Regorafenib (Reg) and Lorigerlimab (Lor), RELO Regimen, in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy [ReLOAD Trial]

To learn about the effects of the drugs regorafenib and lorigerlimab on circulating tumor DNA (ctDNA) in patients with CRC and who have radiographic occult minimal residual disease (MRD) after completing standard-of-care therapy

开始日期2026-01-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+2]

NCT05477953

/ Not yet recruitingN/A

Observational Pregnancy Safety Study of Women Exposed to Nifurtimox During Pregnancy to Describe the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant

This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied.
Chagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems.
Nifurtimox has been used for more than 50 years to treat Chagas disease in children and adults.
It is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. Currently, there are not enough data to know if this is also the case in humans.
In this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. To do this, researchers will collect the following information:
* Birth defects (abnormal and problematic structures or functions, a child is born with)
* Pregnancy outcomes (like live birth, preterm birth, still birth/death of the unborn baby, miscarriage, or abortion)
* Certain health problems of the child up to 12 months of age
* Certain health problems of the women experienced during pregnancy The data will be collected from different sources including telephone calls with the women or their doctor, CRFs (case reprt forms) or from medical records The researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population.
The study will run for approximately 10 years.

开始日期2025-12-31

申办/合作机构

Bayer AG

NCT05900388

/ Not yet recruitingN/A

Xarelto Paediatric VTE PASS Drug Utilization Study: An Observational, Longitudinal, Multi-source Drug Utilization Safety Study to Evaluate the Drug Use Patterns and Safety of Rivaroxaban Oral Suspension in Children Under Two Years With Venous Thromboembolism

This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE).
VTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening.
Rivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information.
The purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old.
The main information that researchers will collect in this study:
* Age, gender, and other information about the child and their illness
* Type of VTE treatment given to the child
* Occurrence of medically important bleeding and its severity
Further information that researchers will collect:
* Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE
* Return of VTE symptoms
* Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study.
The data for this study will be collected from electronic health records and health insurance claims data until 2026.
Researchers will observe each child during treatment until:
* end of the anticoagulation treatment period e.g. discontinuation of all study drugs,
* their information is no longer available, or
* the study ends.

开始日期2025-12-31

申办/合作机构

Bayer AG

[+1]

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0 项与 Bayer AG 相关的专利（医药）

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14,696

项与 Bayer AG 相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of regorafenib dose optimization for refractory metastatic colorectal cancer

Article

作者: Appukkuttan, Sreevalsa ; Cho, Sang Kyu ; Barzi, Afsaneh ; Grossman, Jamie ; Lee, Woojung ; Babajanyan, Svetlana ; Hocum, Brian ; Marian, Marisca ; Yang, Min ; Bekaii-Saab, Tanios

BACKGROUND:

New regimens have emerged as third-line or later therapies for metastatic colorectal cancer (mCRC), including regorafenib dose optimization (ReDO), trifluridine/tipiracil and bevacizumab (TAS-BEV) combination therapy, and fruquintinib. We evaluated relative cost-effectiveness of these therapies in patients with mCRC from a US payer's perspective.

MATERIALS AND METHODS:

A partitioned survival model (PSM) was constructed to estimate total costs and quality-adjusted life years (QALYs). Clinical parameters were obtained from pivotal trials of the respective therapies and incremental cost-effectiveness ratios (ICERs) were estimated to assess relative cost-effectiveness of these treatments. Model robustness was assessed using deterministic (DSA) and probabilistic sensitivity analysis (PSA). Three scenario analyses were conducted: (1) assuming equal efficacy across treatments, (2) with prior exposure to anti-vascular endothelial growth factor (VEGF) therapy, and (3) alternative clinical inputs for fruquintinib from a different clinical trial.

RESULTS:

Under the conventional willingness-to-pay (WTP) threshold in US ($150,000 per QALY gained), ReDO was cost-effective when compared with TAS-BEV and was dominant over fruquintinib. TAS-BEV was associated with an incremental QALY of 0.197 over ReDO, resulting in an ICER at $554,567 per QALY gained. The base case results were robust in DSA and PSA. Most influential parameters were treatment cost and effectiveness. In patients with prior anti-VEGF therapy, ReDO remained cost-effective compared to TAS-BEV and fruquintinib under the conventional WTP threshold.

LIMITATION:

Differences in trial populations may affect the comparability of the outcomes. Sensitivity and scenario analyses were conducted to address these limitations.

CONCLUSION:

ReDO was cost-effective compared with TAS-BEV from the US payer's perspective despite a higher QALY gain associated with TAS-BEV. ReDO was dominant over fruquintinib, consistently having a higher QALY gain and lower cost.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost savings from prioritization of non-invasive modalities within CAD diagnostic protocols: a systematic review

Review

作者: Sánchez-Collado, Irene ; Kluge, Ben ; Pérez-Román, Inés ; Harris, James ; Blankenburg, Michael ; Christophel, Sina ; Greenwood, John P. ; Paffett, Molly ; Harz, Cornelia

AIMS:

While the clinical benefits of non-invasive modalities to diagnose coronary artery disease (CAD) are well recognized, the economic implications of their use over invasive options remain unclear. This review aims to understand the health economic consequences of using non-invasive versus invasive modalities in symptomatic patients with low-to-intermediate pre-test probability (PTP) of CAD, and to explore whether economic and humanistic data can inform future investment decisions around non-invasive and invasive diagnostic modalities.

MATERIALS AND METHODS:

We performed a systematic review of MEDLINE and Embase, MEDLINE In-process, the Cochrane Database of Systematic Reviews, and the Cochrane Central Register of Controlled Trials. Studies from January 1992 to January 2023 were included, if they were based in the UK, France, Germany, Italy, Japan, China, and/or the USA (published in any language). Risk of bias was assessed using the Drummond checklist.We evaluated invasive techniques, including invasive catheterization angiography (ICA) and ICA with fractional flow reserve (ICA-FFR), as well as non-invasive modalities, including coronary computerized tomography angiography (CCTA), CCTA-FFR, cardiovascular magnetic resonance (CMR), stress electrocardiogram, myocardial perfusion scintigraphy-single photon emission computed tomography, positron emission tomography, and stress echocardiography.

RESULTS:

Thirty-nine unique records reported relevant outcomes and were fully extracted. In patients with a low-to-intermediate PTP of CAD, most of the comparisons of non-invasive modalities followed or not by confirmatory ICA imaging, versus ICA demonstrated cost savings. The use of non-invasive modalities, followed or not followed by confirmatory ICA, was reported to reduce the number of revascularizations and length of hospital stays, versus ICA alone.

CONCLUSION:

This study suggests that investment in CAD diagnosis should prioritize the use of CCTA and CMR imaging over ICA and other non-invasive modalities.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-minimisation analysis of anti-VEGF therapies in neovascular age-related macular degeneration and diabetic macular oedema in Switzerland

Article

作者: Maamari, S. ; Quist, S.W. ; Boer, M. ; Ambresin, Aude ; Barthelmes, D.

OBJECTIVE:

This study compares the direct healthcare costs of anti-VEGF therapies, including treat-and-extend (T&E) and other durable regimens, for unilateral neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DMO) in Switzerland.

METHODS:

An adapted cost-minimisation model estimated healthcare costs over two years for aflibercept 2 mg, aflibercept 8 mg, faricimab, ranibizumab, and ranibizumab biosimilars using clinical trial injection frequencies. Break-even analyses identified the medication prices and injection frequencies required for higher-cost therapies to achieve cost parity with the least expensive options. A one-way sensitivity analysis (OWSA) assessed key drivers of cost outcomes.

RESULTS:

Aflibercept 8 mg was estimated to be associated with the lowest treatment costs for both indications (CHF 11,814 for nAMD; CHF 11,242 for DMO). Faricimab (CHF 13,737) and aflibercept 2 mg (CHF 15,243) followed in nAMD and DMO. Ranibizumab and its biosimilars incurred the highest costs: for nAMD, biosimilars ranged from CHF 16,243 to CHF 17,497 and the reference product reached CHF 18,424; for DMO, biosimilars ranged from CHF 18,187 to CHF 19,596, with the reference product at CHF 20,637. Break-even analyses for nAMD showed that prices would need to drop by -22% (faricimab, CHF 644) to -64% (ranibizumab reference, CHF 218) relative to aflibercept 8 mg. For DMO, reductions ranged from -42% (aflibercept 2 mg, CHF 493) to -81% (ranibizumab reference, CHF 114). The OWSA highlighted medication price and injection frequency as primary cost drivers.

CONCLUSIONS:

This study estimated that the potentially minimized injection frequency of aflibercept 8 mg in a clinical trial regimen may result in the lowest treatment costs for nAMD and DMO, followed by faricimab and aflibercept 2 mg, respectively.

7,513

项与 Bayer AG 相关的新闻（医药）

2025-09-09

·E药经理人

爆雷！Biotech怒告CRO小巨头，1.5亿索赔背后……

首例创新药Biotech把明星CRO上市公司告上公堂，或折射出双方生存空间受限的困境，以及低水平价格战下长期积累的矛盾公开化。撰文| Erin 继CRO行业接连爆出破产、欠薪、实控人被限高的阴影之后，CRO明星公司——美迪西，也被卷入了风暴眼。 9月4日，美迪西公告称，子公司美迪西普亚被Biotech客户鸿绪生物一纸诉状，告上公堂，550多万元的合同金额，索赔1.5亿。官司未定、是非未明，但这组陡峭差额的背后，是两端同时失速的现实：被头部Pharma与头部Biotech“夹击”尾部Biotech，既“等不到风来”，也“迎不住风去”，研发竞速、临床进展与融资预期本就三线拉扯，又遇上正在打“价格战”的CRO，更是难上加难。而一批中小CRO在今年投融资回暖中“表面回温”，曾用低价换规模的单子，开始在项目节奏、临床预期与时间成本上被反噬。价格战这两年拖累的，不只是毛利，更是客户对项目交付质量与速度的信任。风口退潮后，曾经埋下的雷，似乎要爆了。首例创新药Biotech把临床CRO告上公堂，这场风波能够引起广泛讨论也不是在宣判谁对谁错，而是在提醒整个行业：靠压价堆出来的规模，经不起快赛道的兑现考验；把成本省在前面，可能要在速度与质量上加倍偿还。行情回暖未必等于风险消散，恰恰相反，它更像一束强光，把每一个被低价掏空的项目，清清楚楚地呈现在台前。 550万合同款，却索赔1.5亿背后 9月4日，美迪西一纸《关于子公司涉及诉讼的公告》，把“索赔1.5亿元”迅速送上业界热搜榜。舆论的第一反应并非这笔金额会否危及美迪西的业绩，而是更尖锐的矛盾：约550多万元的合作款，怎么就放大到1.5亿元的索赔？根据美迪西的公告内容，目前该案件已立案，尚未开庭审理。因此，呈现在业界眼前的，还是双方各有各的理。一边是美迪西的表述。其子公司与鸿绪生物在2020年12月签署《技术服务合同》，开展一项中美双报的IND非临床安评研究，约定8个月内完成分析检测、安全性评价、翻译和SEND转化四项工作。项目最终于2023年12月14日拿到NMPA临床试验批件（IND）。美迪西称公司“已全面、适当地履行合同义务”，2025年上半年该项目遭遇“有因检查”，但“未查见真实性问题”，其研发质量体系亦获得全球主要药监机构认可。也就是说，美迪西不认可原告所指，合同义务已全面、适当地履行，所谓违约并不存在。另一边是原告鸿绪生物的逻辑。合同里非临床安评8个月的时限，现实中却到第三年才完成IND。并且虽然2023年拿到了批件，却在之后又遭遇“有因检查”，这种带有申报资料真实性存疑“暗示”的检查。 2020年签下非临床安评合同，2023年才拿到IND批件，时间是否过长难以评价，但从市场竞争角度来看，在GLP-1/GIP这种“短跑式”、高速迭代的热门赛道里，时间价值尤显残酷，而鸿绪生物显然慢了一步。要知道，全球FIC——礼来的替尔泊肽在2022年获批，2023年销售额突破51亿美元；彼时，国内头部药企也在争相提速推进，恒瑞的同双靶点HRS9531注射液已经进入关键临床阶段，信达甚至在2023年H1中报已经能够预告出全球首个GCG/GLP-1双受体激动剂玛仕度肽（IBI362）预计2024年底或2025年初上市。同时，华东、翰森等头部Pharma的GLP-1产品也都相继进入了临床。如今，恒瑞HRS9531已提交上市申请，信达的GCG/GLP-1双受体激动剂玛仕度肽IBI362已获批上市并成为当红产品。节点洪流滚滚向前，一家想抓风口的Biotech，若在IND阶段拖了后腿，研究进展赶不上头部大药企，甚至连IND批件都没拿到，又赶上资本寒冬，说破了天，投资人似乎不会愿意对其拿出一分钱。于是，在鸿绪生物的账本里，与美迪西的矛盾早已不再局限在一纸550多万的合同，而是真实折损的经济损失，融资与估值冲击、研发开发周期的沉没成本，再加上突然降临带有申报材料存疑“暗示”的有因检查，这些统统被“写入”1.5亿元的诉讼主张中，才造成与合同对价的巨大落差。推荐阅读 * 谁“杀”死了中小CRO？ * 市值蒸发400亿后，CRO小巨头曲线自救，难反转 “信任危机将爆发？从本质上来说，这起“中国首次CRO与Biotech之间就风口创新药产品对簿公堂”事件，还折射出了创新药产业链上下游在穿越周期过程中，难以调和的矛盾。对于鸿绪生物等中小型Biotech来说，无论是押注一个赛道“等风来”，还是在热门赛道“随风去”，核心竞争力都少不了研发竞速。然而，当研发竞速遇上CRO调整周期里的不确定性，研究质量、研发速度以及预期之间的矛盾也因此产生。而对于美迪西这样的中小CRO来说，本来在创新药研发风口过后，就是“价格战”的最先被波及的群体，不仅订单量骤缩、客单价跳水，更难的是客户几乎都是初创Biotech，他们融资断档、现金流吃紧，让中小CRO们又面临回款周期无限拉长，日子更不好过了。 Wind数据显示，截至2025年H1，A股29家医疗研发外包公司的应收账款平均为6.85亿元，应收账款周转天数约为93.88天；而美迪西的应收账款虽然为5.4亿元，但应收账款周转天数高达181.18天，远高于平均水平。而到了如今，当下二级市场回暖、全球创新研发频出，一级市场也开始重新审视Biotech资产，BD交易升温，一度绷紧的产业链仿佛松了口气。位于创新研发产业链上的中小CRO们日子刚好过一点，业绩曾“爆雷”的“美迪西们”业绩刚有起色，但这起诉讼像一记回声巨响，提醒行业：调整周期遗留的信任危机，并不会因为行情转暖而自动失效。以美迪西为例，2023年其营收与利润大幅跳水，药物发现与药学研究、临床前研究两条线的客单价分别骤减36.81%与23.59%，唯一向上的是“客户数量”，分别同比增加35.98%与3.97%。更进一步的是，过去两年，不少这类中小CRO还困在“价格战”带来的业绩下滑、回款困难的境地，而这起新发生的诉讼直接让行业意识到，项目交付质量与速度，与客户研发投入的沉没成本、管线估值直接挂钩，卷价格的尽头将不再只是现金流风险与经营压力，还将面临更加严苛的远超项目金额的赔偿风险与法律风险，也让在全行业的回暖周期中，制药企业对中小CRO的信任亮出一张黄牌。此外，这起事件也提醒中小CRO，效率与质量本身才是招牌，若不在合同和定价中设限，它或将在法庭里以更高的代价向你收回。而对于初创Biotech来说，不仅要在合作方筛选环节做好尽调，更要从合同条款设计、履行监控到争议解决构建全流程管理体系。此外，对于行业而言，此时也亟需一份指南标准，明确进度延误赔偿比例、质量缺陷认定标准、责任划分节点等保护研发企业的条款，同时也要设置针对中小CRO的回款周期保障规则。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册

临床申请专利侵权

2025-09-09

·摩熵医药

聚焦150亿市场！$4亿造影剂跻身新国采，人福药业入局分羹！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 9月9日，CDE官网显示，宜昌人福药业有限责任公司按4类化药注册申报的钆布醇注射液上市申请已获受理。该药全球销售额超4亿美元，吸引了多家知名药企参与布局，且已被纳入第11批集采名单，市场竞争正不断加剧。截图来源：CDE官网钆布醇注射液（gadobutrol）是一种用于磁共振成像（MRI）的顺磁性对比剂，是临床应用最广泛的第二代钆造影剂，适用于成人及全年龄段儿童（包括足月新生儿）的磁共振成像。截图来源：摩熵医药全球药物研发数据库该药物由拜耳（Bayer）公司研发，1998年首次在瑞士获批上市。2011年3月获FDA批准，2012月7月进入中国市场，商品名为“加乐显”。目前其已在100多个国家或地区获批上市。近年来，钆布醇注射液的市场表现持续向好。公开数据显示，2020年其全球销售额约为3.07亿美元，2021年钆布醇相关剂型全球销售额跃升至约4.95 亿美元。其国内市场表现更为突出，据摩熵医药数据库显示，2023年钆布醇注射液在我国院内市场的销售额突破2亿元，同比增幅高达45.78%，2024年攀升至2.24亿元，同比增长9.4%，市场潜力不断释放。截图来源：摩熵医药全国医院（全终端）销售数据库我国造影剂市场长期保持增长态势，2015-2021年，院内销售额从93亿元增至178亿元。后受集采冲击，市场历经约20%的大幅下跌，但2023年止跌回升8.31%，销售规模重返155亿元，2024年度保持在150亿元。截图来源：摩熵医药全国医院（全终端）销售数据库从品种竞争来看，钆布醇注射液在2024年造影剂院内销售排名中位列第16位，占据一定市场份额。钆布醇注射液的国内市场竞争格局已逐步形成，据摩熵医药数据，目前已有8家企业拥有该药生产批文，海南倍特药业、湖南科伦药业、扬子江药业、山东新时代等7家企业成功过评，行业竞争不断加剧。截图来源：摩熵医药中国药品批文数据库其中，恒瑞医药的表现尤为突出 —— 不仅斩获了钆布醇注射液国内外双首仿地位，还成为国内首家通过该药品一致性评价的企业，在品种布局上占据双重先发优势，市场竞争力显著。截图来源：摩熵医药一致性评价数据库除现有已获生产批文的企业外，钆布醇注射液仿制药申报仍在持续推进，宜昌人福药业、海南葫芦娃药业、石家庄四药、海南普利制药等6家企业均已提交该药物的上市申请。截图来源：摩熵医药中国药品审评数据库后续随着这些上市申报审评工作的有序推进，再加上钆布醇注射液被纳入第11批集采这一关键政策变量，国内钆布醇注射液市场的参与主体或将迎来新一轮扩容。拟纳入第十一批集采的药品（部分节选）来源：国家组织药品联合采购办公室新竞争者的加入将打破当前相对稳定的竞争态势，为市场注入新活力的同时，也会推动市场格局加速演变；而集采背景下的价格调整与份额分配，或将促使竞争维度从单纯的价格比拼，逐步延伸至成本控制、渠道覆盖等更多领域，让市场竞争更具多样性。 END 本文为原创文章，转载请留言获取授权近期热门资源获取中国临床试验趋势与国际多中心临床展望-202505 2024年医药企业综合实力排行榜-202505 中国带状疱疹疫苗行业分析报告-202505 2023H2-2024H1中国药品分析报告-202504 数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-202503 2024年中国1类新药靶点白皮书-202503 中国AI医疗健康企业创新发展百强榜单-202502 解码护肤抗衰：消费偏好洞察与市场格局分析-202502 2024年FDA批准上市的新药分析报告-202501 小分子化药白皮书（上）-202501 2024年中国医疗健康投融资全景洞察报告-202501 2024年医保谈判及市场分析报告-202501 近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

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2025-09-09

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