The objective of this study is to evaluate the safety and image quality of the investigational dye, MB-102, compared to the control dye (fluorescein sodium) in healthy and diseased eyes using fluorescent angiography for retinal vascular disease diagnosis and monitoring.

开始日期2025-11-01

申办/合作机构

MediBeacon, Inc.

NCT05777174

/ Completed临床3期

An Open Label, Multi-Center, Safety and Pharmacokinetic Bridging Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring in Normal and Renal Compromised Subjects for the Evaluation of Kidney Function

The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound. Adults with kidney function ranging from estimated glomerular filtration rate (eGFR) <120 to >15 mL/min/1.73 m2 and spanning the entire range of human skin colors as defined by the Fitzpatrick Skin Scale (FSS) were included in the study.
The main questions that the study aimed to answer were:
* To establish that the MB-102 transdermal fluorescence assessed GFR using the MediBeacon Transdermal GFR System with the TGFR reusable sensor with disposable adhesive ring was comparable to the measured MB-102 plasma GFR.
* To evaluate the safety and effectiveness of the MediBeacon Transdermal GFR System and the TGFR reusable sensor with disposable adhesive ring for the non-invasive transdermal fluorescence detection of MB-102 in participants
On dosing day, participants had the TGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. When this was completed, participants then received a single dose of MB-102. Blood samples were collected and fluorescent measurements were taken over a 12- or 24-hour (or longer) period, depending upon enrollment group. For those with significant renal compromise, fluorescent measurements were continued until the sensor no longer detected MB-102 in the body. Following completion of the treatment period, participants returned to the study center approximately 1 week later for a safety follow-up visit. Researchers compared the results to see if the transdermal GFR measurements were comparable to the measured plasma GFR.

开始日期2023-03-20

申办/合作机构

MediBeacon, Inc.

NCT05943977

/ Completed临床3期

A Randomized, Open Label, 2-Period, Cross-over Study to Evaluate the Bioequivalence of the Oversea Manufactured Sample and Domestic Manufactured Sample in Single Intravenous Dose of MB-102 (Relmapirazin) (Part I), and an Efficacy Study to Assess the Performance of the MediBeacon Transdermal GFR Measurement System and Domestic Manufactured Sample of MB-102 (Relmapirazin) for Evaluation of Kidney Function in Chinese Normal and Renal Compromised Subjects (Part II)

Part I (bioequivalence) will evaluate the bioequivalence of the Oversea Manufactured Sample (used in the MediBeacon Phase 3 Study 100-103; NCT05425719) and Domestic Manufactured Sample in Single Intravenous Dose of MB-102 (Relmapirazin) in healthy Chinese adults. Part II (efficacy) will evaluate the performance of the MediBeacon Transdermal GFR Measurement System and Domestic Manufactured Sample of MB-102 (Relmapirazin) for Evaluation of Kidney Function in Chinese participants.

开始日期2023-03-02

申办/合作机构

杭州中美华东制药有限公司

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100 项与瑞美吡嗪相关的临床结果

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100 项与瑞美吡嗪相关的转化医学

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100 项与瑞美吡嗪相关的专利（医药）

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项与瑞美吡嗪相关的文献（医药）

2025-04-01·European Journal of Internal Medicine

Beyond creatinine: New methods to measure renal function?

Review

作者: Kashani, Kianoush B ; Sheikh, M Salman

Accurate assessment of kidney function is essential for diagnosing and managing chronic kidney disease (CKD) and acute kidney injury (AKI), adjusting drug dosages, and predicting clinical outcomes. Despite its ubiquitous use, serum creatinine has significant limitations, necessitating the exploration of alternative and complementary biomarkers and technologies. This review revisits the benefits and limitations of serum creatinine, explores other kidney function biomarkers such as Cystatin C and ProEnkephalin, and examines traditional gold-standard techniques, including creatinine clearance, radioisotopes, and inulin clearance. Furthermore, it highlights innovations in real-time glomerular filtration rate (GFR) measurement, such as transdermal monitoring using MB-102 and dual fluorescent tracers. We conclude with a discussion on the development, validation, and clinical integration of these advancements, which may redefine renal function assessment in the years to come.

2024-10-01·KIDNEY INTERNATIONAL

Relmapirazin, a new exogenous filtration marker, and more widespread use of measured GFR

Article

作者: Tuttle, Marcelle ; Levey, Andrew S

Plasma or urinary clearance of exogenous filtration markers is required for assessment of measured glomerular filtration rate. Although multiple methods are available, none is widely used because of their complexity, each has measurement error, and standardization is limited. Recently, a study validated the plasma clearance of a new exogenous filtration marker, relmapirazin, which can be detected by its transdermal fluorescence, potentially simplifying the procedure and increasing access to measured glomerular filtration rate.

2024-10-01·KIDNEY INTERNATIONAL

Clinical validation of the novel fluorescent glomerular filtration rate tracer agent relmapirazin (MB-102)

Article

作者: Dorshow, Richard B ; Goldstein, Stuart L ; Shieh, Jeng-Jong ; Debreczeny, Martin P

The fluorescent compound relmapirazin has been rationally designed for use in point-of-care measurement of glomerular filtration rate (GFR), with attributes including negligible protein binding, negligible metabolites in vivo, negligible tubular secretion, and excellent chemical and photo stability. Twenty-four nonclinical assays were performed in accordance with FDA requirements yielding negligible toxicology concerns. Here, a clinical study was performed to validate relmapirazin as a GFR tracer in patients by comparison to iohexol. This was evaluated in 120 adults at three clinical sites with eGFR values ranging from normal to Stage 4 chronic kidney disease. Relmapirazin and iohexol were administered intravenously in consecutive boluses to each subject and serial blood samples obtained over the subsequent 12 hours. Plasma concentrations were measured and the corresponding plasma GFR for each agent was determined using a standard two-compartment pharmacokinetic assessment. Urine from each subject was collected for the entire 12-hour study period to measure the amount of administered dose appearing in the urine. A near perfect linear regression correlation was observed between the GFRs measured by these two tracers (r²=0.99). Bland-Altman analysis confirmed agreement between these two measures of GFR (limits of agreement -7.0 to +5.6 mL/min; mean of -0.7 mL/min). The GFR determined by relmapirazin was independent of GFR stratification by chronic kidney disease stage, and importantly by race. The percent of the administered relmapirazin dose recovered in the urine was greater than or equal to that of iohexol with no reported severe adverse events. Thus, relmapirazin may be used as a GFR tracer agent in humans.

项与瑞美吡嗪相关的新闻（医药）

2025-02-25

·Pharmaindustrial

MediBeacon Transdermal GFR System Receives Device Approval in China

MediBeacon Inc. announced the National Medical Products Administration (NMPA) in China has approved the MediBeacon® TGFR Monitor and TGFR Sensor for the assessment of kidney function in patients with normal or impaired renal function. Lumitrace® (relmapirazin) injection, categorized as a drug in China, is under review and is targeted for approval in late 2025. The transdermal GFR technology includes Lumitrace (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR tracer agent, which together with the TGFR Monitor and TGFR Sensor allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. In 2021, the NMPA granted the TGFR Innovative Medical Device Designation. Only 10 percent of applications are granted this designation. Benefits of this registration route including early product promotion are considerable. In February, the Clinical Kidney Journal published MediBeacon data in an article on Chronic Kidney Disease (CKD) stage misclassification via estimated GFR (eGFR) compared to measured GFR (mGFR) using relmapirazin. In a stable CKD population, more than one-third of the subjects had an actual mGFR (relmapirazin) that differed by at least one CKD stage from their estimated GFR (eGFR). Relmapirazin is indicated for use with the TGFR. "The Clinical Kidney Journal study raises serious concerns about how chronic kidney disease is diagnosed today," said Dr. Ira Kurtz, Chief of the Division of Nephrology at UCLA Medical Center. "Researchers found that current eGFR methods misclassified 35 percent of patients, leading to potentially incorrect treatments and delayed interventions." In the February ahead of print section in the Journal of the American Society of Nephrology (JASN), MediBeacon clinical study data from the use of transdermal detection of relmapirazin in patients with normal to impaired kidney function across a range of skin color types was posted online. JASN publishes high-impact research to advance the understanding and treatment of kidney diseases. In addition to his leadership role at UCLA Medical Center, Dr. Kurtz is active in the development of an artificial kidney and artificial intelligence in the training and practice of nephrology. Dr. Kurtz commented that: "The study in the Journal of the American Society of Nephrology introduces a wearable, transdermal device that assesses GFR without the need for blood samples. The fluorescence-based test, developed by MediBeacon, demonstrated an exceptional correlation (r² = 0.90) with plasma mGFR across all skin types, paving the way for more equitable and accurate kidney function assessment. These two new studies have reshaped the landscape of kidney disease diagnostics, offering both a cutting-edge innovation and a stark warning about current practices. The findings underscore the urgent need for improved kidney function assessment tools, with non-invasive, point of care GFR measurement emerging as a game-changing solution." "Awareness of kidney disease is relatively low despite the fact that it is the 7th leading risk factor for mortality worldwide.4 MediBeacon is pleased to have the opportunity to aid in the assessment of kidney function in China," said Steve Hanley CEO of MediBeacon. "NMPA approval is the culmination of a rigorous device application process that required close collaboration of the MediBeacon and Huadong Medicine teams. We look forward to the next phase of our partnership with Huadong Medicine and eagerly anticipate Lumitrace approval in China later this year."

2025-02-25

·PRNewswire

MediBeacon® Transdermal GFR System receives device approval in China

Peer-reviewed articles on MediBeacon technology published Transdermal GFR System (TGFR) is a first-in-kind product for point of care assessment of kidney function in patients with normal or impaired renal function. The Clinical Kidney Journal in February published MediBeacon study results on measured GFR (mGFR) using relmapirazin versus estimated GFR (eGFR) for the purpose of classifying patient Chronic Kidney Disease (CKD) stages. MediBeacon TGFR study results have been posted online in the February ahead of print section in the Journal of the American Society of Nephrology (JASN). ST. LOUIS, Feb. 25, 2025 /PRNewswire/ -- MediBeacon Inc. today announced the National Medical Products Administration (NMPA) in China has approved the MediBeacon® TGFR Monitor and TGFR Sensor for the assessment of kidney function in patients with normal or impaired renal function. Lumitrace® (relmapirazin) injection, categorized as a drug in China, is under review and is targeted for approval in late 2025. The transdermal GFR technology includes Lumitrace (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR tracer agent, which together with the TGFR Monitor and TGFR Sensor allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. In 2021, the NMPA granted the TGFR Innovative Medical Device Designation. Only 10% of applications are granted this designation. Benefits of this registration route including early product promotion are considerable. In February, the Clinical Kidney Journal published MediBeacon data in an article on Chronic Kidney Disease (CKD) stage misclassification via estimated GFR (eGFR) compared to measured GFR (mGFR) using relmapirazin. In a stable CKD population, more than one-third of the subjects had an actual mGFR (relmapirazin) that differed by at least one CKD stage from their estimated GFR (eGFR).1 Relmapirazin is indicated for use with the TGFR. "The Clinical Kidney Journal study raises serious concerns about how chronic kidney disease is diagnosed today," said Dr. Ira Kurtz, Chief of the Division of Nephrology at UCLA Medical Center. "Researchers found that current eGFR methods misclassified 35% of patients, leading to potentially incorrect treatments and delayed interventions." In the February ahead of print section in the Journal of the American Society of Nephrology (JASN), MediBeacon clinical study data from the use of transdermal detection of relmapirazin in patients with normal to impaired kidney function across a range of skin color types was posted online.2 JASN publishes high-impact research to advance the understanding and treatment of kidney diseases.3 In addition to his leadership role at UCLA Medical Center, Dr. Kurtz is active in the development of an artificial kidney and artificial intelligence in the training and practice of nephrology. Dr. Kurtz commented that: "The study in the Journal of the American Society of Nephrology introduces a wearable, transdermal device that assesses GFR without the need for blood samples. The fluorescence-based test, developed by MediBeacon, demonstrated an exceptional correlation (r² = 0.90) with plasma mGFR across all skin types, paving the way for more equitable and accurate kidney function assessment. These two new studies have reshaped the landscape of kidney disease diagnostics, offering both a cutting-edge innovation and a stark warning about current practices. The findings underscore the urgent need for improved kidney function assessment tools, with non-invasive, point of care GFR measurement emerging as a game-changing solution." "Awareness of kidney disease is relatively low despite the fact that it is the 7th leading risk factor for mortality worldwide.4 MediBeacon is pleased to have the opportunity to aid in the assessment of kidney function in China," said Steve Hanley CEO of MediBeacon. "NMPA approval is the culmination of a rigorous device application process that required close collaboration of the MediBeacon and Huadong Medicine teams. We look forward to the next phase of our partnership with Huadong Medicine and eagerly anticipate Lumitrace approval in China later this year." The TGFR, which includes Lumitrace (relmapirazin), was approved on January 17th by the U.S. Food and Drug Administration (FDA). MediBeacon continues development of future TGFR products including a next-generation TGFR Sensor with updated software and algorithms. About MediBeacon Inc. MediBeacon is a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection. MediBeacon's use of proprietary fluorescent tracer agents coupled with transdermal detection technology focuses on providing vital and actionable measurement of organ function. MediBeacon owns over 55 granted U.S. patents and over 215 granted patents worldwide that provide extensive coverage of the MediBeacon ® TGFR, including Lumitrace ® injection, the sensor and algorithms, as well as other strategic uses of its proprietary pyrazine platform and sensor technology. The TGFR is approved for human use. Potential technology applications in gastroenterology, ophthalmology and surgery are in various stages of clinical development. MediBeacon is based in St. Louis, Missouri, with additional operations in Mannheim, Germany. For more information, please visit: . About Lumitrace® (relmapirazin) injection Relmapirazin is a non-radioactive, non-iodinated pyrazine-based compound, which has been engineered to be inert, highly fluorescent, and have the clearance properties of a GFR tracer agent in the body. The unique photophysical characteristics of Lumitrace have been designed to enable the collection of fluorescence data via a photodetector sensor placed on the skin. Data collected by the sensor measures the change in the intensity of Lumitrace fluorescence over time and is converted into a transdermal GFR (tGFR) by proprietary algorithms. In a phase 2 investigational study mGFR deduced from Lumitrace matched that of mGFR deduced from iohexol over a range of GFR values. See the peer reviewed article published in the October 2024 issue of Kidney International by Dorshow et al.5 About MediBeacon® Transdermal GFR System (TGFR) The TGFR is comprised of the TGFR Sensor, TGFR Monitor, and Lumitrace® (relmapirazin), which together allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. The system records Lumitrace fluorescence intensity transdermally as a function of time via a sensor placed on the skin. The TGFR Sensor records 2.5 fluorescent readings per second and the TGFR Monitor will display the average session tGFR reading at the patient's bedside or in the outpatient setting. IMPORTANT SAFETY INFORMATION FOR TGFR (U.S. FDA) Indication for Use: The MediBeacon® Transdermal GFR System (TGFR) is intended to assess the Glomerular Filtration Rate (GFR) in adult patients with impaired or normal renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent over time. This device has been validated in patients with stable renal function. The MediBeacon® TGFR is not approved for use in patients with GFR <15 ml/min/1.73 m2, GFR >120 ml/min/1.73m2, patients on dialysis, or anuric patients. The use of this device in patients with dynamic and rapidly changing renal function has not been validated. This device is not intended to diagnose acute kidney injury (AKI). The MediBeacon® TGFR Sensor and exogenous tracer agent, Lumitrace® injection, are single use and are only used with the MediBeacon® TGFR. The MediBeacon® TGFR Sensor is a single use device intended to attach to the patient's skin and excite fluorescence in Lumitrace® injection, the tracer agent, and measure the returning light intensity. The data is sent to the MediBeacon® TGFR Monitor. Lumitrace® is an injectable exogenous fluorescent tracer indicated for use with the MediBeacon® Transdermal GFR System (TGFR) for Glomerular Filtration Rate assessment. Contraindications: There are no known contraindications. Warnings and Precautions: See ifu.medibeacon.com for full instructions, warnings, and cautions. In clinical studies no serious or severe adverse events have been observed. Lumitrace® injection has light absorbance at 266nm and 435nm, and broad fluorescent emission at ~560nm when excited at ~440nm. Any drug activated at these wavelengths should not be used in conjunction with Lumitrace. Lumitrace injection may interfere with clinical laboratory tests. DO NOT ADMINISTER if the patient is expected to need clinical laboratory testing while Lumitrace is present in their system (up to 72 hours for renally-impaired patients). The presence of Lumitrace decreased B-Type Natriuretic Peptide (BNP) results by around 20% in limited testing. Bolus infusions may impact the GFR assessment temporarily while the vasculature-tissue equilibrium is re-established. During a TGFR session, the patient should be as still as possible, especially during the "Establishing Baseline" stage. The current system is designed to compensate for light activity such as reading or eating after the Baseline stage. 1 CKD stage misclassification between estimated GFR and measured GFR in a clinical study of chronic kidney patients, Clinical Kidney Journal, Dorshow, Richard B. et al., 2025 Jan 9;18(2):sfaf006. DOI: 10.1093/ckj/sfaf006 2 Glomerular Filtration Rate Measurement Utilizing Transdermal Detection Methodology, Journal of the American Society of Nephrology (JASN), Dorshow, Richard B. et al., February 7, 2025, DOI: 10.1681/ASN.0000000639 3 4 Chronic kidney disease and the global public health agenda: an international consensus, Nature Reviews Nephrology, 20, 473-485 (2024), doi.org/10.1038/s41581-024-00820-6 5 Clinical validation of the novel fluorescent glomerular filtration rate tracer agent relmapirazin (MB-102), Kidney International, Volume 106, Issue 4, P679-687, October 2024, DOI: 10.1016/j.kint.2024.06.012 SOURCE MediBeacon WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床2期

2025-02-25

·医药健闻

华润医药西部创新中心落地成都；迈瑞医疗参建埃及首个超声工厂；安进将向印度工厂投资2亿美元 | 日报

全球医疗行业每日重点资讯文 | 苏丁企业动态 2月24日，成都高新区与华润医药集团有限公司签约。华润医药拟在成都高新区打造华润医药西部创新中心，着力建设华润医药医疗器械创新及产业化基地、华润医药区域细胞制备中心等项目，双方还将合作设立创新产业基金，重点投向化学创新药、生物药、疫苗、高端医疗器械等领域，覆盖早中期、并购类、成长类、拟上市类等各阶段项目。 Tatweer Medical Industries与中国医疗器械制造商迈瑞医疗签署了一项合作协议，将建立埃及第一家超声设备制造工厂。第一台埃及本土制造超声设备计划于今年4月上市，预计年生产能力约2500台。此外，该项目还将对埃及技术人员和工程师进行培训，以促进技术转让和技能发展。美国制药商安进公司董事长兼首席执行官罗伯特·布拉德韦在印度南部新技术中心的落成典礼上说，安进公司今年将向该中心投资约2亿美元，并计划进一步投资。安进公司去年宣布了其在印度开设“技术与创新”中心的计划，该中心的重点是增加对人工智能和数据科学的使用，以支持新药开发。美国私募巨头KKR集团已同意以4亿美元收购印度医院运营商HealthCare Global Enterprises的控股权，增加了在印度医疗保健行业的投资。KKR将从CVC Capital Partners手中收购HealthCare Global至多54%的股份，并全权控制其运营。HealthCare Global创始人阿贾库马尔(BS Ajaikumar)将担任非执行董事长，专注于临床、学术和研发工作。总部位于班加罗尔的HealthCare Global成立于1989年，是印度最大的癌症医疗服务提供商之一，拥有25家医疗中心。葛兰素史克公司发表声明，开始实施股票回购计划，首批回购金额高达7亿英镑。首批回购预计将于2月24日开始，并于6月13日前完成。黑石集团正就收购Summit Partners支持的疫苗管理公司VaxCare Corp. 进行深入谈判，交易金额约为17亿美元（包括债务）总部位于奥兰多的VaxCare为医疗机构和卫生系统提供了一个平台，用于管理疫苗和避孕设备的库存、计费和跟踪。私募股权公司Summit于2020年投资了VaxCare。在诺华和罗氏去年实现销售额增长后，这两家瑞士制药巨头正在向其首席执行官提供更高的薪酬方案。根据诺华的年度报告，首席执行官Vas Narasimhan 2024年的整体薪酬按赠款价值计算增长了6.9%，达到1420万瑞士法郎。罗氏年度报告显示，首席执行官Thomas Schinecker的2024年薪酬略高于1000万瑞士法郎，比2023年增长了4.6%。勃林格殷格翰宣布任命Brian Hilberdink为U.S. Human Pharma总裁。Hilberdink将在培养公司文化和为患者带来有意义的影响方面发挥关键作用。Hilberdink在制药行业拥有超过25年的经验，专注于推动影响力和绩效，并培养一种敬业和负责任的文化。他最近担任LEO Pharma的执行副总裁，担任北美地区负责人和美国附属公司总裁。在加入LEO Pharma之前，他曾在诺和诺德担任过多个高级职位。美国司法部近几个月对医疗保险巨头联合健康集团(UnitedHealth Group)的医疗保险计价行为展开了调查。美国司法部正在调查联合健康记录诊断的做法，该公司被怀疑从联邦医疗保险优势计划中获取额外的利益。联合健康将未治疗过的疾病诊断添加到患者的病历中，使得美国联邦政府在2021年增加了87亿美元的额外支出。不过，联合健康称该报道为“错误信息”。波罗的海制药公司Grindeks继续通过进入新的出口市场来加强其全球影响力。今年，Grindeks的产品将首次运往巴拿马。该公司的出口市场已经包括智利、墨西哥、澳大利亚、新加坡、菲律宾和欧洲大部分国家。活性药物成分也出口到日本、韩国和美国。Grindeks是世界卫生组织的预先认证供应商，向联合国人口基金和联合国儿童基金会等国际组织提供人造注射剂。宁波天益医疗器械股份有限公司联合其实际控制人成功收购日本日机装株式会社（Nikkiso Co., Ltd）全球CRRT（连续性肾脏替代治疗）业务。天益医疗是国内血液净化领域的领先企业，日机装株式会社为日本知名的血液透析设备制造商。本次投资金额约4亿元。瑞康医药公告，公司下属子公司吉祥山（山东）医学科技有限公司拟以现金方式收购关联方烟台衡悦健康科技合伙企业（有限合伙）持有的浙江衡玖医疗器械有限责任公司76.01%股权，交易金额为1.51亿元。浙江衡玖整体估值为1.99亿元，交易完成后，浙江衡玖将成为瑞康医药的合并报表子公司。圣方医药研发正式更名为“太美智研医药”，重新定位为“AI驱动的临床研发解决方案提供商”。目前仅在AI整体规划、AI中心筛选、AI患者招募、AI智能运营、AI统计分析等领域，太美智研就有超过50套AI应用正在替代或赋能传统流程，部分领域如PV报告处理超90%的人工作业已被AI替代，AI自动化统计编程更能够将数据处理全流程由30天缩短至一周内，实现数据分析结果的自动输出。深圳瑞德林生物技术有限公司近日完成超5亿元C轮融资，由松禾资本、基石资本、常德兴鑫、白银科键、常德德源共同投资。C轮融资将重点用于产能建设和新品研发。普洛药业宣布正式启动AIGC工作服务平台建设项目。该平台将着力构建算力中心，依托本地化部署AI大模型及文件密级体系，在确保公司核心数据安全的前提下，通过定制化模型训练实现对各场景效率提升的精准赋能。产业动态诺和诺德宣布，美国食品和药物管理局（FDA）已确定Wegovy和Ozempic的短缺问题已经解决。FDA的评估确认，这些处方GLP-1药物的美国供应量现已满足或超过美国当前和预计的需求量。诺和诺德将继续每周七天、每天24小时运营生产设施，并定期向批发商发运所有剂量的Wegovy和Ozempic。诺和诺德为提高产能做出了巨大努力，仅今年就在美国投资了65亿美元。辉瑞公司宣布，距离其B型血友病基因治疗药物fidanacogene elaparvovec（在美国名为Beqvez，欧洲名为Durveqtix）上市不到一年，便决定停止该产品的开发和商业化活动。Beqvez于去年四月在美国获得批准，并自七月起在欧洲上市，该治疗的价格为350万美元。辉瑞声明，“血友病基因疗法目前患者和医生的兴趣有限”。在Beqvez退出市场后，辉瑞没有剩余的商业或临床阶段基因疗法正在开发中。勃林格殷格翰宣布，其在研肺纤维化疗法口服磷酸二酯酶4B（PDE4B）抑制剂nerandomilast的上市申请已获得中国国家药品监督管理局（NMPA）药品审评中心（CDE）的受理，用于治疗成人特发性肺纤维化（IPF）。此前，该疗法已被CDE纳入优先审评审批程序，以加速其在中国获批上市的步伐。亚马逊云科技与癌症研究机构纪念斯隆-凯特琳癌症中心（MSK）达成合作，利用人工智能（AI）、高性能计算（HPC）等云技术加速癌症领域的研究突破。MSK可以利用大型语言模型突破AI模型构建中的数据质量瓶颈。信达生物宣布，伊匹木单抗注射液（CTLA-4单抗）联合信迪利单抗用于可切除的微卫星高度不稳定型（MSI-H）或错配修复缺陷型（dMMR）结肠癌患者的新辅助治疗的新药上市申请（NDA）已获中国国家药品监督管理局（NMPA）药品审评中心（CDE）受理并纳入优先审评程序。伊匹木单抗是首个递交NDA的中国研发的CTLA-4单抗，同时，这也是信迪利单抗奠定其肿瘤免疫治疗领先品牌的又一里程碑。华东医药全资子公司杭州中美华东制药有限公司收到国家药品监督管理局（NMPA）签发的《医疗器械注册证》，其代理申报的创新产品三类医疗器械经皮肾小球滤过率测量设备注册申请获得上市批准。由经皮肾小球滤过率测量设备和Lumitrace（瑞玛比嗪，Relmapirazin）注射液共同组成的MediBeacon Transdermal GFR System（TGFR），为中美华东与公司美国参股子公司MediBeacon Inc.合作开发，已于2025年1月获得美国FDA批准，是全球首个获批用于肾功能正常或受损患者肾功能评估的床旁产品。联系美通社 +86-10-5953 9500 info@prnasia.com

并购疫苗

100 项与瑞美吡嗪相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11637	-	-	-

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
肾脏疾病	美国	MediBeacon, Inc.	2025-01-17

未上市

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
肾小球疾病	申请上市	中国	杭州中美华东制药有限公司	2024-01-11
慢性肾病	临床3期	美国	MediBeacon, Inc.	2022-06-14
慢性肾病	临床3期	中国	MediBeacon, Inc.	2022-06-14
肾功能不全	临床3期	美国	Curia Global Holdings Ltd.	2022-06-14
肾功能不全	临床3期	美国	杭州中美华东制药有限公司	2022-06-14
急性肾损伤	临床2期	美国	MediBeacon, Inc.	2016-05-11
糖尿病性视网膜病变	临床1期	美国	MediBeacon, Inc.	2025-11-01
黄斑变性	临床1期	美国	MediBeacon, Inc.	2025-11-01
视网膜静脉阻塞	临床1期	美国	MediBeacon, Inc.	2025-11-01
克罗恩病	临床1期	美国	MediBeacon, Inc.	2019-10-27

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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


NCT05777174 (CTgov)	临床3期	肾功能不全	149	MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)+MB-102 (Participants With eGFR ≥ 70 mL/Min/1.73 m^2)	鏇醖鑰願壓壓鏇餘壓憲 = 夢糧壓廠膚齋餘顧築壓廠夢遞壓衊繭鏇糧艱廠 (艱鏇窪壓簾憲廠鹽鏇願, 鬱製膚鬱選齋遞鏇廠憲 ~ 憲製鹽築積襯鑰艱遞廠) 更多	-	2025-03-28
				MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)+MB-102 (Participants With eGFR < 70 mL/Min/1.73 m^2)	鏇醖鑰願壓壓鏇餘壓憲 = 鏇壓觸鹹膚憲觸蓋淵齋廠夢遞壓衊繭鏇糧艱廠 (艱鏇窪壓簾憲廠鹽鏇願, 窪鑰願繭顧願廠網選網 ~ 鏇網顧蓋遞選繭遞獵窪) 更多
NCT05425719 (CTgov)	临床3期	慢性肾病	249	MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)+MB-102 (eGFR ≥ 70 mL/Min/1.73 m^2)	繭觸膚糧餘襯網壓衊廠 = 簾鏇淵顧齋鑰鏇窪鹽窪鏇範衊繭廠窪鏇願顧壓 (衊鑰鏇簾艱艱廠觸網鹹, 糧餘製製淵壓壓鹽壓鏇 ~ 鏇選鏇鹹遞鹹淵餘壓鏇) 更多	-	2024-04-18
				MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)+MB-102 (eGFR < 70 mL/Min/1.73 m^2)	繭觸膚糧餘襯網壓衊廠 = 鬱築鬱齋獵窪壓鏇襯膚鏇範衊繭廠窪鏇願顧壓 (衊鑰鏇簾艱艱廠觸網鹹, 襯窪製衊觸顧醖範廠襯 ~ 窪遞積淵範憲鹹願鹽選) 更多