This 2020 installment of the annual 'Antibodies to Watch' series documents the antibody therapeutics approved in 2019 and in regulatory review in the United States or European Union, as well as those in late-stage clinical studies, as of November 2019*. At this time, a total of 5 novel antibody therapeutics (romosozumab, risankizumab, polatuzumab vedotin, brolucizumab, and crizanlizumab) had been granted a first approval in either the US or EU, and marketing applications for 13 novel antibody therapeutics (eptinezumab, teprotumumab, enfortumab vedotin, isatuximab, [fam-]trastuzumab deruxtecan, inebilizumab, leronlimab, sacituzumab govitecan, satralizumab, narsoplimab, tafasitamab, REGNEB3 and naxituximab) were undergoing review in these regions, which represent the major markets for antibody therapeutics. Also as of November 2019, 79 novel antibodies were undergoing evaluation in late-stage clinical studies. Of the 79 antibodies, 39 were undergoing evaluation in late-stage studies for non-cancer indications, with 2 of these (ublituximab, pamrevlumab) also in late-stage studies for cancer indications. Companies developing 7 (tanezumab, aducanumab, evinacumab, etrolizumab, sutimlimab, anifrolumab, and teplizumab) of the 39 drugs have indicated that they may submit a marketing application in either the US or EU in 2020. Of the 79 antibodies in late-stage studies, 40 were undergoing evaluation as treatments for cancer, and potentially 9 of these (belantamab mafodotin, oportuzumab monatox, margetuximab, dostarlimab, spartalizumab, 131I-omburtamab, loncastuximab tesirine, balstilimab, and zalifrelimab) may enter regulatory review in late 2019 or in 2020. Overall, the biopharmaceutical industry's clinical pipeline of antibody therapeutics is robust, and should provide a continuous supply of innovative products for patients in the future. *Note on key updates through December 18, 2019: 1) the US Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev) on December 18, 2019, bringing the total number of novel antibody therapeutics granted a first approval in either the US or EU during 2019 to 6; 2) the European Commission approved romosozumab on December 9, 2019; 3) the European Medicines Agency issued a positive opinion for brolucizumab; 4) Sesen Bio initiated a rolling biologics license application (BLA) on December 6, 2019; 5) GlaxoSmithKline submitted a BLA for belantamab mafodotin; and 6) the status of the Phase 3 study (NCT04128696) of GSK3359609, a humanized IgG4 anti-ICOS antibody, in patients with head and neck squamous cell carcinoma was updated to recruiting from not yet recruiting.

中文翻译：

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2020年值得关注的抗体。

2020年年度``关注的抗体''系列分册记录了2019年批准的抗体治疗剂以及美国或欧洲联盟以及截至2019年11月的后期临床研究中*的监管审查。目前，在美国或欧盟，总共有5种新的抗体治疗药物（罗莫珠单抗，risankizumab，polatuzumab vedotin，brolucizumab和crizanlizumab）已获得首批批准，并且有13种新抗体治疗药物（eptinezumab，teprotumumab，这些区域的抗体市场正在接受治疗，这些药物主要针对enfortumab vedotin，isatuximab，[fam-] trastuzumab deruxtecan，inebilizumab，leronlimab，sacituzumab govitecan，satralizumab，narsoplimab，tafasitamab，REGNEB3和naxituximab进行治疗。同样从2019年11月开始，79种新型抗体正在后期临床研究中进行评估。在这79种抗体中，有39种正在非癌症适应症的后期研究中进行评估，其中2种（ublituximab，pamrevlumab）也在癌症适应症的后期研究中进行评估。开发这39种药物中的7种（tanezumab，aducanumab，evinacumab，etrolizumab，sutimlimab，anifrolumab和teplizumab）的公司表示，它们可能会在2020年在美国或欧盟提交市场申请。在后期研究中的79种抗体中，有40个正在接受癌症治疗评估，其中9种（贝兰单抗mafodotin，oportuzumab monatox，margetuximab，dostarlimab，spartalizumab，131I-omburtamab，loncastuximab tesirine，balstilimab和zalifrelimab）可能于2019年末进入监管审查或。 全面的，生物制药行业的抗体疗法临床渠道十分强大，并且将来应该为患者提供不断创新的产品。*截至2019年12月18日的重要更新说明：1）美国食品和药物管理局于2019年12月18日加速批准enfortumab vedotin-ejfv（Padcev），使两种药物中获首批批准的新型抗体疗法总数美国或欧盟在2019到6年期间；2）欧盟委员会于2019年12月9日批准了romosozumab; 3）欧洲药品管理局对溴珠单抗发表了积极意见；4）Sesen Bio于2019年12月6日启动了滚动生物制剂许可证申请（BLA）; 5）GlaxoSmithKline提交了belantamab mafodotin的BLA；和6）GSK3359609的3期研究（NCT04128696）的状态，