Antibodies to watch in 2024.

IF 5.6 2区 医学 Q1 MEDICINE, RESEARCH & EXPERIMENTAL mAbs Pub Date : 2024-01-01 Epub Date: 2024-01-05 DOI:10.1080/19420862.2023.2297450
Silvia Crescioli, Hélène Kaplon, Alicia Chenoweth, Lin Wang, Jyothsna Visweswaraiah, Janice M Reichert
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引用次数: 0

Abstract

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

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2024 年值得关注的抗体
值得关注的抗体 "系列文章对目前处于临床开发后期、监管审查和最近在任何国家获得首次批准的商业赞助单克隆抗体疗法进行了年度总结。在本期文章中,我们将讨论截至 11 月 17 日在 2023 年获得首次批准的 16 种抗体疗法(lecanemab (Leqembi)、rozanolixizumab (RYSTIGGO)、pozelimab (VEOPOZ)、mirikizumab (Omvoh)、talquetamab (Talvey))的主要细节、elranatamab(Elrexfio)、epcoritamab(EPKINLY)、glofitamab(COLUMVI)、retifanlimab(Zynyz)、concizumab(Alhemo)、lebrikizumab(EBGLYSS)、tafolecimab (SINTBILO)、narlumosbart (金立泰)、zuberitamab (Enrexib)、adebrelimab (Arelili) 和 divozilimab (Ivlizi))。我们简要回顾了至少有一个国家或地区正在考虑上市申请的 26 种候选产品,以及根据公司披露的信息预计将于 2024 年底进入监管审查的 23 种在研抗体疗法。这近 50 种候选产品包括许多创新的双特异性抗体,如 odronextamab、ivonescimab、linvoseltamab、zenocutuzumab 和 erfonrilimab,以及抗体-药物共轭物,如 trastuzumab botidotin、patritumab deruxtecan、datopotamab deruxtecan 和 MRG002,以及两种免疫细胞因子的混合物(bifikafusp alfa 和 onfekafusp alfa)。我们还讨论了抗体疗法的临床阶段转换和总体批准成功率,这对生物制药行业至关重要,因为这些成功率为资源分配决策提供了依据。我们的分析表明,这些分子的获批成功率在 14% 到 32% 之间,非癌症适应症抗体的获批成功率更高。总之,我们的数据表明,生物制药行业的抗体治疗研发工作正在蓬勃发展,而且越来越成功。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
mAbs
mAbs 工程技术-仪器仪表
CiteScore
10.70
自引率
11.30%
发文量
77
审稿时长
6-12 weeks
期刊介绍: mAbs is a multi-disciplinary journal dedicated to the art and science of antibody research and development. The journal has a strong scientific and medical focus, but also strives to serve a broader readership. The articles are thus of interest to scientists, clinical researchers, and physicians, as well as the wider mAb community, including our readers involved in technology transfer, legal issues, investment, strategic planning and the regulation of therapeutics.
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