The essence of genetic engineering drugs is protein. At present, they are mainly obtained by microbial fermentation and animal cell culture. There are nearly 40 kinds of genetic engineering drugs on the market.Since 1982, the world's first genetically engineered drug recombinant human insulin has been approved by the US FDA for marketing, genetically engineered drugs have been emerging.Genetically engineered drugs have become the focus of investment and development by governments and enterprises around the world, and have developed rapidly in the past 20 years.In 1989, China developed the first recombinant interferon a-1b with independent intellectual property rights. So far, more than 20 varieties of recombinant interferon a-1b have been approved for marketing. Its quality is equivalent to that of imported similar varieties, but its price is only about one-third of that of imported drugs.With the rapid development of biotechnology in China, the price of domestic genetic engineering drugs continues to decrease, which will further promote the clinical application of genetic engineering drugs.Genetically engineered drugs have broad application prospects in diabetes, cardiovascular diseases, viral infectious diseases, rheumatoid arthritis, wound repair and anti-tumor.[1-2]
The so-called genetic engineering medicine is to first determine the protein that has preventive and therapeutic effects on a certain disease, then take out the gene that controls the protein synthesis process, through a series of gene operations, and finally put the gene into the receptor cells that can be mass produced (including bacteria, yeast, animal or animal cells, plant or plant cells),In the receptor cells, they continue to multiply, and mass produce proteins that can prevent and treat these diseases, that is, gene vaccines or drugs.
2、 Development of Genetically Engineered Drugs
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In 1977, American scientists produced the active human brain hormone growth hormone releasing inhibin with Escherichia coli for the first time.This is the first major breakthrough in the history of genetic engineering, which has laid a theoretical foundation for further elucidating gene expression in higher biology, and its huge economic value is also very attractive.This hormone can inhibit the secretion of auxin, insulin and glucagon, and can be used to treat acromegaly, acute pancreatitis and other diseases.
In 1978, American scientists transferred the synthetic human insulin gene into E. coli to make the latter produce human insulin, thus providing a reliable, large and stable source of drugs for the majority of diabetic patients.In 1983, insulin products manufactured by genetic engineering began to be put on the market.
In 1979, American scientists announced the production of human growth hormone by genetic engineering.This is a hormone secreted by the anterior lobe of the pituitary gland. It is a specific drug for the treatment of dwarfism, and can be used to treat senile osteoporosis, bleeding ulcers, burns, trauma, fractures, etc.This drug has strong specificity and cannot be used as a substitute for animal growth hormone to treat human diseases.Previously, a child with dwarfism with hypophyseal insufficiency was treated, and the growth hormone needed for one year was extracted from at least 50 corpses, so most patients could not get treatment.The human growth hormone produced by genetic engineering, which entered the market in 1983, is only 5 dollars per international unit.
Interferon is an active protein secreted by human or animal cells. When cells are infected by foreign viruses, they will be stimulated to produce interferon, which helps cells produce antibodies.Therefore, interferon can be used to treat serious viral infections, such as hepatitis B, herpes, etc. It can also inhibit cell proliferation, and has immune regulation function, thus showing a certain anti-cancer effect.But in the past, interferon can only be extracted from human body, so the source is difficult and the price is very expensive.In 1980, American Gene Technology Company successfully transferred human α interferon gene into E. coli and produced interferon.In June 1986, the US Food and Drug Administration approved the launch of interferon alpha A produced by Genentech and Biogen.
According to the survey of the American Pharmaceutical Research and Manufacturing Association (PRMA), the US Food and Drug Administration had approved 24 kinds of genetically engineered drugs and vaccines to be put on the market at the end of 1995.By July 1997, 39 kinds of 17 categories of genetically engineered drugs, vaccines and monoclonal antibodies for injection had been approved.In November 1998, the genetic engineering drug IL-11 was approved to be put on the market.There are more than 100 kinds of genetically engineered drugs in the United States that are under research.Japan has also made rapid progress in the research of genetic engineering drugs, with more than 20 kinds of products.
China has also paid enough attention to the research of genetic engineering drugs.More than 10 kinds of genetic engineering drugs, such as hepatitis B vaccine, interferon and interleukin-2, have been approved to be put on the market.
3、 Current status of genetic engineering drugs
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According to incomplete statistics, there are nearly 100 kinds of genetically engineered drugs already on the market in Europe and the United States, about 300 kinds of drugs are in clinical trials, and about 2000 varieties are under research and development.It is worth noting that the marketing cycle of gene drugs has significantly shortened in the past two years.Compared with general drug research and development, genetic engineering drug research investment is large.In the United States, the research funding for this drug is nearly 10 times the average investment in industrial research, and is increasing year by year.Some large multinational companies venture into the market in order to monopolize the market. For example, Johnson&Johnson of the United States invested more than $2 billion to develop a recombinant human erythropoietin (EPO) product, making huge profits.
