The development of antibody drugs has been 30 years, from 1984 when world’s first monoclonal antibody drug Orthoclone OKT3 was approved by FDA to the year when AbbVie’s Humira became world’s best-selling drug.
This article summaries the 7 focuses on antibody drugs, and covers introduction, classification, R&D hotspots and process breakthroughs, etc. of antibody drugs, to strive to detail the development situation of antibody drugs to the readers.
Introduction:
74 antibody-based drugs have been approved by FDA to enter market as of May 1, 2017, and additionally, there are 70 and 525 in Phase III and phase I/II clinical trials, respectively, namely, 719 antibody drugs in total.
The distribution is as shown below:
|
抗体719种 |
719 antibodies |
|
免疫球蛋白493种 |
493 immunoglobulins |
|
ADC 87种 |
87 ADCs |
|
Fc融合蛋白37种 |
37 Fc fusion proteins |
|
放射免疫球蛋白17种 |
17 radioimmunoglobulins |
|
抗体片段13种 |
13 antibody fragments |
|
免疫细胞因子11种 |
11 immunocytokines |
|
免疫细胞因子1.5% |
Immunocytokines 1.5% |
|
抗体片段1.8% |
Antibody fragments 1.8% |
|
放射免疫球蛋白2.3% |
Radioimmunoglobulins 2.3% |
|
Fc融合蛋白5% |
Fc fusion proteins 5% |
|
ADC 12% |
ADCs 12% |
|
免疫球蛋白68% |
Immunoglobulins 68% |
|
抗体100% |
Antibodies 100% |
New antibodies are being discovered each year. Many exciting new approaches emerge in the oncology involving modulation of T-cells. There are over 80 antibodies in clinical trials targeting T-cell modulation, 26 T-cell redirected bispecific antibodies, and 145 chimeric antigen receptor (CAR) cell-based candidates (all currently in phase I or II clinical trials), totaling more than 250 antibody-based candidates used for T-cell modulation.
We still find it incredible that such a great diversity of antibodies appears all of a sudden, however, the antibody-based preparations will meet the medical needs of tumor treatment in an innovative and diversified manner.
I. How many antibody drugs have been marketed over the 30 years?
Data of monoclonal antibodies and proteins approved for treatment in EU, U.S., and Japan
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