Cancer treatment black technology! Peptide preparation will become the next "big variety"?

With the increasing difficulty of new drug research and development, the competition of biopharmaceuticals research and development is becoming increasingly fierce.

Peptide drugs are between small molecular chemical drugs and macromolecular protein and antibody drugs, which balance the advantages of small molecular chemical drugs and macromolecular protein drugs.

With stable properties and easy control of production process, polypeptide drugs have become the current research and development hotspot.

In recent years, like a raging fire, new peptide drugs have been developed in the field of diabetes, cancer, peptide vaccine and eye diseases. They are mainly microspheres, oral and in situ gel formulations. In addition, the polypeptides can also be widely used in the field of cosmetics, which has significant effects on anti wrinkle, anti-aging, whitening and freckle removing of skin.

China’s polypeptide drug industry is still in its infancy and growth stage, with huge development potential. But at present, nearly half of the peptide drug molecules on the market in the world have not yet been listed in China, and the utilization rate of the top ten peptide molecular products in China is relatively low.

Expand quickly! The global market of peptide drugs is booming

According to the 2013 report of the global peptide therapy foundation, in the past few decades, the number of peptide drugs entering clinical development has been increasing: the average annual number of peptide drugs in the 1990s was 9.7, and it increased to 19.5 from 2000 to 2010.

It can be predicted that with the rapid development of molecular biology and biochemical synthesis technology, the development of peptide drugs will step to a new level, and peptide products will become a major category of products in the international pharmaceutical market, and their market prospects can not be underestimated.

“Peptide drugs are one of the research and development directions with broad market prospects in the pharmaceutical industry, and may replace existing small molecular chemical drugs in the future.”

These include anti infection, anti-tumor, physiological regulation and heart failure, he said. At the same time, most peptide drugs have the characteristics of direct oral ineffectiveness, short biological half-life and long treatment cycle. Therefore, to improve patient compliance, the secondary development of existing peptide drugs is also a research and development direction with commercial value.

Peptide drugs are a kind of drugs with rapid market growth. At present, nearly 100 peptide products have been approved to be listed in the world. In 2016, the global market scale of peptide drugs reached 23.3 billion US dollars, accounting for 2% of the medical market share, and the 10-year compound growth rate was as high as 10.80%.

In recent years, the compound growth rate of the global peptide drug market is more than 12%, which is higher than that of the overall drug market. It is estimated that the global peptide drug market will 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 grantirel, liraglutide, etc. Therefore, although the overall scale of peptide drugs is still small, with the maturity of synthesis technology and the development of preparation technology, peptide drugs have a large development space.

Black technology! Polypeptide treatment of cancer effect is remarkable

In recent years, tumor immunotherapy has made great progress, but also can not do without the “credit” of peptide drugs. Polypeptides can not only act as tumor antigens to activate anti-tumor immunity, but also block immune checkpoint molecules, so that the individualized differences of tumor patients can be reasonably utilized to explore potential targets and mutation epitopes in tumor tissue and microenvironment. Therefore, more and more anti-tumor drugs have been developed Peptide drugs, personalized treatment of cancer, greatly improve the cure rate of patients with advanced cancer.

“For example, neoplastic antigen is a kind of tumor specific antigen (TSAs), which does not exist in normal tissues and organs. It is a kind of abnormal polypeptide produced by virus infection, mutation or gene rearrangement from body cells during tumor formation, and is presented to cell surface by MHC molecules to activate immune system. They can inhibit the occurrence and development of tumor by promoting tumor cell apoptosis, inhibiting tumor angiogenesis and activating anti-tumor immune response

Peptide drugs are used in the treatment of advanced cancer patients. The new antigen peptide can be synthesized automatically. The clinical activity has been confirmed. It can exist in various dosage forms to enhance the delivery efficiency. The instantaneous activity can be completely degraded.

Besides, the peptide can be widely used in cosmetics, such as cosmetics, cosmetics and cosmetics Above. “

Market opportunities and current R & D difficulties

New dosage forms and long-acting preparations of polypeptide drugs are the future development direction. Due to the fact that most of polypeptide drugs are injection type, and the frequency of administration is high, and the compliance of patients is poor.

Through the development of new dosage forms and long-term preparations, the half-life of polypeptide drugs in vivo has been effectively extended, and the bioavailability has been significantly improved. It provides doctors with alternative treatment methods in the treatment of various difficult diseases, so the promotion of polypeptide drugs is of great significance Benefit.

At the same time, high-end preparations have certain technical barriers, and have greater competitive advantages compared with ordinary formulations. Peptide drug delivery technology has become the research and development hotspot of many pharmaceutical enterprises.

However, the research and development of peptide drugs is very difficult, and there are high technical barriers in raw materials and preparations. In addition, the research manufacturers have patent protection for the products, and the application cycle of generic drugs is long.

Therefore, enterprises need to increase R & D investment, continuously improve the peptide synthesis technology and preparation development ability, avoid patents or challenge patents, and strive for the products to be listed in advance.

Polypeptide drugs are also facing some challenges, such as synthesis technology, production process and product purity, which lead to the product quality can not meet the requirements, or the cost is too high, restricting the development of peptide drugs. At the same time, it is necessary not only to find new peptide drugs, but also to find new dosage forms and drug delivery systems, so that peptide drugs can continue to maintain stability and activity in vivo.

Strengthen ourselves and seize the international market

According to the data, the United States and five European countries are the most important market for peptide drugs, with a market share of more than 70%. As for how to strengthen China’s polypeptide drugs, and with the help of foreign platforms, it can quickly seize the international market.

1. Improve peptide synthesis technology.

Many technical problems, including peptide deletion and racemization, need to be overcome in the synthesis of polypeptide drugs. Overcoming these technical problems can achieve the purpose of controlling the quality of API products, reducing the generation of impurities, and obtaining high purity peptide APIs.

At the same time, it is necessary to improve the peptide synthesis technology to reduce the production cost of polypeptide, which can be reduced by reducing waste production, improving coupling efficiency and total yield.

2. Improve international registration capacity.

By improving the international registration capacity, we can apply for polypeptide drugs in many countries, such as the United States, Europe, Japan, South Korea, etc., so as to accelerate the domestic peptide drugs to enter the international market.

3. Encourage the development of polypeptide innovative drugs.

Peptide itself has the advantages of high activity, easy chemical synthesis and optimization, safety of metabolites and low immunogenicity. Enterprises can carry out transformation and Optimization in different degrees on the basis of leading polypeptide, further improve its physical and chemical properties and biological activity, and have obtained a series of effective components and developed more peptide innovative drugs with independent intellectual property rights.

4. Introduce foreign peptide talents, technology and equipment.

Introduce foreign high-level peptide talents, such as those from peptide companies, universities, new drug companies and other institutions; introduce advanced peptide technology and equipment, such as technologies related to high-end sustained-release and controlled-release preparations; introduce high-quality peptide projects, such as peptide innovative drugs.

It is hoped that through the peptide R & D enterprises to continuously increase the investment in peptide project research and development, the relevant policy departments will give more support in terms of talents, technology, equipment and policy, so as to improve the overall level of China’s polypeptide industry and promote domestic peptide drugs to go global.

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