1. Introduction
From the time the first monoclonal antibody was generated in 1975 and the first monoclonal antibody fully licenced in 1986, 【houtou72 注：這不是人源單抗】the field of monoclonal antibody development represents a novel way in which to target specific mutations and defects in protein structure and expression in a wide range of diseases and conditions. Today, with major rapid advancements in genetic sequencing and the translation of basic medical sciences research into clinical practice, humanised monoclonal antibodies are now the fastest growing group of biotechnology-derived molecules in clinical trials currently [1].
【1】Abstract
Fully human monoclonal antibodies (mAbs) are a promising and rapidly growing category of targeted therapeutic agents. The first such agents were developed during the 1980s, 【houtou72注：我們的首例人源單抗正在文章所說的時間段內---雖然不知道該文作者是否曾知道我們當時研究的進展，但無疑，我們的研究在當時是屬於世界領先的。】but none achieved clinical or commercial success. Advances in technology to generate the molecules for study — in particular, transgenic mice and yeast or phage display — renewed interest in the development of human mAbs during the 1990s. In 2002, adalimumab became the first human mAb to be approved by the US Food and Drug Administration (FDA). Since then, an additional six human mAbs have received FDA approval: panitumumab, golimumab, canakinumab, ustekinumab, ofatumumab and denosumab. In addition, 3 candidates (raxibacumab, belimumab and ipilimumab) are currently under review by the FDA, 7 are in Phase III studies and 81 are in either Phase I or II studies. Here, we analyse data on 147 human mAbs that have entered clinical study to highlight trends in their development and approval, which may help inform future studies of this class of therapeutic agents.....
