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2019 年的制药行业。从分子角度分析 FDA 药物批准情况。

The Pharmaceutical Industry in 2019. An Analysis of FDA Drug Approvals from the Perspective of Molecules.

机构信息

KRISP, College of Health Sciences, University of KwaZulu-Natal, Durban 4001, South Africa.

School of Chemistry and Physics, University of KwaZulu-Natal, Durban 4001, South Africa.

出版信息

Molecules. 2020 Feb 9;25(3):745. doi: 10.3390/molecules25030745.

Abstract

During 2019, the US Food and Drug Administration (FDA) approved 48 new drugs (38 New Chemical Entities and 10 Biologics). Although this figure is slightly lower than that registered in 2018 (59 divided between 42 New Chemical Entities and 17 Biologics), a year that broke a record with respect to new drugs approved by this agency, it builds on the trend initiated in 2017, when 46 drugs were approved. Of note, three antibody drug conjugates, three peptides, and two oligonucleotides were approved in 2019. This report analyzes the 48 new drugs of the class of 2019 from a strictly chemical perspective. The classification, which was carried out on the basis of chemical structure, includes the following: Biologics (antibody drug conjugates, antibodies, and proteins); TIDES (peptide and oligonucleotides); drug combinations; natural products; and small molecules.

摘要

2019 年,美国食品和药物管理局 (FDA) 批准了 48 种新药物(38 种新化学实体和 10 种生物制品)。尽管这一数字略低于 2018 年登记的数字(59 种,其中 42 种为新化学实体,17 种为生物制品),创下了该机构批准新药的纪录,但这一数字延续了 2017 年以来的趋势,当时批准了 46 种药物。值得注意的是,2019 年有三种抗体药物偶联物、三种肽和两种寡核苷酸获得批准。本报告从严格的化学角度分析了 2019 年的 48 种新药。该分类是基于化学结构进行的,包括以下几类:生物制品(抗体药物偶联物、抗体和蛋白质);TIDES(肽和寡核苷酸);药物组合;天然产物;和小分子。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2929/7037960/898c7c10f0af/molecules-25-00745-g001.jpg

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