Healthcare will accelerate the industry upgrade recommended 5 shares
On July 25th, CFDA announced the "Drug Registration Management Measures (Revised Draft)" draft for comments, and revised the 2007 version of the "Regulations on Drug Registration" for the first time. We believe that this revision is of great significance and is generally oriented to clinical needs and encourages innovation. It is expected to accelerate the upgrading of the pharmaceutical industry. Emphasis on clinical demand-oriented, encourage innovative drugs, combat adjunctive drugs and pseudo-innovative drugs: 1) Encourage: The revised draft explicitly encourages clinical value-oriented drug innovation, and prioritizes drugs that require accelerated review according to law. Innovative drugs should have clear clinical value; improved new drugs should have obvious clinical advantages over the original varieties; generic drugs should Consistent with the quality and efficacy of the original drug. 2) Strike: The revised draft clarifies that the two types of conditions are not approved: one is the application for registration of drugs that change the original dosage form, acid base, base and route of administration. The applicant cannot prove its technical innovation and clinical value. The original varieties have obvious advantages, except for the application for registration of children's drugs that change the dosage form and specifications; the other is the application for registration of drugs that is not identical to the structure of the domestically listed biological products, or changes its clinical characteristics, formulation characteristics, cell matrix, etc. The applicant cannot prove that its technical innovation and clinical value have obvious advantages compared with the original variety; the overall emphasis on clinical needs, encourage innovative drugs with clinical value, if it can not prove the clinical value is higher than the original drug modification, acid and alkali salt Pseudo-innovation such as roots has not been approved. Single column and implementation of the bioequivalence test, which is good for high-quality generics and CRO industry: In order to improve the quality of generic drugs and cooperate with the evaluation of generic drug conformity, this revision will be the first bioequivalent and 1-4 The clinical trials are conducted in parallel and the filing system is implemented. The revised draft is accompanied by strict supervision in the implementation of the filing system, which stipulates that there is inconsistency in the information on the bioequivalence test filing in the daily supervision and management. If the authenticity problem exists, the corresponding registration application will not be approved. We believe that the bioequivalence experiment filing system will accelerate the upgrading of the domestic generic drug industry, and the CRO industry is expected to benefit from the consistent evaluation of the bioequivalence filing system. Relevant declarations on medicinal packaging materials, medicinal excipients and APIs are encouraged to encourage industrial upgrading: the revised draft is clear, the state implements the relevant review and approval of the listing application for pharmaceutical and pharmaceutical packaging materials and pharmaceutical excipients, and the state The application and the application for listing of the preparation or the supplementary application of the listed preparation shall be examined and approved, and the application for listing of the separate bulk drug will not be accepted. The related review and approval is to align with the foreign countries, and let the enterprise take the responsibility of the main body of the drug quality while simplifying the administration of power, and contribute to the industrial upgrading of the packaging materials, auxiliary materials and raw materials. Encourage the innovation of traditional Chinese medicine, and obtain market protection after listing: The revised draft clearly stipulates that if the Chinese medicine new medicine that has obtained the marketing authorization is also protected by the Chinese medicine variety at the same time, the application for listing of the same variety will be stopped. Compared with the 2007 version of the "application for the protection of traditional Chinese medicines, from the date of acceptance of the application for the protection of traditional Chinese medicines to the period of making administrative decisions, the suspension of the application for generic drugs of the same variety" is further encouraged to encourage innovation in Chinese medicine. Investment strategy and focus on individual stocks: The draft for comments, based on clinical value as a whole, combating auxiliary drugs, low-quality generic drugs and pseudo-innovative drugs, and benefiting innovative drugs and related industries. From the perspective of innovative medicines, it is recommended to focus on Hengrui Medicine, a leading pharmaceutical innovative drug, Tianshili, a Chinese medicine innovation company, and Kanghong Pharmaceutical, a model of biopharmaceutical innovation; and good quality CRO companies, Taige Medicine and Boji Medicine. Biochemical products are a large number of products obtained by various biological reaction processes, including, or other processes. Their common feature is that the materials mainly derived from biological sources are used as raw materials, which are formed in the bioreactor through the action, and are extracted and purified by relevant means. Some of these products can also be produced by chemical synthesis, such as, etc. Whether to use chemical synthesis or biosynthesis should be determined from the comprehensive consideration of economic technology; some products can only be produced by biosynthesis or it is more economical and reasonable to use biosynthesis , such as, amylase, vitamin B, interferon and other substances with complex molecular structures; some products are produced by both chemical synthesis and biosynthesis, such as semi-synthetic penicillin, cortisone, vitamin C, etc. Benzopinacole,Cyclohexyl Mercaptan,Allyl Mercaptan,1-Heptanethiol,Isobutylmercaptan Xi'an Henrikang Biotech Co.,Ltd , https://www.xianhenrikang.com
Biochemical products can be divided into:
â‘ Bulk Chemical Products, such as ethanol, acetone, n-butanol, glycerol, citric acid, lactic acid, gluconic acid, etc.;
â‘¡Fine chemical products, such as various amino acids, enzyme preparations, nucleic acid products, etc.;
â‘¢Medical products, such as various, various steroids, conventional bacterin, vaccines, etc.;
â‘£Other products, such as biological pesticides, edible and medicinal yeast, feed protein (single-cell protein), biogas, etc.; Wait.