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]

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]

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

100 项与 Bayer AG 相关的临床结果

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0 项与 Bayer AG 相关的专利（医药）

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19,357

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-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.

2025-09-01·REGULATORY TOXICOLOGY AND PHARMACOLOGY

HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions

Article

作者: Cheairs, Tetyana ; Jolly, Robert ; Atrakchi, Aisar ; Zeller, Andreas ; Trejo-Martin, Alejandra ; Hoffmans, Roy ; McGettigan, Katherine K ; Gandhi, Raj D ; Marchand, Christine ; Westerink, Walter ; Hellmann, Anna ; Ziegler, Verena ; Noteboom, Jessica ; McGovern, Timothy J ; Thomas, Dean ; Schaefer, Michelle ; Waese, Kerstin ; Bercu, Joel ; Elespuru, Rosalie ; Simon, Stephanie ; Puglisi, Raechel ; Liao, Yang ; Bishop, Michelle E ; Vespa, Alisa ; Glick, Connor ; Tennant, Rachael E ; Heflich, Robert H ; Hargreaves, Victoria ; Cheung, Jennifer ; Schuler, Maik ; Leavitt, Penny ; Czich, Andreas ; Yang, Yi ; Sobol, Zhanna ; Elloway, Joanne ; Lynch, Anthony M ; Gollapudi, Pavan ; Christensen, Joel S ; Dieckhoff, Jessica ; Chen, Connie ; Froetschl, Roland

A multi-sector study (i.e., Ring Trial) was designed to improve the in vitro detection of N-nitrosamine (NA)-associated mutagenicity by optimizing the bacterial reverse mutation (i.e., Ames) assay protocol and testing various conditions on the sensitivity and specificity for the prediction of rodent carcinogenicity. A total of 29 NAs and 3 N-nitroso drug-like compounds from different structural classes and carcinogenicity outcomes were tested (two independent laboratories per compound) across 5 bacterial strains using a 30-min pre-incubation protocol. To evaluate the impact of different metabolic activating systems (MASs), testing conditions included the use of 10 or 30 % liver S9 fractions prepared from rats or hamsters pretreated with inducers of enzymatic activity. Results indicate that E. coli and Salmonella typhimurium strains detecting single base pair mutations, coupled with MASs containing 30 % hamster S9s were the most sensitive (90 %) for identifying NAs that are rodent carcinogens. Regarding MAS combinations, the highest sensitivity was 30 % rat and 30 % hamster (93 %), but has low specificity (45 %), with good laboratory agreement for the Ames calls (91 %). DMSO and water were considered suitable solvents, except for small-molecular weight alkyl NAs. These results will support harmonized Ames testing of NAs, giving high confidence for a negative result.

7,373

项与 Bayer AG 相关的新闻（医药）

4 小时之前

·医药健闻

艾伯维将投资1.95亿美元扩大API生产；前辉瑞全球首席科学官加入MC Sciences；康基医疗拟私有化退市 | 日报

全球医疗行业每日重点资讯文 | 苏丁企业动态艾伯维（AbbVie）宣布，将投资1.95亿美元用于其位于伊利诺伊州北芝加哥的制造工厂，以扩大美国国内活性药物成分（API）的生产能力。此次扩建是艾伯维此前宣布的投资计划的一部分，该计划旨在通过投入超过100亿美元的资本，全面支持创新并扩大关键制造能力和产能。新北芝加哥API工厂的建设将于2025年秋季启动，预计该工厂将于2027年全面投产。新北芝加哥API设施将提升艾伯维在美国境内的化学合成能力，支持当前及下一代神经科学、免疫学和肿瘤学药物的国内生产。近日，《法兰克福汇报》对罗氏首席执行官托马斯·希内克（Thomas Schinecker）进行了专访。希内克强调，德国是罗氏全球战略的核心之一。罗氏在德国拥有超过1.8万名员工，过去五年在彭茨贝格、曼海姆、格伦察赫和路德维希港等地的投资超过30亿欧元。对于2026年罗氏将推出的阿尔茨海默病血检，希内克表示会亲自接受检测，早期诊断至关重要。罗氏正在加速阿尔茨海默病新药的研发，预计三年内上市。礼来的减肥药试验数据令人失望并导致股价大跌后，礼来的几位高管和董事会成员看到了买入的机会。根据提交给美国证券交易委员会的文件，五名礼来的内部人士在最近几天总共购买了价值290万美元的股票。这些内部人士包括礼来的首席执行官David Ricks，他于周二买入了略高于100万美元的股票。专注于血管内成像创新的Gentuity公司宣布与GE医疗签署战略合作协议，双方将在介入心脏病学成像解决方案的商业化、技术整合及市场拓展等领域展开深度协作。根据协议，双方将联合开展市场推广活动，并探索技术系统的无缝集成。此外，GE医疗计划依托其覆盖全美的分销网络，扩大Gentuity产品的市场覆盖范围，惠及更多医疗机构。 MC Sciences宣布任命前辉瑞全球首席科学官兼研发总裁Mikael Dolsten博士为独立董事会主席。在此职位上，他将助力公司实现其使命，即开发针对多种高需求疾病适应症的创新疗法，推动疗法从实验室走向临床应用并惠及患者。Dolsten博士在辉瑞的16年任期内，推动了超过150个候选药物进入临床研究，并领导了36种药物和疫苗的监管审批，创下了纪录。除辉瑞外，Dolsten博士还曾担任勃林格殷格翰、Wyeth Research及阿斯利康等公司的执行领导职务。 Intas Pharmaceuticals子公司Accord Plasma B.V.宣布已签署协议，将全资收购Prothya Biosolutions Belgium BV及其所有子公司。后者是血浆衍生药物（PDMP）领域的领军企业，业务主要分布于荷兰与比利时。Intas在印度的血浆部门自2015年起持续为医院供应PDMP，该部门拥有年处理超100万升血浆的分离产能，产品已出口至多个国际市场。随着Intas古吉拉特邦工厂的扩建，新增产能将上线。该交易预计将很快完成。 Maravai生命科学公司宣布一项年度化5000万美元的成本削减计划，目标是到2026年实现EBITDA转正。该公司特别强调其生物制品安全检测和核酸生产业务板块。康基医疗与要约人Knight Bidco Limited公司联合公布，将以协议安排方式进行私有化；私有化完成后，康基医疗将成为要约人的全资附属公司，并在联交所撤销上市。康基医疗现由创始人钟鸣夫妇共同控制，二人合计持有该公司52.98%股份；私有化完成后，钟氏夫妇仍将通过Fortune Spring ZM与Fortune Spring YG继续持有要约方最终控股公司TopCo 40%股权，并保持第一大股东地位。深圳质子治疗中心8月8日正式启用。该中心是华南地区布局建设的首家质子治疗机构，总建筑面积3.5万平方米，配置5间治疗舱、300张床位，配备全球领先的IBA Proteus PLUS质子治疗系统。产业动态拜耳将对美国生物科技公司Kumquat Biosciences开发的KRAS G12D抑制剂承担后续临床开发与商业化。按照协议，Kumquat负责完成1a期试验，此后由拜耳接手推进上市。该药物靶向驱动肿瘤生长的KRAS G12D基因突变，该突变在胰腺癌、结直肠癌与非小细胞肺癌中较为常见。Kumquat将获得最高13亿美元里程碑付款，并按净销售额获得分级版税。辉瑞证实，美国食品药品监督管理局（FDA）正考虑撤销其新冠疫苗对5岁以下健康儿童的紧急使用授权。辉瑞在声明中表示，FDA告知可能不会延续其对6个月至4岁儿童的长期紧急使用授权。辉瑞称已申请在即将到来的秋冬季维持该授权，并“正与FDA就潜在解决方案进行讨论”。 CDE官网显示，恒瑞海曲泊帕乙醇胺片新适应症上市申请获受理。根据临床试验进展，业内推测用于肿瘤化疗所致血小板减少症（CIT）。海曲泊帕乙醇胺片是恒瑞医药研发的1类创新药，也是中国首个自主研发的非肽类口服血小板生成素受体激动剂，通过激活TPO-R介导的STAT和MAPK信号转导通路，促进血小板生成。迈威生物宣布其靶向Nectin-4 ADC创新药（研发代号：9MW2821，通用名：Bulumtatug Fuvedotin）用于ADC经治三阴性乳腺癌患者的临床试验在美国完成首例患者给药。这是9MW2821在海外开展的首个临床试验，也是迈威生物在ADC领域品种全球化的重要一步。联系美通社 +86-10-5953 9500 info@prnasia.com

并购疫苗高管变更

8 小时之前

·药研发

【药研日报0813】安科生物CD7 CAR-T疗法拟纳入突破性治疗品种

「本文共：10条资讯，阅读时长约：15分钟」药研资讯 1.安科生物CD7 CAR-T疗法拟纳入突破性治疗品种。安科生物参股公司博生吉医药开发的PA3-17注射液（靶向CD7的自体CAR-T疗法）被国家药监局纳入拟突破性治疗品种，用于治疗成人复发/难治性T淋巴母细胞白血病/淋巴瘤。早期临床数据显示客观缓解率高达85%，采用非基因编辑技术避免脱靶风险，为全球首个针对T细胞血液肿瘤的CAR-T疗法。 2. 恒瑞医药双药联合疗法获突破性治疗认定。恒瑞医药子公司研发的注射用瑞康曲妥珠单抗（HER2 ADC）联合阿得贝利单抗（PD-L1抑制剂）被纳入拟突破性治疗品种，用于PD-L1阳性三阴性乳腺癌一线治疗。两款药物累计研发投入超21亿元，此前已分别获批肺癌和小细胞肺癌适应症。 3. 中国创新药交易额全球占比首破50%。医药魔方数据显示，2025年中国创新药BD交易总额占全球52.5%，首次成为全球第一。License-out占比达44%，如恒瑞与GSK达成120亿美元合作。董事长周立运指出，中国从“跟随创新”转向“源头创新”，但需避免靶点扎堆导致的“内卷”。 4. 国家医保局公示534个药品通过国谈初审。国家医保局公告显示，534个药品通过2025年医保目录形式审查，其中目录外创新药310个，同比增加24.5%。今年首次增设“商保创新药目录”，121个药品通过初审，形成“医保+商保”双通道机制，减轻患者负担并缓解医保基金压力。 5. 拜耳13亿美元合作开发KRAS G12D抑制剂。拜耳与金橘生物科学公司达成全球独家协议，共同开发靶向KRAS G12D突变体的精准肿瘤药物。该突变存在于25%的癌症中，金橘将完成Ia期研究，拜耳负责后续开发及商业化，金橘最高可获得13亿美元款项。 6. AI药物研发最大合作落地：XtalPi获60亿美元订单。AI制药公司XtalPi与DoveTree达成总价值60亿美元的合作，聚焦“不可成药”靶点（如RAS、Myc）的药物开发，覆盖肿瘤、神经疾病等领域。XtalPi获得5100万美元首付款，后续可通过里程碑付款及特许权使用费获得总计58.9亿美元。 7. FDA批准7月五大创新疗法，覆盖多发性骨髓瘤与肺癌。7月FDA批准包括再生元制药双靶点抗体林沃塞他单抗（多发性骨髓瘤，缓解率70%）和迪扎尔制药EGFR抑制剂松沃替尼（肺癌，缓解率53.3%）。此外，首款遗传性血管水肿口服药塞贝拉司特、心衰药物非奈立酮及手部湿疹药德尔戈替尼均获批上市。 8. 2025上半年全球医药交易首付金额激增136%。2025年H1全球医药交易总额1304亿美元（同比+58%），首付款118亿美元（同比+136%）。中国贡献近50%交易金额，License-out达72笔，首付款总额首次超过一级市场融资额，成为Biotech资金回笼主要渠道。 9. 泰恩康白癜风创新药II期临床成功，将申请突破性疗法。泰恩康宣布1类新药CKBA软膏治疗非节段型白癜风的II期临床结果积极，高剂量组36%患者实现皮肤复色，安全性良好。公司计划立即申请突破性疗法认定并启动III期临床。 10. 科济药业实体瘤CAR-T提交上市申请，疗效突破晚期胃癌治疗。科济药业靶向Claudin18.2的CAR-T疗法“舒瑞基奥仑赛”已提交上市申请，II期数据显示其显著延长晚期胃/食管癌患者生存期，为末线患者提供突破性选择。中国企业在全球25个CD7 CAR-T研发项目中占比80%，引领实体瘤技术突破。股市资讯 8月12日A股医药公司涨幅TOP 3 赛诺医疗（688108.SH） +14.00% 南微医学（688029.SH） +6.00% 复星医药（600196.SH） +5.60% 8月12日A股医药公司跌幅TOP 2 科华生物（002022.SZ） -3.44% 润都股份（002923.SZ） -1.22% 8月12日港股医药公司涨幅TOP 3 复星医药（02196.HK） +7.55% 晶泰控股（02228.HK） +3.22% 丽珠医药（01513.HK） +2.35% 评审动态 8月11日新药临床试验申请IND（8月12日无新增数据） 8月8日新药上市申请NDA（8月9日至8月12日无新增数据） END

免疫疗法细胞疗法抗体药物偶联物引进/卖出申请上市

9 小时之前

·药明康德

13亿美元！拜耳囊获KRAS小分子抑制剂；首次！Keytruda联合疗法达3期试验主要与所有关键次要终点……

13亿美元！拜耳囊获KRAS小分子抑制剂拜耳（Bayer）与Kumquat Biosciences今日宣布，双方已就Kumquat公司KRAS G12D小分子抑制剂的全球独家许可及合作开发与商业化达成协议。根据协议，Kumquat将负责该药物1a期临床试验的启动与完成，而拜耳将接手后续的开发及商业化工作。Kumquat于2025年7月获得美国FDA许可开展该药物的临床试验。根据协议，Kumquat将获得最高达13亿美元的款项，包括预付款、临床与商业化里程碑付款等。此次合作聚焦于KRAS G12D抑制剂的研发，将补充拜耳在胰腺癌、结直肠癌及肺癌等精准肿瘤学领域的研发管线。KRAS突变存在于近四分之一的人类癌症中，其中KRAS G12D是最常见且致癌性最强的突变类型之一，但至今仍缺乏有效治疗手段。本次合作的达成，有望加速针对这一高未满足医疗需求的创新疗法研发进程。首次！Keytruda联合疗法达3期试验主要与所有关键次要终点默沙东（MSD）今日宣布，其3期临床试验KEYNOTE-905（EV-303）在患有肌层浸润性膀胱癌（MIBC）且不适合使用以顺铂为基础化疗的患者中取得积极的主要结果。研究显示，在手术（根治性膀胱切除术）前后联合使用PD-1抑制剂Keytruda（pembrolizumab）与抗体偶联药物Padcev（enfortumab vedotin），与单纯手术相比，在主要终点无事件生存期（EFS），以及关键次要终点总生存期（OS）和完全病理学缓解率（pCR）方面均取得了具有统计学意义和临床意义的改善。安全性方面，联合疗法的耐受性与各药物已知的安全性特征一致，未发现新的安全性信号。根据新闻稿，这是在不适合使用顺铂化疗的MIBC患者中，手术前后联合用药能够改善生存结局的首个系统性治疗方案，这也是该患者群体中首次取得积极结果的3期临床研究，标志着MIBC治疗领域的重要进展。 Keytruda是一种PD-1单克隆抗体，可阻断PD-1与其配体PD-L1和PD-L2之间的相互作用，从而激活T淋巴细胞，以发挥抗肿瘤功效。Padcev是一种抗体偶联药物，其靶点为nectin-4，这是一种位于细胞表面并在膀胱癌中高表达的蛋白质。临床前数据表明，这种药物的抗癌活性是由于它与表达nectin-4的细胞结合，然后将抗肿瘤药物MMAE内化并释放到细胞中，导致细胞不再增殖并出现程序性细胞死亡。每月一次！诺华抗体联合疗法3期试验结果积极诺华（Novartis）今日宣布，其在3期临床试验VAYHIT2中取得积极的主要结果。该研究评估了抗体ianalumab联合口服血小板生成素受体激动剂Promacta（eltrombopag）用于既往接受糖皮质激素治疗的原发性免疫性血小板减少症（ITP）患者的疗效。与安慰剂联合eltrombopag相比，ianalumab联合eltrombopag显著延长了至治疗失败的时间（TTF），这一主要终点衡量患者在治疗期间及之后维持安全血小板水平的时间长短。此外，在次要关键终点方面，接受联合治疗的患者在六个月时血小板计数持续改善的比例显著高于对照组。安全性分析显示，ianalumab的安全性特征与既往临床研究一致，未发现新的安全性信号。 Ianalumab是一款阻断BAFF受体的抗体疗法，在阻断BAFF信号传导的同时，可通过增强的抗体依赖性细胞毒性（ADCC）清除B细胞，有潜力带来更持久的疾病缓解。Ianalumab在ITP治疗中以每月一次、连续四次给药的方案，有望通过短程治疗实现长期疾病控制。目前，该药还在针对B细胞驱动的其他自身免疫性疾病中开展研究，包括正在进行的一线ITP及复发/难治性温抗体型自身免疫性溶血性贫血3期临床试验。参考资料： [1] Novartis ianalumab Phase III trial meets primary endpoint in ITP, demonstrating statistically significant improvement in time to treatment failure. Retrieved https://www.novartis.com/news/media-releases/novartis-ianalumab-phase-iii-trial-meets-primary-endpoint-itp-demonstrating-statistically-significant-improvement-time-treatment-failure [2] KEYTRUDA® (pembrolizumab) plus Padcev® (enfortumab vedotin-ejfv) Significantly Improved Event-Free and Overall Survival and Pathologic Complete Response Rate for Certain Patients with Muscle-Invasive Bladder Cancer When Given Before and After Surgery. Retrieved August 12, 2025 from https://www.businesswire.com/news/home/20250811757766/en/KEYTRUDA-pembrolizumab-plus-Padcev-enfortumab-vedotin-ejfv-Significantly-Improved-Event-Free-and-Overall-Survival-and-Pathologic-Complete-Response-Rate-for-Certain-Patients-with-Muscle-Invasive-Bladder-Cancer-When-Given-Before-and-After-Surgery [3] Bayer and Kumquat Biosciences Enter Global Exclusive License and Collaboration in Precision Oncology. Retrieved August 12, 2025 from https://businesswire.com/news/home/20250812240388/en/Bayer-and-Kumquat-Biosciences-Enter-Global-Exclusive-License-and-Collaboration-in-Precision-Oncology 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

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