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.

100 项与安巴韦单抗相关的临床结果

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100 项与安巴韦单抗相关的转化医学

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100 项与安巴韦单抗相关的专利（医药）

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项与安巴韦单抗相关的文献（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.

136

项与安巴韦单抗相关的新闻（医药）

2024-11-18

·赛柏蓝

1类新药、百亿市场，新一代3CLpro抑制剂重磅招商

已在顶级期刊发布研究成果、1类新药、单药双靶、安全性及疗效优于同类产品、广谱性及潜力突出、可填补老年合并基础疾病人群抗新冠病毒治疗药物空白......奥格特韦钠火热招商中！ 01 新冠药物市场将达百亿老年群体感染后早治疗是关键根据中国疾病预防控制中心公布的最新数据，2024年10月1日-10月31日，全国31个省（自治区、直辖市）及新疆生产建设兵团共报送4545例本土病例新冠病毒基因组有效序列，均为奥密克戎变异株。主要流行病毒株为XDV系列变异株和JN.1系列变异株1。新冠病毒的传播一直没有停止。研究显示，第一波和第二波疫情高峰间隔天数的中位数是164天，第一波和第三波为247天，新冠是一种持续循环的呼吸道疾病，且不呈现季节性变化234。随着新冠病毒逐渐流感化，新冠口服药的市场需求长期存在。根据中国经济信息社和招商证券等机构发布的报告，中国新冠药物市场的未来市场规模预计将达到280亿元至330亿元5。新冠治疗最关键的是时机，复旦大学附属华山医院感染科主任张文宏教授曾多次在公开场合反复强调：“抓住新冠病毒感染后的‘黄金72小时’，尽早启动抗病毒药物治疗，是阻断病毒复制，从而降低重症和死亡率的关键。” 尤其是存在基础疾病的老年人在感染新冠后，各种症状持续的时间会更长，“长新冠”的治疗更加棘手。“早使用早治疗”，只有科学、安全、合理地使用抗病毒药物，才能降低重症转化的风险。 02 多家药企布局3CLpro抑制剂老年患者临床治疗仍存在空白百亿新冠药市场已经吸引了众多药企布局，目前通过我国药监局审批的抗新冠病毒药物包括奈玛特韦片/利托那韦片、阿兹夫定片、安巴韦单抗/罗米司韦单抗注射液等。随着国内外疫情的持续，人们对有效抗病毒药物的需求不断增加。3CLpro作为新冠病毒复制的关键酶，成为抗病毒药物研发的重要靶点之一。 3CLpro抑制剂的抗病毒效果显著，不仅可以抑制病毒复制，还具备广谱抗病毒能力。抑制3CLpro蛋白酶的活性，可有效阻断病毒复制，达到抗新型冠状病毒的作用。此外，3CLpro抑制剂安全性更好。由于其是已知冠状病毒共有的非结构蛋白，人体内没有3CL同源蛋白，所以3CLpro抑制剂具有更高的选择性，发生脱靶毒副作用的风险更小。不过，目前市场上的3CLpro抑制剂大多用于减少重症和死亡、轻中度COVID-19的成年患者。而新冠老年患者临床治疗中仍存在空白，亟需一款既安全又有效的药物。截至2023年底，我国60岁及以上中老年人口达2.97亿，其中约75%的60岁及以上中老年人至少患有1种慢性病，而43%的老年人则同时患有两种或更多种疾病6。多病共存和多重用药的现象在老年人群中尤为突出。目前市场上的大多数3CLpro抑制剂需联用利托那韦，但因老年病基础病患者用药风险高，应用受限。作为新一代3CLpro抑制剂，奥格特韦钠单药给药，无合并用药的风险，是老年合并基础疾病人群抗新冠病毒治疗优选。 03 新冠明星药物“奥格特韦钠”优势突出，已在顶级医学期刊发表研究成果、单药双靶、疗效显著... 作为一款国产1类口服小分子创新药，奥格特韦钠实现了通过抑制3CL蛋白酶和组织蛋白酶L这两个靶点，从而阻断新冠病毒入侵人体细胞并阻止其在人体细胞中复制。双靶点抑制剂的设计，使奥格特韦钠在抗病毒效果上更具优势7。目前，奥格特韦钠的III期临床研究数据已经发表在顶级医学期刊《新英格兰医学杂志》的子刊《新英格兰医学杂志循证（NEJM Evidence）》上。研究结果显示，奥格特韦钠对不同年龄、有无进展为重症高风险因素、既往是否感染过新冠的患者均有效，且临床疗效佳8。特别是在老年群体或有基础疾病（如大于60岁或进展成重症高风险因素的心血管疾病）的新冠患者中，奥格特韦钠的疗效更加显著9。在安全性、耐受性、广谱性和潜力上，奥格特韦钠也展示出了独特的优点。奥格特韦钠组绝大部分不良事件为1-2级，发生率基本与安慰剂组类似，拥有较好的安全性和耐受性。与同类产品非头对头对比，奥格特韦钠的疗效和安全性都较为突出，并且拥有克服其它产品耐药的潜力，有望成为新冠长期存在期间的有效防治工具10。新冠药物市场有望达到百亿，但老年患者临床治疗仍存在空白点，奥格特韦钠现向全国火热招商，市场不等人，赶紧拿起电话联系下方工作人员咨询详情！联系电话：【东区】李总 13661633528 （江浙沪赣皖）【南区】谢总 18665089677 （粤闽琼桂鄂湘）【西南区】王总 18021509875 （川渝滇黔藏）【北区】李总 18630109707 （京津冀晋鲁豫蒙黑吉辽）【西北区】陆总 13310975506 （陕甘宁青新）公司内勤： 13671500020 021-54681666 公司地址：上海市徐汇区枫林路380号枫林国际大厦2层向下滑动阅读参考文献 1. 中国疾病预防控制中心https://www.chinacdc.cn 2.https://yzcdc.com/index/news/detail/newsid/9684.html 扬州市疾病预防控制中心 3.Ewen Callaway. Nature . 2023 May;617(7960):229-230. 4.卢洪洲,刘映霞,袁静.长新冠综合征临床诊治专家共识[J].新发传染病电子杂志,2024,9(01):80-97. 5.新版中国新冠药物市场规模与投资前景调研 https://www.sgpjbg.com/info/34a47a50d18aef3e43dbd859d7671f9a.html 6.《2023年度国家老龄事业发展公报》 https://www.mca.gov.cn/n152/n166/c1662004999980001780/content.html 7.Olgotrelvir as a Single-Agent Treatment of Nonhospitalized Patients with Covid-19 8.Lu H,et al. Olgotrelvir as a Single-Agent Treatment of Nonhospitalized Patients with Covid-19. NEJM Evid. 2024 Jun;3(6):EVIDoa2400026. 9.Olgotrelvir, a dual inhibitor of SARS-CoV-2 Mpro and cathepsin L, as a standalone antiviral oral intervention candidate for COVID-19 10.奥格特韦钠中国 III期研究（MPR-COV-301CN）总结以及各已获批药物说明书 *声明：此篇文章受众仅为医药、医疗等健康产业专业伙伴，仅供医学药学专业人士使用，不针对普通消费大众。

临床研究临床结果疫苗

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

100 项与安巴韦单抗相关的药物交易

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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	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,

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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	申请上市	美国	Brii Biosciences Ltd.	2022-06-22

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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


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)	窪壓網鏇顧積衊積鬱鹹(築廠憲網鹹簾鹹壓夢膚) = 壓簾鑰鹽壓願衊襯選夢繭遞衊顧鹹淵觸夢齋廠 (壓夢餘鹹艱衊餘築鏇鬱, 鑰獵鹹選觸餘醖憲憲憲 ~ 艱選構選積遞選獵積憲) 更多	-	2024-02-05
				Placebo+Remdesivir (Placebo Plus SOC)	窪壓網鏇顧積衊積鬱鹹(築廠憲網鹹簾鹹壓夢膚) = 衊積襯鹽簾選鬱製構窪繭遞衊顧鹹淵觸夢齋廠 (壓夢餘鹹艱衊餘築鏇鬱, 廠積糧網鏇範遞壓積衊 ~ 壓醖繭淵選廠廠醖獵製) 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	(齋齋淵衊廠醖壓遞獵繭) = All infusions were well-tolerated without systemic or local infusion reactions, dose-limiting AEs, serious AEs, or deaths. 範簾糧廠餘顧獵醖鹹遞 (製鑰衊選願網膚製鹽獵 ) 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	(鑰顧簾鏇壓構鬱餘壓窪) = 獵憲醖糧鏇製獵簾餘窪獵鹽齋網獵遞鬱膚築鬱 (蓋艱艱網選遞選遞憲鏇 ) 更多	积极	2021-08-24
				Placebo	(積餘餘觸願淵衊憲鹹衊) = 壓齋獵窪糧鑰選淵構衊遞鏇遞淵範醖範鑰廠壓 (襯艱遞築糧獵遞鑰壓夢 ) 更多