Medical network - on February 6th February 4, the national development and reform commission website announcement no. 1, 2017, announced the catalog for the guidance of strategic emerging industries focus on products and services (2016 edition). Directory five strategic emerging industry fields, eight industries related services (separately), 40 key under the direction of 174 is a direction, nearly 4000 niche products and services.
Among them, biological medicine industry is located in the "catalog for the guidance of strategic emerging industries focus on products and services in the fourth chapter in the first quarter, contains the" new vaccine ", "biotech drugs", "made chemicals and active pharmaceutical ingredients" and "modern Chinese medicine and national medicine", "biomedical critical equipment and raw materials" and "biological medicine service" six section, and in the middle of 2016 released draft deleted "Marine biological medicine" in this section.
Below is each section in biological medicine industry guidance directory specific content on February 4, issued a formal draft and the draft in the mid - 2016 contrast analysis and interpretation.
▍ new vaccines
Change interpretation: the overall content of the basic no change, only has carried on the integration and the section below, will be "new dosage form of oral vaccine, aspiration to vaccines and vaccine production with clean animal and cell matrix, culture medium and so on." Down to the "new dosage form of oral vaccines, inhaled vaccine."
Hepatitis, malaria, tuberculosis, AIDS, hand, foot and mouth disease and other major new infectious diseases or vaccine, genetic engineering vaccine, nucleic acid vaccine of new vaccine. Zoonoses vaccine against tumor, autoimmune disease and chronic infectious disease therapeutic vaccines. Flu diphtheria-pertussis-tetanus (no cells), chicken pox, measles, hepatitis a, polio and other traditional basic immunization with the vaccine upgrading and combined vaccine. New dosage forms of oral vaccine, inhaled vaccine (compared with draft remove content for "and vaccine production clean animal and cell matrix, culture medium and so on", hereinafter the same).
Vaccine antigens of mass culture, to produce new vaccine antigen purification technology, protein purification technology, vaccine safety and immunity related technology, freeze-dried vaccine technology to quickly evaluate thermal protection technology and quality of vaccine and methods, etc.
▍ biotech drugs
Changes will unscramble: peptides and restructuring clotting factors, genetic recombinant albumin drugs. With China's "twelfth five-year" period polypeptide drugs and restructuring clotting factors, genetic recombinant albumin drugs has been a rapid development, have produced a batch of representative enterprises.
Treatment of malignant tumor, autoimmune disease, nervous system diseases such as refractory diseases and for emergency prevention and treatment of infectious diseases of antibody drugs, low immunogenicity, good stability and targeting property of strong, long-lasting, high bioavailability of genetic engineering (and polypeptide drugs) of protein drugs. In view of the refractory diseases such as malignant tumor cell therapy and gene therapy drug products. (recombinant coagulation factor, gene recombinant albumin), specific immune globulin, and other products. To improve the utilization ratio of plasma blood products.
Genetic engineering drugs, antibody drugs, (polypeptide drugs,) nucleic acid drug, stable expression cell line construction technology of large-scale preparation of production technology, protein engineering, chemical modification, biological preparation technology such as long-term, slow release and controlled release, (polypeptide drugs on a large scale synthesis technology, etc.,) the new carrier of the vaccine, adjuvants and protective agent, stabilizer, cell therapy related technologies.
▍ chemicals with API manufacturing
Reading: "a delete, add". Delete the supervision of "target" "adjuvant", increase the shortage of our country and the world of children's drugs and disease "the orphan" drug use.
Antiviral, deep and multiple resistance against drug-resistant bacteria, fungus, drug-resistant mycobacterium tuberculosis resistance, resistance to other microorganisms, such as chlamydia, mycoplasma, malaria, parasites, etc.) of new anti-infective drugs, the high incidence of tumor diseases such as lung cancer, liver cancer treatment side effects, high clinical curative effect of small target, high selective anti-tumor medicine (drug and auxiliary), the prevention and treatment of cardiovascular diseases such as hypertension and diabetes endocrine and metabolic diseases such as the mechanism of action of the novel, long-term available and easy to use the new single and compound medicine, treatment of rheumatoid arthritis, systemic lupus erythematosus (sle), psoriasis, gout, low immune diseases and transplant rejection of a new immune regulator.
For depression, anxiety, insomnia, mental disorders such as schizophrenia, alzheimer's disease, Parkinson's disease and other neurodegenerative diseases, such as chronic neuropathic pain, relieve symptoms of new available drugs and alleviate the new long-term medication. Childhood diseases treatment of new drugs, "orphan disease treatment. (compared with discussion content, hereinafter the same)
The separation and purification of drug production, chiral synthesis and separation, biological preparation and catalytic synthesis, crystal type on-line quality control of drug production and drug information technology such as; Slow release and controlled release preparations production, long-term preparations, quick release preparations, targeted drug release, through skin and new dosage forms such as mucosal drug delivery preparation technology.
▍ modern Chinese medicine and national medicine
Relatively large section change interpretation: belong to change. Focus is to increase the drug treatment such as medicinal herbs planting link of pesticide residues, heavy metals and treatment control in the process of production and processing, etc. At the same time remove the relation with Chinese medicine and ethnic medicine has been relatively modest endangered species protection and related content.
Around the major advantage of disease for clinical treatment of traditional Chinese medicine disease and traditional Chinese medicine health product development of new drug of TCM research. Curative effect, high safety and effective components of clear, clear mechanism, advanced preparation technology of traditional Chinese medicine new medicine. The exact curative effect and high market share of the secondary development of proprietary Chinese medicine big variety.
Has significant curative effect of secondary development ethnic medicine, for the new use of national and local traditional medicine, the new technology to develop new varieties, from insects animals develop the national characteristics of new drugs.
Traditional Chinese medicine extraction and purification of TCM, Chinese herbal medicine planting, Chinese medicine yinpian processing technology and equipment, Chinese herbal medicine pesticide residues, heavy metals and harmful elements such as safety limit to study traditional Chinese medicine, the quality control standard, etc., and has important economic value is the result of insect animal medicine extraction and purification of quality control in the special technology etc.
Traditional Chinese medicine (TCM) system of green manufacturing, intelligent manufacturing technology and equipment development. Chinese medicine yinpian processing technology, the traditional Chinese medicine quality control technology and equipment, etc.
▍ biomedical key equipment and raw materials
Change reading: this section is the only section of the title change, title by discussion version of the "biological separation medium and the medicinal materials" instead of "biological medicine" key equipment and raw materials, basic no change, but the substance is to integrate the new vaccine related content and the section, at the same time will be the production of clean animals (including embryo), cell lines and culture medium." By the discussion of the emerging vaccine production to expand to the drug production.
Used for the manufacture of clean animal vaccines and drugs (including embryo), cell lines and culture medium, genetic engineering, cell engineering, fermentation engineering, natural medicine production, drug active ingredient such as separation with high precision, automation, programming, and the equipment for efficient medium, and is suitable for the production of biological products factory equipment, etc. New type of solid preparation with accessories, new coating material, a new supplementary material for injection, the medicinal preparation premixed accessories.
▍ Marine biological medicine
Change interpretation: this section is the only section on formal delete the contents of the draft the whole section. The author thinks that delete the reason is that the content has been in the vaccine, biotechnology, medicine, chemical medicines and proprietary Chinese medicine related chapters, without the need for a separate section.
(derived from Marine organisms of antibacterial, antiviral, anti-tumor, antioxidant, anti osteoarthropathy, fall blood sugar, diet and cardiovascular, nervous system and efficient Marine biological innovation drugs. Marine animal vaccine and diagnostic reagent, Marine biological veterinary drugs, veterinary medicine, in the modern Marine fauna and flora bioreactor drugs, modern traditional Chinese medicine (TCM).)
▍ biological medicine service
Change interpretation: in this section, the key is to increase the big data, platform, and personalized service related content, with the current public health services demand is more fit.
For chemical medicine, biological products, traditional Chinese medicine and medical equipment such as different types of innovative products, in order to obtain authorisation for the target of preclinical research, clinical trials of entrust contract research (CRO). Different sizes of raw materials, auxiliary materials and the preparation of the agency appointment contract manufacturing (CMO). Biological resources (including human, animal and plant and microorganism resources) and other special sample library (compound libraries, library, cells antibody libraries and other biological components library) of the collection, conservation and utilize the services. Biological information system (genome information, protein group information and information systems biology, etc.) and the database establishment, maintenance, and utilize the services, biological big data, medical health data sharing platform.
Gene sequencing, drug screening, experimental animal models, scale of plants and animals genetically modified (gm) and other aspects of professional and technical services. The supply of laboratory equipment, reagents, maintenance, test monitoring service. Biological safety laboratory, GMP production workshop design, construction, maintenance, approval and monitoring services. For personalized health care and precision medical genetic testing services, online intelligent diagnosis and treatment of the combination of ecological system, in view of the biological treatment services to major disease, based on the Internet and other technology to carry out the community and family remote health management service. |
