Genetic engineering polypeptide drugs are one of the fastest effective fields of genetic engineering technology in practical application. Polypeptide drugs include polypeptide hormones, cell growth factors, lymphatic factor, coagulation factors and enzymes. During the "Eighth Five-Year Plan" and "Ninth Five-Year Plan" period, through the efforts of relevant scientific and technological personnel in China, the research and development of genetic engineering drugs laid a good foundation and initially formed a certain industrial base, but there were few innovative projects with independent intellectual property rights, and the problem of repeated research and production was more serious. Therefore, during the Tenth Five-Year Plan period, priority will be given to supporting innovative projects, and according to the incidence situation in China, we will focus on supporting genetic engineering therapeutic drugs for the following major diseases:
(1) drugs for cardiovascular and cerebrovascular diseases
(2) Antitumor drugs
(3) Therapeutic drugs for neuropsychiatric diseases
(4) antiviral drugs for serious infectious diseases.
2. Genetically engineered vaccine
Genetic engineering vaccine has played an important role in preventing diseases that seriously endanger human life and health. In recent years, China has developed rapidly in the research and development of genetic engineering vaccines, and some genetic engineering vaccines such as hepatitis B, dysentery and cholera have been successfully developed. There are still many genetically engineered vaccines in the research and development stage. Key support:
(1) Genetic engineering vaccine against bacterial infection
(2) Genetic engineering vaccine against virus infection
(3) Genetic engineering vaccine against parasitic infection
(4) therapeutic vaccine
(5) nucleic acid vaccine
3, nucleic acid drugs and antisense nucleic acid drugs
Oligonucleotide drugs are oligonucleotides with specific sequences, which are used to block the expression of harmful genes. Its characteristic is high specificity. At present, there are mainly antisense nucleic acids, peptide nucleic acids and ribozymes developed. More than 60 kinds of nucleic acid drugs have been developed abroad. Antisense nucleic acids for the treatment of cytomegalovirus retinitis have been approved for marketing. There are many kinds of nucleic acid drugs 10 in clinical trials. The research of nucleic acid drugs in China has a good foundation, so we should support therapeutic drugs with good prospects and promote the clinical research to be completed and put on the market as soon as possible.
4. Therapeutic agents
Gene therapy is a new research field in contemporary medicine and biology. It tries to regulate the expression of defective genes in cells at the gene level or correct and replace defective genes with normal genes, so as to treat genetic diseases caused by gene defects and immune defects and tumors caused by oncogene activation or tumor suppressor gene inactivation, that is, gene-related diseases. Broadly speaking, gene therapy is to introduce an expressible gene with normal function into target cells, thus correcting genetic diseases caused by gene defects. In recent years, China has made some progress in gene therapy and key technologies and products of gene therapy for malignant tumors, cardiovascular diseases and nervous system diseases, but the overall level is far from the international level. Key support:
(1) Gene therapy products for malignant tumors
(2) Gene therapy products for hereditary diseases
(3) Gene therapy products for nervous system diseases
(4) Gene therapy products for cardiovascular diseases
5. Monoclonal antibodies and genetically engineered antibodies
Monoclonal antibodies and genetically engineered antibodies have a wide range of uses and markets. More than 500 kinds of therapeutic and diagnostic antibodies have been put on the market in the world, and dozens of products have been approved for listing in China, but the scale is small and the varieties are incomplete. Therefore, during the tenth five-year plan period, we will focus on supporting:
(1) Novel monoclonal antibody diagnostic reagent and kit
(2) New enzyme-linked diagnostic reagents and kits
(3) Humanized genetically engineered antibody therapeutic agent
6, diagnostic reagents
Immunodiagnostic reagents are used to diagnose the specific reaction between antigens and antibodies by labeling tracer substances, and they have a wide range of applications, which can be
Determination of endocrine hormones, protein, peptides, nucleic acids, neurotransmitters, cell surface antigens and other active biological substances. At present, immunoassay kits include radioimmunoassay kits, enzyme immunoassay kits, chemiluminescence kits and time identification kits. During the Tenth Five-Year Plan period, we will focus on supporting new diagnostic reagents with high sensitivity and remarkable characteristics, and there is no diagnostic method at present.
7.DNA probes and gene diagnostic reagents
8. Biochip system
Biochip is an epoch-making microanalysis technology developed in the mid-1990s, and it is a hot research topic in the world today. Key support:
(1)DNA sequence analysis
(2) Diagnosis of genetic diseases and tumors
(3) Diagnosis of infectious diseases
(4) New drug development and ingredient screening.
9. New drugs, thrombolytic enzymes and preparations
10, new active protein and polypeptide drugs.
1 1, medical amino acid
At present, medical amino acid infusion needs imported varieties;
12, new antibiotic
Using modern biotechnology, the original antibiotic properties and the existing problems in antibiotic treatment are designed and reformed to create antibiotics that are more suitable for clinical use or have brand-new curative effects;
13, genetically modified animal and plant medical engineering products
Using transgenic animals and plant bioreactors to produce gene drugs is a brand-new production model, which has incomparable advantages compared with previous pharmaceutical technologies and should be supported.
14, tissue engineering products
In the past few decades, the number of organs available for transplantation in the world is very scarce, and the development of tissue engineering will greatly alleviate these problems. At present, we first support some building materials in tissue engineering, such as extracellular matrix and biodegradable polymers.
15, Biotechnology Development of Natural Drugs
China has traditional advantages in the research and application of traditional Chinese medicine, and shows unique advantages in the prevention and treatment of diseases, especially intractable diseases. In order to promote the modernization of traditional Chinese medicine, it is extremely important to develop biological resources and traditional Chinese medicine resources by using new technologies. Key support:
(1) Large-scale culture technology and products of animal and plant cells
(2) Fermenting to produce precious and rare medicinal raw materials.
(3) separating and extracting bioactive raw materials and new drugs from animal and plant tissues.
(4) chemically modified products and new drugs that naturally extract active substances.
16, active substances and drugs made by marine organisms
Using modern biotechnology such as biochemical engineering to develop marine biological resources is a new industry in pharmaceutical industry. China is rich in marine resources and there are many varieties available for research and development, which provides conditions for the development of new marine biological drugs for the treatment of cardiovascular and cerebrovascular diseases, tumors, nephropathy, viral hepatitis and other major diseases; Key support:
(1) A new marine biological drug for the treatment of cardiovascular and cerebrovascular diseases.
(2) New antiviral marine biological drugs
(3) raw materials and new drugs of various bioactive substances in marine life
17, a new efficient enzyme preparation
China's enzyme engineering and related technology research is close to the international level, and its large-scale production strength is strong, but the supporting capacity of upstream and downstream engineering technology is poor. Adding new varieties of enzyme preparations and expanding new application fields are important ways to develop the product structure adjustment of enzyme preparations.
18, biological separation technology device and related reagents
In biotechnology products, separation and purification technology plays an increasingly important role in product quality, output and cost. In traditional fermentation industry, the separation cost accounts for about 60% of the total cost, while in modern genetic engineering products, the separation and purification cost is as high as 90%. Therefore, separation and purification technology plays a very important role in product industrialization. The demand for separation media for medicine, natural medicine, fermented products, biological products and genetic engineering products in China is about 3000 tons per year, and high-performance separation media mainly rely on imports. In order to reverse this situation, measures must be taken to gain support from many parties;
At present, China has the synthetic ability and technology of various separation media, and there are a number of media with quality reaching or close to imported products, but the production capacity is low. Therefore, high-precision, automatic, programmed, continuous and efficient equipment and media suitable for genetic engineering, cell engineering, fermentation engineering, natural medicine production and separation of effective components of traditional Chinese medicine, such as macroporous resin, and production equipment suitable for biopharmaceutical enterprises, are urgent problems to be solved in industrialization at present. In addition, the research and development and production of biotechnology need a large number of supporting reagents and kits. At present, 80% of reagents need to be imported, which should be paid attention to. Key support:
(1) Development and production of new and efficient separation media and equipment in the fields of biology and medicine.
(2) Development and production of new high-efficiency membrane separation components and devices for biology and medicine.
(3) Development and production of new and efficient biological and medical chromatographic media and equipment.
(4) Development and production of preparative electrophoretic separation technology and equipment.
(5) Development and production of reagents and kits for biological and medical research and production.
19, biosensor
Biosensors are widely used in pharmaceutical industry, food fermentation industry, clinical medical treatment and other fields, with great market potential. The sensors developed in China have few varieties and unstable performance, and have not yet formed mass production capacity, which can not meet the market demand.
Seek; Key support:
(1) Biosensors for medical, pharmaceutical and scientific research
(2) Multifunctional sensors for clinical diagnosis, such as dialysis biochemical parameters joint inspection sensor and senile diseases joint inspection sensor.
(3) On-line optimization control system and multi-parameter biosensor on-line monitoring system for amino acids, antibiotics and other fermentation industrial processes.