贝伐珠单抗生物类似药(Outlook Therapeutics)(Bevacizumab biosimilar(Outlook Therapeutics)) - 药物靶点：VEGF-A_在研适应症：湿性年龄相关性黄斑变性，糖尿病性黄斑水肿，视网膜静脉阻塞_专利_临床

概要

基本信息

药物类型

生物类似药、单克隆抗体

别名

Bevacizumab Biosimilar (Outlook Therapeutics, Inc.)、Bevacizumab gamma(Outlook Therapeutics)、Bevacizumab-vikg(Outlook Therapeutics)

+ [7]

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)、血管生成抑制剂

治疗领域

遗传病与畸形眼部疾病肿瘤+ [8]

在研适应症

湿性年龄相关性黄斑变性糖尿病性黄斑水肿视网膜静脉阻塞+ [13]

非在研适应症

脉络膜新生血管

原研机构

Outlook Therapeutics, Inc.

在研机构

上海君实生物医药科技股份有限公司

Outlook Therapeutics, Inc.

上海华奥泰生物药业股份有限公司

+ [2]

非在研机构-

权益机构

Cencora, Inc.

Mediconsult Oy

上海华奥泰生物药业股份有限公司

+ [3]

最高研发阶段批准上市

首次获批日期

欧盟 (2024-05-27),

湿性年龄相关性黄斑变性

最高研发阶段(中国)临床3期

特殊审评-

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结构/序列

Sequence Code 41632

Sequence Code 41637

关联

9

项与贝伐珠单抗生物类似药(Outlook Therapeutics) 相关的临床试验

NCT07503756

/ Recruiting临床2期

An Open-label, Multicenter Phase 2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JS212 Combination Therapies in Patients With Metastatic Colorectal Cancer

This is an open-label, multicenter Phase 2 clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS212-based combination therapies in patients with metastatic colorectal cancer (mCRC).
JS212 is a bispecific antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) and HER3 with a topoisomerase I inhibitor payload. Preclinical and early clinical data suggest that dual targeting of EGFR and HER3 may enhance antitumor activity and overcome resistance mechanisms associated with EGFR- or HER2-directed therapies.
This study will investigate JS212 in combination with capecitabine, with or without Bevacizumab, and JS212 in combination with chemotherapy (XELOX: capecitabine and oxaliplatin), with or without the PD-1/VEGF bispecific antibody JS207, in patients with mCRC.
The study will assess safety, determine the recommended Phase 3 dose (RP3D), and evaluate preliminary antitumor activity of the combination regimens.

开始日期2026-04-25

申办/合作机构

上海君实生物医药科技股份有限公司

NCT06839105

/ Recruiting临床1期

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AWT020 Alone and in Combination With Other Antitumor Therapies in Patients With Advanced Malignancies

The purpose of this phase I clinical study was to evaluate the safety and tolerability of AWT020 monotherapy and combination with other antitumor therapies in patients with advanced malignancies

开始日期2025-02-21

申办/合作机构

上海君实生物医药科技股份有限公司

NCT06190093

/ Completed临床3期

Safety and Effectiveness of ONS-5010 Compared to Lucentis® in Subjects With Neovascular Age-related Macular Degeneration; NORSE EIGHT

Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.

开始日期2024-01-24

申办/合作机构

Outlook Therapeutics, Inc.

100 项与贝伐珠单抗生物类似药(Outlook Therapeutics) 相关的临床结果

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100 项与贝伐珠单抗生物类似药(Outlook Therapeutics) 相关的转化医学

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100 项与贝伐珠单抗生物类似药(Outlook Therapeutics) 相关的专利（医药）

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2

项与贝伐珠单抗生物类似药(Outlook Therapeutics) 相关的文献（医药）

Journal of market access & health policy

Network Meta-Analysis of Bevacizumab Gamma Versus Competing Interventions for Treating Neovascular Age-Related Macular Degeneration in the United Kingdom

Review

作者: Ebohon, Stephen ; Garnham, Andy ; Bouchet, Christine ; Paap, Mayke ; Comiskey, Jedd ; Lorenzi, Maria ; Wissinger, Erika ; Kissner, Jennifer

This study aimed to determine the relative efficacy of bevacizumab gamma (an ophthalmic formulation of bevacizumab) versus alternative interventions relevant to the treatment of neovascular age-related macular degeneration (nAMD) in the United Kingdom (UK) via a systematic literature review (SLR) and network meta-analysis (NMA). An SLR was conducted to identify randomized controlled trials (RCTs) of anti-vascular endothelial growth factor (anti-VEGF) therapies for the treatment of nAMD in adult patients relevant to the UK context. The included anti-VEGF treatments were ranibizumab, aflibercept, faricimab, and bevacizumab gamma. Bayesian NMA models were used to estimate relative efficacy in terms of change from baseline (CFB) in best-corrected visual acuity (BCVA) at 12 months, the proportion of patients gaining 15 or more letters at 12 months, and the proportion of patients losing less than 15 letters at 12 months. Twenty-two relevant RCTs were included in the NMA. At 12 months, all anti-VEGF treatments were similarly efficacious to ranibizumab 0.5 mg every four weeks (Q4W) in terms of CFB in BCVA, the proportion of patients gaining 15 or more letters, and the proportion of patients losing less than 15 letters (except for ranibizumab 0.5 mg every 12 weeks [Q12W] and ranibizumab 0.5 mg pro re nata [PRN]). Bevacizumab gamma provided similar improvements in visual acuity to other anti-VEGF treatments.

Frontiers in pharmacology2区 · 医学

A Randomized, Double-Blind, Single-Dose Study Comparing the Biosimilarity of HOT-1010 With Bevacizumab (Avastin®) in Chinese Healthy Male Subjects

2区 · 医学

ArticleOA

作者: Gu, Xianghong ; Zhu, Xiangyang ; Wang, Jiakun ; Tang, Yuan ; Zhang, Lin ; Li, Zhenni ; Que, Linling ; Shi, Yunfei ; Zhang, Jisheng ; Huang, Kai ; Yang, Yongmin ; Qian, Zhenzhong ; Qin, Wei ; Chen, Yuanxin ; Ding, Ying ; Chu, Nannan ; He, Qing

Objective: This study was conducted to compare the pharmacokinetics, safety and immunogenicity of HOT-1010 with bevacizumab (Avastin®) in Chinese healthy male subjects.Methods: A single-center, randomized, double-blind, single-dose, parallel trial was performed in 84 Chinese healthy male subjects who randomly (1:1) received a single intravenous infusion of 1 mg/kg HOT-1010 or Avastin® for 90 min and followed up for 85 days. Serum concentrations of bevacizumab were analyzed by enzyme-linked immunosorbent assay. Primary pharmacokinetic parameters, Cmax, AUC0-t and AUC0-∞, were calculated and evaluated the bioequivalence between HOT-1010 and Avastin®, the safety and immunogenicity of investigational drugs were also assessed.Results: A total of 82 subjects completed the study. The 90% Confidence Intervals for geometric mean ratios of Cmax, AUC0-t and AUC0-∞ were 91.81–103.64%, 85.19–95.39% and 85.04–95.36%, which were all within the bioequivalence margin. Treatment-emergent adverse events were reported in 27 (65.9%) subjects in HOT-1010 group and 23 (56.1%) subjects in Avastin® group. Most TEAEs were mild or moderate. No TEAEs, Serious Adverse Events or deaths leading to discontinuation was reported. Subjects were all tested negative for Anti-drug Antibody.Conclusion: HOT-1010 exhibited the similar pharmacokinetics, safety and immunogenicity profiles of bevacizumab (Avastin®) in Chinese healthy male subjects.Clinical Trial Registration:http://www.chinadrugtrials.org.cn/index.html, CTR20181610.

299

项与贝伐珠单抗生物类似药(Outlook Therapeutics) 相关的新闻（医药）

2026-08-06

·拓展生命无限可能

【II期临床试验】免疫增强+抗血管协同增效！PD-L1/VEGF双抗新药HB0025联合化疗招募MSS或MSI-L/pMMR的初治转移性结直肠癌患者！

#肠癌一线临床试验简要入排本临床药物为靶向PD-L1/VEGF的双特异性融合蛋白；目前招募MSS或MSI-L/pMMR的转移性结直肠癌患者；年龄≥18岁；既往未接受过针对复发或转移性结直肠癌的全身系统性抗肿瘤治疗，且不适合接受根治性手术切除或局部治疗；排除已知MSI-H或dMMR的结直肠癌患者；排除原发灶位于左侧（自脾曲到直肠）且肿瘤部位检测BRAF、KRAS和NARS基因为野生型的结直肠癌患者（上述基因为突变型可纳入研究）；排除既往接受过干细胞、骨髓或实体器官移植者；脑转移患者需治疗后稳定4周以上；全国多中心。研究中心陕西汉中、西安重庆广西南宁河南郑州湖北武汉山西太原上海四川成都山东济南、临沂、济宁安徽亳州、合肥福建福州、厦门广东深圳、广州、佛山北京贵州贵阳黑龙江哈尔滨湖南长沙吉林长春江苏南京、徐州江西南昌辽宁沈阳新疆乌鲁木齐云南昆明浙江杭州天津具体启动情况以后期咨询为准【研究中心若有更新请拉至文末查看】试验名称一项评价HB0025注射液联合不同化疗方案一线治疗不可手术切除的转移性结直肠癌患者中的疗效与耐受性的多中心II期临床研究。试验药物 HB0025是一款创新型抗PD-L1/VEGF双特异性融合蛋白，同时靶向肿瘤免疫逃逸通路PD-L1和肿瘤血管生成通路VEGF。可阻断PD-L1可解除PD-1/PD-L1通路介导的免疫抑制作用、活化细胞毒T淋巴细胞，从而抑制肿瘤生长；阻断VEGF可抑制血管内皮细胞增殖和新生血管的形成，抑制肿瘤生长。该药设计实现了两个靶点的高亲和力结合，协同调控肿瘤免疫微环境与血管生成，具备“免疫增强+抗血管”双重抗肿瘤机制。临床前研究表明，HB0025对上述两条信号通路的阻断具有协同作用，其疗效显著优于单药及两单药的联合用药。目前HB0025已进入多个临床II期研究，并在不同瘤种中观测到积极信号，包括不同肿瘤类型患者的完全缓解（CR）和部分缓解（PR）。研究药物：HB0025注射液联合不同化疗方案（II期）登记号：CTR20254814 试验类型：对照试验（VS 贝伐珠单抗联合化疗）适应症：转移性结直肠癌（一线）申办方：华博生物医药技术（上海）有限公司/上海华奥泰生物药业股份有限公司用药周期 HB0025注射液的规格：100mg/4ml/瓶；用法用量：按照体重计算给药剂量，给药剂量为10mg/kg或20mg/kg。每2周(14天)为一个治疗周期。受试者在每个周期的第一天接受HB0025注射液静脉输注。对照药如下：贝伐珠单抗的规格：100mg:4ml/支；用法用量：1、每个治疗周期D1给药，5mg/kg，静脉输注；2、以首次给药前基线体重测量进行计算。更多项目信息请参考： http://www.chinadrugtrials.org.cn/index.html 温馨提示：文章入排信息来源于国家临床试验官网公示信息，具体情况以实际咨询为准！报名方式参与临床试验，获取国际前沿新药新疗法使用机会！更有一线专家团队为你的治疗保驾护航！【印塔健康】目前有肺癌、肝癌、肾癌、胃癌、肠癌、胰腺癌、妇瘤、泌尿肿瘤、血液肿瘤......等几乎涵盖所有癌种的临床试验正在招募患者！扫描下方二维码添加医学运营一对一咨询或点击左下角“阅读原文”直接报名！我们将会在24小时内（工作日）与您电话或微信联系，请保持手机畅通！ #HB0025 #华博生物 #华奥泰生物 #PD—L1×VEGF靶向免疫双抗 #结直肠癌新药临床招募 #MSS肠癌新药临床招募 #MSI—L肠癌新药临床招募 #pMMR肠癌新药临床招募【重要提示】印塔健康旗下公众号【拓展生命无限可能】所有文章信息仅供参考，具体治疗谨遵医嘱！

2026-08-06

·BioSpace

Outlook Therapeutics to Report Third Quarter Fiscal Year 2026 Financial Results and Host a Corporate Update Conference Call and Webcast on August 14, 2026

ISELIN, N.J., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal diseases, today announced that it will report its financial results for the third quarter fiscal year 2026 and will host a corporate update conference call and webcast on Friday, August 14, 2026, at 8:30 AM ET. The call will be hosted by members of Outlook Therapeutics’ leadership team, Bob Jahr, Chief Executive Officer, and Lawrence A. Kenyon, Executive Vice President and Chief Financial Officer. Interested participants and investors may access the conference call by dialing 877-407-8291 (domestic) or +1 201-689-8345 (international) and referencing the Outlook Therapeutics conference call. The webcast will be accessible on the Events page of the Investor section of the Outlook Therapeutics website, outlooktherapeutics.com . It will also accessible here and will be archived for 90 days. About Outlook Therapeutics, Inc. Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of LYTENAVA™ (bevacizumab-vikg (U.S.), bevacizumab gamma (E.U.)). LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive U.S. FDA approval and European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany, Austria, and the UK as a treatment for wet AMD. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Investor Inquiries: Jenene Thomas Chief Executive Officer JTC Team, LLC T: 908.824.0775 OTLK@jtcir.com

上市批准财报

2026-08-04

·拓展生命无限可能

【II期临床试验】君实生物新型强效EGFR/HER3双抗ADC药物注射用JS212联合治疗招募既往经过一线标准治疗失败的晚期结直肠癌患者！

#肠癌≥二线临床试验简要入排本临床药物为EGFR/HER3双抗ADC药物；目前招募晚期结直肠癌患者；要求既往经过一线标准治疗失败或不耐受的患者；年龄：18~75岁；入组前需提供合格的当地医院出具的RAS/RAF检查报告；提供存档或最近采集的（优先最近采集的）福尔马林固定石蜡包埋（FFPE）肿瘤组织切片进行生物标志物检测；排除既往接受过以EGFR和/或HER3为靶点的ADC（伦康依隆妥单抗等）治疗，或既往接受过以拓扑异构酶I抑制剂为毒素载荷的ADC（德曲妥珠单抗、戈沙妥珠单抗等）治疗；脑转移患者需治疗后稳定4周以上；全国多中心。研究中心北京重庆福建福州、厦门河南郑州湖北武汉辽宁沈阳四川遂宁浙江温州安徽合肥广东广州、东莞、梅州黑龙江哈尔滨吉林长春江苏南京山西大同上海云南昆明具体启动情况以后期咨询为准【研究中心若有更新请拉至文末查看】试验名称一项评价JS212联合治疗在晚期结直肠癌患者中的安全性、耐受性、药代动力学和初步疗效的开放、多中心II期临床研究。试验药物注射用JS212是重组人源化抗表皮生长因子受体（EGFR）和人表皮生长因子受体3（HER3）双特异性抗体偶联药物（ADC），主要用于晚期恶性实体瘤的治疗。EGFR和HER3在多种肿瘤细胞表面存在高表达，如肺癌、结直肠癌、头颈部肿瘤等。EGFR和HER3之间存在信号通路的相互作用，共同参与促进肿瘤细胞的增殖、存活、迁移和血管生成等过程；此外，HER3参与多种抗肿瘤药物（包括EGFR靶向药物和化疗等）的耐药性机制。与单一靶点ADC药物相比，JS212能够通过与EGFR或HER3结合发挥肿瘤抑制作用，有望对更广泛的肿瘤有效，同时有望克服耐药性问题。临床前研究显示，JS212与EGFR和HER3具有高亲和力、特异性结合作用，在多个动物模型中展示了显著的抑瘤作用。同时，JS212具备良好、可接受的安全性。研究药物：JS212联合治疗（II期）登记号：CTR20261157 试验类型：单臂试验适应症：晚期结直肠癌（二线）申办方：上海君实生物医药科技股份有限公司用药周期注射用JS212的规格：50mg/瓶，1瓶/盒；用法用量：用法：静脉滴注给药用量：本试验中的用法用量，非说明书信息，根据剂量组选择用药剂量，静脉滴注；用药时程：多次给药，用药至影像学证实的疾病进展、毒性不耐受等。注射用JS207的规格：210mg/瓶，1瓶/盒；用法用量：用法：静脉滴注给药用量：本试验中的用法用量，非说明书信息，根据剂量组选择用药剂量，静脉滴注；用药时程：多次给药，用药至影像学证实的疾病进展、毒性不耐受等。卡培他滨片的规格：0.5g/片，12片/盒；0.15g/片，10片/盒；用法用量：用法：口服，用量：每周期第1-14天，800mg/m2；用药时程：多次给药，用药至影像学证实的疾病进展、毒性不耐受等。注射用奥沙利铂的规格：50mg/支，1支/盒；用法用量：用法:静脉注射给药用量：每周期第一天，100mg/m2；用药时程：多次给药，用药至影像学证实的疾病进展、毒性不耐受等。贝伐珠单抗注射液的规格：100mg:4ml/支，1支/盒；用法用量：用法:静脉注射给药，用量：每周期第一天，7.5mg/kg；用药时程：多次给药，用药至影像学证实的疾病进展、毒性不耐受等。更多项目信息请参考： http://www.chinadrugtrials.org.cn/index.html 温馨提示：文章入排信息来源于国家临床试验官网公示信息，具体情况以实际咨询为准！报名方式参与临床试验，获取国际前沿新药新疗法使用机会！更有一线专家团队为你的治疗保驾护航！【印塔健康】目前有肺癌、肝癌、肾癌、胃癌、肠癌、胰腺癌、妇瘤、泌尿肿瘤、血液肿瘤......等几乎涵盖所有癌种的临床试验正在招募患者！扫描下方二维码添加医学运营一对一咨询或点击左下角“阅读原文”直接报名！我们将会在24小时内（工作日）与您电话或微信联系，请保持手机畅通！ #注射用JS212#君实生物 #EGFR×HER3双抗ADC药物 #结直肠癌新药临床招募【重要提示】印塔健康旗下公众号【拓展生命无限可能】所有文章信息仅供参考，具体治疗谨遵医嘱！

100 项与贝伐珠单抗生物类似药(Outlook Therapeutics) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
湿性年龄相关性黄斑变性	欧盟	Outlook Therapeutics NL BV	2024-05-27
湿性年龄相关性黄斑变性	冰岛	Outlook Therapeutics NL BV	2024-05-27
湿性年龄相关性黄斑变性	列支敦士登	Outlook Therapeutics NL BV	2024-05-27
湿性年龄相关性黄斑变性	挪威	Outlook Therapeutics NL BV	2024-05-27

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适应症	最高研发状态	国家/地区	公司	日期
糖尿病性黄斑水肿	临床3期	美国	Outlook Therapeutics, Inc.	2021-11-15
视网膜静脉阻塞	临床3期	美国	Outlook Therapeutics, Inc.	2021-11-15
视力低下	临床3期	美国	Outlook Therapeutics, Inc.	2021-11-15
非鳞状非小细胞肺癌	临床3期	中国	上海华奥泰生物药业股份有限公司	2021-03-16
年龄相关性黄斑变性	临床3期	美国	Outlook Therapeutics, Inc.	2019-06-25
脉络膜新生血管	临床3期	美国	Outlook Therapeutics, Inc.	2019-06-25
湿性黄斑变性	临床3期	美国	Outlook Therapeutics, Inc.	2019-06-25
大肠腺癌	临床1期	中国	上海君实生物医药科技股份有限公司	2025-02-21
结直肠癌	临床1期	中国	上海君实生物医药科技股份有限公司	2025-02-21
黑色素瘤	临床1期	中国	上海君实生物医药科技股份有限公司	2025-02-21

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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


NCT03834753 (NORSE 2, CTgov)	临床3期	脉络膜新生血管 \| 年龄相关性黄斑变性 \| 湿性年龄相关性黄斑变性 ... 更多	228	bevacizumab (Bevacizumab)	鏇構糧鏇顧壓獵淵蓋壓 = 簾淵鏇構選積鑰遞鹹選遞餘獵鏇齋鏇遞餘餘築 (鏇糧醖鑰構夢製艱築餘, 衊蓋壓膚遞網淵蓋廠蓋 ~ 廠餘觸構淵構衊憲壓艱) 更多	-	2026-08-03
				ranibizumab (Ranibizumab)	鏇構糧鏇顧壓獵淵蓋壓 = 製網糧鑰醖憲窪衊淵遞遞餘獵鏇齋鏇遞餘餘築 (鏇糧醖鑰構夢製艱築餘, 艱範衊積糧艱選糧鬱範 ~ 鏇顧憲憲鑰遞衊願積齋) 更多
NCT06190093 (NORSE EIGHT, CTgov)	临床3期	湿性年龄相关性黄斑变性	400	bevacizumab (ONS-5010 Bevacizumab)	襯齋窪遞醖醖選襯鏇鬱(觸鬱觸製醖鬱觸夢艱網) = 襯窪鏇艱積選糧獵獵觸遞蓋廠獵繭簾網餘製積 (蓋遞夢積窪鏇醖簾願蓋, 13.5) 更多	-	2026-06-30
				ranibizumab (Ranibizumab)	襯齋窪遞醖醖選襯鏇鬱(觸鬱觸製醖鬱觸夢艱網) = 簾憲淵夢築醖鹹膚遞鹽遞蓋廠獵繭簾網餘製積 (蓋遞夢積窪鏇醖簾願蓋, 12.6) 更多
NCT06190093 (NORSE EIGHT, GlobeNewswire) 人工标引	临床3期	湿性年龄相关性黄斑变性	-	ONS-5010 1.25 mg	蓋簾構襯鹽膚製艱繭衊(廠醖鹽網觸艱窪夢構壓) = 顧鬱鬱鹽網鏇構繭願鹹齋簾觸淵餘製鑰鬱繭鹽 (淵觸積築艱餘鏇蓋衊蓋 ) 未达到	不佳	2024-11-27
				Ranibizumab 0.5mg	蓋簾構襯鹽膚製艱繭衊(廠醖鹽網觸艱窪夢構壓) = 網蓋艱築製範範製鹽願齋簾觸淵餘製鑰鬱繭鹽 (淵觸積築艱餘鏇蓋衊蓋 ) 未达到
NCT03834753 (NORSE 2, GlobeNewswire) 人工标引	临床3期	湿性年龄相关性黄斑变性	228	ONS-5010	獵鑰構積網簾範選選醖(鏇鬱網衊夢鏇繭選顧醖) = 遞鏇鑰鏇構選繭鏇獵襯願範築蓋窪鑰構觸獵廠 (簾選願窪網鹽膚齋蓋齋 ) 更多	优效	2021-08-03
				Ranibizumab	獵鑰構積網簾範選選醖(鏇鬱網衊夢鏇繭選顧醖) = 鬱選艱膚選壓範鹹壓鹹願範築蓋窪鑰構觸獵廠 (簾選願窪網鹽膚齋蓋齋 ) 更多