Xia Yu, Chen Qingqing, Liu He-Nan, Chi Yuan, Zhu Ying, Shan Li-Shen, Dai Bing, Wu Lin, Shi Xiaobao
Department of Obstetrics and Gynecology, Shengjing Hospital of China Medical University, Shenyang, China.
Department of Ophthalmology, Shengjing Hospital of China Medical University, Shenyang, China.
Eur J Med Chem. 2024 Nov 5;277:116762. doi: 10.1016/j.ejmech.2024.116762. Epub 2024 Aug 13.
In 2023, the European Medicines Agency (EMA) granted approval to 77 new molecular entities (NMEs), consisting of 45 new chemical entities (NCEs) and 32 new biological entities (NBEs). These pharmacological agents encompass a broad spectrum of therapeutic domains, including oncology, cardiology, dermatology, diagnostic medicine, endocrinology, gastroenterology and hepatology, metabolic disorders, and neurology. Among the 77 approved pharmaceuticals, three received accelerated review status, and 17 (22 %) were granted orphan drug designation for the treatment of rare diseases. This review provides an overview of the clinical applications and synthetic routes of 42 newly approved NCEs by the EMA in 2023. The objective is to offer a comprehensive understanding of the synthetic approaches used in the development of these drug molecules, thereby inspiring the creation of novel, efficient, and applicable synthetic methodologies.
2023年，欧洲药品管理局（EMA）批准了77种新分子实体（NMEs），其中包括45种新化学实体（NCEs）和32种新生物实体（NBEs）。这些药物涵盖了广泛的治疗领域，包括肿瘤学、心脏病学、皮肤病学、诊断医学、内分泌学、胃肠病学和肝病学、代谢紊乱以及神经病学。在这77种获批药物中，有三种获得了加速审评状态，17种（22%）被授予孤儿药资格用于治疗罕见病。本综述概述了2023年EMA新批准的42种NCEs的临床应用和合成路线。目的是全面了解这些药物分子开发中所采用的合成方法，从而激发新型、高效且适用的合成方法的创造。
