\1. The concept and introduction of polypeptide

\2. Definition and brief introduction of polypeptide drugs

\3. Sales of peptide drugs in the world

\4. Development trends of peptide drugs

\5. Development status of peptide medicine industry in China

\6. Market competition pattern of peptide drugs

\1. The concept and introduction of polypeptide

Polypeptide is a kind of compound which is made up of amino acids connected by peptide bond. It is the same as protein in connection mode. Generally, it is called polypeptide which is composed of less than 100 amino acids and protein which is composed of more than 100 amino acids. Compared with protein, peptide has the advantages of simple spatial structure, high stability, low immunogenicity or no immunogenicity.

Polypeptides are bioactive substances related to various cell functions in vivo, and indispensable participants in life activities, involving hormone, nerve, cell growth and reproduction and other fields. Their importance lies in widely participating in and regulating the functional activities of various systems, organs and cells in vivo. With the rapid development of biotechnology, peptide has become another important field of life science research after gene. At present, peptide products have been widely used in medicine, food, health products, cosmetics, biomaterials, biopesticides and many other fields.

\2. Definition and brief introduction of polypeptide drugs

(1) Definition of polypeptide drugs

Peptide drugs refer to peptides with specific therapeutic effects extracted from chemical synthesis, gene recombination or animals and plants, which are the specific application of peptides in the field of medicine. The bioactivity of polypeptide is extensive and important, and it can widely act on endocrine system, immune system, digestive system, cardiovascular system, blood system, musculoskeletal system, etc. Therefore, although the development history of polypeptide as a drug is short, it has developed rapidly, and it has become a hot spot of market development.

(2) Classification of polypeptide drugs

In terms of preparation methods, there are three main methods for the preparation of polypeptide drugs: chemical synthesis, gene recombination and extraction from driven plants. Because the content of polypeptides is very small in vivo and the purity of polypeptides is not enough, the clinical application of polypeptides extracted from driven plants is limited. The solid-phase synthesis technology in chemical synthesis has greatly promoted the development of peptide drugs.

Gene recombination refers to the process of exchanging and recombining DNA fragments due to the breakage and connection of different DNA chains, so as to form new DNA sequences; gene recombination is mainly used for the preparation of long peptides in peptide drugs. According to the action and secretion site of polypeptide drugs, they can be divided into vasopressin and its derivatives, oxytocin and its derivatives, corticotropin and its derivatives, hypothalamic pituitary peptide hormone, gastrointestinal hormone, other hormones and active peptides.

(3) Development of polypeptide drugs

The production of solid-phase peptide synthesis technology has greatly promoted the development of peptide drugs. At present, some drugs have been formed in the world: insulin for diabetes; thyrotropin releasing hormone for brain and nerve diseases (Alzheimer's disease, etc.) and thyroid diseases; thyroid stimulating hormone for autoimmune thyroid diseases; luteinizing hormone releasing hormone for prostate cancer and reproductive system tumors;

Keywords corticotropin in the treatment of rheumatoid arthritis; oxytocin in the obstetrics; ACEP in the treatment of diabetes insipidus; oxytocin in the treatment of hypertension; somatostatin in the treatment of gastrointestinal bleeding; human growth hormone in the treatment of senile diseases and dwarfism;

There are more than 50 varieties of chorionic gonadotropin, human menopausal gonadotropin and prolactin for gynecology and Obstetrics; adrenocorticotropic hormone releasing factor for anti anxiety; glucagon for hypoglycemia; calcitonin for bone calcium production; natriuretic hormone for cardiovascular diseases; thymus hormone (thymopentin, thymus method new) for improving immunity, among which there are about one or two Hundreds of new polypeptide drugs have entered the preclinical and clinical research stage.

The best-selling products are thymopentin, thymosin, somatostatin, acetic acid deamination vasopressin, salmon calcitonin, octreotide acetate, exenatide, pranlinin, leuprorelin, goserellin, enkephalin, bivalludin, tripatine, kapason, Fuzeon, zikono peptide, etc. Among them, many polypeptide drugs, such as calcitonin, leuprorelin, goserelin, enkephalin, and kapasun, have been sold for hundreds of millions of dollars annually.

With the rapid development of biotechnology and genetic engineering, more and more peptide drugs can be synthesized in a short period of time. Therefore, peptide drugs may replace more and more existing drugs in the near future, and become one of the important directions of new drug research and development of pharmaceutical companies. Peptide drugs are one of the most concerned hot spots in the field of new drug research in the post genomic era.

\3. Sales of peptide drugs in the world

Peptide medicine is a kind of medicine with rapid market growth. At present, nearly 100 peptide products have been approved for marketing in the world. In 2016, the market scale of peptide medicine in the world reached 23.3 billion US dollars,It accounts for 2% of the market share of medical drugs, with a compound growth rate of 10.80% in ten years, and the total sales volume has tripled from 2006 to 2016. In recent years, the compound growth rate of the global peptide drug market is more than 12%, higher than the overall drug market, and it is expected to reach 31.7 billion US dollars by 2020, among which there are many large varieties with the level of more than 1 billion US dollars, such as galatiride, lilalutide, etc.

In 2016, there were six varieties with sales of more than US $1 billion, with total sales of about US $9.9 billion. Therefore, although the overall scale of peptide drugs is still small, but with the maturity of synthesis technology and the development of preparation technology, peptide drugs have a larger development space.

\4. Development trends of peptide drugs

Peptide medicine is one of the research and development directions with wide market prospect in the pharmaceutical industry. With the rapid development of biotechnology and genetic engineering, more and more peptide drugs can be synthesized in a short period of time. The development of peptide drugs has extended many disease treatment fields, including anti infection, anti-tumor, physiological regulation, pain, heart failure, osteoporosis, diabetes, vaccine, etc. peptide drugs may replace the existing small molecule chemical drugs in the future.

At the same time, because most polypeptide drugs have the characteristics of direct oral ineffectiveness, short biological half-life and long treatment cycle, so to improve patients' compliance, the second development of existing polypeptide drugs is also a research and development direction of commercial value.

Average number of peptide drugs entering clinical trials in different time periods

Sourse: public data sorting

According to a 2013 report from the global peptide therapy foundation,In the past few decades, the number of peptide drugs entering clinical development has been increasing. In the 1990s, the annual average number was 9.7, and from 2000 to 2010, it increased to 19.5. It can be predicted that with the rapid development of molecular biology and biochemical synthesis technology, the development of polypeptide drugs will take a new step, and polypeptide products will become a large class of products in the international pharmaceutical market, whose market prospect can not be underestimated.

\5. Development status of peptide medicine industry in China

(1) Analysis on the market scale and growth of peptide drugs in China in recent years with the steady growth of China's pharmaceutical market, the market sales scale of peptide drugs is also expanding year by year. From 2013 to 2016, the market sales of peptide drugs in China maintained a rapid growth momentum, from 41.7 billion yuan to 58.1 billion yuan, with a compound growth rate of 11.71%. The market growth is good.

(2) Domestic market scale and growth of synthetic peptide drugs

At present, there are 26 kinds of chemically synthesized peptide drugs on the market in China, 17 of which have been localized. In recent years, with the development of chemical synthetic peptide technology in China, the product quality and yield have been improved significantly, the cost is more controllable, and the market scale has been expanded year by year. From 2013 to 2016, the market sales of Chinese synthetic peptide drugs maintained a rapid growth momentum, from 14.152 billion yuan in 2013 to 21.296 billion yuan in 2016, with a compound growth rate of 14.59%, significantly higher than the overall market growth rate of peptide drugs, with good market growth.

(3) The market scale has been expanded year by year, the market position has been improved continuously, and the growth rate is good from 2013 to 2016,The market of chemically synthesized polypeptides has maintained a rapid growth, accounting for about 36% of the polypeptide drug market, and has steadily increased.

(4) The clinical status of polypeptide drugs

With the continuous expansion of the clinical application of polypeptide drugs and the continuous listing of new products, this kind of drugs are gradually accepted by experts and clinicians with their exact efficacy and better safety (low incidence of adverse reactions), and their clinical treatment status is also constantly improving. Many kinds of drugs are included in the international and domestic guidelines and consensus of experts on the treatment of related diseases Guiding clinical medication and increasing the amount of doctors' prescriptions play a positive role in academic support. At the same time, it also provides a better authoritative support for pharmaceutical enterprises to carry out relevant academic research.

\6. Market competition pattern of peptide drugs

(1) The overall market competition is relatively relaxed

China's pharmaceutical industry has a high degree of marketization and fierce competition. However, in terms of peptide drugs, due to the limitations of process, equipment and technology, there are few domestic enterprises with the capacity of large-scale chemical synthesis of peptide drugs, and the market competition is relatively relaxed. At present, polypeptide drugs in China are mainly foreign brands, and foreign products occupy a large share in the polypeptide drug market in China.

The domestic polypeptide drugs are imitated from those that have passed the patent protection period or have not applied for patent in China. In recent years, with the rapid rise of a group of pharmaceutical enterprises with the ability of chemical synthesis of peptide drugs, a few pharmaceutical enterprises with large-scale production capacity, such as our company and Dior Jiuhong, Hanyu pharmaceutical and Shuangcheng pharmaceutical, have begun to emerge.

(2) Competition pattern of products and manufacturers in polypeptide drug market in China

① Competition pattern of market products of synthetic peptide drugs in China

At present, the main products of peptide drug market in China are thymopentin, thymosin, octreotide acetate, somatostatin and leuprorelin. From 2013 to 2016, the above five drugs accounted for 71.09%, 71.96%, 68.36% and 67.44% of the market share of chemically synthesized peptide drugs, respectively. The market concentration was relatively high, among which thymopentin and thymus method were the representative varieties in this field.

In terms of specific products, the sales scale and growth momentum of thymopentin and thymus method are good in recent years, and they have been in the forefront of market sales for three years. In 2016, the sales of the two varieties reached 4.602 billion yuan and 3.310 billion yuan respectively, with market shares of 21.61% and 15.54% respectively. Octreotide acetate, somatostatin and leuprorelin ranked third to fifth with sales of 2.749 billion yuan, 2.300 billion yuan and 1.401 billion yuan respectively.

② Competition pattern of Chinese chemical synthetic peptide drug manufacturers

At present, in the domestic market of chemical synthetic peptide drugs, the representative manufacturers include Novartis pharmaceutical, neutralization pharmaceutical, Hanyu pharmaceutical, American saisheng and Merck xuelano. From 2013 to 2016, the total sales of the above five enterprises accounted for 32.65%, 33.33%, 32.71% and 33.87% of the total sales of this kind of drugs, respectively. The market share of a single enterprise was not more than 10%, the market concentration was still low, and no obvious market monopoly pattern had been formed.

According to the sales volume of the former five manufacturers, although foreign-funded enterprises such as Novartis, American saisheng and Merck xuelanuo still have some advantages, domestic enterprises represented by Zhonghe pharmaceutical and Hanyu pharmaceutical are rising.

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Chengdu Shengnuo Biotechnology Co., Ltd. has "Chengdu polypeptide drug engineering technology research center" in Chengdu, mainly engaged in polypeptide, polypeptide drug and beauty peptide research. Our zero defect has passed the FDA certification, and now it has become the first-class professional peptide drug and product development, technology transfer, technical service and peptide drug industry in the scale production and export of China's parks.