Biotech drugs (biotech drugs) or biopharmaceutics (biopharmaceutics) is a collection of advanced technology in biology, medicine, and pharmacy as a whole, based on the high technology of combinatorial chemistry, pharmacological genes (functional antigens, bioinformatics and other high technology, and based on molecular genetics, molecular biology, Biophysics and other basic disciplines as the backbone of breakthroughs in the formation of the industry. Now, the industrialization of the world's biopharmaceutical technology has entered the investment harvest period, biotechnology drugs have been applied and penetrated into the pharmaceutical, health food and daily products and other fields, especially in the research, development, production of new drugs and transformation of the traditional pharmaceutical industry has been increasingly widely used, the biopharmaceutical industry has become one of the most active and fastest-progressing industry.
Some scholars believe that the science and technology of the 20th century is dominated by the achievements of physics and chemistry, while the science and technology of the 21st century is dominated by the achievements of biology. Whether or not this statement is universally agreed upon, it seems indisputable that biotechnology is the fastest growing area of high technology today. Scientists predict that the life sciences will make revolutionary advances by 2015. These advances can help mankind to solve the treatment of many currently incurable diseases, completely eliminate malnutrition, improve the production of food, eliminate all kinds of pollution, extend human life, improve the quality of life, and provide new means of social security and criminal investigation. Some of the results can also help mankind to accelerate the artificial evolution of plants and animals as well as to improve the impact of the ecological environment on human beings. Research to generate new organic life will also make progress.
1. Status of Biopharmaceuticals
Currently, biopharmaceuticals are mainly concentrated in the following directions:
1 Tumor The mortality rate of tumors is the highest in the world, and the United States diagnosed with tumors every year is 1 million patients, and those who died of tumors amount to 547,000 people. The cost of treatment for tumors is $102 billion. Tumor is a complex disease with multiple mechanisms, which is still treated with early diagnosis, radiotherapy, chemotherapy and other integrated means. Anti-tumor biological drugs will increase dramatically in the next 10 years. For example, the application of genetically engineered antibodies to inhibit tumors, the application of fusion toxins directed to IL-2 receptors to treat CTCL tumors, and the application of gene therapy methods to treat tumors (e.g., the application of gamma-interferon gene therapy for myeloma). Matrix metalloproteinase inhibitors (TNMPs) inhibit tumor blood vessel growth and stop tumor growth and metastasis. These inhibitors have the potential to be broad-spectrum antitumor therapeutic agents, and three compounds have entered clinical trials.
2 Neurodegenerative diseases Biotechnology drug therapy for Alzheimer's disease, Parkinson's disease, stroke and spinal trauma, insulin growth factor rhIGF-1 has entered phase III clinical. Nerve growth factor (NGF) and BDNF (brain-derived neurotrophic factor) are used in the treatment of peripheral neuritis, amyotrophic sclerosis, both have entered phase III clinical.
There are 600,000 stroke patients in the United States each year, and 150,000 die from stroke. There are not many effective preventive and curative drugs for stroke, especially fewer drugs that can treat irreversible brain damage. Cerestal has been shown to significantly improve and stabilize the brain energy of stroke patients, and has now entered phase III clinic. Genentech's thrombolytic active enzyme (Activase recombinant tPA) is used in the treatment of stroke patients, and it can eliminate 30% of the symptoms.
3 Autoimmune diseases Many inflammatory conditions are caused by autoimmune deficiencies, such as asthma, rheumatoid arthritis, multiple sclerosis, and lupus erythematosus. Rheumatoid arthritis patients more than 40 million, the annual medical cost of hundreds of billions of dollars, some pharmaceutical companies are actively attacking these diseases. For example, Genentech research a humanized monoclonal antibody immunoglobulin E for the treatment of asthma, has entered the phase II clinical; Cetor′s company developed a TNF-α antibody for the treatment of rheumatoid arthritis, the effective rate of 80%; Chiron's β-interferon is used for the treatment of multiple sclerosis. There are also companies in the application of gene therapy for the treatment of diabetes, such as the insulin gene into the patient's skin cells, and then inject the cells into the human body, so that the engineered cells to produce a full supply of insulin.
4 Coronary heart disease One million people in the United States die of coronary heart disease, and the annual cost of treatment is higher than $117 billion. In the next 10 years, drugs to combat coronary heart disease will be an important growth point for the pharmaceutical industry. Centocor′s Reopro has achieved success in applying monoclonal antibodies to treat angina pectoris in coronary heart disease and to restore cardiac function, marking the prolongation of a new type of coronary heart disease therapeutic drug.
The establishment of genomic science and the increasing sophistication of gene manipulation technology have made possible the commercialization of gene therapy and gene sequencing technology, which is reaching new heights in future therapeutics. Transgenic technology is used to construct transgenic plants and transgenic animals, which have gradually entered the industrial stage, and the production of ATT, a protease inhibitor, with transgenic sheep for the treatment of emphysema and cystic fibrosis has entered the phase II and III clinics. A large number of research results indicate that transgenic animals and plants will become another important area of development of the pharmaceutical industry in the future.
2. Biopharmaceutical outlook
The next 10 years biotechnology will create more effective drugs for contemporary therapeutic agents for major diseases and form new fields in all cutting-edge medical fields. The current hot drug biotechnologies are as follows:
Table 1 Hot Drug Biotechnologies
Vaccines 62 Tissue Fibrinogen Activator 4
Gene Therapy 28 Coagulation Factor 3
Interleukins 11 Colony Cell Stimulating Factor 3
Interferons 10 Erythropoietin 2
Growth Factors 10 SOD 1
Recombinant Soluble Receptors 6 Others 56
Antisense Drugs 6 Total 284
The revolution in biology relies not only on the development of biological sciences and biotechnology itself, but also on the technological trends in many related fields, such as microelectromechanical systems, materials science, image processing, sensors and information technology. Progress in genome mapping, cloning, genetic modification, biomedical engineering, disease therapies, and drug development is accelerating, although the rapid pace of biotechnology makes it difficult to make accurate predictions.
Beyond genetics, biotechnology can continue to improve therapies for preventing and treating disease. These new therapies can block the ability of pathogens to enter and spread through the body, make pathogens more vulnerable, and make the human immune system responsive to new pathogens. These approaches can overcome the negative trend of pathogens becoming increasingly resistant to antibiotics, creating a new offensive against infections.
In addition to addressing traditional bacterial and viral problems, new therapies are being developed to address chemical imbalances and the accumulation of chemical components. For example, antibodies are being developed that attack cocaine in the body and could be used in the future to treat addiction. Such an approach would not only help to improve the condition of addicts, but would also have a major impact on solving the global problem of the illegal drug trade.
A variety of new technologies have emerged to aid the development of new drugs. The combination of computer simulation and molecular image-processing techniques (e.g., atomic force microscopy, mass spectrometry, and scanning probe microscopy) continues to improve the ability to design molecules with specific functional properties, and has become a powerful tool in drug research and drug design. Simulation of the interaction of a drug with the biological system in which it is used will become an increasingly useful tool in understanding drug efficacy and drug safety. For example, the U.S. Food and Drug Administration (FDA) utilizes Dennis Noble's virtual cardiac simulation system in the drug approval process to understand the mechanisms of cardiac drugs and the significance of clinical trial observations. This approach may become the dominant method for clinical drug trials in systems such as the heart by 2015, and clinical trials of drugs for complex systems (e.g., the brain) will require more in-depth studies of the function and biology of these systems.
The number of biotech drug classes will not yet exceed the total number of generic drugs by the turn of the next century, but the total number of biotech pharmaceutical companies will be more than six times that of the previous decade. At present, the main biotechnology companies are located in the United States, such as Amgen, Genetics institute, Genzyme, Genentech and Chiron, and Biogen is also developing faster. 1987 has not been a recombinant DNA drugs into the world's top list of drug sales, but by 1996 there have been a variety of bioengineered drugs. By 1996, however, a number of bioengineered drugs had made the list. There are three main categories of marketed biotechnology drugs, namely recombinant therapeutic proteins, recombinant vaccines, and monoclonal antibodies for diagnostic or therapeutic use.
The cost of research and development of drugs is now unsustainably high, averaging about $600 million per drug before it reaches the market. Such high costs will force the pharmaceutical industry to make huge investments in technological advances to enhance its long-term viability. The combined use of technologies such as genetic mapping, customized phenotype-based drug development, chemical simulation programs and engineering programs, and drug trial simulation has already shifted drug development from a trial-by-trial approach to customized development, where new drugs are designed, tested, and used based on an in-depth understanding of the drug response of the population taking the drug. This approach can also rescue drugs that have been rejected by a small number of patients in clinical trials in the past but have the potential to be accepted by the majority of patients. This approach can improve success rates, reduce trial costs, open up new markets for drugs with narrower applicability, and make drugs more suitable for the needs of the applicable symptomatic population. If this technology matures, it could have a significant impact on the pharmaceutical industry and the health insurance industry.
It is worth noting that intellectual property protection in the pharmaceutical industry is uneven around the world. Certain regions (e.g., Asia) will continue to be dominated by the production of drugs with expired patents, while others (e.g., the U.S. and Europe) will continue to develop new drugs in addition to continuing to produce low-margin drugs.
In short, the synthesis of multidisciplinary efforts through the creation of new technologies can greatly broaden the space and increase the opportunity and speed of inventing new drugs. Because these means can look for rapid identification of the target of drug action, more effective discovery of more new chemical entities of the precursor, thus providing a broader prospect for the invention of new drugs.
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