100种单克隆抗体产品在日本获批。

The 100 Monoclonal Antibody Product is Approved in Japan.

作者信息

Hariu Aya, Shirahata Yukiko, Shinohara Kayo, Kuribayashi Ryosuke

机构信息

Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-Ku, Tokyo, 100-0013, Japan.

Office of Regulatory Science Research, Pharmaceuticals, and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-Ku, Tokyo, 100-0013, Japan.

出版信息

AAPS J. 2025 Jun 4;27(4):105. doi: 10.1208/s12248-025-01091-0.

DOI:10.1208/s12248-025-01091-0

PMID:40468128

Abstract

The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese authority responsible for reviewing the quality, efficacy, and safety of drugs and medical devices to be marketed for public health protection. This study investigated the approval numbers of monoclonal antibodies (mAbs). In addition, it classified canonical and modified antibodies, such as antibody-drug conjugates (ADCs), antibody fragments, and bispecific antibodies (bsAb), excluding the biosimilar versions of mAbs in each fiscal year (FY) based on the PMDA website (1). Moreover, the approval FY data, brand names, international nonproprietary names, cell substrates, targets, disease areas at initial approval, and regulatory pathways were compiled (Supplement Document 1).

摘要

日本药品和医疗器械管理局（PMDA）是一个负责审查拟上市药品和医疗器械的质量、疗效及安全性以保护公众健康的日本官方机构。本研究调查了单克隆抗体（mAb）的获批数量。此外，根据PMDA网站（1），对各财政年度（FY）的经典抗体和修饰抗体进行了分类，如抗体药物偶联物（ADC）、抗体片段和双特异性抗体（bsAb），不包括单克隆抗体的生物类似药版本。此外，还汇总了获批财政年度数据、商品名、国际非专利名、细胞基质、靶点、首次获批时的疾病领域以及监管途径（补充文件1）。