Protein medicine and its development

Protein is the executor of gene function, and protein protein interaction is the basis of life activities. When any protein that performs a specific function in the body mutates or is abnormal, or when the concentration of a certain protein in the body is too high or too low, the corresponding disease will occur. This means that there is great opportunity and potential to use protein to treat or alleviate diseases. Theoretically, protein drugs can be used to treat almost all diseases with clear pathogenesis and clear pathological targets.

In a broad sense, protein drugs include all products whose chemical nature is protein or polypeptide, such as hormones, growth factors/cytokines, proteases, receptor molecules, monoclonal antibodies and antibody related molecules, some proteins or polypeptide vaccines, etc., among which various drug complexes using proteins (such as antibodies) as carriers are also included. Compared with small molecule compound drugs (new chemical entities, NCE), the development of protein drugs representing biomacromolecule drugs fmoc-osu (new molecular entities, NME; also known as new biological entities, NBE) has experienced a tortuous process from empirical science to experimental science. Its maturity depends on the continuous accumulation of protein structure and function knowledge in the past 30 years, And the gradual improvement of production, separation and purification technology of high purity and large batch protein products. The earlier protein therapy products mainly come from the functional classification of plasma, body fluid or tissue protein drugs including human or some specific animals

FDA of the United States approves protein drugs according to the regulations of biological license applications (BLA). As of 2008, the US FDA has approved more than 130 therapeutic proteins (including about 100 recombinant proteins) for clinical use, and more protein drugs are under development. The classification of these protein drugs will help to better play its therapeutic role, and help to clarify the thinking and direction of research and development. semaglutide api However, there is no uniform classification method for protein drugs. Small molecule protein drugs can be classified according to their physical and chemical properties, while large molecule protein drugs obviously cannot be classified according to this principle. They can be divided into hematopoietic factors, growth factors, IFN, IL, monoclonal antibodies, recombinant hormones/egg whites, etc. according to the continued naming and mechanism of action, but they are obviously not adapted to the growing family of protein drugs.

In 2008, Leader and others first proposed the idea of classification based on protein pharmacological effects, and divided protein drugs into the following four categories:

① protein drugs that use protein enzyme activity and regulatory activity for treatment; 

② Protein drugs with special targeting activity;

③ Recombinant protein vaccine; 

④ Recombinant protein drugs for diagnosis. The first and second categories are mainly used for basic protein therapy, while the third and fourth categories focus on the application of proteins in vaccines and diagnostic drugs. Based on the classification of functions and therapeutic applications, protein drugs that have been approved at present are divided into seven categories.