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第100个单克隆抗体产品在日本获得批准
Aya Hariu1, Yukiko Shirahata1, Kayo Shinohara1
1Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-Ku, Tokyo, 100-0013, Japan.
The AAPS journal
|June 4, 2025
概括
这项研究分析了日本对单克隆抗体 (mAbs) 的批准,包括诸如抗体-药物合物 (ADC) 等修饰型. 它追踪了抗体批准的趋势,以了解它们对公共卫生的影响.
科学领域:
- 生物技术是生物技术.
- 制药科学 制药科学
- 监管科学 监管科学
背景情况:
- 日本的制药和医疗器械局 (PMDA) 负责监督药物和医疗器械的批准.
- 单克隆抗体 (mAbs) 是关键的治疗药物,了解它们的批准环境至关重要.
研究的目的:
- 调查日本对单克隆抗体 (mAbs) 的批准趋势.
- 根据PMDA数据对不同类型的批准抗体进行分类,包括正规和修改形式.
主要方法:
- 从PMDA网站提取用于抗体批准的数据.
- 抗体的分类为正规的,抗体-药物联合体 (ADC),抗体碎片和双特异性抗体 (bsAbs).
- 从分析中排除mAbs的生物类似版本.
主要成果:
- 对各种抗体类型的批准财政年度 (FY) 数据的编制.
- 收集了详细的记录,包括品牌名称,国际非专利名称,细胞基质,点,疾病区域和调控途径.
- 分析的重点是非生物类似物mAb的批准.
结论:
- 该研究提供了日本批准的单克隆抗体的全面概述.
- 这些数据对于理解基于抗体的疗法的演变和应用至关重要.
- 这些发现支持监管机构和研究人员跟踪治疗进展.
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