With the increasing difficulty of new drug research and development, the competition of biological drug research and development is becoming increasingly fierce. Peptide drugs, which are between small molecule chemical drugs, large molecule protein drugs and antibody drugs, balance the advantages of small molecule chemical drugs and large molecule protein drugs, with stable properties and easy production process control, have become the current research and development hotspot.
In recent years, the research and development of new peptide drugs has been in full swing, focusing on diabetes, cancer, peptide vaccine, eye disease and other fields, mainly in microspheres, oral, in situ gel and other dosage forms.
Not only that, the polypeptide can also be widely used in the field of cosmetics, for the anti-wrinkle, anti-aging, whitening and freckle of the skin and other aspects of remarkable effect.
The peptide industry in China is still in its infancy and growth stage, with huge development potential.
However, at present, nearly half of the peptide drug molecules listed in the world have not yet been listed in China, and the utilization rate of the top ten peptide molecular products in sales is relatively low in China.
In the face of this historic opportunity, Yao Zhi interview special interview Zhejiang Pai peptide biological co., LTD. Founder, director Liu Zhiguo, listen to the experts in the eyes of the “empire of polypeptide preparations”!
Liu Zhiguo, founder of Zhejiang Pai Peptide Biological Co. Ltd
The global market for polypeptide drugs is booming
According to a 2013 report by the Global Peptide Therapy Foundation, over the past few decades, the number of peptide drugs entering clinical development has increased: from 9.7 per year in the 1990s to 19.5 per year between 2000 and 2010.
“It can be predicted that with the rapid development of molecular biology and biochemical synthesis technology, the development of peptide drugs will step up to a new level, and peptide products will become a major category of products in the international pharmaceutical market, and its market prospect can not be underestimated.”
Liu Zhiguo said.
“Peptide drugs are one of the promising research and development directions in the pharmaceutical industry, which may replace existing small molecule chemical drugs in the future.”
These include anti-infection, anti-tumor, physiological regulation and heart failure, he said.
At the same time, due to the fact that most of the polypeptide drugs have the characteristics of direct oral ineffective, short biological half-life and long treatment cycle, the secondary development of the existing polypeptide drugs is also a research and development direction with commercial value for the purpose of improving patient compliance.
Peptide drugs are a rapidly growing market for drugs.
At present, nearly 100 peptide products have been approved to market in the world. In 2016, the global market size of peptide drugs reached 23.3 billion US dollars, accounting for 2% of the pharmaceutical market share, with a 10-year compound growth rate of 10.80%.
In recent years, the compound growth rate of 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 some large varieties of more than 1 billion US dollars, such as glatirelle, liraglutide and so on.
Therefore, although the overall scale of polypeptide drugs is still small, with the maturity of synthesis technology and the development of preparation technology, polypeptide drugs have a large space for development.
Peptides are effective in treating cancer
In recent years, great progress was made in tumor immunotherapy, also cannot leave the polypeptide drugs “merit”, activate anti-tumor immune peptides not only can be used as a tumor antigens, and can also be blocking immune checkpoints, can make reasonable use of the individual differences of tumor patients, explore potential targets in tumor tissues and microenvironment and mutation, thus developed as antineoplastic polypeptide drugs, to personalized cancer treatment, greatly improve the cure rate of cancer patients.
‘Neoantigens, for example, are a class of tumor specific antigens (TSAs) that are not present in normal tissues and organs.
It is an abnormal polypeptide produced during tumor formation due to viral infection, somatic mutation or gene rearrangement, and is delivered to the cell surface by MHC molecules to activate the immune system.
They can inhibit the development of tumors by promoting tumor cell apoptosis, inhibiting tumor angiogenesis, and activating anti-tumor immune response.”
Liu ZhiGuo explained that polypeptide drugs for the treatment of advanced cancer patients, neoantigenic peptides can be automated synthesis, clinical activity has been proven, can exist in a variety of dosage forms to enhance delivery efficiency, instantaneous activity, can be completely degraded.
In addition, the polypeptide is also widely used in cosmetics, “we can be used in skin care products, cosmetic effect of small molecular peptide called beauty peptide, this kind of polypeptide non-toxic, highly active and easy to absorb, has special physiological activity, mainly used for skin whitening, spot, etc., in the aspects of the application effect is very good, cosmetics industry market scale growth above 25%.”
Market opportunities and current research and development difficulties
New dosage form and long – acting preparation of polypeptide medicine are the future development direction.
As peptide drugs is more for injection dosage forms, and dosing frequency is high, the patient’s compliance is poorer, based on the development of new dosage forms and long-term preparation, effectively extended polypeptide drugs in vivo half-life, bioavailability, in the treatment of many difficult diseases provides doctors with alternative treatments, so is beneficial for the promotion of peptide drugs.
At the same time, high-end preparations have certain technical barriers, compared with the common dosage form has a greater competitive advantage, polypeptide drug delivery technology has become the research and development of many pharmaceutical enterprises.
But peptide drug development itself is difficult, in terms of raw materials and preparation has high technical barriers, and manufacturer of products are patent protection, with a long cycle of generic drugs to declare, need enterprises increase investment in research and development, constantly improve the peptide synthesis technology and development capability, and avoid patents or a challenge, for products listed in advance.
At present, peptide drugs still face some challenges, such as synthesis technology, production process and product purity problems, resulting in product quality is not up to the requirements, or high cost factors, which limit the development of peptide drugs.
At the same time, it is not only necessary to find new polypeptide drugs, but also to find new dosage forms and drug delivery system, so that the polypeptide drugs can continue to maintain stability and activity in the body.
Strong itself, 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%. For China’s peptide drugs, how to strengthen itself, with the help of foreign platforms, quickly conquer the international market, Liu Zhiguo put forward his own suggestions.
- Improve the technology of polypeptide synthesis.
In the synthesis process of API, peptide drugs need to overcome many technical problems, including peptide deficiency, racemic, etc., which can achieve the purpose of controlling the quality of API products, reducing the generation of impurities, and obtaining high purity polypeptide API.
At the same time, it is necessary to improve peptide synthesis technology to reduce the cost of peptide production, which can be reduced by reducing waste production, improving coupling efficiency and total yield.
- Improve the ability of international registration.
By improving the international registration capacity, peptide drugs can be declared in many countries, such as the United States, Europe, Japan, South Korea, etc., so as to accelerate the development of domestic peptide drugs into the international market.
- Encourage the development of innovative peptides.
Peptide itself has high activity, easy to chemical synthesis optimization, metabolic product safety, low immunogenicity, advantages, enterprises can be based on the forerunner polypeptide, varying degrees of modification and optimization, to further improve the physical and chemical properties and biological activity, has been a series of effective components, developed a more independent intellectual property rights innovation peptide drugs.
4, the introduction of foreign peptide talents, technology and equipment.
The introduction of high-level foreign peptide talents, such as from peptide companies, universities, new drug companies and other institutions of talent;
Introducing advanced technology and equipment of polypeptide, such as the technology related to slow and controlled release of high-end preparations;
Introduction of high quality peptide projects, such as peptide innovation drugs, etc.
Liu Zhiguo said that the peptide research and development enterprises continue to increase the investment in peptide project research and development, policy related departments to give more support in personnel, technology, equipment, policy, so as to improve the overall level of China’s peptide industry, promote domestic peptide drugs to the global market.