A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetic Profiles, and Immunogenicity of JS026 and JS026 in Together With JS016 Administered Intravenously to Healthy Chinese Subjects

This is a first-in-human (FIH), randomized, double-blind, placebo-controlled, single-center phase I clinical trial of JS026 and JS026 + JS016 Injection. The objective of the study is to evaluate the safety, tolerability, PK profile and immunogenicity of a single intravenous infusion of JS026 and JS026 + JS016 Injection in healthy subjects.
In this study, the single ascending dose design will be adopted, JS026 will be administered sequentially from low dose group to high dose group, and each subject can only receive an intravenous infusion at one dose level. Five dose groups (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg) will be set to receive an intravenous infusion of JS026, and two dose groups (300 mg JS026 + 1200 mg JS016, and 600 mg JS026+ 1200 mg JS016) will be set for JS026 + JS016. The investigational product and placebo will be distributed in each dose group in a ratio of 3:1. Four subjects will be enrolled in each of JS026 30 mg and 100 mg groups, and 8 subjects will be enrolled in each of other dose groups, totally 48 subjects.

开始日期2021-12-16

申办/合作机构

上海君实生物医药科技股份有限公司

NCT04790786

/ Terminated临床4期IIT

The UPMC OPtimizing Treatment and Impact of Monocolonal antIbodieS Through Evaluation for COVID-19 Trial

Multiple monoclonal antibodies (mABs) have been shown to reduce viral burden and improve clinical outcomes, have been granted FDA Emergency Use Authorization (EUA) for use in select populations, and are routinely used in the UPMC Health System, which has made expanded access a priority. However, the comparative effectiveness of these mABS is unknown. The National Academies of Sciences, Engineering, and Medicine has called for expanded access and clinical use of mABs, noting it is "critical to collect data and evaluate whether they are working as predicted". This pragmatic evaluation will determine the relative effects of the EUA-governed mABs versus each other. When U.S. government mAB policies change (e.g., FDA grants or revokes EUAs), UPMC Health System policies and the evaluated mABs will accordingly change.

开始日期2021-03-10

申办/合作机构

University of Pittsburgh Medical Center

[+1]

NCT04931238

/ Unknown status临床2期IIT

Efficacy and Safety of a Recombinant Neutralizing Human Anti-SARS-CoV-2 Monoclonal Antibody JS016 in Chinese Hospitalized Patients With SARS-CoV-2 Infection (COVID-19): a Multicenter, Randomized, Open-label, Controlled Trial

The human monoclonal antibody CB6 showed potent neutralization activity in vitro against SARS-CoV-2. CB6-LALA (also called JS016) has been developed for clinical use. Phase I trials among healthy volunteers has demonstrated a tolerable and safe drug profile of JS016. We aim to evaluate the efficacy and safety of JS016 in patients hospitalized with COVID-19.

开始日期2021-01-20

申办/合作机构

北京协和医院

100 项与埃特司韦单抗相关的临床结果

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100 项与埃特司韦单抗相关的转化医学

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100 项与埃特司韦单抗相关的专利（医药）

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155

项与埃特司韦单抗相关的文献（医药）

2025-12-31·Emerging Microbes & Infections

Discovery of a pan anti-SARS-CoV-2 monoclonal antibody with highly efficient infected cell killing capacity for novel immunotherapeutic approaches

Article

作者: Roux-Portalez, Vincent ; Simonelli, Luca ; Varani, Luca ; Calderon, Hugo ; Gros, Nathalie ; Chentouf, Myriam ; Tamagnini, Elia ; Pugnière, Martine ; Vazquez, Mario ; Naranjo-Gomez, Mar ; Souchard, Manon ; Marsile-Medun, Soledad ; Juan, Manel ; Lyonnais, Sebastien ; Dinter, Heiko ; Pedotti, Mattia ; Pelegrin, Mireia ; Martineau, Pierre ; Ngo, Giang ; Abba Moussa, Daouda ; Chable-Bessia, Christine

Unlocking the potential of broadly reactive coronavirus monoclonal antibodies (mAbs) and their derivatives offers a transformative therapeutic avenue against severe COVID-19, especially crucial for safeguarding high-risk populations. Novel mAb-based immunotherapies may help address the reduced efficacy of current vaccines and neutralizing mAbs caused by the emergence of variants of concern (VOCs). Using phage display technology, we discovered a pan-SARS-CoV-2 mAb (C10) that targets a conserved region within the receptor-binding domain (RBD) of the virus. Noteworthy, C10 demonstrates exceptional efficacy in recognizing all assessed VOCs, including recent Omicron variants. While C10 lacks direct neutralization capacity, it efficiently binds to infected lung epithelial cells and induces their lysis via natural killer (NK) cell-mediated antibody-dependent cellular cytotoxicity (ADCC). Building upon this pan-SARS-CoV-2 mAb, we engineered C10-based, Chimeric Antigen Receptor (CAR)-T cells endowed with efficient killing capacity against SARS-CoV-2-infected lung epithelial cells. Notably, NK and CAR-T-cell mediated killing of lung infected cells effectively reduces viral titers. These findings highlight the potential of non-neutralizing mAbs in providing immune protection against emerging infectious diseases. Our work reveals a pan-SARS-CoV-2 mAb effective in targeting infected cells and demonstrates the proof-of-concept for the potential application of CAR-T cell therapy in combating SARS-CoV-2 infections. Furthermore, it holds promise for the development of innovative antibody-based and cell-based therapeutic strategies against severe COVID-19 by expanding the array of therapeutic options available for high-risk populations.Trial registration: ClinicalTrials.gov identifier: NCT04093596.

2025-02-04·JOURNAL OF INFECTIOUS DISEASES

Viral and Symptom Rebound Following Anti–Severe Acute Respiratory Syndrome Coronavirus 2 Monoclonal Antibody Therapy in a Randomized Placebo-Controlled Trial

Article

作者: Murtaugh, William ; Colsh, Kelly ; Singh, Upinder ; Kosmyna, Jan ; Rwakazina, Irene ; Corado, Katya ; Currier, Judith S ; Jilg, Nikolaus ; Eron, Joseph ; Giganti, Mark ; Shahkolahi, Akbar ; Greenfelder, Brian ; Pillay, Sandy ; Fischer, William ; Smith, Davey M ; Moser, Carlee ; Chew, Kara W ; Taiwo, Babafemi ; Evering, Teresa ; Ritz, Justin ; Cardoso, Sandra ; Riviere, Cynthia ; Wohl, David ; Wohl, David A ; Newell, Matthew ; Jagannathan, Prasanna ; Eron, Joseph J ; Beck, Justine ; Hosey, Lara ; Chew, Kara ; Patel, Nilam ; Gottesman, Joan ; Hughes, Michael D ; Dragavon, Joan ; Ignacio, Rachel Bender ; Perelson, Alan ; Hughes, Michael ; Pedersen, Susan ; Sieg, Scott ; Li, Jonathan ; Daar, Eric ; Smith, David (Davey) ; Roa, Jhoanna ; Currier, Judith ; Fletcher, Courtney ; Evering, Teresa H ; Li, Jonathan Z ; Gapara, Morgan ; Jennings, Cheryl ; McGinley, Brooke ; Daar, Eric S ; Margolis, David ; Javan, Arzhang Cyrus

Abstract:

We explored viral and symptom rebound after coronavirus disease 2019 amubarvimab-romlusevimab monoclonal antibody therapy versus placebo in the randomized ACTIV-2/A5401 trial. Participants underwent nasal severe acute respiratory syndrome coronavirus 2 polymerase chain reaction testing at study days 3, 7, 14, and 28. Viral rebound was defined as RNA ≥3 and ≥0.5 log10 copies/mL increase from day 3 or 7, and symptom rebound as hospitalization or any moderate/severe symptom for ≥2 days after initial symptom improvement. There was no difference in viral rebound (∼5%/arm) (analysis population n = 713) or symptom rebound among participants who initially improved (hazard ratio, 0.95 [95% confidence interval, .52–1.75]; analysis population n = 574); <1% had both viral/symptom rebound.

2025-02-01·Health Equity

Advancing Health Equity for American Indian and Alaska Native People Through Inclusion in Clinical Trials: Anti-SARS-CoV-2 Monoclonal Antibody Treatment and COVID-19 Outcomes Among Ambulatory Cherokee Nation Health Services Patients

Article

作者: Comiford, Ashley ; Essex, Whitney ; Feder, Molly A. ; Coyle, Elizabeth Menstell ; Mera, Jorge

Background:

Racial/ethnic minority groups are underrepresented in clinical trials with American Indian and Alaska Native (AI/AN) people having the lowest representation. This article aims to contribute to the literature to address that gap by sharing the results of the use of anti-SARS-CoV-2 monoclonal antibodies among AI/AN people at risk for severe COVID-19.

Methods:

This retrospective cohort study assessed data from ambulatory AI/AN patients enrolled in Cherokee Nation Health Services in Northeastern Oklahoma, who had a positive test for SARS-CoV-2, high risk for progression, and were offered anti-SARS-CoV-2 monoclonal antibody treatment active against the circulating SARS-CoV-2 strain from December 1, 2020, to April 16, 2021. The outcomes of interest were all-cause and COVID-19-related emergency department visits, hospitalizations, intensive care admissions, and deaths within 28 days of being offered treatment.

Results:

Among 1,447 participants, 813 (56.2%) were treated and 634 (43.8%) were not. When adjusted for potential confounders, there was a significant difference in the odds of treated versus untreated patients experiencing a COVID-19-related emergency department visit (OR, 0.42; 95% CI, 0.27-0.63) and hospitalization (OR, 0.10; 95% CI, 0.03-0.31).

Discussion:

Anti-SARS-CoV-2 monoclonal antibody treatment was associated with lower odds of COVID-19-related emergency department visits and hospitalization among high-risk AI/AN patients.

Health Equity Implications:

To advance health equity, it is critical to have representation of AI/AN in clinical trials and other research. This project is an example of how community partnerships with AI/AN health systems can strengthen the evidence for new and emerging treatments, address past harm, and advance equity.

277

项与埃特司韦单抗相关的新闻（医药）

2025-05-28

·美通社

君实生物宣布君适达®(抗PCSK9单抗）新增两项适应症在中国获批

上海 2025年5月28日 /美通社/ -- 北京时间2025年5月27日，君实生物（1877.HK，688180.SH）宣布，由公司自主研发的昂戈瑞西单抗注射液（重组人源化抗PCSK9单克隆抗体注射液，商品名：君适达 ® ）用于：1）杂合子型家族性高胆固醇血症（HeFH）的成人患者；2）在他汀类药物不耐受或禁忌使用的患者中，单独或与依折麦布联合用药用于非家族性高胆固醇血症和混合型血脂异常的成人患者的两项新适应症上市申请近日获得国家药品监督管理局（NMPA）批准。此次获批包括2种规格，分别为150mg（1ml）/支（预充式注射器）、150mg（1ml）/支（预充式自动注射器）。昂戈瑞西单抗成为首个获批用于他汀不耐受人群的国产PCSK9靶点药物。《中国血脂管理指南（2023年）》 [1] 指出，心血管疾病是我国城乡居民第一位死因，其中以动脉粥样硬化性心血管疾病（ASCVD）为主。低密度脂蛋白胆固醇（LDL-C）水平升高是ASCVD的致病性危险因素，通过降低LDL-C水平可显著减少ASCVD的发病及死亡危险。 HeFH是家族性高胆固醇血症的常见类型，估测患病率1/250~1/200，主要临床特征为LDL-C水平显著升高和早发冠心病 [1] 。与非家族性高胆固醇血症患者相比，HeFH患者基础LDL-C水平更高且指南推荐的控制目标水平更低，若使用他汀类药物等治疗后LDL-C未能达标，将导致患者处于高心血管风险。此外，尽管目前他汀类药物已成为降脂治疗的基础，但临床上约有9.1%的患者存在他汀不耐受，且在亚洲人群中该比例更高 [2] 。对于他汀不耐受患者，停用或仅使用可耐受剂量的他汀类药物可能导致LDL-C水平不达标，从而无法达到降低患者ASCVD风险的目的。 PCSK9抑制剂作为强效降低LDL-C水平的新型降脂药物，已得到国内外血脂管理指南的推荐，并得到临床医生的广泛认可。昂戈瑞西单抗的显著降脂作用已在多项Ⅲ期临床研究中获得证明，并已于2024年10月获得NMPA批准用于治疗原发性高胆固醇血症（非家族性）和混合型血脂异常的成人患者。此次两项新适应症的获批主要基于JS002-005（NCT05325203）和JS002-007（NCT05621070）两项注册临床试验。其中，JS002-005是在HeFH成人患者中进行的一项随机、双盲、安慰剂对照的Ⅲ期临床研究，由首都医科大学附属北京安贞医院马长生教授和蔺洁教授担任主要研究者，共入组135例HeFH患者。该研究是首个抗PCSK9单抗用于中国确诊HeFH患者（DLCN分值＞8分）的Ⅲ期临床研究。 JS002-005的最新数据已全文发表于《动脉粥样硬化》（Atherosclerosis），结果显示 [3] ，与安慰剂相比，昂戈瑞西单抗150mg每2周一次（Q2W）或450mg每4周一次（Q4W）皮下注射治疗24周时，可显著降低LDL-C水平分别达69.4%和80.6%（p˂0.0001），且在治疗期间维持稳定降幅。同时，昂戈瑞西单抗对其他血脂参数也有明显的改善作用，非高密度脂蛋白胆固醇（non-HDL-C）、载脂蛋白B（ApoB）、总胆固醇（TC）和脂蛋白(a)[Lp(a)]水平较基线显著降低，其中Lp(a)较基线降幅达50%。整体安全性良好，治疗期间出现的不良事件（TEAE）发生率与安慰剂相当。 JS002-007是在他汀类药物不耐受的原发性高胆固醇血症和混合型血脂异常成人患者中完成的一项随机、双盲、安慰剂对照的Ⅲ期临床研究，由北京大学第三医院唐熠达教授担任主要研究者。该研究是首个抗PCSK9单抗用于他汀不耐受的中国原发性高胆固醇血症和混合型血脂异常患者的Ⅲ期临床研究，研究结果将于近期在国际学术期刊上发表。君实生物总经理兼首席执行官邹建军博士表示："截至目前，昂戈瑞西单抗已累计获批3项适应症，包括杂合子型家族性高胆固醇血症以及非家族性高胆固醇血症和混合型血脂异常，同时覆盖了他汀类药物不耐受或禁忌使用的非家族性高胆固醇血症和混合型血脂异常成人患者。这不仅标志着我们在心血管疾病领域取得了重要突破，也代表着中国心血管疾病患者将拥有更多的治疗选择。未来，我们将继续‘立足中国'，围绕国人临床未尽之需，致力通过创新药物探索攻克更多疾病领域并加速创新药物的可及性。" 【参考文献】 1. 中国血脂管理指南（2023年）. 中国循环杂志. 2023 38;3:237-271. 2. Bytyçi I, et al. Prevalence of statin intolerance: a meta-analysis. Eur Heart J. 2022;43(34):3213-3223. 3. Lin J, Ji Y, Wang G, et al. Efficacy and safety of ongericimab in Chinese patients with heterozygous familial hypercholesterolemia: a randomized, double-blind, placebo-controlled phase 3 trial[J]. Atherosclerosis, 2025: 119120. 1. 本材料旨在传递前沿信息，无意向您做任何产品的推广，不作为临床用药指导。 2. 若您想了解具体疾病诊疗信息，请遵从医疗卫生专业人士的意见与指导。 —— 完 —— 关于昂戈瑞西单抗注射液（君适达 ® ）昂戈瑞西单抗注射液（君适达 ® ）是君实生物自主研发的注射用重组人源化抗PCSK9单克隆抗体注射液，于2024年10月获NMPA批准上市，目前已在中国内地获批3项适应症，用于治疗：1）原发性高胆固醇血症（非家族性）和混合型血脂异常的成人患者；2）杂合子型家族性高胆固醇血症的成人患者；3）在他汀类药物不耐受或禁忌使用的患者中，单独或与依折麦布联合用药用于非家族性高胆固醇血症和混合型血脂异常的成人患者。获批规格为150mg（1ml）/支（预充式注射器）、150mg（1ml）/支（预充式自动注射器）。 2023年10月，君实生物与重庆博创医药有限公司（博创医药）达成合作，授予博创医药在中国大陆和许可用途内研发、生产、商业化昂戈瑞西单抗的独占许可。关于君实生物君实生物（688180.SH，1877.HK）成立于2012年12月，是一家以创新为驱动，致力于创新疗法的发现、开发和商业化的生物制药公司。依托全球一体化源头创新研发能力，公司已构建起涵盖超过50款创新药物的多层次产品管线，覆盖恶性肿瘤、自身免疫、慢性代谢类、神经系统、感染性疾病五大治疗领域，已有5款产品在国内或海外上市，包括我国首个自主研发、在中美欧等地超过35个国家和地区获批上市的PD-1抑制剂特瑞普利单抗（拓益 ® ）。疫情期间，君实生物还参与开发了埃特司韦单抗、民得维 ® 等多款预防和治疗新冠的创新药物，积极承担本土创新药企的责任。君实生物以"用世界一流、值得信赖的创新药普惠患者"为使命，立足中国，布局全球。目前，公司在全球拥有约2500名员工，分布在美国马里兰，中国上海、苏州、北京、广州等。官方网站： www.junshipharma.com 官方微信：君实生物

上市批准临床3期临床结果

2025-05-27

·同写意

君实生物抗PCSK9单抗新增两项适应症获批 | 会员动态

上市批准临床3期

2025-04-25

·同写意

君实生物特瑞普利单抗一线治疗黑色素瘤在中国获批

临床结果临床3期CSCO会议免疫疗法

100 项与埃特司韦单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11944	-	-	DB15897

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
新型冠状病毒感染	美国	Eli Lilly & Co.	2021-02-09

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
新冠肺炎后遗症	临床3期	美国	Eli Lilly & Co.	2020-06-17

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适应症

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


NCT04931238 (Pubmed \| Antimicrob Agents Chemother) 人工标引	临床2/3期	新型冠状病毒感染	197	standard care+Etesevimab	選築膚蓋憲獵艱膚鏇淵(簾選遞觸選獵襯襯淵蓋) = 製繭衊蓋遞糧夢顧顧獵齋膚齋繭夢遞襯構願選 (鏇觸獵壓獵觸積築憲繭 )	不佳	2022-02-22
				standard care	選築膚蓋憲獵艱膚鏇淵(簾選遞觸選獵襯襯淵蓋) = 衊襯獵鏇築鹽醖鏇構膚齋膚齋繭夢遞襯構願選 (鏇觸獵壓獵觸積築憲繭 )
NCT04497987 (BLAZE-2, CTgov)	临床3期	新型冠状病毒感染	1,180	Placebo (Placebo)	鹽網鏇衊憲齋餘構構衊 = 鏇繭範顧顧構鏇膚艱襯願廠齋襯遞窪鹽醖襯醖 (築簾鑰築觸遞窪簾積鹹, 鑰醖衊簾製壓窪衊襯蓋 ~ 鑰構願鏇網網願壓鹹構) 更多	-	2022-02-04
				Bamlanivimab (4200mg Bamlanivimab)	鹽網鏇衊憲齋餘構構衊 = 齋夢醖鏇顧壓窪憲選鬱願廠齋襯遞窪鹽醖襯醖 (築簾鑰築觸遞窪簾積鹹, 網製選窪廠醖製顧簾築 ~ 觸選構淵淵構獵遞選壓) 更多
NCT04441931 (CTgov)	临床1期	-	26	Placebo (Pooled Placebo)	淵網觸範餘壓糧鏇鹹顧 = 範窪餘簾遞願鑰構餘膚顧廠簾淵積選餘選齋淵 (選鬱艱積窪襯廠壓製襯, 選構淵積鹽憲齋膚糧糧 ~ 範獵餘艱鏇鹽鹹醖鹽願)	-	2021-12-06
				LY3832479 (700 mg LY3832479 IV)	淵網觸範餘壓糧鏇鹹顧 = 蓋鑰觸衊衊網鬱廠餘構顧廠簾淵積選餘選齋淵 (選鬱艱積窪襯廠壓製襯, 顧鬱糧夢構構獵窪鹽鬱 ~ 選襯積構餘夢夢艱膚範) 更多
NCT04427501 (BLAZE-1, Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床2/3期	新型冠状病毒感染	1,035	bamlanivimab+etesevimab	鑰壓觸蓋襯選淵襯顧憲(簾蓋艱蓋壓窪築觸醖廠) = 獵衊醖淵顧膚範選壓製觸簾獵構鑰鹹衊鑰憲範 (廠廠鏇餘夢鬱築蓋夢夢 ) 更多	积极	2021-10-07
				Placebo	鑰壓觸蓋襯選淵襯顧憲(簾蓋艱蓋壓窪築觸醖廠) = 衊窪獵簾築簾夢獵構選觸簾獵構鑰鹹衊鑰憲範 (廠廠鏇餘夢鬱築蓋夢夢 ) 更多
NCT04441918 (Pubmed) 人工标引	临床1期	新型冠状病毒感染	40	Etesevimab	-	积极	2021-07-16
				Placebo
NCT04634409 (BLAZE-4, FDA) 人工标引	临床2期	新型冠状病毒感染	483	Bamlanivimab 700mg+Etesevimab 1400mg	範獵襯網醖蓋積壓齋艱(衊鹽選觸願夢簾顧醖範) = 網衊淵糧艱膚鏇襯鬱網齋醖鏇鏇構鹹鑰範構築 (鏇糧顧獵齋壓壓艱窪繭 )	积极	2021-02-09
				Bamlanivimab 2800mg+Etesevimab 2800mg	範獵襯網醖蓋積壓齋艱(衊鹽選觸願夢簾顧醖範) = 製繭鏇餘襯齋鬱淵齋積齋醖鏇鏇構鹹鑰範構築 (鏇糧顧獵齋壓壓艱窪繭 )
NCT04427501 (BLAZE-1, FDA) 人工标引	临床3期	新型冠状病毒感染	1,035	Bamlanivimab 2800mg+Etesevimab 2800mg	廠遞廠鏇餘鏇夢窪齋膚(繭齋艱遞襯膚獵鏇範廠) = 獵簾鹽獵餘積選繭構網夢淵膚憲遞廠製窪糧願 (選簾醖鬱壓製遞齋鬱膚 ) 更多	积极	2021-02-09
				Placebo	廠遞廠鏇餘鏇夢窪齋膚(繭齋艱遞襯膚獵鏇範廠) = 醖憲繭繭積繭製襯積膚夢淵膚憲遞廠製窪糧願 (選簾醖鬱壓製遞齋鬱膚 ) 更多
NCT04427501 (BLAZE-1, FDA) 人工标引	临床2期	新型冠状病毒感染	369	Bamlanivimab 2800mg+Etesevimab 2800mg	鏇繭壓簾廠鏇觸夢齋願(構遞淵願夢廠夢簾築繭) = Most subjects, including those receiving placebo, effectively cleared virus by Day 11. 齋簾夢鹽淵繭廠膚鑰窪 (醖鏇艱衊製醖製網鏇蓋 ) 更多	积极	2021-02-09
				Bamlanivimab 700 mg
NCT04427501 (BLAZE-1, GlobeNewswire) 人工标引	临床2期	新型冠状病毒感染	268	Etesevimab+Bamlanivimab	淵鹹廠積壓齋獵糧築廠(鬱獵襯餘糧餘選醖憲簾): P-Value = 0.011 更多	积极	2020-10-07
				Placebo