Antibodies to watch in 2021.
Antibodies to watch in 2021.
复制标题
DOI：
10.1080/19420862.2020.1860476
复制
发表时间：
2021-01
期刊：
影响因子：
5.3
通讯作者：
Reichert JM
中科院分区：
文献类型：
--
作者：
Kaplon H;Reichert JM
在第12期年度“抗体观察”文章系列中，我们讨论了2020年发生的抗体疗法开发中的关键事件，并预测了2021年可能发生的事件。2019冠状病毒病（COVID-19）疫情于二零二零年为医疗系统带来一系列挑战及机遇，并将于二零二一年继续带来挑战及机遇。值得注意的是，截至2020年11月下旬，两种抗SARS-CoV抗体产品bamlanivimab和casirivimab与imdevimab混合物已获美国食品药品监督管理局（FDA）批准紧急使用，而改性抗体levilimab和itolizumab已分别在俄罗斯和印度注册紧急使用作为COVID-19治疗药物。尽管发生了大流行，截至11月，2020年已有10种抗体治疗药物在美国或欧盟获得首次批准，另外2种（tanezumab和margetuximab）可能在2020年12月获得批准。此外，prolgolimab和olokizumab已在俄罗斯获得首次批准，西妥昔单抗saratolacan钠首次在日本获得批准。2021年的批准数量可能会创下纪录，因为16种研究性抗体疗法的上市申请已经在接受FDA或欧洲药品管理局的监管审查。在这16种mAb中，11种可能用于治疗非癌症适应症，5种可能用于治疗癌症。根据截至2020年11月公开的信息，44种抗体治疗药物处于非癌症适应症的后期临床研究中，包括6种COVID-19，并计划于2021年至少有6种（leronlimab，tezepelumab，faricimab，ligelizumab，lactosumab和fasinumab）的上市申请。此外，44种抗体疗法正处于癌症适应症的后期临床研究中。在这44项申请中，13项申请的上市申请可能会在2021年底前提交。* 在2020年12月1日至21日期间宣布的关键事件的证明中添加了注释：margetuximab-cmkb和ansuvimab-zykl分别于2020年12月16日和21日获得FDA批准; ublituximab和amivantamab提交了生物制剂许可申请。
In this 12th annual installment of the Antibodies to Watch article series, we discuss key events in antibody therapeutics development that occurred in 2020 and forecast events that might occur in 2021. The coronavirus disease 2019 (COVID-19) pandemic posed an array of challenges and opportunities to the healthcare system in 2020, and it will continue to do so in 2021. Remarkably, by late November 2020, two anti-SARS-CoV antibody products, bamlanivimab and the casirivimab and imdevimab cocktail, were authorized for emergency use by the US Food and Drug Administration (FDA) and the repurposed antibodies levilimab and itolizumab had been registered for emergency use as treatments for COVID-19 in Russia and India, respectively. Despite the pandemic, 10 antibody therapeutics had been granted the first approval in the US or EU in 2020, as of November, and 2 more (tanezumab and margetuximab) may be granted approvals in December 2020.* In addition, prolgolimab and olokizumab had been granted first approvals in Russia and cetuximab saratolacan sodium was first approved in Japan. The number of approvals in 2021 may set a record, as marketing applications for 16 investigational antibody therapeutics are already undergoing regulatory review by either the FDA or the European Medicines Agency. Of these 16 mAbs, 11 are possible treatments for non-cancer indications and 5 are potential treatments for cancer. Based on the information publicly available as of November 2020, 44 antibody therapeutics are in late-stage clinical studies for non-cancer indications, including 6 for COVID-19, and marketing applications for at least 6 (leronlimab, tezepelumab, faricimab, ligelizumab, garetosmab, and fasinumab) are planned in 2021. In addition, 44 antibody therapeutics are in late-stage clinical studies for cancer indications. Of these 44, marketing application submissions for 13 may be submitted by the end of 2021. *Note added in proof on key events announced during December 1-21, 2020: margetuximab-cmkb and ansuvimab-zykl were approved by FDA on December 16 and 21, 2020, respectively; biologics license applications were submitted for ublituximab and amivantamab.
登录
查看更多内容
影响因子：
5.3
作者：
Kaplon, Helene;Reichert, Janice M.
通讯作者：
Reichert, Janice M.
DOI：
10.1056/nejmoa2029849
发表时间：
2021-01-21
期刊：
The New England journal of medicine
影响因子：
--
作者：
Chen P;Nirula A;Heller B;Gottlieb RL;Boscia J;Morris J;Huhn G;Cardona J;Mocherla B;Stosor V;Shawa I;Adams AC;Van Naarden J;Custer KL;Shen L;Durante M;Oakley G;Schade AE;Sabo J;Patel DR;Klekotka P;Skovronsky DM;BLAZE-1 Investigators
通讯作者：
BLAZE-1 Investigators
影响因子：
7.3
作者：
Adams, Ralph;Maroof, Asher;Griffiths, Meryn
通讯作者：
Griffiths, Meryn
影响因子：
11.1
作者：
Regula JT;Lundh von Leithner P;Foxton R;Barathi VA;Cheung CM;Bo Tun SB;Wey YS;Iwata D;Dostalek M;Moelleken J;Stubenrauch KG;Nogoceke E;Widmer G;Strassburger P;Koss MJ;Klein C;Shima DT;Hartmann G
通讯作者：
Hartmann G
影响因子：
5.3
作者：
Kaplon, Helene;Muralidharan, Mrinalini;Reichert, Janice M.
通讯作者：
Reichert, Janice M.