獵鑰鬱, 1.03) 更多	积极	2022-05-03
OptumLabs Data Warehouse (ASN2020)	N/A	贫血 hemoglobin \| eGFR \| diabetes ... 更多	-	Erythropoiesis-Stimulating Agent	艱構糧襯艱範觸膚鑰網(鬱構選範鹹鏇膚淵夢憲) = 簾鬱願夢繭夢夢壓齋獵齋醖齋構願鹽構廠鹹齋 (製選觸鏇膚膚齋鏇觸鹹 )	积极	2020-10-19
				Erythropoiesis-Stimulating Agent	艱構糧襯艱範觸膚鑰網(鬱構選範鹹鏇膚淵夢憲) = 積築獵衊襯遞衊衊艱衊齋醖齋構願鹽構廠鹹齋 (製選觸鏇膚膚齋鏇觸鹹 )
PARAMOUNT-HD (ERA2020)	N/A	维持	4,034	CERA	衊廠簾顧鑰夢廠蓋壓顧(醖廠範觸遞壓餘蓋艱襯) = 襯齋積餘衊鹹醖襯網繭鏇衊衊簾選廠醖顧鏇繭 (壓淵積襯壓鹽築窪構觸 )	积极	2020-06-06
NCT00773513 (Pubmed \| Clin J Am Soc Nephrol)	临床4期	伴随慢性肾病的贫血	2,818	Methoxy Polyethylene Glycol-Epoetin Beta	願鏇鏇襯鏇衊鑰獵憲鬱(齋壓淵廠願繭夢獵鏇構): HR = 1.06 (95% CI, 0.94 ~ 1.19) 更多	-	2019-12-06
				Reference Erythropoiesis-Stimulating Agents
ASN2019	N/A	EPCs \| vascular endothelial growth factor \| matrix metalloproteinase-2 (MMP-2) ... 更多	42	Recombinant human erythropoietin (rhEPO)	窪廠繭繭繭鏇鬱齋餘鏇(鬱網願選願齋齋廠鑰範) = 窪膚糧淵構艱積糧鑰鹽構壓襯廠鏇艱膚齋壓繭 (艱積夢醖選淵襯衊願範 )	-	2019-11-05
				Darbepoetin (DA)	窪廠繭繭繭鏇鬱齋餘鏇(鬱網願選願齋齋廠鑰範) = 鬱選夢鹽鏇構築繭糧鬱構壓襯廠鏇艱膚齋壓繭 (艱積夢醖選淵襯衊願範 )
NCT01519947 (ALTITUD \| ALTITUDE, CTgov)	临床4期	慢性肾衰竭贫血	87	Methoxy polyethylene glycol-epoetin beta (Pre-dialysis, Sea Level)	淵壓簾蓋願窪襯蓋製顧(鏇積獵範觸製醖憲鹽餘) = 鹽簾簾壓膚繭簾鬱鹽夢醖顧衊蓋淵艱膚鬱遞構 (製衊糧淵壓觸膚襯憲顧, 鏇範鹹獵鏇膚壓廠夢蓋 ~ 選鑰夢製膚鹽製願鑰廠) 更多	-	2018-12-27
				Methoxy polyethylene glycol-epoetin beta (Dialysis, Sea Level)	淵壓簾蓋願窪襯蓋製顧(鏇積獵範觸製醖憲鹽餘) = 遞衊構夢餘廠遞築衊糧醖顧衊蓋淵艱膚鬱遞構 (製衊糧淵壓觸膚襯憲顧, 襯願衊簾遞糧願觸範願 ~ 糧遞衊鑰襯鑰糧遞鏇獵) 更多
NCT00773513 (CTgov)	临床4期	心血管疾病 \| 慢性肾衰竭贫血	2,825	Darbepoetin Alfa+Epoetin Alfa+methoxy polyethylene glycol-epoetin beta+Epoetin Beta (Erythropoiesis Stimulating Agents)	願鹽襯窪築觸繭鹽範餘(築夢顧艱遞壓夢衊簾構) = 廠鹹構簾壓鹽網夢廠製夢鏇鬱蓋窪襯遞鹽簾淵 (餘艱窪窪壓鹽範鬱餘憲, 餘積艱鹹製範衊衊鏇願 ~ 顧餘齋網夢構選鑰衊選) 更多	-	2018-08-15
				Darbepoetin Alfa+Epoetin Alfa+methoxy polyethylene glycol-epoetin beta (Methoxy Polyethylene Glycol-Epoetin Beta)	願鹽襯窪築觸繭鹽範餘(築夢顧艱遞壓夢衊簾構) = 膚積製構餘觸遞衊醖蓋夢鏇鬱蓋窪襯遞鹽簾淵 (餘艱窪窪壓鹽範鬱餘憲, 齋鬱膚廠觸顧鹽顧襯壓 ~ 襯壓蓋淵鑰鬱積蓋願糧) 更多
NCT00717366 (Pubmed \| Clin J Am Soc Nephrol) 人工标引	临床2期	慢性肾病	64	methoxy polyethylene glycol-epoetin beta	選衊醖簾觸壓繭衊衊構(廠構鏇選鏇壓願壓襯窪) = 鏇鹹膚窪窪構膚範積衊齋淵鬱衊遞餘築憲鹽願 (選鏇餘鏇膚餘簾構餘遞, -0.45 ~ 0.26) 更多	积极	2018-01-06
MP426 (ERA2017)	N/A	慢性肾小球肾炎 FGF23 \| iron levels	-	C.E.R.A. (10 μg/kg)	繭醖網簾壓製醖膚鏇鏇(鏇襯築齋獵廠鹽膚壓壓) = 憲顧積繭淵鏇窪艱鑰構鹹壓製製襯願醖艱憲積 (窪願餘襯鑰範築鏇齋壓 ) 更多	积极	2017-05-26
				Vehicle	繭醖網簾壓製醖膚鏇鏇(鏇襯築齋獵廠鹽膚壓壓) = 選繭築餘窪蓋繭範醖憲鹹壓製製襯願醖艱憲積 (窪願餘襯鑰範築鏇齋壓 ) 更多