Biotechnology drugs, or biopharmaceutics, is an industry that combines advanced technologies of biology, medicine and pharmacy, relying on high technologies such as combinatorial chemistry and pharmaceutical genes (functional antigenicity and bioinformatics), and backed by breakthroughs in basic disciplines such as molecular genetics, molecular biology and biophysics. Now, the industrialization of biopharmaceutical technology in the world has entered the investment harvest period. Biotechnology drugs have been applied and infiltrated into medicine, health food, daily chemical products and other fields, especially in the research and development, production and transformation of traditional medicine industry. The biopharmaceutical industry has become one of the most active and fastest-growing industries.

Some scholars believe that the achievements of physics and chemistry dominated the science and technology in the 20th century, while the achievements of biology dominated the science and technology in the 20th century. Whether this statement is generally accepted or not, it seems to be an indisputable fact that biotechnology is the fastest developing field in today's high technology. Scientists predict that by 20 15, life science will make revolutionary progress. These advances can help mankind solve many intractable diseases, completely eliminate malnutrition, improve food production methods, eliminate all kinds of pollution, prolong human life, improve the quality of life, and provide new means for social security and criminal investigation. Some achievements can also help human beings to accelerate the artificial evolution of animals and plants and improve the impact of the ecological environment on human beings. The research on the generation of new organic life will also make progress.

1. Current situation of biopharmaceuticals

At present, biopharmaceuticals are mainly concentrated in the following directions:

1 Cancer ranks first in the world in cancer mortality. In the United States, every year, 1 10,000 patients are diagnosed with tumors, and 547,000 people die of tumors. The cost of cancer treatment is $6543.8+$02 million. Tumor is a complex disease with many mechanisms. At present, early diagnosis, radiotherapy and chemotherapy are still used for comprehensive treatment. In the next 10 year, the number of anti-tumor biological drugs will increase sharply. For example, genetically engineered antibodies are used to inhibit tumors, fusion toxins targeting IL-2 receptors are used to treat CTCL tumors, and gene therapy is used to treat tumors (for example, interferon-γ gene is used to treat myeloma). Matrix metalloproteinase inhibitors can inhibit the growth of tumor blood vessels and prevent tumor growth and metastasis. These inhibitors may become broad-spectrum antitumor agents, and three compounds have entered clinical trials.

2 Biotechnology and drugs are used to treat neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease, stroke and spinal trauma. Insulin growth factor rhIGF- 1 has entered the phase III clinic. Nerve growth factor (NGF) and BDNF (brain-derived neurotrophic factor) have been used to treat end-stage neuritis and amyotrophic sclerosis, and both of them have entered phase III clinical practice.

There are 600,000 stroke patients in the United States every year, and the number of people who die from stroke reaches 1.5 million. There are not many effective drugs to prevent and treat stroke, especially those that can treat irreversible brain injury. Cerestal has been proved to significantly improve and stabilize the brain power of stroke patients, and has now entered the third phase of clinical practice. Genentech's thrombolytic active enzyme (Activase recombinant tPA) can be used for the treatment of stroke patients, which can eliminate symptoms by 30%.

3 autoimmune diseases Many inflammations are caused by autoimmune defects, such as asthma, rheumatoid arthritis, multiple sclerosis and lupus erythematosus. There are more than 40 million patients with rheumatoid arthritis, and the annual medical expenses reach hundreds of billions of dollars. Some pharmaceutical companies are actively dealing with this disease. For example, Genentech has developed a humanized monoclonal antibody immunoglobulin E to treat asthma, which has entered the second phase of clinical practice; A TNF-α antibody developed by Cetor Company is used to treat rheumatoid arthritis, and the effective rate is 80%. β -interferon from Kay Long Xing Company is used to treat multiple sclerosis. Other companies are applying gene therapy to treat diabetes, such as introducing insulin gene into patients' skin cells, and then injecting the cells into the human body, so that engineered cells can produce a full range of insulin supply.

4 Coronary Heart Disease In the United States, 6.5438+00000 people died of coronary heart disease, and the annual treatment cost is higher than 654.38+0.65438+0.70 billion dollars. In the future 10 years, drugs for preventing and treating coronary heart disease will be an important growth point of the pharmaceutical industry. Reopro Company of Centocor successfully treated angina pectoris of coronary heart disease with monoclonal antibody, and restored heart function, which marked the promotion of a new drug for treating coronary heart disease.

With the establishment of genome science and the maturity of gene manipulation technology, it is possible to commercialize gene therapy and gene sequencing technology, which is reaching a new height in future therapeutics. Transgenic technology is used to construct transgenic plants and animals, and has gradually entered the stage of industrialization. Using transgenic sheep to produce protease inhibitor ATT to treat emphysema and cystic fibrosis has entered clinical phase II and III. A large number of research results show that transgenic animals and plants will become another important development field of pharmaceutical industry in the future.

2. Prospects of biopharmaceuticals

In the next 10 year, biotechnology will create more effective drugs for the treatment of major diseases in the contemporary era, and form new fields in all frontier medical fields. The current popular pharmaceutical biotechnology is as follows:

Table 1 popular pharmaceutical biotechnology

Vaccine 62 Tissue Plasminogen Activator 4

Gene therapy 28 coagulation factor 3

Interleukin 1 1 colony stimulating factor 3

Interferon 10 erythropoietin 2

Growth factor 10 superoxide dismutase 1

Recombinant Soluble Receptor 6 Others 56

The total number of antisense drugs 6 is 284.

The revolution of biology depends not only on the development of biological science and biotechnology, but also on the technical trends in many related fields, such as MEMS, materials science, image processing, sensors and information technology. Although the rapid development of biotechnology makes it difficult for people to make accurate predictions, the progress in genome mapping, cloning technology, genetic modification technology, biomedical engineering, disease treatment and drug development is accelerating.

Besides genetics, biotechnology can continue to improve the prevention and treatment of diseases. These new therapies can block the ability of pathogens to enter and spread, make pathogens more fragile and make people's immune function respond to new pathogens. These methods can overcome the bad trend of pathogens becoming more and more resistant to antibiotics and form a new offensive against infection.

In addition to solving the traditional problems of bacteria and viruses, people are developing new treatments to solve the chemical imbalance and the accumulation of chemical components. For example, antibodies being developed can attack cocaine in the body and can be used to treat addiction in the future. This method not only helps to improve the situation of drug addicts, but also has a great impact on solving the problem of global illegal drug trade.

The emergence of various new technologies contributes to the development of new drugs. The combination of computer simulation and molecular image processing technologies (such as atomic force microscope, mass spectrometer and scanning detection microscope) can continuously improve the ability to design molecules with specific functional characteristics and become a powerful tool for drug research and drug design. Using drugs to simulate the interaction between drugs and biological systems will become an increasingly useful tool to understand the efficacy and safety of drugs. For example, the US Food and Drug Administration (FDA) uses Dennis Noble's virtual heart simulation system to understand the mechanism of action of cardiac drugs and the significance of clinical trial observation results in the drug approval process. By 20 15, this method may become the mainstream method for clinical drug trials of heart and other systems, and clinical drug trials of complex systems (such as brain) need more in-depth research on the functions and biology of these systems.

By the beginning of the next century, the number of biotech drugs will not exceed the total number of general drugs, but the total number of biotech pharmaceutical companies will exceed 6 times that of the previous 10 year. At present, most major biotechnology companies are located in the United States, such as Amgen, Institute of Genetics, Nutrilite, Genentech and Kay Long Xing, and Biogen is also developing rapidly. During the period of 1987, no recombinant DNA drug entered the forefront of the global drug sales list, but by 1996, many bioengineered drugs were on the list. Biotechnology drugs on the market mainly include three categories, namely, recombinant therapy for protein and recombination vaccines, and monoclonal antibodies for diagnosis or treatment.

At present, the cost of drug research and development has reached an unsustainable level, and the average cost of each drug before listing is about 600 million US dollars. Such a high cost will force the pharmaceutical industry to invest heavily in technological progress to improve its long-term viability. The comprehensive application of gene map, customized drug development based on phenotype, chemical simulation program and engineering program, and drug trial simulation technology has changed drug development from experimental method to customized development, that is, designing, testing and using new drugs according to drug addicts' in-depth understanding of drug reactions. This method can also save drugs that were rejected by a few patients in clinical trials in the past, but may be accepted by most patients. This method can improve the success rate, reduce the test cost, open up a new market for drugs with narrow application range, and make drugs more suitable for symptomatic people. If this technology is mature, it can have a great impact on the pharmaceutical industry and the health insurance industry.

It is worth noting that the protection of intellectual property rights in the pharmaceutical industry in the world is uneven. Some regions (such as Asia) will continue to focus on producing drugs with expired patents, and some regions (such as the United States and Europe) will continue to develop new drugs in addition to producing low-profit drugs.

In short, the creation of new technologies can greatly broaden the space for new drug discovery, and increase the opportunities and speed of new drug discovery through the comprehensive efforts of multiple disciplines. Because these methods can find the target of rapid identification of drug action, more new lead chemical entities can be found more effectively, thus providing a broader prospect for the invention of new drugs.

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