As a hotspot in the post-gene era, peptides have been widely used in drug development. Peptide drugs are restricted by various conditions such as sequence design, drug screening, structural modification, preparation technology, research equipment, and preparations, and the market competition has eased. Looking at the world, Eli Lilly, Novo Nordisk, AstraZeneca, Takeda, Amgen, Ferring and other foreign established manufacturers continue to carry out strategic layouts such as R&D and acquisitions in the field of peptides, and births such as dulaglutide (2021 67.57 billion dollars in sales), semaglutide/semaglutide (sales of 5.875 billion U.S. dollars in 2021) and other blockbusters.
In recent years, with the development of omics technology, information technology, gene technology and in-depth research on disease biology, technologies such as rational design of peptide drugs, virtual screening, high-throughput synthesis, structural modification, and preparation technology have been continuously improved, and emerging A representative company of "New Polypeptide Economy". In 2021, Apellis' bifunctional peptide Pegcetacoplan was approved for listing, marking the official opening of the commercialization of the new polypeptide economy; in 2022, the bifunctional peptide Tirzepatide was approved for listing, pushing the "new polypeptide economy" industry to a climax.
Peptide new economy refers to the economic form led by the emerging peptide technology industry, which is different from the traditional peptide industry in the past and driven by the revolution of omics technology and bioinformation technology under the background of globalization. It includes new technologies, new industries, new formats and new models, so as to achieve new development and new breakthroughs in the peptide industry.
Peptide is a compound formed by linking α-amino acids with peptide bonds, and its molecular weight is generally below 10 kDa. Generally speaking, peptides consisting of less than 10 amino acids are called oligopeptides, and peptides consisting of 10-100 amino acids are called peptides, which have no clear boundary with proteins. According to the revision of BPCIA (Biologics Price Competition and Innovation Act of 2009) by FCA (Further Consolidated Appropriations Act, 2020), FDA interprets the term "protein" as "any alpha protein with a well-defined sequence and greater than 40 amino acids -Amino acid polymer” belongs to the biological product license application (BLA), and the development of peptide drugs less than or equal to 40 amino acids can still refer to the regulatory requirements of small molecules. So small molecular weight proteins and peptides have some conceptual overlap.
When it comes to peptides, we have to start with proteins. Protein is the material basis of life, and polypeptide is an essential component of protein. Proteins are divided into two categories: "globular proteins" and "fibrous proteins". The former are mostly water-soluble and active, such as enzymes, antibodies, transport proteins, protein hormones, and interstitial nerves; the latter are mostly fibrinogen. , myosin, keratin, collagen, etc. Therefore, polypeptides are the constituent fragments and active sites of enzymes, antibodies, and protein hormones, and can be developed into a variety of drugs with the same or even better efficacy. For example, insulin is a hormone, which was developed into the first human polypeptide drug, which completely changed the management of diabetic patients, which has a history of 101 years.
There is no uniform standard for the classification of peptides, and they can be divided into "endogenous bioactive peptides" and "exogenous bioactive peptides" according to their secretion sites. Endogenous bioactive peptides are the natural bioactive peptides that exist in the human body, with very little content but strong effects. At present, nearly 8,000 species have been discovered; exogenous bioactive peptides are widely found in animals (except humans), plants, Natural bioactive peptides in microorganisms and bioactive peptides produced after protein degradation.