"The 21st century is the century of biological industry, and the prospect of active peptide industry is bright. This conference specially held a sub Forum on polypeptide biological industry development, which is to make the domestic pharmaceutical industry pay full attention to polypeptide drugs and not miss the good opportunity for development. " Recently, at the China International Biomedical Industry Development Summit held in Hangzhou, Li Xiang, chairman of China peptide Biochemical Co., Ltd., pointed out that in the past 10 years, the commercial interests of peptide drugs have been rising all the way, and peptide drugs will become a major class of important products in the international pharmaceutical market, with a very broad market prospect.

Rapid growth of global market

What is polypeptide drug? According to the current classification in the international pharmaceutical field, all drugs with more than 100 amino acid molecules belong to proteins (including insulin, auxin, interferon, etc.) and drugs with less than 100 amino acid molecules belong to polypeptides. Du Junyi, chairman of Henan Qiangsheng Biotechnology Development Co., Ltd., said that in the past 10 years, due to the increasingly difficult development of new drugs with new chemical structure, the investment cost has increased year by year. For example, antibiotics have no classic products in the past 40 years, and scientists have gradually turned their attention to the development of active peptide drugs. It can be predicted that peptide drugs will become the substitutes of traditional antibiotics.

The advantages of polypeptide drugs are: it belongs to protein drugs, comes from nature, has high biological activity, does not accumulate in the human body, and has no side effects. Its disadvantages are fast degradation in vivo, low stability, limited administration, poor water solubility and high production cost. Li Xiang said that polypeptide antibiotics have many biological characteristics such as antibacterial, antitumor and wound healing, especially the potential to replace broad-spectrum and high-efficiency antibiotics.

"In the 1990s, the research and development of international peptide drugs was in a downturn. At that time, the high cost of production seriously restricted the development of peptide drugs. " Li Xiang said that due to the complexity of synthesis technology, the cost of reagents used for peptide APIs is very high. Usually, the synthesis requires dozens or even hundreds of steps of chemical reactions, and there is a tedious high-performance liquid-phase purification process, and the technical requirements for equipment and staff are not often stringent. In addition, the production scale of peptide drugs has a great impact on the cost. The larger the scale is, the smaller the cost is. Many factors lead to the high price of final products, some of which even cost thousands of dollars per gram. At the same time, peptide drugs have high risk of research and development and high requirements for synthesis technology. Even if the product can be approved, but in the production process, due to various reasons such as process, the purity of the product can not meet the requirements, resulting in the product can not be marketed.

In the past 10 years, with the rapid development of related technologies, the problem of production cost has been solved, and the production of peptide drugs has entered the golden stage of development. Zhang Lianshan, vice president and director of R & D of Jiangsu Hengrui Pharmaceutical Co., Ltd., pointed out that technologies such as synthesis, purification and liquid combination have promoted the R & D and production of peptide drugs, and many large biomedical companies are making full efforts to enter into this field. Among the multinational pharmaceutical enterprises, Roche and Lilly are more active in this field. Eli Lilly's peptide drug, ubile, has an annual sales volume of US $1.2 billion.

"According to statistics, the sales of peptide drugs now account for 2% of the whole international drug market, about 19 billion US dollars." Li Xiang pointed out that by the end of 1990s, scientists had discovered tens of thousands of natural polypeptide physiological substances, involving hormone, nerve, cell growth, reproduction, tumor lesions, neurotransmitter and immune regulation. In the past 20 years, more than 50 kinds of peptide drugs have been developed and marketed in the world. For example, leuprorelin, gorelin, buserelin, luteinizing hormone antagonists, etc., which are popular in the international market.

Professor Zhu Xun, School of pharmacy, Jilin University, believes that the use of chemical synthesis and the combination of chemical and biotechnology methods to carry out peptide and related new drug research and development is an important direction of global new drug research and development. Many new peptide drugs have been developed and marketed, and can effectively treat various incurable or difficult diseases (including cancer, AIDS and various diseases caused by immune disorders). At present, the R & D and sales of polypeptides and related new drugs in the world are increasing rapidly by 34% every year.

Local enterprises have a long way to go

In recent years, the research and development of polypeptide drugs in China has also shown a promising development situation. More and more attention has been paid to polypeptide drugs, and new drugs are emerging and approved for production. But at the same time, there are still some problems in this field, such as the lack of innovation. Many new drugs still have a big gap in technical level compared with foreign countries in order to change the dosage form and the way of administration.

At present, 14 peptide preparations have been sold on the market in China, 4 of which are all imported, 10 of which are generic or modified. According to incomplete statistics, there are more than 400 pharmaceutical enterprises engaged in biochemical and biotechnological drug production in China, and about 80% of them produce different types of peptide drug preparations or APIs, which are mainly distributed in economically developed provinces and cities, such as Beijing, Shanghai, Guangdong, Zhejiang and other places, Du said.

Most of these enterprises use modern biotechnology for production, but some of them still use the traditional extraction and separation method, enzymatic method and solid-phase synthesis method for production.

Referring to the development trend of polypeptide drugs in the future, Zhu Xun pointed out that at present, active polypeptides are mainly obtained from human and animal organs in China. In fact, polypeptides widely exist in various organisms, and their sources need to be further expanded. The search for new peptide drug resources can be considered from the following aspects: the further comprehensive utilization of animal organs, the full utilization of plant resources, and the utilization of marine biological resources.

In addition, polypeptide drugs have high molecular weight and poor liposolubility, so they are difficult to penetrate the biofilm, so they can only be injected. However, it is inconvenient for patients to use the drugs by injection, especially the drugs that need to be given frequently. Therefore, in order to solve the problem of the stability of the general peptide drug injection, the development of its non injection type is also one of the way out for the peptide drug innovation in China. The non injection route of polypeptide drugs can be divided into lung route, mucous membrane route, transdermal route, oral route, etc. each route of drug administration needs to develop corresponding preparations or drug delivery systems.

"In comparison, the production of peptide APIs consumes less reagents and energy than the synthesis of other chemical APIs. Therefore, with the same sales revenue, the pressure of environmental protection for enterprises to produce peptide drugs will be much smaller, which also fully meets the requirements of green GDP development." Li Xiang stressed that through more than 10 years of follow-up research and the development stage of the combination of innovation and imitation, the research of biotechnology drugs in China has started to enter the period of independent innovation, especially the use of modern biotechnology to produce peptide drugs will become the main way to produce peptide drugs in the future. Our country should further strengthen the research and development of peptide drugs, strive to form style and advantage, make brand internationally, and gradually expand the share of local peptide drugs in the international market.

At the same time, we should increase investment in basic research, strengthen the training and introduction of talents, attach importance to and support the combination of production, learning and research, and speed up the transformation process of scientific research results industry.

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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.