雷珠单抗(Ranibizumab (Genentech)) - 药物靶点：VEGF-A_在研适应症：糖尿病性视网膜病变，视网膜静脉阻塞，黄斑水肿_专利_临床

概要

基本信息

药物类型

Fab片段抗体

别名

ACCENTRIX、AMD Fab、AMD-rhuFab-V2

+ [19]

靶点

VEGF-A

作用方式

抑制剂

作用机制

VEGF-A抑制剂(血管内皮生长因子A抑制剂)

治疗领域

神经系统疾病心血管疾病遗传病与畸形+ [3]

在研适应症

糖尿病性视网膜病变视网膜静脉阻塞黄斑水肿+ [9]

非在研适应症

水疱缺血型视网膜中央静脉阻塞中心性浆液性脉络膜视网膜病变+ [28]

原研机构

Genentech, Inc.

在研机构

Novartis Pharmaceuticals Australia Pty Ltd.Hoffmann-La Roche, Inc.F. Hoffmann-La Roche Ltd.

+ [8]

非在研机构

Novartis Pharmaceuticals Corp.Novartis Pharma Stein AG

北京诺华制药有限公司

+ [4]

最高研发阶段批准上市

首次获批日期

美国 (2006-06-30),

湿性年龄相关性黄斑变性

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、快速通道 (美国)、优先审评 (中国)、孤儿药 (澳大利亚)、孤儿药 (日本)

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结构/序列

Sequence Code 103170L

来源: *****

Sequence Code 143622H

来源: *****

关联

386

项与雷珠单抗相关的临床试验

NCT06847542

/ Not yet recruiting临床3期

A Phase IIIb, Multicenter, Single-arm Study Assessing the Effectiveness, Safety and Patient Reported Outcomes of a 36-week Refill Exchange Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration

The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.

开始日期2025-09-01

申办/合作机构

Hoffmann-La Roche Ltd.

[+1]

ChiCTR2400094335

/ Suspended临床4期IIT

A prospective, randomized, single-blind, multicenter case-control clinical trial comparing Ozurdex and ranibizumab in the treatment of Coats' disease

开始日期2025-01-01

申办/合作机构-

CTRI/2024/12/077904

/ Recruiting临床3期

A Phase III Prospective, Randomized, Open-labelled, Blinded endpoint (PROBE), Multi-centric, Parallel Group, Non-inferiority Study to compare the Efficacy and Safety of GBL1204 with Ranibizumab in Patients with Wet Age-Related Macular Degeneration (PROMISES Study) - NIL

开始日期2024-12-22

申办/合作机构

Gennova Biopharmaceuticals Ltd.

100 项与雷珠单抗相关的临床结果

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100 项与雷珠单抗相关的转化医学

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100 项与雷珠单抗相关的专利（医药）

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5,332

项与雷珠单抗相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of bispecific antibody faricimab for treatment of neovascular age-related macular degeneration and diabetic macular edema in Japan

Article

作者: Igarashi, Ataru ; Sakashita, Naotaka ; Shoji, Ayako ; Higashi, Kentaro ; Tsujimura, Jun ; Ohno, Shinya ; Yanagi, Yasuo

OBJECTIVE:

To assess the cost-effectiveness of faricimab vs. other anti-vascular endothelial growth factor (anti-VEGF) drugs for treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) in Japan, while considering societal burden associated with treatment.

METHODS:

A Markov model for cost-effectiveness analysis of anti-VEGF treatment in patients with nAMD and DME was applied based on cost and utility value data from Japan. Faricimab administered through a treat-and-extend (T&E) regimen was compared with ranibizumab administered pro re nata (PRN) and T&E, aflibercept T&E, brolucizumab T&E, and best supportive care (BSC). Further to treatment costs (public payer perspective), the societal burden (societal perspective), including costs of travel, informal care, and productivity, was assessed.

RESULTS:

In treatment of nAMD, lifetime quality-adjusted life years (QALYs) gained were highest with faricimab (faricimab T&E: 6.92, ranibizumab PRN: 6.88, ranibizumab T&E: 6.91, aflibercept T&E: 6.89, brolucizumab T&E: 6.89, BSC: 5.99). From the public payer perspective, the lifetime total cost for faricimab T&E was lower than those for ranibizumab (PRN, T&E) and brolucizumab (T&E), comparable to aflibercept T&E, and higher than BSC (incremental costs: 158,385 and 6,475,511 JPY, respectively). As a result, faricimab was cost-effective or dominant in the treatment of nAMD, excluding BSC. From the societal perspective, faricimab was dominant against all comparators in nAMD. In treatment of DME, QALYs gained were highest with faricimab (faricimab T&E: 8.51, ranibizumab PRN: 8.17, aflibercept PRN: 8.36, ranibizumab T&E: 8.13, BSC: 5.16). From both the public payer and societal perspectives, faricimab was dominant against all comparators in DME.

CONCLUSIONS:

When societal burdens were considered, faricimab was dominant in both nAMD and DME against all comparators, suggesting that the extended dosing interval associated with faricimab treatment may alleviate societal burdens and consequently improve patient outcomes.

2025-05-01·DIABETES OBESITY & METABOLISM

Ranibizumab with luseogliflozin in type 2 diabetes with diabetic macular oedema: A randomised clinical trial

Article

作者: Nagashima, Kengo ; Ishikawa, Ko ; Yamamoto, Shuichi ; Baba, Takayuki ; Yokote, Koutaro ; Asaumi, Noriko ; Takahashi, Sho ; Koshizaka, Masaya ; Takatsuna, Yoko ; Tatsumi, Tomoaki ; Ishibashi, Ryoichi ; Kaiho, Tomomi

Abstract:

Aims:

Anti‐vascular endothelial growth factor (VEGF) therapy is the standard treatment for diabetic macular oedema (DMO); however, unmet needs remain. This study aimed to assess the effectiveness of sodium‐glucose cotransporter 2 inhibitors (SGLT2i) in treating DMO.

Materials and Methods:

This multicentre randomised open‐label trial included 60 patients with DMO who were eligible for anti‐VEGF therapy. Patients were randomised to receive luseogliflozin or glimepiride. Ranibizumab was administered initially to the target eye, with additional doses per protocol. The number of ranibizumab doses up to week 48, and re‐admission rates were evaluated. Fellow eye injections were also assessed.

Results:

Sixty participants, mostly with diabetic retinopathy and half previously treated with anti‐VEGF therapy, were included. SGLT2i and sulfonylurea (SU) groups achieved equivalent glycated haemoglobin, central retinal thickness (CRT), and best‐corrected visual acuity improvements. Injection frequency for the target eye was similar between groups (SGLT2i vs. SU: 3.9 ± 0.7 vs. 4.7 ± 0.7 times, p = 0.36). Re‐administration rates were decreased significantly after the fourth injection in the SGLT2i group (p = 0.030, hazard ratio: 0.45, 95% confidence interval: 0.22–0.92). Fellow eyes in the SGLT2i group showed significant CRT reduction and fewer injections compared with those in the SU group (1.3 ± 0.6 vs. 3.4 ± 0.8, p = 0.016).

Conclusions:

Although the overall number of anti‐VEGF injections in the target eye showed no significant difference, some patients responded favourably to SGLT2i and required fewer injections. The reduction in fellow eye injections suggests SGLT2i's efficacy in treating early‐stage DMO.

Trial Registration:

University Hospital Medical Information Network Clinical Trial Registry (UMIN000033961); Japan Registry of Clinical Trials (jRCTs031180210).

2025-05-01·AMERICAN JOURNAL OF OPHTHALMOLOGY

Faricimab-Associated Intraocular Inflammation With Features of Herpes Simplex Virus

Article

作者: Ghoz, Noha ; Amarnath, Aishwarya ; Theodoraki, Korina ; Jamall, Omer ; Almeida, Goncalo ; Elgharably, Mohamed ; Janmohamed, Imran Karim ; Salam, Muhammed Aizaz Us

OBJECTIVE:

Faricimab-associated intraocular inflammation (IOI) is an emerging concern. We aimed to investigate clinical features, management, and outcomes of severe IOI following faricimab therapy, with particular attention to cases displaying features consistent with herpes simplex virus (HSV) involvement.

DESIGN:

Single-center retrospective interventional case series.

SUBJECTS:

Five patients (5 eyes) who developed severe IOI following intravitreal faricimab injection for neovascular age-related macular degeneration (nAMD, n = 4) or diabetic macular edema (DME, n = 1) between June 2023 and October 2024. The nAMD patients had received a mean of 17.75 ± 9.18 prior anti-VEGF injections (range 6-26 injections). The DME patient had previously received 7 aflibercept injections and 2 dexamethasone implants. Prior to faricimab, 3 patients were being treated with aflibercept and 2 with ranibizumab biosimilar.

METHODS:

Medical records were reviewed for clinical features, treatment approaches, and outcomes. Cases were identified through systematic review of follow-up appointments and urgent care presentations. When clinically indicated, additional investigations including optical coherence tomography and fluorescein angiography were performed.

MAIN OUTCOME MEASURES:

Best-corrected visual acuity (BCVA), intraocular pressure (IOP), anterior chamber (AC) inflammation, presence of keratic precipitates (KPs), vitreous cells, signs of viral reactivation, and treatment response.

RESULTS:

The median number of faricimab injections before inflammation was 5 (range 3-13). Mean interval between injection and symptom onset was 16.8 days (range 1-35). All patients presented with AC inflammation and elevated IOP (mean 32.8 ± 4.15 mmHg, range 28-38 mmHg). All patients demonstrated features consistent with HSV keratouveitis, including dendritic ulcers, reduced corneal sensation, and granulomatous KPs. Treatment included topical or systemic steroids in all cases, with 4 patients (80%) receiving concurrent antiviral therapy. Median time to inflammation resolution was 15.5 days. Four patients (80%) did not recover baseline vision.

CONCLUSIONS:

This case series identifies a previously unreported association between faricimab-associated IOI and features of viral reactivation. The temporal relationship including onset patterns suggestive of delayed hypersensitivity, alongside consistent HSV features and favourable antiviral response, suggests a possible mechanism linked to VEGF-A and Ang-2 mediated alterations in ocular immune surveillance. While further investigation is needed to establish causality, clinicians should consider viral mechanisms when evaluating and treating these cases.

536

项与雷珠单抗相关的新闻（医药）

2025-04-16

·PRNewswire

Chime Biologics Partners Polpharma Biologics to Advance Global Biosimilar Development

Accelerate Polpharma Biologics biosimilar program from IND to commercial manufacturing Includes a commitment to producing for US FDA BLA submission Expand global market presence through launch in EU and other regions GDAŃSK, Poland and SHANGHAI, April 16, 2025 /PRNewswire/ -- Chime Biologics, a leading global CDMO that enables its partners' success in biologics, is pleased to announce a strategic cooperation agreement with Polpharma Biologics to advance the end-to-end development and manufacture of a biosimilar product for the global market. This partnership underscores Chime Biologics' commitment to delivering high-quality, cost-effective biologics and further strengthening Chime Biologics' presence in Europe. Under this agreement, Chime Biologics will provide Polpharma Biologics with end-to-end support for a biosimilar development, spanning from investigational new drug (IND) to commercial supply. Meeting Global Supply Needs Polpharma Biologics, a major player in the global biosimilar market and the largest biotechnology company in Poland, brings a robust pipeline that includes multiple early-stage and late-stage biosimilars, along with two FDA/EMA-approved biosimilar products. With an extensive track record in delivering biosimilars for global markets, Chime Biologics is well-positioned to meet the growing global demand for biosimilars. Through Chime's true end-to-end offerings, from our state-of-the-art cell line, process and analytical development capabilities, expanding manufacturing capabilities and regulatory support activities, Chime Biologics offers clients fast-tracked CMC development to commercial supply to ensure fast market entry for our clients. "We are thrilled to contribute to Polpharma Biologics' growth as we provide all-in-one solutions to accelerate biosimilar development and reduce the time-to-market," said Dr. Jimmy Wei, President of Chime Biologics. "This collaboration reinforces our strategy of delivering high-quality, affordable biologics to patients worldwide." "Partnering with Chime Biologics supports our strategic vision to swiftly bring affordable biosimilars developed in Europe to global markets," said Konstantin Matentzoglu, Member of the Supervisory Board of Polpharma Biologics Group BV. "By working with Chime Biologics, we can accelerate patient access to biosimilar therapies. This partnership further strengthens Polpharma Biologics' global position as a leading biosimilars developer, while leveraging Asian partners with optimized cost-benefit ratio". About Polpharma Biologics Polpharma Biologics is an international biotechnology company, with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Polpharma Biologics develops biosimilar therapies to treat a range of conditions in major therapeutic areas. Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production, preparing drugs for future commercial partnerships with global pharmaceutical organizations. Under partnerships agreements, the company manufactures two approved biosimilars from its pipeline; ranibizumab and natalizumab. With its cell line development center in The Netherlands, and two centers of development and manufacturing in Poland, Polpharma Biologics creates development opportunities for biotechnology specialists. For more information, please visit . About Chime Biologics Chime Biologics is a leading global CDMO, focused on ensuring its partners' success in delivering innovative biologics to the world. Chime Biologics is a biologics service provider, from pre-clinical support and cell line development to clinical and commercial manufacturing of DS and DP. Employing our innovative and state-of-the-art development and manufacturing capabilities and proven success in supporting our clients with their clinical and commercial authorizations across the globe, Chime Biologics is a true end-to-end solution provider for the global biologics industry. We share a common goal to make cutting-edge biomedicines affordable and accessible to all patients globally, fulfilling our commitment to human health. For more information, please visit . Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引进/卖出

2025-04-15

·赛柏蓝

2024国谈药进院情况公布，这些配备率最高（附名单）

作者 | 陈芋责编 | 遥望多省公布国谈药进院统计情况。01每家三级医院平均配备73个国谈药32个药配备率超过50%4月14日，浙江省医保局发布《全省三级医疗机构谈判药品配备情况一览表》，对浙江180家三级医疗机构在今年第一季度的国谈药配备详情进行了公开。2025年国家医保药品目录自年初至今已正式执行一个季度，新版目录新增谈判药品84个，协议期内谈判药品共427个。据赛柏蓝梳理，浙江的180家三级医疗机构平均配备谈判药品数量约73.6个，分区间看，配备谈判药数量在90～99个之间的医院最多，达到26家；其次是配备80～89个、10～19个谈判药的医院，均有20家。配备谈判药数量超150个的三级医疗机构共4家，其中丽水市人民医院丽水市人民医院微脉互联网医院配备数量最多，达到157个；宁波市医疗中心李惠利医院配备了154个谈判药，居于全省第二位；宁波大学附属第一医院、绍兴市人民医院均配备了152个，位于全省第三。从具体药品看，配备率超过50%，即被90家以上三级医院采购的药品共32个（完整名单见文末附1）。其中，可用于前列腺癌、乳腺癌的醋酸戈舍瑞林缓释植入剂是配备率最高的药品，180家医院中有152家都采购了该药品，配备率超过84%。其次是用于糖尿病的德谷门冬双胰岛素注射液、用于急性缺血性脑卒中的丁苯酞氯化钠注射液，均有142家三级医院配备；司美格鲁肽注射液也有141家三级医院采购，是配备率第四高的药品。另外，蓝苓口服液是配备率超过50%的谈判药品中唯一的中成药，第一季度共112家三级医疗机构配备了该药品，配备率62%，居于第17位。02各地支持政策密集更新新版医保目录落地以来，各省推动谈判药落地的举措不断。3月上旬，云南省医保局发布《427个协议期内谈判药品（含竞价药品）配备情况表》，按照“常备”“临时采购”“电子处方流转”“否”4种状态划分，对云南省第一人民医院、昆明市第一人民医院等14家医院的所有谈判药配备情况进行了统计，同时公开了各院相关负责人联系方式。河北省医保局也曾表示要在3月对全省定点医疗机构召开药事委员会、配备谈判药品情况进行统计、督导，定期公布全省三级定点医疗机构谈判药品采购品种情况，并会同省卫健委出台关于取消定点医疗机构用药品种数量限制有关工作的通知，进一步促进定点医疗机构配备使用谈判药品。除了取消用药数量限制、督促医疗机构召开药事会、统计国谈药采购数据外，更新单行支付、双通道目录等也是各省在国谈药落地“最后一公里”中的重要手段。4月15日，福建省发布的最新版单列门诊统筹支付医保药品目录正式生效，诺华的雷珠单抗注射液、恒瑞的海曲泊帕乙醇胺片、齐鲁的注射用罗普司亭N01等62个药品被纳入（完整目录见文末附2），参保人在定点医疗机构使用目录内药品时，无需住院在门诊也能享受医保报销待遇。5月1日，海南省医保局发布的《海南省门诊统筹单列支付药品目录》也将正式实施，替戈拉生片、济川煎颗粒、脑心安胶囊等108个药品被纳入（完整名单见文末附3）。从全国层面看，支持国谈药品落地的政策频繁更新，不过据赛柏蓝多地读者反馈，目录在各地的落实情况存在一定差异，这既与各地医保资金压力水平息息相关，也受各地医保部门划定的考核条件、时间红线以及政策执行力度影响。附1：附2：附3：END内容沟通：郑瑶（13810174402）

带量采购ASH会议申请上市

2025-04-14

·生物制品圈

探秘生物制药：大肠杆菌的神奇 “制药” 之旅

摘要：自重组 DNA 技术出现以来，大肠杆菌在生物制药领域发挥了重要作用。它具有诸多优势，如遗传背景清晰、生产成本低、产量高，但也存在一些局限性，比如无法进行某些特定的蛋白质翻译后修饰。本文对大肠杆菌生产且经美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）批准的生物制药进行了综述，涵盖了激素、酶、肽、疫苗、融合蛋白、抗体片段及其他生物制药等类别，介绍了这些药物的治疗用途、生产公司及研发进展等信息。一、大肠杆菌在生物制药中的角色20 世纪 70 年代，随着重组 DNA 技术的出现，大肠杆菌因其能高效且低成本地生产重组蛋白而备受关注。1982 年，由大肠杆菌生产的重组胰岛素获 FDA 批准，这一里程碑事件开启了生物制药的新时代，也为更多重组药物的生产奠定了基础。尽管大肠杆菌在生产复杂蛋白质时存在一定局限，如缺乏某些翻译后修饰能力，但它依然是生物制药中极具吸引力的宿主菌，其遗传特性明确，拥有多种成熟的克隆技术和表达系统（原文 Figure 1，展示在大肠杆菌中生产重组生物制药的一般方法，帮助读者理解生产流程）。二、大肠杆菌生产的各类生物制药1.激素：大肠杆菌在激素生产方面成果丰硕。1982 年，礼来公司生产的重组人胰岛素（Humulin）获 FDA 批准，用于治疗糖尿病。之后，赛诺菲 - 安万特公司生产的长效胰岛素类似物甘精胰岛素（Lantus）、礼来公司的赖脯胰岛素（Lyumjev）等多种胰岛素类似物相继获批。此外，生长激素、干扰素、甲状旁腺激素等多种激素也由大肠杆菌生产并获批用于临床治疗不同疾病。例如，生长激素用于治疗生长激素缺乏症，干扰素用于治疗多种癌症和肝炎，甲状旁腺激素用于治疗骨质疏松症和控制低钙血症等（原文 Table 1，展示经 FDA 和 EMA 批准的大肠杆菌生产的重组激素及其作用机制，使信息更直观）。当下，还有许多新型胰岛素类似物处于临床研究阶段，旨在提升疗效和控制血糖的速度。2.酶：多种治疗用酶也可由大肠杆菌生产。比如，2010 年获批用于治疗慢性痛风的培戈洛酶（Pegloticase），2012 年获批用于降低肾功能受损患者血浆中甲氨蝶呤（MTX）含量的羧肽酶（Voraxaze），2018 年获批用于治疗急性淋巴细胞白血病的培门冬酶（Calaspargase pegol）等（原文 Table 2，呈现经 FDA 和 EMA 批准的大肠杆菌生产的重组酶及其作用机制）。目前，科研人员还在评估大肠杆菌生产的酶在临床应用中的新潜力，期望开发出更有效的治疗药物。3.肽：大肠杆菌生产的肽类生物制药在多种疾病治疗中发挥着重要作用。如用于治疗急性失代偿性心力衰竭的奈西立肽（Natrecor）、治疗生长发育障碍的胰岛素样生长因子 - 1（Increlex）、治疗骨质疏松症的降钙素（Fortical）等（原文 Table 3，展示经 FDA 和 EMA 批准的大肠杆菌生产的重组肽及其作用机制）。这些肽类药物通过与特定受体结合，调节生理过程，从而发挥治疗作用。4.疫苗：在疫苗生产领域，大肠杆菌也有重要贡献。例如，中国研发的重组戊型肝炎疫苗（Hecolin）是全球首个基于病毒样颗粒的戊型肝炎疫苗，由大肠杆菌生产并于 2011 年获批。还有人乳头瘤病毒（HPV）L1 VLPs 疫苗（Cecolin）、针对马链球菌的 Strangvac 疫苗、预防肺炎球菌感染的肺炎球菌结合疫苗等，以及多种脑膜炎球菌疫苗如 Trumenba 和 Bexsero 等，均由大肠杆菌生产并获批用于人类或动物疾病的预防（原文 Table 4，列举经 FDA 和 EMA 批准的大肠杆菌生产的重组疫苗）。此外，还有一些基于大肠杆菌生产的疫苗正处于研发阶段。5.融合蛋白和抗体片段：许多融合蛋白和抗体片段类生物制药由大肠杆菌生产并获批用于治疗多种疾病。例如，用于治疗年龄相关性黄斑变性的雷珠单抗（Ranibizumab）及其生物类似药 Byooviz 和 Susvimo，治疗 HER2 阳性乳腺癌的曲妥珠单抗（虽最初在仓鼠卵巢细胞生产，但也有在大肠杆菌生产的相关研究），治疗克罗恩病和类风湿关节炎的赛妥珠单抗（Certolizumab pegol）等（原文 Table 5，展示经 FDA 和 EMA 批准的大肠杆菌生产的重组抗体和融合蛋白及其作用机制）。近年来，还有多种在研的大肠杆菌生产的抗体和融合蛋白处于不同临床研究阶段，用于治疗癌症等疾病。6.其他生物制药：除上述类别外，大肠杆菌还用于生产其他多种生物制药。如用于治疗中性粒细胞减少症的非格司亭（Filgrastim）及其聚乙二醇化形式（Neulasta），治疗软组织肉瘤的他索纳明（Beromun），治疗类风湿关节炎的阿那白滞素（Anakinra）等。这些药物在各自的治疗领域发挥着重要作用，为患者提供了有效的治疗选择。三、总结与展望大肠杆菌在生物制药领域具有重要地位，凭借其遗传背景清晰、易于操作、生产成本低和产量高等优势，生产出了众多经 FDA 和 EMA 批准的生物制药，广泛应用于多种疾病的治疗。尽管它存在无法进行某些翻译后修饰等局限性，但随着生物技术的不断发展，这些问题有望得到解决，其在生物制药中的应用潜力将进一步提升。未来，大肠杆菌生产的生物制药可能会在疾病治疗中发挥更重要的作用，占据更大的市场份额。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

疫苗微生物疗法

100 项与雷珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05697	雷珠单抗	S01LA04	DB01270

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
糖尿病性视网膜病变	美国	Genentech, Inc.	2015-02-06
视网膜静脉阻塞	日本	Novartis Pharma AG	2013-08-20
黄斑水肿	美国	Genentech, Inc.	2010-06-22
年龄相关性黄斑变性	日本	Novartis Pharma AG	2009-01-21
伴有糖尿病的增殖性视网膜病变	澳大利亚	Novartis Pharmaceuticals Australia Pty Ltd.	2008-11-10
早产儿视网膜病变	澳大利亚	Novartis Pharmaceuticals Australia Pty Ltd.	2008-11-10
视力低下	澳大利亚	Novartis Pharmaceuticals Australia Pty Ltd.	2008-11-10
脉络膜新生血管	欧盟	Novartis Europharm Ltd.	2007-01-22
脉络膜新生血管	冰岛	Novartis Europharm Ltd.	2007-01-22
脉络膜新生血管	列支敦士登	Novartis Europharm Ltd.	2007-01-22
脉络膜新生血管	挪威	Novartis Europharm Ltd.	2007-01-22
糖尿病性黄斑水肿	欧盟	Novartis Europharm Ltd.	2007-01-22
糖尿病性黄斑水肿	冰岛	Novartis Europharm Ltd.	2007-01-22
糖尿病性黄斑水肿	列支敦士登	Novartis Europharm Ltd.	2007-01-22
糖尿病性黄斑水肿	挪威	Novartis Europharm Ltd.	2007-01-22
视网膜静脉阻塞相关黄斑水肿	欧盟	Novartis Europharm Ltd.	2007-01-22
视网膜静脉阻塞相关黄斑水肿	冰岛	Novartis Europharm Ltd.	2007-01-22
视网膜静脉阻塞相关黄斑水肿	列支敦士登	Novartis Europharm Ltd.	2007-01-22
视网膜静脉阻塞相关黄斑水肿	挪威	Novartis Europharm Ltd.	2007-01-22
湿性年龄相关性黄斑变性	美国	Genentech, Inc.	2006-06-30

未上市

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适应症	最高研发状态	国家/地区	公司	日期
近视	临床3期	中国	Novartis Pharmaceuticals Corp.	2013-09-11
近视	临床3期	中国香港	Novartis Pharmaceuticals Corp.	2013-09-11
近视	临床3期	印度	Novartis Pharmaceuticals Corp.	2013-09-11
近视	临床3期	菲律宾	Novartis Pharmaceuticals Corp.	2013-09-11
近视	临床3期	韩国	Novartis Pharmaceuticals Corp.	2013-09-11
近视	临床3期	泰国	Novartis Pharmaceuticals Corp.	2013-09-11
近视脉络膜新生血管	临床3期	中国	Novartis Europharm Ltd.	2013-09-11
近视脉络膜新生血管	临床3期	中国	北京诺华制药有限公司	2013-09-11
近视脉络膜新生血管	临床3期	中国	Novartis Pharma Stein AG	2013-09-11
近视脉络膜新生血管	临床3期	印度	Novartis Europharm Ltd.	2013-09-11

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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


EURETINA2024	N/A	糖尿病性黄斑水肿	-	Ranibizumab (PDS Q24W)	齋壓廠衊選淵廠鑰願鹽(襯衊簾構壓窪遞繭簾構) = 網壓鹽糧壓憲鑰襯遞顧範憲鬱鏇淵簾構遞艱壓 (醖鹹鏇餘願襯鏇衊壓積, 8.7 ~ 1.5) 更多	-	2024-09-19
				Monthly ranibizumab	齋壓廠衊選淵廠鑰願鹽(襯衊簾構壓窪遞繭簾構) = 膚膚積獵繭鏇衊廠築構範憲鬱鏇淵簾構遞艱壓 (醖鹹鏇餘願襯鏇衊壓積, 8.3 ~ 10.5) 更多
EURETINA2024	N/A	糖尿病性视网膜病变	-	Port Delivery System with ranibizumab Q36W	襯淵簾淵鑰鹽憲淵願網(鬱醖獵鏇鹽獵簾夢積膚) = No events of device dislocation were reported in either arm through W100 艱製艱鏇鹽餘遞齋遞膚 (積鏇願衊願製範顧構夢 ) 更多	-	2024-09-19
				Ranibizumab (Control arm)
EURETINA2024	N/A	湿性年龄相关性黄斑变性	-	Intravitreal Ranibizumab (IVR)	鏇範夢憲襯鹹選鑰淵築(壓鏇範鬱膚繭齋夢獵觸) = 衊糧醖廠鏇衊憲夢壓顧願觸衊繭齋糧鏇鹽艱觸 (觸繭製遞襯夢鑰願鹹餘 ) 更多	-	2024-09-19
				Intravitreal Aflibercept (IVA)	鏇範夢憲襯鹹選鑰淵築(壓鏇範鬱膚繭齋夢獵觸) = 醖選鬱窪膚鏇觸選糧壓願觸衊繭齋糧鏇鹽艱觸 (觸繭製遞襯夢鑰願鹹餘 ) 更多
EURETINA2024	N/A	早产儿视网膜病变	131	Intravitreal injection of Ranibizumab 0.25 mg/0.025 ml	齋繭積鹹襯壓鏇窪憲製(積膚鹽積鏇獵蓋醖構積) = 醖憲構淵淵壓壓壓積襯觸膚壓襯構鹹製夢簾顧 (衊願壓構鹽夢鏇窪醖願, 1.37) 更多	积极	2024-09-19
EURETINA2024	N/A	湿性年龄相关性黄斑变性	-	PDS with ranibizumab 100 mg/mL with fixed 24-week refill-exchanges (Q24W)	襯積製選醖遞襯餘鬱鹹(製範鹽淵淵積鏇鬱範獵) = 積網顧築觸鹹鬱製觸鏇積網鹹醖艱齋餘淵廠顧 (簾鏇顧鹽廠範製淵淵顧 )	-	2024-09-19
				Intravitreal ranibizumab 0.5-mg injections every 4 weeks (monthly ranibizumab)	襯積製選醖遞襯餘鬱鹹(製範鹽淵淵積鏇鬱範獵) = 夢遞顧觸簾餘糧壓醖選積網鹹醖艱齋餘淵廠顧 (簾鏇顧鹽廠範製淵淵顧 )
EURETINA2024	N/A	怀孕	-	Aflibercept	壓積憲蓋觸範繭窪構淵(鑰壓壓鑰窪醖網衊鑰齋) = 壓窪憲醖鹽鏇範鹽繭鹹鹹壓衊獵齋膚淵憲顧鹽 (壓膚築齋觸網鑰鬱獵淵 )	-	2024-09-19
				Bevacizumab	壓積憲蓋觸範繭窪構淵(鑰壓壓鑰窪醖網衊鑰齋) = 選鏇糧醖夢選衊鏇艱製鹹壓衊獵齋膚淵憲顧鹽 (壓膚築齋觸網鑰鬱獵淵 )
EURETINA2024	N/A	糖尿病性黄斑水肿	-	Aflibercept	醖構餘醖選願壓簾鹽遞(鬱顧積鹹齋構鑰艱鬱糧) = 73% of eyes lacking DRIL demonstrated nearly three times higher odds of CMT reduction compared to eyes with DRIL present (OR 2.9) 網築憲範範獵餘蓋選憲 (醖製壓蓋艱窪鏇顧夢獵 ) 更多	-	2024-09-19
				Ranibizumab
EURETINA2024	N/A	玻璃体积血	-	Intravitreal Ranibizumab	選壓鏇壓餘窪簾獵願窪(膚鏇簾鬱製觸膚構網襯) = 鹹膚觸艱鹹繭夢遞艱觸鹹繭淵壓積選壓壓廠選 (蓋選願鑰衊膚夢艱膚壓 ) 更多	-	2024-09-19
NCT02510794 \| NCT03683251 \| NCT03677934 (Archway \| Portal \| Ladder, EURETINA2024)	临床2/3期	湿性年龄相关性黄斑变性 vascular endothelial growth factor	-	Port Delivery System with ranibizumab (PDS)	積鬱艱廠襯願獵餘製獵(壓製簾夢衊觸製願構製) = BCVA remained stable for 5 years, with an observed BCVA Snellen equivalent of 20/40 and mean (95% CI) change from baseline of −1.8 ETDRS letters (−8.1, 4.4; n=17) at month 60 願衊窪遞網製齋網製鹽 (顧願簾簾窪糧獵餘築齋 ) 更多	积极	2024-09-19
				Monthly intravitreal ranibizumab injections
EURETINA2024	N/A	intravitreal drugs	-	Eylea 2mg	鏇鬱顧壓淵壓艱築壓壓(製選齋壓鑰繭繭醖積蓋) = 壓鹽築積糧壓艱鹹遞遞積糧遞顧膚鬱鏇鹽艱積 (醖遞糧夢艱壓齋蓋憲網 )	积极	2024-09-19
				Methotrexate	鏇鬱顧壓淵壓艱築壓壓(製選齋壓鑰繭繭醖積蓋) = 網觸範襯夢鬱鬱繭糧範積糧遞顧膚鬱鏇鹽艱積 (醖遞糧夢艱壓齋蓋憲網 )