Institut De Recherches Internationales Servier , Translational Medicine Department, Suresnes, France.
The Antibody Society, Inc ., Framingham, MA, USA.
MAbs. 2021 Jan-Dec;13(1):1860476. doi: 10.1080/19420862.2020.1860476.
In this 12 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.
在本系列的第 12 期《值得关注的抗体》文章中，我们讨论了 2020 年抗体治疗药物开发中的关键事件，并预测了 2021 年可能发生的事件。2020 年，新型冠状病毒病（COVID-19）大流行给医疗保健系统带来了一系列挑战和机遇，这种情况在 2021 年还将继续。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 鸡尾酒疗法，已获得美国食品和药物管理局（FDA）的紧急使用授权，而重新定位的抗体 levilimab 和 itolizumab 已分别在俄罗斯和印度注册为 COVID-19 的紧急使用治疗药物。尽管受到大流行的影响，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，另外还有 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，cetuximab saratolacan sodium 在日本首次获得批准。2021 年的批准数量可能会创历史新高，因为 16 种研究性抗体治疗药物的营销申请正在由 FDA 或欧洲药品管理局进行监管审查。在这 16 种 mAb 中，有 11 种可能用于非癌症适应症的治疗，5 种可能用于癌症的治疗。根据截至 2020 年 11 月的公开信息，有 44 种抗体治疗药物正在进行非癌症适应症的后期临床研究，其中 6 种用于 COVID-19，至少有 6 种（leronlimab、tezepelumab、faricimab、ligelizumab、garetosmab 和 fasinumab）计划在 2021 年上市。此外，还有 44 种抗体治疗药物正在进行癌症适应症的后期临床研究。在这 44 种药物中，有 13 种药物的营销申请可能在 2021 年底前提交。*补充说明：在 2020 年 12 月 1 日至 21 日期间公布的关键事件：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 的生物制品许可申请已提交。
