A single dose, randomized, double-blind 2-arm parallel-group study to compare the pharmacokinetics, immunogenicity, and safety for PB016 versus US-licensed Entyvio® after subcutaneous administration in healthy participants

开始日期2025-11-14

申办/合作机构

Polpharma Biologics S.A.

NCT06405087

/ Recruiting临床3期

A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC.
In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 [NCT06100289]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study.
During the study, participants will visit their study clinic several times.

开始日期2025-10-27

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

100 项与维得利珠单抗相关的临床结果

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100 项与维得利珠单抗相关的转化医学

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100 项与维得利珠单抗相关的专利（医药）

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1,953

项与维得利珠单抗相关的文献（医药）

2026-04-01·DEN open

Vedolizumab Induces Remission in Two Cases of Ulcerative Colitis With Upper Gastrointestinal Involvement

Article

作者: Katagiri, Atsushi ; Otoyama, Yumi ; Yoshida, Hitoshi ; Higuchi, Kensuke ; Suzuki, Norihiro ; Nakatani, Shinya ; Ohara, Jyun ; Fujiwara, Takahisa ; Kikuchi, Kazuo ; Yamazaki, Yuta

ABSTRACT:

Ulcerative colitis (UC) predominantly affects the colon; upper gastrointestinal involvement (UGI) has been reported, but no established treatments exist. We report two cases of UC with concomitant UGI that showed positive responses to vedolizumab therapy. Case 1 involved a 29‐year‐old man who developed continuous inflammation extending from the stomach to the jejunum 1 month after an initial UC diagnosis. Intravenous prednisolone provided clinical remission; however, maintenance therapy with oral azathioprine was unsuccessful. Vedolizumab was initiated. Three months later, esophagogastroduodenoscopy (EGD) and colonoscopy confirmed the resolution of inflammation. Case 2 involved a 19‐year‐old man diagnosed with UGI via endoscopy while being evaluated for nausea and fever during UC treatment. 5‐aminosalicylic acid and prednisolone therapies were ineffective; therefore, vedolizumab was administered. Three months later, EGD confirmed mucosal healing. Both patients have maintained clinical remission for >2 years. To our knowledge, this is the first report of UC with UGI involvement that was successfully treated with vedolizumab. These findings suggest that vedolizumab is effective and safe for UGI treatment.

2026-02-01·ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Research Communication: Comparative Effectiveness of Ustekinumab and Vedolizumab in the Management of Chronic Pouchitis—A Population‐Based Study

Article

作者: Farraye, Francis A. ; Pardi, Darrell S. ; Alsakarneh, Saqr ; Tome, June

ABSTRACT:

Introduction:

Chronic pouchitis is a major therapeutic challenge in patients with ulcerative colitis following ileal pouch‐anal anastomosis.

Methods:

We conducted a real‐world, propensity‐matched cohort study of 856 patients from a healthcare database to compare ustekinumab and vedolizumab.

Results:

Ustekinumab was associated with significantly lower relapse rates (aHR = 0.69; p < 0.001), longer time to relapse, reduced hospitalisation and decreased need for steroids or antibiotics. No differences were observed in surgery rates or therapy switching.

Conclusion:

Our findings suggest that ustekinumab may offer advantages over vedolizumab in the management of chronic pouchitis.

2026-02-01·Clinical Gastroenterology and Hepatology

Development and External Validation of an Endoscopic and Histologic Pouchitis Assessment Tool: The Atlantic Pouchitis Index

Article

作者: Travis, Simon ; Samaan, Mark A ; Panaccione, Remo ; McFarlane, Stefanie C ; Rémillard, Julie ; Hogan, Malcolm ; Silverberg, Mark S ; Ma, Christopher ; Marchal, Aude ; Dotan, Iris ; Hart, Ailsa ; Rosenfeld, Gregory ; Bojic, Bozidar ; Kirsch, Richard ; Sands, Bruce E ; Feagan, Brian G ; D'Haens, Geert R ; Feakins, Roger M ; Zou, Guangyong ; Sedano, Rocio ; Bressler, Brian ; Jairath, Vipul ; Shackelton, Lisa M

BACKGROUND & AIMS:

No fully validated indices to measure pouchitis activity exist. We aimed to develop and externally validate a novel endoscopic and histologic index.

METHODS:

Endoscopists and pathologists used 11 (4 endoscopic, 4 histologic, 3 composite) existing indices and items from a prior Research and Development/University of California Los Angeles appropriateness exercise to assess pouchitis disease activity in videos and images from 98 patients with chronic antibiotic-refractory pouchitis who participated in a randomized placebo-controlled alicaforsen trial. Reliability was assessed with the intraclass correlation coefficient (ICC). Responsiveness was quantified by the area under the receiver operating characteristic curve (AUROC). A novel index was developed using linear regression with a visual analog scale (VAS) of pouchitis endoscopic and histologic disease activity as the dependent variable and was externally validated with the EARNEST vedolizumab trial data.

RESULTS:

The Atlantic Pouchitis Index (API) (range, 0-69) comprises the Simple Endoscopic Score for Crohn's Disease and Robarts Histopathology Index. The API exhibited almost perfect intra-rater (ICC, 0.88; 95% confidence interval [CI], 0.81-0.92) and substantial inter-rater reliability (ICC, 0.72; 95% CI, 0.60-0.79). A high degree of responsiveness (AUROC, 0.95; 95% CI, 0.89-0.98), greater than existing endoscopic indices (ΔAUROC, 0.09-0.24; P ≤ .005), was observed when the change criterion was a decrease in the VAS of one-half of the standard deviation. Good responsiveness was observed in external validation when vedolizumab was the change criterion (AUROC, 0.63; 95% CI, 0.51-0.73).

CONCLUSIONS:

Development and validation of the API advances pouchitis disease assessment. Integration of endoscopy and histopathology results in an objective, reliable, and responsive instrument to evaluate therapy effectiveness in research and clinical settings.

473

项与维得利珠单抗相关的新闻（医药）

2026-01-27

·搜狐新闻

超12亿美元！先声药业与BI达成交易，掘金千亿热门市场

来源：21世纪经济报道21世纪经济报道记者季媛媛1月27日，先声药业（2096.HK）宣布与德国勃林格殷格翰(BI)达成一项独家许可与合作协议，双方将共同开发先声药业自研的TL1A/IL-23p19双特异性抗体SIM0709，用于炎症性肠病（IBD）的治疗。根据该协议条款，先声药业有权收取4,200万欧元的首付款，以及基于研发进展，监管审批及商业化等情况，最高达10.16亿欧元的里程碑付款，这意味着，本次交易合计约为10.58亿欧元（约合12.54亿美元）。此外，先声药业亦有权就大中华区以外的净销售额收取分级特许权使用费。对此，有券商医药行业分析师对21世纪经济报道记者表示，这笔交易标志着中国本土企业在IBD这一全球高潜赛道上的创新能力获得跨国巨头认可。先声药业不仅将产品授权给拥有全球临床开发和商业化能力的勃林格殷格翰，还保留了在部分市场的可能参与权，这既有利于加速SIM0709的全球临床推进，又能在早期实现技术变现，优化公司研发资金结构。“对港股创新药板块而言，这是一次‘中国创新+国际资源嫁接’的积极信号，有望提升投资者对先声药业管线国际竞争力的信心。”该分析师说。瞄准千亿市场新年伊始的这项合作标志着中国创新药在国际舞台上的又一重要突破。根据先声药业披露，SIM0709是先声药业多抗技术平台开发的长效人源化双特异性抗体，可同时靶向肿瘤坏死因子样细胞因子1A（TL1A）和白介素23（IL-23），阻断导致IBD发生发展的两条核心通路。SIM0709在体外原代细胞实验和体内动物实验中均表现出优异的药效协同效果，甚至优于两个单药的联用。对于勃林格殷格翰而言，这笔交易延续了其在2025年积极拓展免疫学管线的战略。这家德国制药巨头在2025年已完成多起针对自身免疫疾病的重要交易，其中，2025年11月4日，勃林格殷格翰BI与CDR-Life宣布达成一项新的全球许可协议，共同开发用于治疗自身免疫性疾病的在研药物CDR111。CDR111是一款基于抗体片段的三特异性T细胞衔接器，旨在选择性清除致病B细胞以实现免疫系统重置。根据协议，CDR-Life将获得约4800万美元的前期及近期付款，并有资格获得总计约5.7亿美元的潜在里程碑款项，以及基于未来销售额的分层特许权使用费。2025年10月30日，勃林格殷格翰与协和麒麟共同宣布，勃林格殷格翰已获得协和麒麟的一个临床前阶段小分子药物项目的许可，旨在开发一种潜在的同类首创疗法，用于治疗自身免疫性疾病患者。勃林格殷格翰将获得该小分子项目在全球的独家开发权。另外，2025年4月15日，勃林格殷格翰与Cue Biopharma签订了一项研究合作和许可协议，支付1200万美元的预付款和额外的研究支持费用，该合作的潜在价值可能超过3.57亿美元。这项合作旨在开发一种双特异性候选药物，同样用于治疗自身免疫和炎症性疾病。如此不难看出，勃林格殷格翰正通过合作扩展其在自免领域的差异化的研发管线。对于此次与先声药业的合作，勃林格殷格翰美国创新中心负责人兼全球免疫与呼吸系统疾病研发负责人Carine Boustany表示：“炎症性肠病影响着巨大患者群体，许多人尽管使用了现有抗炎疗法，病情依然持续进展并经历严重并发症。我们很高兴与先声药业携手，加速开发这种可能改变IBD患者生活的潜在创新疗法。”根据业内人士透露，现有IBD治疗药物中，约40%的患者对传统生物制剂反应不佳，存在复发率高、副作用明显等问题。双特异性抗体通过同时阻断两个疾病通路，理论上可提供更强的疗效和更持久的缓解。而全球IBD药物市场正迅速扩大。Organovo官网的预测，到2032年全球IBD市场（UC+CD）将达到1000亿美元规模。巨头抢市场中信证券分析指出，炎症性肠病(Inflammatory Bowel Disease,IBD)包括溃疡性结肠炎(Ulcerative Colitis,UC)和克罗恩病(Crohn Disease,CD)，是一种复杂的自身免疫性疾病，目前发病机制仍不清晰，无治愈疗法，仍有大量未满足临床需求。全世界有超过1000万人患有克罗恩病和溃疡性结肠炎，该机构预测到2025年，中国的炎症性肠病患者将达到150万人。1998年，强生靶向TNF-α的英夫利昔单抗获批CD适应症，开启了IBD的靶向治疗时代，此后阿达木单抗、维得利珠单抗、乌司奴单抗不断抬高IBD领域的市场潜力。当前IBD领域进入了IL-23 p19单抗+JAK抑制剂的快速放量阶段。据中信证券分析，尽管IBD领域的靶点不断丰富，但诱导期的临床缓解率依然非常有限，大多数药物的临床缓解率在10%～20%之间的水平，已获批药物的高剂量组临床缓解率通常在15%以上。目前，全球IBD治疗市场目前由几类主要药物主导：抗TNF-α药物（如阿达木单抗）、整合素抑制剂（如维多珠单抗）、IL-12/23抑制剂（如乌司奴单抗）和JAK抑制剂（如托法替布）。不过，IBD的千亿市场潜力也使得无数跨国制药积极布局，市场竞争较为激烈。就在本月早些时候，1月7日，礼来宣布以约12亿美元的总价收购 Ventyx Biosciences，以推进针对炎症介导疾病的口服疗法。Ventyx 的临床研发管线包含多种用于治疗慢性炎症相关疾病的口服小分子药物，其主导管线靶向炎症小体 NLRP3，此次收购将进一步巩固礼来在炎症介导疾病领域的既有实力。新兴的TL1A靶向药物被视为下一代IBD治疗的重要方向。近年来，多款TL1A单抗和多特异性抗体在2/3期临床中表现较佳，为难治性溃疡性结肠炎（UC）和克罗恩病（CD）患者带来了新的希望。同时这一进展引发了多起巨额资本交易，进一步引发了对该靶点的高度关注。前述分析师指出，在IBD赛道，强生、艾伯维、辉瑞、武田等均有重磅产品布局，靶点集中在TNF-α、IL-12/23、JAK抑制剂等。国内企业近年在生物类似药和小分子创新药上有所突破，但在双抗、多靶点机制等前沿领域仍处起步阶段。“SIM0709同时作用于TL1A和IL-23p19，直击IBD病理链条中两条关键炎症信号，这种双通路抑制思路在国际上也属前沿，若临床验证成功，将形成差异化优势。”该分析师说。中外BD交易热2025年成为中国创新药对外授权的“大年”。中国创新药交易额现已超越美国，本土创新成果正逐步获得全球主流市场认可。医药魔方NextPharma数据库显示，截至2025年12月31日，中国创新药商务拓展（BD）出海授权全年交易总金额达到1356.55亿美元（约9483亿元人民币），首付款70亿美元，交易总数量达到157笔，远超2024年全年519亿美元和94笔，各个维度的数据统计均达到了历史新高。2025年，先声药业就完成了三项BD交易，其中包括2025年12月，先声药业旗下先声再明与法国益普生（Ipsen）达成独家授权协议，共同开发其自研的靶向LRRC15的抗体偶联药物（ADC）SIM0613。益普生获得该药在大中华区以外的全球权益。潜在交易总额最高可达10.60亿美元。2025年6月，先声再明与美国NextCure公司订立许可与战略合作协议，共同开发靶向CDH6的ADC新药SIM0505，用于治疗实体瘤。先声再明在该项目中有望获得最高达7.45亿美元的付款。2025年1月，先声再明与艾伯维（AbbVie）就其临床阶段的多发性骨髓瘤候选药物——一款靶向GPRC5D/BCMA/CD3的三特异性抗体SIM0500——达成一项许可选择权协议。潜在里程碑付款总额最高可达10.55亿美元。“中国生物科技企业凭借扎实的科研基础、较少的监管限制和更高的临床试验效率，成为跨国药企寻求创新药物研发合作的首选。”前述行业分析指出，中国在临床试验方面的效率优势明显。中国已经成为全球生物医药创新的重要来源。随着越来越多的中国创新药进入全球市场，同质化竞争风险也在增加。以PD-1/VEGF双抗赛道为例，康方生物、三生制药、荣昌生物分别以50亿、60.5亿和56亿美元的总金额达成海外授权。此前安永团队对21世纪经济报道记者指出，未来一到两年内，全球最易持续成为争夺焦点的领域，仍将集中在以下几类方向：其一为肿瘤赛道。产业焦点正发生转变，一方面，将从“是否拥有ADC、双抗”转向“是否属于下一代形态”；另一方面，自免与炎症领域也备受关注。过去数年，肿瘤赛道过度拥挤，相比之下，自免领域因拥有庞大的长期用药人群、稳定的支付基础以及庞大的疾病规模，成为孕育真正大单品的理想土壤。中国在该领域的变化尤为显著：不再简单跟随TNF、IL-17等传统老靶点，而是开始向更贴近机制源头的新通路探索。礼来公司在两天内宣布三项交易，总价值超过35亿美元；勃林格殷格翰在2025年完成多笔免疫领域合作。跨国药企对中国创新药的态度已从试探性接触转向战略性投资。中国生物科技公司不再是全球研发的边缘参与者，而是创新生态系统的核心贡献者。随着SIM0709这样的双特异性抗体走向全球临床试验，中国创新药企的角色正在经历根本性转变——它们正在帮助定义下一代治疗方法。返回搜狐，查看更多

引进/卖出

2026-01-26

·和仕咨询集团

消化系统用药：从治疗到管理的市场转型与创新突围

消化系统用药作为涵盖胃肠、肝胆、胰腺等器官疾病防治的药品总称，在中国医疗卫生体系中占据着举足轻重的地位。当前，这一传统医药领域正经历着从规模化扩张向高质量发展的深刻转型，其发展脉络紧密交织于国家政策导向、疾病谱演变以及技术创新浪潮之中。从行业现状审视，中国消化系统疾病负担持续加重，构成了市场发展的底层逻辑。一方面，生活方式改变导致功能性胃肠病、胃食管反流病等疾病发病率显著上升；另一方面，病毒性肝炎、脂肪肝、消化道肿瘤等器质性疾病仍是重要公共卫生问题。这种疾病谱的"双重压力"催生了多层次、多样化的临床需求。与此同时，在国家药品集中带量采购常态化实施背景下，传统消化用药价格大幅下降，市场结构加速调整。一致性评价政策的深入推进，则从供给侧提升了药品质量门槛，推动行业优胜劣汰。值得关注的是，《"十四五"国民健康规划》明确提出加强消化系统疾病防治能力建设，为行业发展提供了长期政策支撑。而创新药优先审评审批、医保目录动态调整等机制，则为消化领域新药研发注入了强劲动力。根据和仕咨询集团数据显示，2023年中国公立医疗机构终端消化系统用药市场规模达到约1850亿元，较五年前增长超过40%。其中，质子泵抑制剂(PPI)仍占据最大份额，但增长率已明显放缓；而微生态制剂、新型胃肠动力药、炎症性肠病(IBD)治疗药物等细分领域则保持两位数的高速增长。值得注意的是，随着消化道早癌筛查项目的推广和患者健康意识提升，消化系统用药市场正从单纯的"治疗市场"向"防治结合市场"拓展。预计到2028年，中国消化系统用药市场规模将突破2500亿元，其中创新药和生物制剂的占比有望从目前的不足15%提升至25%以上。在成熟仿制药领域，扬子江药业、正大天晴、奥赛康药业通过集采以价换量，在PPI、胃肠动力药等大宗品种上占据主导地位。在消化专科领域，济民可信的肝病用药、康弘药业的消化中成药形成差异化优势。而在高技术壁垒的创新药赛道上，跨国药企仍保持领先，如武田制药在炎症性肠病领域凭借维多珠单抗等生物制剂深耕市场，阿斯利康凭借新型酸分泌抑制剂巩固其在酸相关疾病治疗领域的优势。国内创新药企正在快速追赶，百济神州的PD-1抑制剂在肝癌适应症上的拓展，荣昌生物的ADC药物在胃癌领域的突破，标志着中国药企开始涉足消化系统肿瘤的靶向治疗前沿。此外，在微生态治疗这一新兴领域，东海药业、华大基因等企业正加大研发投入，抢占技术制高点。整体来看，市场竞争已从价格竞争转向产品线广度、研发深度和商业化能力的综合较量。展望未来，三大趋势将重塑行业生态。首先，诊疗一体化成为新方向。消化系统疾病诊断与治疗的界限日益模糊，胶囊内镜、人工智能辅助诊断等新技术与药物治疗的结合将催生新模式。其次，肠道微生态研究引领治疗理念革新。粪菌移植、精准益生菌等微生态疗法可能颠覆传统消化疾病治疗范式，带来全新市场机遇。再次，中西医结合疗法获得政策加持。在《关于进一步加强中西医结合工作的指导意见》推动下，中药在功能性胃肠病、肝纤维化等慢性病管理中的价值将进一步凸显。此外，随着数字化医疗的发展，基于互联网医院的消化慢病管理平台将改变传统药品流通和服务模式。总体而言，中国消化系统用药行业正处于转型升级的关键时期。在政策引导、临床需求和科技创新的共同驱动下，行业将加速向创新驱动、质量优先、患者为中心的发展模式转变。那些能够前瞻布局新技术赛道、构建差异化产品管线、并建立全周期患者服务能力的企业，将在未来市场竞争中赢得先机。从更大的视角看，消化系统用药行业的演变不仅反映了中国医药产业的升级路径，也折射出全民健康管理理念的深刻变革。

优先审批抗体药物偶联物引进/卖出申请上市上市批准

2026-01-26

·BioSpace

Samsung Epis Holdings Reports Fourth Quarter and Fiscal Year 2025 Financial Results

In its first financial results announcement after the spin-off, Samsung Bioepis recorded FY2025 revenue of KRW 1.672 trillion, highest annual revenue in its 14-year history Excluding milestone revenue, annual sales revenue grew 28% year-over-year (YoY), recording KRW 1.626 trillion, with 101% YoY growth in operating profit to KRW 330.8 billion INCHEON, Korea--(BUSINESS WIRE)-- #ADCs --Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced financial results for the fourth quarter and fiscal year 2025. “We are very pleased to report strong year-to-date sales growth in our first financial results following the spin-off. Our organic growth has been driven by solid performance across our biosimilars portfolio," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We are continuing to make meaningful progress in our regulatory and commercial milestones with our existing biosimilars portfolio, while strategically investing in our future pipeline with a disciplined, long-term approach. We aim to drive sustainable growth and create long-term value for our shareholders, so that we can remain committed to improving patient access worldwide.” Samsung Bioepis Fourth Quarter & Fiscal Year 2025 Results In the fourth quarter of 2025, Samsung Bioepis achieved a consolidated revenue of KRW 429.4 billion with an operating profit of KRW 29.2 billion. Revenue and operating profit based on product sales (excluding milestone revenue) in the fourth quarter increased by 23% and 14% year-over-year (YoY), respectively. Full-year 2025 (FY2025) revenue reached KRW 1.672 trillion (+9%) while operating profit stood at KRW 375.9 billion (-14%). Excluding milestone revenue, sales revenue and operating profit stood at KRW 1.626 trillion (+28%) and KRW 330.8 billion (+101%), respectively. [Consolidated Earnings, KRW billion] Q4’23 Q4’24 Q4’25 YoY Change FY23 FY24 FY25 YoY Change Revenue 288.9 397.4 429.4 +32.0 1 (+8%) 1,020.3 1,537.7 1,672.0 +134.3 1 (+9%) Excluding Milestone Revenue 288.9 347.0 425.2 +78.2 (+23%) 1,008.3 1,266.8 1,626.9 +360.1 (+28%) Operating Profit 78.2 72.3 29.2 -43.1 (-60%) 205.4 435.4 375.9 -59.5 (-14%) Excluding Milestone Revenue 78.2 21.9 25.0 +3.1 (+14%) 193.4 164.5 330.8 +166.3 (+101%) The growth was driven by Samsung Bioepis’ continued global expansion through product launches, regulatory approvals, and new partnerships. EPYSQLI™ (SB12), a biosimilar to Soliris 2 (eculizumab), indicated for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and generalized Myasthenia Gravis (gMG), was launched in the United States (US) in April 2025 through its commercialization partner Teva Pharmaceuticals, improving access for patients with rare diseases. OBODENCE™ / OSPOMYV™ 3 (SB16), a biosimilar to Prolia 4 (denosumab), and XBRYK™ (SB16), a biosimilar to Xgeva 3 (denosumab), were approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in February 2025. In Europe, OBODENCE was launched in December 2025, consequently followed by the launch of XBRYK in January 2026. As of January 2026, four products are directly commercialized by Samsung Bioepis in Europe, namely EPYSQLI (eculizumab), OBODENCE (denosumab), XBRYK (denosumab), and BYOOVIZ™ (ranibizumab). 5 PYZCHIVA™ (SB17), a biosimilar to Stelara 6 (ustekinumab), was launched in the US in partnership with Sandoz in February 2025. PYZCHIVA has also been available as private label brands since the second and third quarter of 2025. In Japan, SB17 was approved as Ustekinumab BS Subcutaneous Injection 45mg Syringes 「NIPRO」 by Pharmaceuticals and Medical Devices Agency (PMDA) in December 2025. It is the first product to gain marketing approval in Japan under the partnership with NIPRO CORPORATION entered in June 2025. Samsung Bioepis entered into a partnership agreement with Harrow for commercialization of BYOOVIZ (SB11), a biosimilar referencing Lucentis 7 (ranibizumab) and OPUVIZ™ (SB15), a biosimilar referencing Eylea 8 (aflibercept), in the US. Fiscal Year 2026 Outlook Samsung Epis Holdings is actively supporting its subsidiaries' core businesses under the holding company structure, with a goal of increasing global biosimilar sales by more than 10% compared YoY. Samsung Bioepis plans to secure 20 biosimilars in its portfolio by 2030, including dupilumab, guselkumab, ixekizumab, trastuzumab deruxtecan, vedolizumab, and ocrelizumab. Beyond biosimilars, the company has also embarked on its novel therapeutic development. It plans to have one novel therapeutic candidate enter into clinical study every year, starting with SBE303. SBE303 is Samsung Bioepis’ first novel antibody-drug conjugate (ADC) engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including bladder cancer, urothelial cancer, lung cancer, and breast cancer. 9 The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year. Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform. About Samsung Epis Holdings Co., Ltd. As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: . About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . About Epis NexLab Co., Ltd. Established in 2025 as a 100% owned subsidiary of Samsung Epis Holdings, Epis NexLab is committed to driving innovation through the development of next-generation biotechnology platforms. By transforming highly scalable peptide-related technologies into development platforms, Epis NexLab is focused on the discovery of innovative treatment modalities for the development of multiple therapeutic candidates targeting a wide range of diseases. For more information about Epis NexLab, please visit: . 1 The year-over-year (YoY) change in operating profit is reflective of the ‘milestone payment’ – a payment system that pays out upon completion of specific milestones within a project’s development. 2 Soliris is a trademark of Alexion Pharmaceuticals, Inc. 3 SB16 was approved under different names in Europe and the US; OBODENCE in Europe and OSPOMYV in the US 4 Prolia and Xgeva are trademarks of Amgen Inc. 5 In Europe, Samsung Bioepis has assumed full responsibility for commercialization of BYOOVIZ upon the transfer of commercial rights from Biogen back to Samsung Bioepis, effective as of January 2026. 6 Stelara is a trademark of Johnson & Johnson Corporation. 7 Lucentis is a trademark of Genentech Inc. 8 Eylea is a trademark of Regeneron Pharmaceuticals, Inc 9 Li K, Zhou Y, Zang M, Jin X, Li X. Therapeutic prospects of nectin-4 in cancer: applications and value. Front Oncol. 2024 Mar 28;14:1354543. doi: 10.3389/fonc.2024.1354543. PMID: 38606099; PMCID: PMC11007101. Contacts Media Contact Yoon Kim, yoon1.kim@samsung.com Anna Nayun Kim, nayun86.kim@samsung.com

上市批准临床1期

100 项与维得利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08083	维得利珠单抗	L04AA33	DB09033

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
回肠疾病	韩国	Takeda Pharmaceuticals Korea Co., Ltd.	2015-06-19
活动性中度克罗恩病	欧盟	Takeda Pharma A/S	2014-05-22
活动性中度克罗恩病	冰岛	Takeda Pharma A/S	2014-05-22
活动性中度克罗恩病	列支敦士登	Takeda Pharma A/S	2014-05-22
活动性中度克罗恩病	挪威	Takeda Pharma A/S	2014-05-22
活动性重度克罗恩病	欧盟	Takeda Pharma A/S	2014-05-22
活动性重度克罗恩病	冰岛	Takeda Pharma A/S	2014-05-22
活动性重度克罗恩病	列支敦士登	Takeda Pharma A/S	2014-05-22
活动性重度克罗恩病	挪威	Takeda Pharma A/S	2014-05-22
隐窝炎	欧盟	Takeda Pharma A/S	2014-05-22
隐窝炎	冰岛	Takeda Pharma A/S	2014-05-22
隐窝炎	列支敦士登	Takeda Pharma A/S	2014-05-22
隐窝炎	挪威	Takeda Pharma A/S	2014-05-22
活动性中度溃疡性结肠炎	欧盟	Takeda Pharma A/S	2014-05-22
活动性中度溃疡性结肠炎	冰岛	Takeda Pharma A/S	2014-05-22
活动性中度溃疡性结肠炎	列支敦士登	Takeda Pharma A/S	2014-05-22
活动性中度溃疡性结肠炎	挪威	Takeda Pharma A/S	2014-05-22
活动性重度溃疡性结肠炎	欧盟	Takeda Pharma A/S	2014-05-22
活动性重度溃疡性结肠炎	冰岛	Takeda Pharma A/S	2014-05-22
活动性重度溃疡性结肠炎	列支敦士登	Takeda Pharma A/S	2014-05-22

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
小儿克罗恩病	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	中国	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	日本	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	澳大利亚	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	比利时	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	加拿大	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	克罗地亚	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	捷克	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	希腊	Takeda Pharmaceutical Co., Ltd.	2022-02-10
小儿克罗恩病	临床3期	匈牙利	Takeda Pharmaceutical Co., Ltd.	2022-02-10

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临床结果

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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


ASH2025	N/A	类固醇难治性移植物抗宿主病	69	Vedolizumab + basiliximab	餘襯鹽願淵鏇鹽鏇淵鹽(鑰襯膚觸簾襯壓夢糧簾) = 鹽衊願鹹鹹顧顧憲蓋廠顧壓願遞網艱鑰獵蓋糧 (構鏇鏇壓構獵鹽構淵醖 ) 更多	积极	2025-12-06
NCT06227910 (VICTRIVA, Pubmed \| Contemp Clin Trials Commun)	临床3期	克罗恩病	396	Vedolizumab + Upadacitinib	鹹艱鑰顧構積艱鹽淵網(積獵憲壓遞憲構糧壓觸) = 齋獵鹹廠衊顧憲憲簾艱範醖繭獵範鏇顧鹽蓋廠 (鹽顧積鹹構願蓋簾顧淵 ) 更多	积极	2025-12-01
NCT06227910 (VICTRIVA, Pubmed \| Contemp Clin Trials Commun)	临床3期	克罗恩病	396	Vedolizumab	襯淵鏇簾艱艱鬱繭觸鏇(鑰憲獵願簾築範膚鬱憲) = 壓鹹蓋構鬱積憲衊窪蓋鏇醖顧鑰蓋醖選糧選糧 (獵壓醖壓蓋簾齋顧蓋簾 ) 更多	积极	2025-12-01
NCT03142321 (CTgov)	临床4期	肠炎 \| 克罗恩病	48	Vedolizumab 300 MG Injection [Entyvio]	顧餘淵鏇夢繭範齋選蓋 = 窪憲醖鏇網齋網範獵醖餘繭顧鬱廠夢選構選衊 (觸窪壓網糧襯糧製糧餘, 醖餘醖製襯艱夢淵鑰遞 ~ 鹹顧遞蓋衊廠齋齋糧網) 更多	-	2025-09-17
NCT02620046 (CTgov)	临床3期	克罗恩病 \| 溃疡性结肠炎	746	Vedolizumab SC (Ulcerative Colitis: Vedolizumab 108 mg)	齋簾鑰願鏇顧鏇製鹽艱 = 簾選獵選獵遞醖鏇醖築夢齋選鹽鏇鏇淵觸繭膚 (簾鬱獵艱願餘選膚鹽觸, 醖積構廠淵觸鏇蓋夢艱 ~ 鏇鬱顧構鬱選範築顧製) 更多	-	2025-04-03
NCT02620046 (CTgov)	临床3期	克罗恩病 \| 溃疡性结肠炎	746	Vedolizumab SC (Crohn's Disease: Vedolizumab 108 mg)	齋簾鑰願鏇顧鏇製鹽艱 = 鹽築蓋艱獵積構觸網積夢齋選鹽鏇鏇淵觸繭膚 (簾鬱獵艱願餘選膚鹽觸, 壓願築憲製齋積鏇蓋觸 ~ 醖醖網遞顧夢艱廠醖築) 更多	-	2025-04-03
NCT02862132 (VEDOKIDS, Pubmed \| Lancet Gastroenterol Hepatol)	N/A	炎症性肠病维持	137	Vedolizumab	鬱觸窪鑰築顧醖顧範餘(鏇夢積繭醖醖網餘鬱膚) = 糧齋選簾築範憲艱製鏇夢艱醖顧築範憲繭獵齋 (鑰構廠衊顧製簾糧蓋壓 ) 更多	积极	2025-03-01
ChiCTR2200063233 (Early CD, PRNewswire) 人工标引	临床4期	克罗恩病	172	维得利珠单抗	壓廠積鬱鹽製鏇蓋膚鬱(餘醖選衊繭醖繭遞淵憲) = 獵鹽餘鑰膚鬱遞構壓範積糧醖製鹽獵觸簾齋壓 (廠製鏇鬱衊簾範襯廠襯 ) 更多	积极	2025-02-21
NCT04804540 (CTgov)	临床4期	克罗恩病 \| 溃疡性结肠炎	150	Vedolizumab (UC Participants: Vedolizumab 300 mg)	襯鏇餘觸網壓獵獵範選 = 獵鹹範鬱鹽簾齋壓顧觸構鑰齋選顧醖構襯繭蓋 (遞選選範淵願糧製艱願, 壓鹽選鹽鏇衊繭鹽繭膚 ~ 醖衊選憲醖範鏇醖襯觸) 更多	-	2025-02-12
NCT04804540 (CTgov)	临床4期	克罗恩病 \| 溃疡性结肠炎	150	Vedolizumab (CD Participants: Vedolizumab 300 mg)	襯鏇餘觸網壓獵獵範選 = 鏇鬱鑰衊醖襯築獵窪糧構鑰齋選顧醖構襯繭蓋 (遞選選範淵願糧製艱願, 鑰齋窪鹽窪觸選醖夢鹹 ~ 鑰顧廠窪網觸憲顧廠鹹) 更多	-	2025-02-12
ACR2024	N/A	克罗恩病引起的肛周瘘 \| 溃疡性结肠炎	137	Ustekinumab	齋範顧顧觸顧鹽鹹糧鬱(鏇壓壓醖窪遞夢製憲顧) = 餘積遞憲壓蓋餘夢齋築鹽觸顧獵膚鹹遞壓艱網 (窪繭範廠鹽鑰憲膚齋構 ) 更多	积极	2024-11-10
UEGW2024	临床4期	炎症性肠病	115	Vedolizumab 300mg	衊範襯鹽壓鹽鹽淵鏇醖(蓋齋築鏇網簾積製鏇鏇) = 壓窪鑰鏇製繭壓襯築餘窪蓋願鬱觸製願遞積艱 (衊繭廠範遞餘蓋廠觸衊 ) 更多	不佳	2024-10-13
UEGW2024	N/A	溃疡性结肠炎	-	Anti-TNFs	獵構遞願壓範淵醖鹹選(壓積夢製顧構醖鏇選醖) = 1/16 (6.3%) with no cases of herpes zoster or thrombo-embolic events 鏇網艱鑰蓋壓願遞範積 (構構繭觸簾衊艱築遞醖 ) 更多	-	2024-10-13
UEGW2024	N/A	溃疡性结肠炎	-	Ustekinumab		-	2024-10-13