The 100^th Monoclonal Antibody Product is Approved in Japan.

IF 5 3区医学 Q1 PHARMACOLOGY & PHARMACY

AAPS Journal Pub Date : 2025-06-04 DOI:10.1208/s12248-025-01091-0

Aya Hariu, Yukiko Shirahata, Kayo Shinohara, Ryosuke Kuribayashi

引用次数: 0

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).

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第100个单克隆抗体产品在日本获批

药品和医疗器械管理局（PMDA）是日本的一个机构，负责审查为保护公众健康而上市的药品和医疗器械的质量、功效和安全性。本研究考察了单克隆抗体（mab）的批准文号。此外，它还根据PMDA网站对典型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），在每个财政年度（FY）不包括单克隆抗体的生物仿制药版本(1)。此外，还汇编了批准的FY数据、品牌名称、国际非专利名称、细胞底物、靶点、初始批准的疾病领域和监管途径（补充文件1）。

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

AAPS Journal 医学-药学

CiteScore

7.80

自引率

4.40%

发文量

109

审稿时长

1 months

期刊介绍： The AAPS Journal, an official journal of the American Association of Pharmaceutical Scientists (AAPS), publishes novel and significant findings in the various areas of pharmaceutical sciences impacting human and veterinary therapeutics, including: · Drug Design and Discovery · Pharmaceutical Biotechnology · Biopharmaceutics, Formulation, and Drug Delivery · Metabolism and Transport · Pharmacokinetics, Pharmacodynamics, and Pharmacometrics · Translational Research · Clinical Evaluations and Therapeutic Outcomes · Regulatory Science We invite submissions under the following article types: · Original Research Articles · Reviews and Mini-reviews · White Papers, Commentaries, and Editorials · Meeting Reports · Brief/Technical Reports and Rapid Communications · Regulatory Notes · Tutorials · Protocols in the Pharmaceutical Sciences In addition, The AAPS Journal publishes themes, organized by guest editors, which are focused on particular areas of current interest to our field.

The 100th Monoclonal Antibody Product is Approved in Japan.

Abstract

The 100^th Monoclonal Antibody Product is Approved in Japan.