Cancer Treatment Black Technology! Will peptide preparations be the next "big variety"?

Text . . . Lu Lujun with the new drug research and development more difficult, biological drug research and development competition is becoming increasingly white heat, and peptide drugs between small molecular chemical drugs and large molecular proteins, antibody drugs, balanced the advantages of small molecular drugs and large molecular protein drugs, stable nature, production process easy to control, become the current research and development hot spot.
recent years, the research and development of new drugs for peptides has been in full swing, focusing on diabetes, cancer, peptide vaccine, eye disease and other fields, mainly for micro-balls, oral, in-place gels and other dosage forms.
, peptides can also be widely used in the field of cosmetics, for the skin anti-wrinkle, anti-aging, whitening plaque and other effects.
China's peptide drug industry is still in its infancy and growth stage, with great potential for development.
, however, nearly half of the peptide drug molecules listed worldwide are still not yet available in China, and the top 10 peptide molecular products in sales are relatively low in China.
face of this historical opportunity, Pharmaceutical Zhi interview special interview Zhejiang Peptide Biological Co., Ltd. founder and director Liu Zhiguo, listen to the experts in the eyes of the "peptide preparation empire"! Liu Zhiguo, founder of Zhejiang Peptide Biological Co., Ltd., is expanding rapidly! The global market for peptide drugs is booming According to a 2013 report by the Global Peptide Therapeutics Foundation, the number of peptide drugs entering clinical development has increased over the past few decades: 9.7 in the 1990s and 19.5 between 2000 and 2010.
" can be foreseen, with the rapid development of molecular biology, biochemical synthesis technology, the development of peptide drugs will step up to a new level, peptide products will become a large category of products in the international pharmaceutical market, its market prospects can not be underestimated.
," Liu zhiguo said.
" peptides are one of the research and development directions with broad market prospects in the pharmaceutical industry and may replace existing small molecular chemicals in the future.
," he said, including anti-infection, anti-tumor, physiological regulation, heart failure and so on.
At the same time, because most peptide drugs have the characteristics of direct oral ineffectiveness, short biological half-life and long treatment cycle, the secondary development of existing peptide drugs is also a commercially valuable research and development direction for the purpose of improving patient compliance.
peptides are a class of drugs that are growing very fast in the market.
, nearly 100 peptide products have been approved worldwide, with a global market size of $23.3 billion for peptide drugs in 2016, accounting for 2% of the pharmaceutical market share and a 10-year compound growth rate of 10.80%.
In recent years, the global polypeptide drug market has grew at a compound rate of more than 12%, higher than the overall drug market, and is expected to reach $31.7 billion by 2020, including large varieties above the $1 billion level, such as gratide, liraglutide and so on.
, although the overall size of peptide drugs is still small, but with the maturity of synthesis technology and the development of preparation technology, peptide drugs have a greater room for development.
black technology! Peptide treatment of cancer has made significant progress in recent years, cancer immunotherapy has made significant progress, but also can not be separated from the "credit" of peptide drugs, peptides can not only be used as tumor antigens to activate anti-tumor immunity, but also can block the immune checkpoint molecules, so that can reasonably use the individual differences of tumor patients, explore potential targets and mutations in tumor tissue and microenvironment, so the development of anti-tumor polypeptide drugs, personalized treatment of tumors, greatly improve the cure rate of patients with advanced cancer.
" neoantigen is a type of tumor-specific antigen (TSAs) that does not exist in normal tissue organs.
is an abnormal peptide that is produced during tumor formation due to viral infections, mutations from the body's cells, or genetic rearfle, and transmitted by MHC molecules to the cell surface to activate the immune system.
they can inhibit tumor development by promoting tumor apoptosis, inhibiting tumor new blood vessel formation, activating the body's anti-tumor immune response, etc.
" Liu Zhiguo explained that peptide drugs used to treat patients with advanced cancer, new antigen peptides can be automated synthesis, clinical activity has been proven, can be a variety of dosage forms exist to enhance delivery efficiency, instantaneous activity, can be completely degraded.
In addition, peptides are also widely used in the field of cosmetics, "We can be used in skin care products with beauty effect of small molecular peptides called beauty peptides, such peptides non-toxic, highly active and easy to absorb, but also have a special physiological activity, mainly used for skin whitening, plaque, etc., in cosmetics application effect is very good, the industry market size growth rate remained at more than 25%."
market opportunities and the current research and development of difficult peptide drugs new dosage forms, long-acting preparations is the future direction of development.
Because peptide drugs are currently mostly injection forms, and the frequency of administration is high, patient compliance is poor, through the development of new dosage forms and long-acting preparations, effectively prolong the half-life of peptide drugs in the body, biological utilization significantly improved, in the treatment of a variety of difficult conditions for doctors to provide alternative treatment methods, so the promotion of peptide drugs is of great benefit.
, high-end preparations have certain technical barriers, compared with ordinary dosage forms have a greater competitive advantage, peptide drug technology has become a hot research and development of many pharmaceutical enterprises.
But peptide drug research and development itself is difficult, in raw materials and preparations have a high technical barriers, coupled with research manufacturers have patent protection of products, generic drug declaration cycle is longer, the need for enterprises to increase research and development investment, and continuously improve peptide synthesis technology and preparation development capabilities, and circumvent patents or challenge patents, and strive for early market.
drug also faces some challenges, such as synthesis technology, production process and product purity problems, resulting in product quality is not up to standard, or high cost and other factors, limiting the development of peptide drugs.
at the same time, not only need 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 when they enter the body.
strong itself, beach international market data show that the United States and Europe are the five most important markets for peptide drugs, market share of more than 70%, for China's peptide drugs how strong themselves, with the help of foreign platforms, quickly beach international market, Liu Zhiguo put forward his own proposals.
1, improve peptide synthesis technology.
peptide drugs in the synthesis process of API needs to overcome many technical problems, including the lack of peptides, anti-cyclone, etc. , these technical difficulties can achieve the goal of controlling the quality of API products, reduce the production of impurities, access to higher purity of peptide API.
addition, improved peptide synthesis techniques are necessary to reduce peptide production costs, which can be reduced by reducing waste production, increasing coupled efficiency and total production.
2, improve international registration capacity.
to improve the international registration capacity, multi-country declaration of peptide drugs, such as the United States, Europe, Japan, South Korea, etc., to accelerate the domestic drug to the international market.
3, encourage the development of peptide innovative drugs.
peptides themselves have high activity, easy chemical synthesis optimization, metabolite safety, low immunogenicity and other advantages, enterprises can be pilot peptides on the basis of different degrees of transformation and optimization, to further improve its physical and chemical properties and biological activity, has been a series of active ingredients, the development of more independent intellectual property rights of peptide innovative drugs.
4, the introduction of foreign peptide talent, technology and equipment.
The introduction of foreign high-level peptide talent, such as from peptide companies, universities, new pharmaceutical companies and other institutions of talent, the introduction of peptide advanced technology and equipment, such as slow release of high-end preparations related technology, the introduction of high-quality peptide projects, such as peptide innovative drugs.
Liu Zhiguo said that through peptide research and development enterprises continue to increase investment in peptide project research and development, policy-related departments in talent, technology, equipment, policy to give more support, and thus enhance the overall level of China's peptide industry, promote domestic peptide drugs to the world.
Expert Profile: Liu Zhiguo, founder and director of Zhejiang Peptide Biology Co., Ltd., has been engaged in peptide drug research since 2001, has served as research and development manager of Pfizer Pharmaceutical Project, founded Hangzhou Peptide Research and Development Center in 2014, founded Zhejiang Peptide Biology Co., Ltd. as a production base in 2015, focused on peptide drug research and development production and beauty peptide research, access to 12 Chinese invention patents, PCT patent 1 in the world.
.