What is the next breakthrough in the polypeptide market?

In recent years, the rapid development of innovative drugs, small molecule drugs and antibody drugs research and development has attracted much attention.

However, it is more and more difficult to find and screen small molecules. The technical barriers to the research and development of macromolecular antibody drugs are increasing.

According to statistics, it takes 14 years for a new drug to go on the market and costs more than 1 billion US dollars.

In the middle of the two, peptide drug research and development process is relatively simple, the R & D success rate is 2 times higher than that of small molecular drugs, the average R & D cycle is short, and the cost is low, which is considered to be one of the potential new drug therapies.

According to statistics, the global peptide drug market will reach US $28.15 billion in 2019 and will reach US $66.76 billion by 2027. At present, there are many blockbuster products with the level of more than 1 billion US dollars, such as grantirel and liraglutide.

On the whole, peptide drugs have been widely used in cardiovascular disease, central nervous system disease, respiratory, anti-tumor and immune regulation, anti infection and other fields, with a broad market space, and can be complementary with macromolecular antibody drugs and small molecule drugs.

In 1966, China took the lead in synthesizing bovine crystalline insulin, but the first peptide drug to be listed on the market was an American company.

As of January 2020, there are 197 kinds of peptide drugs on the market in the world. At present, there are only more than 48 kinds of peptide drugs in China.

European and American pharmaceutical companies occupy an absolute advantage in the global peptide market, and there are few companies with real R & D strength in China.

The reasons behind China’s first mover advantage but not in the field of polypeptide are thought-provoking.

What are the difficulties in peptide development? What is the development direction of next generation peptides? What is the way out for polypeptide drugs in China?

Oral administration is the development trend of polypeptide drugs

Polypeptides generally refer to short peptides formed by dehydration and condensation of 2-50 amino acids, with relative molecular weight less than 10000.

According to the different sources, peptide drugs can be divided into three categories: chemically synthesized peptides, gene recombinant peptides and extracted peptides.

Among them, chemical synthesis and gene recombinant peptides have obvious advantages in yield, product purity and preparation speed, and are widely used in the international market.

Polypeptides have the characteristics of strong drug preparation, high activity, high specificity and low immunogenicity.

Compared with traditional small molecule drugs and protein drugs, peptide drugs have higher activity than small molecules, no drug interaction, lower production cost than macromolecules, simple research and development, and no immunogenicity.

Since the discovery of insulin in 1920, peptide therapy has attracted more and more attention. In the early 20th century, people began to explore synthetic peptide drugs.

In the 1950s, solid phase peptide synthesis technology appeared in the industry, which laid the foundation for the industrialization of peptide synthesis.

Nowadays, peptide drugs have been widely used in clinical, and from the initial application in metabolic diseases, to cover cancer, neurological diseases, immune diseases, infectious diseases and so on. According to the public data, the total sales of polypeptide drugs in the world has reached 44 billion US dollars in 2019.

However, polypeptide drugs are not perfect. Their instability in vivo, poor oral therapeutic effect and poor membrane permeability limit the rapid development of peptide drugs.

Stability and other problems can be solved by modifying the modification process. The biggest obstacle to the development of peptide drugs is that they can not be given orally.

The key is to improve the long-term efficacy of peptide drugs. Generally speaking, a variety of proteolytic enzymes in the organism can degrade peptide drugs rapidly. Therefore, the oral effect of peptide drugs is not good and the half-life is short, so it needs to be administered by injection or nasal spray.

How to break the situation and solve the biggest obstacle to the development of peptide drugs is very important. Improving the delivery mode of peptide drugs has become the direction of the next generation of peptide drugs.

In 2012, linzess (linalotide), a capsule of American pharmaceutical company Ironwood pharmaceuticals, was approved by FDA for its listing; in 2017, the oral drug trust (procanapeptide) of synergy pharmaceuticals for constipation was approved by FDA. These two drugs lead the development of oral peptide delivery wave, and a large number of other kinds of polypeptide drugs are also being developed.

In 2019, David Brayden, a pharmacologist at Conway College of Berlin University, used nanotechnology to design a safe and effective method for oral ingestion of peptides.

Their results showed that nanotechnology could allow polypeptide to enter the blood at least partially through oral route; in the same year, the oral somalutide for diabetes was obtained by FDA They approved the market, using carboxyl based lipid soluble molecules to carry peptides to promote the absorption of peptide drugs in the small intestine.

This way norhonod used was developed by elisphere, a drug delivery company. As early as 20 years ago, emisphere cooperated with major pharmaceutical companies such as novonord and Novartis to develop oral polypeptide drugs, but all failed. Until 2019, Novo Nord brought oral somalutide.

The breakthrough is to develop innovative peptide preparation with raw materials as the main materials in China

In 1966, China synthesized the first bovine crystalline insulin, but the development of peptide drugs did not play a leading role.

Compared with foreign countries, the market size of polypeptide drugs in China is relatively small, but the growth rate is higher than that of the world.

According to statistics, the market scale of Chinese polypeptide drugs in 2019 exceeded 80billion yuan, with an annual compound growth rate of more than 15%. China has listed about 40 kinds of polypeptide drugs, among which imported products occupy the main market.

In the field of polypeptide drugs, the main domestic peptide raw materials, foreign mainly innovative peptide drugs;

domestic mainly in immune products, tumor and diabetes, and other fields accounted for a low proportion, while foreign mainly used in tumor, neurodegenerative diseases and metabolic diseases.

Multinational pharmaceutical companies attach great importance to the research and development of peptide innovative drugs.

Pfizer, Merck, Roche, Lilly, Novartis, Sanofi and other large pharmaceutical enterprises increased their investment in polypeptide drug research and development through acquisition or merger.

At present, the listed peptide drugs with sales volume of US $1billion are produced by foreign pharmaceutical companies, including gladiere, lillarubin, dulaglutide, somalupeptide, tripeptide, exenatin, etc. In 2018, the sales volume of lilarubin under novo Nord in China was RMB 600 million, accounting for 87% of the total GLP-1 drug market share in China and 1.3% of the diabetes market.

Most domestic polypeptide companies mainly focus on polypeptide API and cdmo/cro business, and there are only a few companies with real strength in new drug research and development, including Chengdu shengnuo biology.

Chengdu shengnuo biology mainly develops new polypeptide drugs in cardiovascular and cerebrovascular, metabolic and nervous system diseases.

Chengdu shengnuo biology is not only a cro/cdmo company, but also a polypeptide drug pipeline for diabetes, obesity and NASH;

The market of polypeptide drugs in China is growing rapidly and has great potential.

Although there are many players in the field of polypeptide, only a few head enterprises occupy the majority of China’s share, and multinational companies have absolute advantages in the field of polypeptide.

The reason why a group of multinational companies can occupy the Chinese market for a long time lies in their R & D strength. Although it needs enough R & D funds and time to independently innovate polypeptide original research and development, once listed,

it can take the lead, have long-term patent protection, and the product competitiveness is stronger, and it has long-term value. However, peptide raw materials and imitation companies often lack such advantages and core competitiveness, and cannot occupy the market.

Many foreign innovative polypeptide drugs undoubtedly reflect the importance of innovation from the side. Innovation and R & D strength will be the core competitiveness of the peptide market. This is also the breakthrough of domestic polypeptide companies.

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Shengnuo Biotechnology is a high-tech China polypeptide manufacturers,who has over 19 years experience for the biotechnology .Our Products involve peptide raw materials,polypeptide drug.

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