在2025年观察到的抗体
Silvia Crescioli1, Hélène Kaplon2, Lin Wang3
1Business Intelligence Research, The Antibody Society, Inc., Framingham, MA, USA.
mAbs
|December 23, 2024
概括
抗体治疗药物在2024年获得了21项新批准,另有30项正在审查中. 双特异性抗体和抗体-药物合物 (ADC) 的关键趋势正在塑造癌症治疗的未来.
科学领域:
- 生物制药开发 生物制药开发
- 瘤学 治疗学 治疗学
- 免疫治疗是一种免疫疗法.
背景情况:
- 200多种抗体治疗药物已获得批准,近1400种候选药物正在临床试验中.
- 抗体治疗药物代表着一个重要的全球生物制药企业.
研究的目的:
- 审查2024年的关键抗体治疗开发事件.
- 预测2025年晚期临床管道事件.
- 分析抗体格式的趋势,如双特异性抗体和抗体-药物联合体 (ADC).
主要方法:
- 对抗体治疗药物的监管批准和营销申请审查的分析.
- 审查2025年预计的2025年营销申请的后期管道候选人.
- 对不同抗体格式的临床阶段过渡和全球批准成功率的检查.
主要成果:
- 21种抗体治疗药物在2024年获得首次批准,包括双特异性抗体和ADC.
- 截至2024年12月9日,有30种抗体治疗药物正在监管审查中.
- 18个晚期管道候选企业可以在2025年底之前提交营销申请.
结论:
- 双特异性抗体和ADC是推动抗体疗法创新的关键形式.
- 预计抗体治疗管道的持续增长和多样化.
- 对批准趋势的分析为基于抗体的药物的不断变化的景观提供了见解.
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