2022年，制药业经历了辉煌的一年，食品药品监督管理局（FDA）共批准了37种新药，其中包括20种新化学实体（NCE）和17种新生物实体（NBE）。这些药物主要集中在肿瘤学、中枢神经系统、抗感染、血液学、心肌病、皮肤病学、消化系统、眼科、MRI增强剂和其他治疗领域。在这37种药物中，25种（68%）是通过快速审查通道获得批准的，19种（51%）是用于治疗罕见疾病的。这些新上市的药物具有独特的结构和新的作用机制，可以作为设计具有相似生物靶点并增强治疗效果的新药的引导化合物。本综述旨在概述2022年FDA批准的19种新化学实体（NCE）的临床应用和合成方法，但排除了对比剂（Xenon Xe-129）。我们相信深入了解药物分子的合成方法将为开发新的、更有效、更实用的合成技术提供创新和实用的启示。根据这些2022年FDA批准的药物的治疗领域，我们将这19种新化学实体（NCE）分为七个类别，并按照它们上市批准的顺序进行介绍。© 2023. 四川国际医学交流与推广协会。

The pharmaceutical industry had a glorious year in 2022, with a total of 37 new drugs including 20 new chemical entities (NCEs) and 17 new biological entities (NBEs) approved by the Food and Drug Administration (FDA). These drugs are mainly concentrated in oncology, central nervous system, antiinfection, hematology, cardiomyopathy, dermatology, digestive system, ophthalmology, MRI enhancer and other therapeutic fields. Of the 37 drugs, 25 (68%) were approved through an expedited review pathway, and 19 (51%) were approved to treat rare diseases. These newly listed drugs have unique structures and new mechanisms of action, which can serve as lead compounds for designing new drugs with similar biological targets and enhancing therapeutic efficacy. This review aims to outline the clinical applications and synthetic methods of 19 NCEs newly approved by the FDA in 2022, but excludes contrast agent (Xenon Xe-129). We believe that an in-depth understanding of the synthetic methods of drug molecules will provide innovative and practical inspiration for the development of new, more effective, and practical synthetic techniques. According to the therapeutic areas of these 2022 FDA-approved drugs, we have classified these 19 NCEs into seven categories and will introduce them in the order of their approval for marketing.© 2023. Sichuan International Medical Exchange & Promotion Association.