A Phase 2 Study to Evaluate the Safety and Efficacy of Human Monoclonal Antibodies, BRII-196 and BRII-198, Administered by Intravenous Infusion for the Treatment of COVID-19 Patients

The aim of this phase 2 study is to evaluate the safety and efficacy of single dose IV infusion of BRII-196 and BRII-198 given as combination therapy in patients with severe COVID-19, and mild to moderate COVID-19 and asymptomatic carrier.

开始日期2021-06-20

申办/合作机构

Brii Biosciences Ltd.

[+1]

NCT04770467 / Withdrawn临床2期

A Phase 2, Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Human Monoclonal Antibodies, BRII-196 and BRII-198, Administered by Intravenous Infusion for the Treatment of COVID-19 Patients

This study is to evaluate the safety, efficacy and pharmacokinetics profile of human monoclonal antibodies, BRII-196 and BRII-198 compared with placebo in patients with COVID-19.

开始日期2021-02-01

申办/合作机构

Brii Biosciences, Inc.

NCT04691180 / Completed临床1期

A Phase 1 Randomized, Single-blind, Placebo-controlled, Single Ascending Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Human Monoclonal Antibodies, Brii-196 and BRII-198, Administered Intravenously to Healthy Adult Volunteers

This is a phase 1 study in which healthy adult volunteers will receive BRII-196/BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.

开始日期2021-01-05

申办/合作机构

Brii Biosciences Ltd.

[+1]

100 项与罗米司韦单抗相关的临床结果

登录后查看更多信息

100 项与罗米司韦单抗相关的转化医学

登录后查看更多信息

100 项与罗米司韦单抗相关的专利（医药）

登录后查看更多信息

项与罗米司韦单抗相关的文献（医药）

2024-09-01·eClinicalMedicine

Post-acute COVID-19 outcomes including participant-reported long COVID: amubarvimab/romlusevimab versus placebo in the ACTIV-2 trial

Article

作者: Manne, Jennifer ; Hughes, Leslie ; Snyman, Elizma ; Daar, Eric S. ; Jagannathan, Prasanna ; Rwakazina, Irene ; Ordway, Joshua J. ; Guillory, Clinton ; Harber, Heather ; Weston, Patrick ; Juneja, Elizabeth ; Loftis, Amy James ; Weinstein, Debra ; Roman, Eloy ; Socorro, Ezequiel ; Hoover, Keila ; Surber, Joseph ; Pérez, Yadilys ; Evering, Teresa H. ; Kompelien, Breanna ; Dentoni-Lasofsky, Dennis ; Fayssoux, Jamraus ; Lalloo, Umesh ; Hazard-Jenkins, Hannah ; McHarry, Kirsten ; Chew, Kara W. ; Madlala, Penelope ; Lynch, Joshua ; Lewinski, Mary ; Pillay-Ramaya, Larisha ; Becker, Becky ; Maranan, Alyxzza ; van der Walt, Eugene ; Cheekati, Purna ; Mahmoudi, Saniyyah ; Williams-Leber, Erin ; Yawetz, Sigal ; Benson, Constance ; Smith, David (Davey) ; Huhn, Virginia ; Beck, Kelly ; Hoover, Susan E. ; Ribeiro, Jorge Eurico ; Pulliam, Sallie D. ; Gonzalez, Ana I. ; Hussen, Nazreen Jeewa ; McEvoy, Kathryn ; Hatlen, Timothy ; Amaya, Jorge P. ; Sullivano, Jennifer ; Letlape, Oteng ; Rivera Martinez, Norma Erendira ; Corado, Katya ; Lopez, Amaru ; Gomez-Martinez, Marissa ; Laborde, Luciana ; Presti, Rachel ; Coetzer, Thomas ; Bennet, Jaclyn Ann ; Cantu, Luis ; Shea, Katrina ; Varughese, Renoj ; Shaik, Sadia ; Hosey, Lara ; Mendez, Luis M. ; Focil, Augusto ; Senthil, Smruthi ; Arar, Celine ; Nakatani, Lisa ; Just, Jessica ; Zwane, Zinhle ; Berardi, Jonathan ; Maldonado, Valarie ; Hughes, Michael D. ; Rodriguez, Marcelo Rodrigo ; Jonkane, Olebogeng ; Singh, Upinder ; Smith, Davey M. ; Soliva, Nathália ; Hall, Chase ; Malla, Midhun ; Fernández, Heriberto ; Call, Robert ; Newell, Matthew ; Sieg, Scott ; Giganti, Mark ; Weston, Khalilah ; Nikolov, Boris ; Cardoso, Sandra Wagner ; Taiwo, Babafemi ; Voena, Felicitas Fernandez ; Haddad, Fadi ; Sebe, Modulakgotla ; Rolle, Charlotte-Paige ; Nuñez, Sebastian ; Gandhi, Rajesh ; Fichtenbaum, Carl ; D'Andrea Nores, Ulises ; Enéas, Miriam Amaral ; Clemency, Brian ; Vahed, Yacoob ; Fernandez, Idania ; Okeke, Nwora Lance ; Betancourt-Garcia, Monica ; Folkens, Eric ; Hendrickx, Steven ; Li, Jonathan Z. ; Leon, Ramon ; Jain, Manish ; Eron, Joseph J. ; Bordese, Fernando ; Cardoso, Sandra ; Swiatek, Joan ; Westerman, Jan ; Arnold, Melanie ; Mohata, Maureen ; Fortier, Samantha ; Lawrance Masilela, Mduduzi Sandile ; Kim, Andrew ; Petrick, Frederick ; Wohl, David ; Izquierdo, Myriam ; Sherer, Donna ; Coyne, Christopher ; Singh, Usha ; Colsh, Kelly ; Gonzalez, Noemi ; Gotur, Deepa ; Kosmyna, Jan ; Slandzicki, Jamie Alex ; Wohl, David A. ; Shahkolahi, Akbar ; Fletcher, Courtney ; Rosas, Griselda ; Herman, Jack ; Aswad, Ahmad ; Dieser, Pablo ; Mbhele, Nokuphiwa ; Ruiz, Aniuska ; Malvestutto, Carlos ; Wallan, Jessica ; Cicarella, Robyn ; Berzins, Baiba ; Day, Donald C. ; Rojas, Yaneicy Gonzalez ; Osiyemi, Olayemi ; Beck, Justine ; Jilg, Nikolaus ; Fischer, William ; Zopo, Alex ; Chew, Kara ; Neytman, Gene ; Rodriguez, Gabriel ; de Carvalho Santana, Rodrigo ; Cheekati, Vasundhara ; Joseph, Natasha ; Hernández, Maureen ; Manentsa, Mmatsie ; Hernandez, Manuel ; Johnson, Misty ; Li, Jonathan ; Free, Almena L. ; Cronin, Alexandrea ; Mbali, Rose ; Moser, Carlee ; Mehta, Sanjay ; Eziri, Emeka ; Suarez, Rosa M. ; Jennings, Cheryl ; Baer, Jenifer ; Taiwo, Babafemi O. ; Pathak, Divya ; Bukhman, Yevgeniy ; Ritz, Justin ; McGuffin, Sarah ; Machado da Silva, Andre Luiz ; Chow, Christopher ; Luetkemeyer, Anne ; Spikes, Leslie ; Farah, Humam ; Perelson, Alan ; Hughes, Michael ; Tebas, Pablo ; Pixler, April ; Torna, Odelsey ; Eron, Joseph ; Hawkins, Claudia ; Pfeffer, Michael M. ; Bohorquez Lopez, Victor Casildo ; Ignacio, Rachel Bender ; Quinn, Randall ; Keenan, Cheryl ; Riaz, Amna ; Pedersen, Susan ; Mohapi, Lerato ; Daar, Eric ; Jagizarov, Zarema ; Margolis, David ; Khan, Saahir ; Heffner, Megan ; Frias, Melchor Victor ; Mwelase, Noluthando ; Gelman, Michael ; Caloura, Matthew ; Santos, Breno ; Jonsson, Chris ; Papasidero, Marcelo ; Karpf, Cinzia ; Veltman, Jennifer ; Pullman, John ; Azizad, Masoud ; Milstone, Aaron ; Easley, Raymond ; Sein, Ni Ni ; Monlux, George W. ; Haile, Alem ; Vasconcellos, Eduardo ; Herpel, Laura Bogan ; Moyano, Susana ; Murtaugh, William ; Andriunas, Olga ; Ramirez, Rosemarie ; Atriss, Hisham ; Lummus, Christie ; Pinto, Jorge ; Moonsamy, Suri ; Rosa, Jennifer ; Wernick, Arthur ; Gottesman, Joan ; Gapara, Morgan ; Roa, Jhoanna ; Alvarez, Tomas ; Kingsley, Jeffrey ; Jain, Mamta K. ; Dragavon, Joan ; Taylor, David ; de Cássia Alves Lira, Rita ; Salusso, Diego ; Short, William ; Tripathi, Kaushlendra K. ; Currier, Judith S. ; Wilkin, Aimee ; Mussi, Marisa ; Mocherla, Bharat ; Bukhman, Eugene ; Gonzalez, Mariana ; Wehbe, Luis ; Mitha, Ismail ; Ruiz, Karelia ; Pillay, Sandy ; Kao, Wei-Hsin ; Innes, James Craig ; Lennox, Pieter ; Greenfelder, Brian ; Malik, Anju ; Fonseca de Morais Caporali, Julia ; Adonis, Tania ; Oakes, Jonathan ; Joubert, Leonard ; Dube, Michael P. ; Pham, David N. ; Dooley, Kelly ; Trentman, Sarah ; Rathore, Mobeen ; Socorro, Estefania ; McClain, Rebekah ; Avery, Ann ; DeJesus, Edwin ; Herman, Craig ; Vergara, Fernando Gonzalez ; Wilkins, Adaliah ; Davis, David ; Lacal, Verónica ; Faleiro Ferreira, Flávia Gomes ; Khodabakhshian, Aleen ; Tiraboschi Bárbaro, Adriana Aparecida ; Lutz, Allison ; Patel, Nilam ; Vaughan, Leroy ; Fetalvero, Krystle ; Hendler, Suzanne ; Pérez, Jose ; Javan, Arzhang Cyrus ; Brumskine, William ; Chiperera, Tendai ; Andrews, Nancy ; Seagle, Hannah ; Planchon, Matthew ; Williamson, Derrick ; Nagpal, Avish ; Choudhary, Madhu ; Bryan, Anna ; Dominguez, Miriam Batule ; Aziz, Mariam ; Hecker, Michelle ; Riviere, Cynthia ; Victoria, Yanly B. ; Haddad, Victoria ; Currier, Judith ; Castro, Mario ; Diniz Ribeiro, Maria Pia ; Idarraga, Samuel ; Burns, Charles M. ; Turner-Gray, Kimberly

BackgroundIt is unknown if early COVID-19 monoclonal antibody (mAb) therapy can reduce risk of Long COVID. The mAbs amubarvimab/romlusevimab were previously demonstrated to reduce risk of hospitalization/death by 79%. This study assessed the impact of amubarvimab/romlusevimab on late outcomes, including Long COVID.MethodsNon-hospitalized high-risk adults within 10 days of COVID-19 symptom onset enrolled in a randomized, double-blind, placebo-controlled phase 2/3 trial of amubarvimab/romlusevimab for COVID-19 treatment. Late symptoms, assessed using a participant-completed symptom diary, were a pre-specified exploratory endpoint. The primary outcome for this analysis was the composite of Long COVID by participant self-report (presence of COVID-19 symptoms as recorded in the diary at week 36) or hospitalization or death by week 36. Inverse probability weighting (IPW) was used to address incomplete outcome ascertainment, giving weighted risk ratios (wRR) comparing amubarvimab/romlusevimab to placebo.FindingsParticipants received amubarvimab/romlusevimab (n = 390) or placebo (n = 390) between January and July 2021. Median age was 49 years, 52% were female, 18% Black/African American, 49% Hispanic/Latino, and 9% COVID-19-vaccinated at entry. At week 36, 103 (13%) had incomplete outcome ascertainment, and 66 (17%) on amubarvimab/romlusevimab and 92 (24%) on placebo met the primary outcome (wRR = 0.70, 95% confidence interval (CI) 0.53-0.93). The difference was driven by fewer hospitalizations/deaths with amubarvimab/romlusevimab (4%) than placebo (13%). Among 652 participants with available diary responses, 53 (16%) on amubarvimab/romlusevimab and 44 (14%) on placebo reported presence of Long COVID.InterpretationAmubarvimab/romlusevimab treatment, while highly effective in preventing hospitalizations/deaths, did not reduce risk of Long COVID. Additional interventions are needed to prevent Long COVID.FundingNational Institute of Allergy and Infectious Diseases of the National Institutes of Health. Amubarvimab and romlusevimab supplied by Brii Biosciences.

2024-09-01·Heliyon

Effect of amubarvimab-romlusevimab for treatment of severe COVID-19 in intensive care units: A retrospective cohort study

Article

作者: Chen, Zhuoer ; Li, Xu ; Chen, Cheng ; Qu, Peng ; Xu, Qihan ; Gong, Jiacheng ; Wang, Canmin ; Bathaiian, Luqman Sadat ; Zhong, Qinglei ; Lou, Anni ; Cui, Wanfu ; Rong, Dan

Amubarvimab-romlusevimab is a commonly recommended antiviral treatment in China for adult patients with mild or moderate SARS-CoV-2 infections, especially for patients with a high risk factor for progression to severe COVID-19. However, its exact efficacy in patients with severe Covid-19 is not yet known.This is a single-center retrospective cohort study, in which we collected the general data, laboratory tests, radiological characteristics, viral conversion status, and prognosis of the disease from patients with COVID-19 hospitalized, from December 2022 to March 2023 in the Department of Critical Care Medicine. The amubarvimab-romlusevimab therapy can reduce the 28-day mortality (29.79 % vs 51.35 %, p = 0.02), and ICU mortality (29.79 % vs 55.41 %, p = 0.006) of severe COVID-19.A 1:1 PSM (Propensity Score Matching) was performed to reduce bias, in order to ensure the two groups were balanced and comparable. In the matched population (n = 47), there were no statistically significant differences between the mAbs (monoclonal antibody)group and the Non-antiviral group in 28-day, and thromboembolic events in COVID-19 patients. The 40-day survival analysis shows that mAbs therapy can improve patient prognosis (HR = 0.45, 95%CI = 0.26-0.76, p = 0.008). However, no significant intergroup difference in the 40-day cumulative viral conversion rate. In a univariate Cox regression analysis, The Amubarvimab - romlusevimab therapy(HR:0.464; CI:[0.252-0.853]; p:0.013) is a protective factor and CRP, PCT, PLT, Lactate, PT, PT-INR, and pt% level at admission were risk factors for clinical prognosis. After including the above covariates, Multifactorial COX regression shows that the Amubarvimab - romlusevimab therapy(HR:0.392; CI:[0.211-0.729]; p:0.003), CRP, Lactate and PT-INR at admission are independent factors for mortality of severe COVID-19. Based on the current data, we conclude that amubarvimab-romlusevimab therapy is beneficial for patients with severe COVID-19.

2024-08-16·The Journal of Infectious Diseases

Characterization of Treatment Resistance and Viral Kinetics in the Setting of Single-Active Versus Dual-Active Monoclonal Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2

Article

作者: Chew, Kara W ; Ya, Li ; Giganti, Mark J ; Currier, Judith S ; Hughes, Michael D ; Ritz, Justin ; Zhon, Lijie ; Deo, Rinki ; Choudhary, Manish C ; Smith, Davey ; Margolis, David ; Zhu, Qing ; Evering, Teresa H ; Greninger, Alexander L ; Regan, James ; Li, Jonathan Z ; Daar, Eric S ; Crain, Charles R ; Flynn, James P ; Eron, Joseph J ; Wohl, David Alain ; Moser, Carlee

AbstractBackgroundMonoclonal antibodies (mAbs) represent a crucial antiviral strategy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, but it is unclear whether combination mAbs offer a benefit over single-active mAb treatment. Amubarvimab and romlusevimab significantly reduced the risk of hospitalizations or death in the ACTIV-2/A5401 trial. Certain SARS-CoV-2 variants are intrinsically resistant against romlusevimab, leading to only single-active mAb therapy with amubarvimab in these variants. We evaluated virologic outcomes in individuals treated with single- versus dual-active mAbs.MethodsParticipants were nonhospitalized adults at higher risk of clinical progression randomized to amubarvimab plus romlusevimab or placebo. Quantitative SARS-CoV-2 RNA levels and targeted S-gene next-generation sequencing was performed on anterior nasal samples. We compared viral load kinetics and resistance emergence between individuals treated with effective single- versus dual-active mAbs depending on the infecting variant.ResultsStudy participants receiving single- or dual-active mAbs had similar demographics, baseline nasal viral load, symptom score, and symptom duration. Compared with single-active mAb treatment, treatment with dual-active mAbs led to faster viral load decline at study days 3 (P < .001) and 7 (P < .01). Treatment-emergent resistance mutations were more likely to be detected after amubarvimab plus romlusevimab treatment than with placebo (2.6% vs 0%; P < .001) and were more frequently detected in the setting of single-active compared with dual-active mAb treatment (7.3% vs 1.1%; P < .01). Single-active and dual-active mAb treatment resulted in similar decrease in rates of hospitalizations or death.ConclusionsCompared with single-active mAb therapy, dual-active mAbs led to similar clinical outcomes but significantly faster viral load decline and a lower risk of emergent resistance.

134

项与罗米司韦单抗相关的新闻（医药）

2024-02-26

·蒲公英Ouryao

「疫苗黑马」康希诺2023年亏损逾14亿

转自：蒲公英Ouryao 综合：无忧由于新冠疫苗市场需求变化，康希诺新冠疫苗相关收入较同期大幅下降，2023年净亏损进一步扩大。归母净利润亏损14.47亿元。新冠去，净亏损超过14亿2023年2月24日，康希诺发布业绩快报，2023年营业总收入3.57亿元，同比下降65.49%；归母净亏损14.47亿元；2022年同期净亏损9.1亿元，同比亏损增加59.14%。2023年净亏损进一步扩大。对于亏损原因，康希诺表示，由于新冠疫苗市场需求变化，公司新冠疫苗相关收入较同期大幅下降；基于新冠疫苗产品实际接种情况及对未来接种情况的预期，公司对已经发生的及未来可能发生的新冠疫苗产品退回金额进行核算及合理估计，并于报告期内冲减疫苗产品收入；营业成本方面，因新冠疫苗产量较低，相关产线产能利用率不足，公司将该部分冗余产能对应的固定成本计入营业成本。停产、裁员，降本止损康希诺2023年以来已经进行了多次降低成本的动作。2023年4月，新冠疫苗生产基地之一，康希诺子公司上药康希诺从4月4日开始暂停产线生产，期限约180天。随后，康希诺相关人士就此事回应称，这是基于新冠疫苗需求情况，公司做出的优化运营的决策。受业绩不佳影响，康希诺也对“疫苗线”展开裁员工作，具体人数未公布。新冠疫苗不香了疫情结束了，靠新冠疫苗躺赢的企业好日子也到头了！虽然更多的企业投入了大量的资金和人力，却难逃陪跑的命运。云顶新耀：2024年2月19日，云顶新耀宣布与加拿大mRNA疫苗公司Providence订立终止协议，双方同意全面终止合作及授权许可协议、COVID-19疫苗授权许可协议及股份发行协议，自2024年2月16日（生效日期）起生效。科兴：2024年1月10日，一份名为“停发新冠项目绩效工资方案”的文件在网上传播，落款为北京科兴中维生物技术公司。科兴控股生物技术有限公司产品咨询热线工作人员确认科兴的新冠疫苗确已停产。腾盛博药：2023年3月24日，腾盛博药发布公告称，决定停止生产旗下控股子公司腾盛华创医药技术（北京）有限公司研发的新冠病毒中和抗体联合治疗药物安巴韦单抗注射液及罗米司韦单抗注射液。斯微生物：2023年7月19日，国内mRNA疫苗三剑客之一的斯微生物天慈工厂暂停试运行。欢迎留言，更多观点。参考：企业公告2023年总结类文章推荐:推荐阅读：蒲公英Ouryao视频号投稿、广告、商务合作： Qinrenlvcha

疫苗财报信使RNA

2024-01-11

·蒲公英Ouryao

这家药企已停产

整理 | 无忧来源 | 蒲公英Ouryao 一份名为「停发新冠项目绩效工资方案」的文件在网络传播，其中提到：公司新冠疫苗已全部停产且公司目前也无新冠疫苗产品销售。落款为北京科兴中维生物技术公司。据极目新闻报道，2024年1月10日中午，科兴控股生物技术有限公司产品咨询热线工作人员确认科兴的新冠疫苗确已停产。成也萧何败也萧何。而科兴公司2021年净利润达到了惊人的963.93亿元人民币，同比增长7705.3%。其他新冠疫苗的药企目前又是什么情况呢？国内唯一新冠抗体药已停产：2023年3月24日，手握中国唯一一个新冠抗体药物的制药公司——腾盛博药发布公告称，决定停止生产旗下控股子公司腾盛华创研发的新冠病毒中和抗体联合治疗药物安巴韦单抗注射液及罗米司韦单抗注射液。而腾盛博药公布的2022年度业绩显示，年收入由零增加至人民币5160万元的主要原因是安巴韦单抗╱罗米司韦单抗联合疗法在中国的商业化。康希诺新冠疫苗生产基地疑似停产：2023年3月31日，康希诺的新冠疫苗生产基地上海上药康希诺被传出进入停产状态，从4月4日开始暂停生产线生产，期限约180天。康希诺在年报中表示，2022年国内外新冠疫苗市场环境发生较大变化，新冠疫苗需求量呈大幅下降趋势，全球新冠疫苗接种增速放缓，且部分地区呈现供大于求的情况，市场竞争不断加剧。康希诺从2016年至2020年，净利润连续亏损5年，累计亏损金额超过8亿元。2021年，康希诺研发生产的新冠疫苗在国外多个国家上市，提振了业绩，最终扭亏为盈，全年大赚19.14亿元净利润。随着新冠疫苗市场需求回落，康希诺2022年净亏损9.02亿元。康希诺2023年前三季度营收约1.76亿元，同比减少75%；净利润亏损约9.85亿元，同比增加107.63%。斯微生物天慈工厂暂停试运行：2023年7月19日，国内mRNA疫苗三剑客之一的斯微生物天慈工厂暂停试运行。斯微生物回应称，天慈工厂主要是因为大环境的客观因素存在，近期也不会有新冠疫苗的生产需求，所以先暂停试运营，把主要精力回归到研发上。辉瑞布局新领域：从昔日不到700亿美元到营收一度飙升为全球首家销售额超过1000亿美元的药企，可以说是“新冠红利”让辉瑞坐上了直升机。但伴随着全球新冠疫苗接种率增长放缓，新冠疫苗企业收入纷纷下滑。2023年三季度财报显示，辉瑞营收同比下滑41%，第三季度亏损23.82亿美元，而去年同期净利润86亿美元。这也是辉瑞自2019年疫情发生以来首次出现季度亏损。2024年1月8日，辉瑞CEO艾伯乐表示，他正在迅速采取行动解决问题，并计划将公司的希望寄托在制药行业最具增长竞争力之一的领域：癌症。一个月前，辉瑞完成了对癌症制药商Seagen的收购，交易价值高达430亿美元，将为辉瑞提供四种获批产品和丰富的ADC候选产品管线。辉瑞预计到2030年，并购案将为公司带来100亿美元的额外年收入。跨国药企布局新领域，国内药企的我们，拿什么拯救利润？欢迎留言，更多观点。2023年精彩文章推荐:推荐阅读：蒲公英Ouryao视频号投稿、广告、商务合作： Qinrenlvcha

疫苗财报信使RNA

2024-01-04

·药研发

GSK前高管入职Biotech

昨日，腾盛博药宣布，Brian Alvin Johns自2024年1月3日起担任首席科学官，他将全面负责新药开发项目，并制定公司的未来管线策略和优先事项。Brian Alvin Johns拥有化学博士学位，在创新药物的发现和早期开发项目方面拥有丰富的经验。在加入腾盛博药之前，Brian Alvin Johns曾在HemoShear Therapeutics, Inc.担任首席科学官，负责带领团队开发各疾病领域的新靶点和平台。更早之前，他还曾在ViiV Healthcare和葛兰素史克担任新药开发副总裁，为ViiV/葛兰素史克的HIV系列药物做出了贡献，发现了多替拉韦和卡替拉韦这两种突破性药物。腾盛博药成立于2017年，2021年7月在港交所上市。目前，腾盛博药的主要业务领域是感染性疾病和中枢神经系统疾病。安巴韦单抗/罗米司韦单抗联合治疗药物是腾盛博药上市的第一款药物，于2022年7月在中国商业化上市。据中国商报报道，这款药物投入的研发成本超过2亿美元；2022年财报数据显示，腾盛博药年收入由零增加至5160万元，均来自这款新冠特效药。今年3月24日，腾盛博药决定停止生产这款产品。腾盛博药表示，这一决定是基于不断演变的新冠疫情趋势和相关政策的更新，包括美国卫生与公众服务部（HHS）计划于2023年5月结束新冠疫情国家紧急状态和公共卫生紧急状态（PHE），以及医药合同定制研发生产企业（CDMO）对药物相关情况的长时间观察。此后，腾盛博药把资源重新转向乙肝病毒（HBV）项目、产后抑郁症（PPD）和重度抑郁症（MDD）项目等核心项目。今年7月6日，腾盛博药与VBI Vaccines, Inc. (VBI) 达成协议，拓展双方在乙型肝炎（HBV）领域的战略合作。腾盛博药将从VBI扩展BRII-179许可至全球权益，并且获得具有临床差异化的3抗原预防性疫苗PreHevbri®在大中华区及亚太市场的独家权益。基于两份协议，腾盛博药形成了针对HBV从预防到治愈的产品组合。近期，11月22日，CDE官网显示，腾盛博药的乙肝治疗性疫苗BRII-179（VBI-2601）注射液拟纳入突破性疗法，用于治疗慢性乙型肝炎病毒感染。除了上述提到的核心项目以外，腾盛博药及其合作伙伴正在推进一条由十余种差异化疗法组成的丰富产品管线，包括焦虑障碍和重度抑郁症、人类免疫缺陷病毒（HIV）感染、多重耐药（MDR）和广泛耐药（XDR）革兰氏阴性感染，及非结核分枝杆菌（NTM）肺病。参考资料：[1]腾盛博药：《腾盛博药任命Brian Alvin Johns博士担任首席科学官》[2]澎湃新闻：《国内唯一新冠抗体药已停产：商业化8个月后腾盛博药主动叫停》[3]药智数据：《1500万美元首付！腾盛博药拿下两款重磅乙肝疫苗》[4]思齐俱乐部：《仅8个月，首款国产新冠药停产》[5]一度医药：《首席医学官严立离职，腾盛博药全面发力百亿乙肝市场》来源：思齐俱乐部

财报高管变更疫苗突破性疗法

100 项与罗米司韦单抗相关的药物交易

登录后查看更多信息

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
新型冠状病毒感染	中国	腾盛华创医药技术（北京）有限公司	2021-12-08

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	临床1期	乌干达	Brii Biosciences Ltd.	2020-12-16
新型冠状病毒感染	临床1期	美国	Brii Biosciences Ltd.	2020-12-16
新型冠状病毒感染	临床1期	西班牙	Brii Biosciences Ltd.	2020-12-16
新型冠状病毒感染	临床1期	波兰	Brii Biosciences Ltd.	2020-12-16
新型冠状病毒感染	临床1期	新加坡	Brii Biosciences Ltd.	2020-12-16
新型冠状病毒感染	临床1期	瑞士	Brii Biosciences Ltd.	2020-12-16
新型冠状病毒感染	临床1期	丹麦	Brii Biosciences Ltd.	2020-12-16
新型冠状病毒感染	临床1期	英国	Brii Biosciences Ltd.	2020-12-16

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05780424 (CTgov)	临床3期	新型冠状病毒感染	353	Remdesivir+BRII-198+BRII-196 (BRII-196/BRII-198 Plus SOC)	壓鹹鑰壓鹽廠觸糧觸網(鏇糧憲積壓鑰淵齋蓋醖) = 鹽憲鬱艱築齋壓鏇壓艱觸獵構獵網獵廠鹹餘衊 (醖網憲範選蓋觸鬱觸選, 遞獵觸醖憲築願願鏇窪 ~ 積艱網膚醖遞構製獵鑰) 更多	-	2024-02-05
				Placebo+Remdesivir (Placebo Plus SOC)	壓鹹鑰壓鹽廠觸糧觸網(鏇糧憲積壓鑰淵齋蓋醖) = 鹽鑰選鬱窪鑰網齋衊廠觸獵構獵網獵廠鹹餘衊 (醖網憲範選蓋觸鬱觸選, 憲鬱鏇蓋壓網選遞糧齋 ~ 鹽艱願遞獵繭淵鑰積襯) 更多
NCT04479631 \| NCT04479644 \| NCT04691180 (BRII-196-198-001, Pubmed) 人工标引	临床1期	新型冠状病毒感染	44	BRII-196/BRII-198	(鬱糧蓋構網鑰壓醖遞齋) = All infusions were well-tolerated without systemic or local infusion reactions, dose-limiting AEs, serious AEs, or deaths. 蓋醖蓋鬱齋衊顧鑰襯膚 (壓憲鬱簾窪窪製顧遞醖 ) 更多	积极	2022-09-06
NCT04518410 (ACTIV-2, PRNewswire) 人工标引	临床3期	新型冠状病毒感染	837	BRII-196+BRII-198	(選選衊繭艱觸願願鑰積) = 夢選憲醖醖襯鑰築構鏇鏇積選簾鹽願窪壓艱積 (鏇夢顧網構醖製鹽範繭 ) 更多	积极	2021-08-24
				Placebo	(繭壓膚鏇獵積蓋窪選範) = 艱鏇願艱窪構鏇繭壓鹹憲憲糧鹹餘願夢簾醖淵 (鏇艱餘觸簾壓顧襯廠淵 ) 更多