Overview of Antibody Drugs
Compared to traditional small molecule drugs, antibody drugs offer several distinct advantages. Firstly, antibody drugs can target a broader range of biological molecules, including proteins, cell surface receptors, and antigens. This expanded range of targets allows for more precise intervention in various diseases, such as cancers, autoimmune disorders, and infectious diseases. Additionally, antibody drugs are less likely to induce drug resistance. This is largely because antibodies bind specifically and with high affinity to their targets, which reduces the likelihood of mutations that confer resistance.
Moreover, the affinity of antibody drugs can be engineered to enhance their effectiveness and safety. By improving the binding affinity of antibodies to their targets, therapeutic efficacy can be increased while minimizing off-target effects, which in turn reduces toxicity and side effects. This engineering can involve modifications to the antibody structure to increase its stability, prolong its half-life in the bloodstream, and improve its interaction with the immune system.
In summary, the versatility, specificity, and engineering potential of antibody drugs makes them a powerful tool in modern medicine, providing more treatment options with potentially fewer side effects and a lower risk of resistance compared to traditional small molecule drugs.
Statistics on FDA-Approved Antibody Drugs
As of 2024, the FDA has approved over 100 antibody drugs in total. This milestone was achieved in 2021 when the FDA approved the 100th monoclonal antibody drug dostarlimab [1]. This growth shows the importance and popularity of antibody drugs in the treatment field, especially in the treatment of cancer, immune diseases, and infectious diseases.
In 2023 and early 2024, the FDA continued to approve multiple new antibody drugs, including lecanemab (Leqembi) for the treatment of Alzheimer’s disease, elanatamab (Elrexfio) for multiple myeloma, and rosanolixizumab (Rystiggo) for generalized myasthenia gravis. [2]
Table 1. Commercially sponsored monoclonal antibody therapeutics granted a first approval in any country during 2023.[3]
| INN (Brand Name) | Target; Format | Indication First Approved |
| Lecanemab (Leqembi) | Amyloid beta protofibrils; Humanized IgG1ҡ | Early Alzheimer’s disease |
| Rozanolixizumab (RYSTIGGO) | FcRn; Humanized IgG4ҡ | Generalized myasthenia gravis |
| Pozelimab (VEOPOZ) | Complement C5; Human IgG4ҡ | CHAPLE disease |
| Mirikizumab (Omvoh) | IL-23p19; Humanized IgG4ҡ | Ulcerative colitis |
| Talquetamab (Talvey) | GPCR5D, CD3; Humanized IgG4ҡ | Multiple myeloma |
| Elranatamab (Elrexfio) | BCMA, CD3; Humanized IgG2ҡ bispecific | Multiple myeloma |
| Epcoritamab (EPKINLY) | CD20, CD3; Humanized IgG1ҡ/λ bispecific | Diffuse large B-cell lymphoma |
| Glofitamab (COLUMVI) | CD20, CD3e; IgG1ҡ/λ bispecific | Diffuse large B-cell lymphoma |
| Retifanlimab (Zynyz) | PD-1; Humanized IgG4ҡ | Merkel cell carcinoma |
| Concizumab (Alhemo) | Tissue factor pathway inhibitor; Humanized IgG4ҡ | Hemophilia A or B with inhibitors |
| Lebrikizumab (EBGLYSS) | IL-13; Humanized IgG4ҡ | Atopic dermatitis |
| Tafolecimab (SINTBILO) | PCSK9; Human IgG2ҡ | Primary hypercholesterolemia and mixed dyslipidemia |
| Narlumosbart (Jinlitai) | RANKL; Human IgG4ҡ | Giant cell tumor of bone |
| Zuberitamab (Enrexib) | CD20; Chimeric IgG1ҡ | Diffuse large B-cell lymphoma |
| Adebrelimab (Arelili) | PD-L1; Humanized IgG4ҡ | Extensive-stage small cell lung cancer |
| Divozilimab (Ivlizi) | CD20; Humanized IgG1ҡ | Multiple sclerosis |
The discovery of antibodies, including phage display antibody screening or yeast screening, antibody sequencing, and subsequent antibody validation evaluation. Among them, antibody screening, as a crucial step, takes the longest time and has low screening efficiency, which also limits the cycle of antibody discovery. In recent years, the rapid development of antibody screening technology has greatly shortened the entire process of antibody discovery.
KMD Bioscience has a professional antibody discovery platform, where customers can choose appropriate antibody screening techniques according to their different needs. Our professional scientists can provide customized solutions, and in subsequent articles, we will deeply analyze antibody discovery techniques. You can follow KMD Bioscience’s official website for more information.
Reference
https://www.antibodysociety.org/antibody-therapeutics-product-data/
Crescioli, S., Kaplon, H., Chenoweth, A., Wang, L., Visweswaraiah, J., & Reichert, J. M. (2024). Antibodies to watch in 2024. mAbs, 16(1). https://doi.org/10.1080/19420862.2023.2297450