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Major event one: On May 14, the CDE issued three documents, including "on the development of the consistency evaluation of the quality and efficacy of generic chemical injections", and the consistency evaluation of chemical injections was formally launched, and the supply-side reform of injections is about to be accelerated.
In October 2017, the Opinion on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Pharmaceuticals and Medical Devices was released, which proposed that "the re-evaluation of listed drug injections should be carried out, and it is strived to be basically accomplished in about 5 to 10 years".
In December 2017, the CDE released the "Consistency Assessment of Listed Chemical Generic Drugs (Injectables)". In December 2017, the CDE issued the Technical Requirements for Consistent Evaluation of Listed Chemical Generic Drugs (Injectable Dosage Forms) (Solicitation Draft), and in April 2019, injectable dosage forms appeared for the first time in the Catalogue of Chemical Generic Pharmaceutical Reference Dosage Forms (the Twenty-First Batch) issued by the CDE, and in October 2019, the 2017 version of Technical Requirements for Consistent Evaluation of Injectable Dosage Forms (Solicitation Draft) was partially changed. After two and a half years, the official draft was formally released on May 14, 2020, the consistency evaluation of generic chemical injections was formally launched, and the supply-side reform of injectables is about to accelerate.
Major Event 2: Biosafety Law and Sound National Emergency Management System
Sound national public **** health emergency management system. Strengthen the rule of law guarantee for public **** health and improve relevant laws and regulations in the field of public **** health. Including biosafety in the national security system, systematically planning the construction of national biosafety risk prevention and control and governance system, and comprehensively improving the national biosafety governance capacity. Improve the public **** health service system, optimize the investment structure of medical and health resources, and strengthen the grassroots prevention and control capacity building in rural areas and communities.
Improve and optimize the treatment system for major epidemics, and establish and improve the mechanism for treating infectious diseases and other major epidemics in a graded, tiered and streamed manner. Improve the prevention and control norms of major outbreaks and emergency treatment management methods. Improve the medical insurance and assistance system for major diseases, and perfect the emergency medical assistance mechanism. Explore the establishment of a medical fee exemption system for special groups and specific diseases. Improve the unified emergency material security system, optimize the production capacity and regional layout of important emergency materials, improve the national reserve system, improve the reserve categories, scale and structure, and enhance the effectiveness of the reserve.
The core content of the consistency evaluation of injectables is as follows:
First, the scope of participating varieties: the listed generic injectable chemical drugs, not in accordance with the principle of consistency with the quality of the original drug and therapeutic efficacy of the approval of the varieties of drugs are required to carry out consistency evaluation, which is clear on the clinical value of the chemical drug injectable chemical drugs, but can not be identified as the reference preparation, the generic drugs need to carry out consistency evaluation. Among them, chemical injections with clear clinical value but no reference preparation can be determined are required to carry out consistency evaluation, such as sodium chloride injection, glucose injection, glucose sodium chloride injection, water for injection, and some radiopharmaceuticals, etc., and the Drug Administration will release the catalog of such varieties in phases and batches in the following period.
Second, reference preparations: reference preparations should be selected based on the "generic reference preparations catalog" issued by the State Drug Administration to carry out consistency evaluation; varieties not yet included in the "generic reference preparations catalog" must be declared in accordance with the "Announcement of the State Drug Administration on the release of the chemical generic reference preparations selection and determination procedures" to carry out consistency evaluation after the determination of the reference preparations. (c) To report on research and development. As of May 15, 2020, the FDA has released twenty-seven batches of generic reference preparations catalog, involving more than 600 varieties of injectables.
Third, technical requirements: the document from the reference preparation, prescription process, raw and auxiliary packages, quality control, quality research and control, stability studies of a number of aspects of the clear technical requirements, which special injections (eg, liposomes, intravenous emulsion, microspheres, suspensions, injectables, oil solutions, gels, and so on), and the FDA has also released a number of other technical requirements. Special injectables (such as liposomes, intravenous emulsions, microspheres, suspensions, oil solutions, micelles, etc.) also need to conduct BE tests and/or clinical trials.
? Approval time limit
Requirements: the review should be completed within 120 days after acceptance, the review of the need for additional information to the applicant, the applicant should be completed within four months of the additional information, the time limit for the issuance of a replacement will not be counted as part of the review time limit.
Injectable consistency evaluation for the pharmaceutical industry
This impact is more intense than the consistency evaluation of oral solid preparations, the impact on the market is even greater
And with reference to the oral solid preparations of the past band purchasing program, through the consistency evaluation is a prerequisite to participate in the band purchasing; even if the solid preparations of oral solid preparations, through the consistency evaluation is a prerequisite to participate in the band purchasing. The first step in the process is to make sure that you are able to get the best out of your product, and that you are able to get the best out of your product, and that you are able to get the best out of your product. Therefore, we judge that enterprises will not hold a wait-and-see attitude towards the consistency evaluation of injectables, and will participate significantly more actively than solid preparations, and the competition for consistency evaluation is expected to be more intense than that of oral solid preparations.
According to the data of Pharmaceutical Intelligence, as of May 15, 2020, only 35 injectable varieties have passed the consistency evaluation, except for azithromycin for injection of Puli Pharmaceuticals and cefminoxib sodium for injection of Fu'an Pharmaceuticals, the rest of the varieties are all in accordance with the new four categories of the consistency of the evaluation of generics deemed to pass. We believe that the number of evaluated varieties will increase rapidly after the formal launch of the consistency evaluation of injectables.
Biosafety law, consistency evaluation, pharmaceutical stocks, good and bad analysis and recommendations
Biosafety law and other policies will soon be landed, will catalyze the pharmaceutical plate related sub-fields of the investment layout of the last two weeks two major events largely affect the pharmaceutical plate in 2020, the two sessions have been held, the national biosafety law and other related policies will gradually fall into place. The two sessions of 2020 have been held, the national biosafety law and other related policies will gradually come to fruition, will catalyze the pharmaceutical sector related sub-fields, is expected to ASCO (American Congress of Clinical Oncology) will be held in the United States on May 29, EST -May 31, virtual meeting, domestic leading enterprises Hengrui Medicine, Baizi Divine State, Yasheng Pharmaceuticals, etc., will publish the results of the research, the formation of the domestic innovative drug plate catalytic.
News injection consistency evaluation officially announced the start, in order to accelerate the consistency evaluation of generic drugs, the State Drug Administration decided to carry out the quality of chemical injections generic drugs and efficacy consistency evaluation work. Provincial quantitative procurement of Zhejiang version of the program in July, the end of September landing, to carry out the provincial centralized quantitative procurement of drugs and supplies classified centralized procurement.
The thresholds of top200 and top100 varieties of global innovative drugs have further increased, further supporting the rise of domestic innovative drugs. Heavyweight drugs are concentrated in the fields of tumor, autoimmune, blood and cerebrovascular, and there are still 3 small molecules in the top5 and 4 small molecules in the top10 in terms of sales. Although its valuation is not cheap, but at the current point in time to focus on sustained holdings of the core assets of the pharmaceutical sector. The domestic biosafety law is about to be released, which will bring significant, long-term strategic catalysts for the pharmaceutical sector again, and it is not excluded that the environment of generic drug band purchasing will be improved. Affected by the overseas epidemic, the global economic integration is full of uncertainty, domestic demand will be the main driving force of economic growth, the medical industry is the most rigid demand, the highest certainty of growth. Most of the company's performance in the second quarter rebounded or accelerated, Q1 by the decline in outpatient and surgical volume, CDC closed and other factors affecting the demand for the entire industry chain, Q2 will appear to be a full recovery.
Medical Industry Opportunity Analysis and Benefit Listed Companies
Firstly, based on the logic of the new medicine's new policies, new infrastructures, new production capacity, and new sales, we believe that the long-term value of innovative medicines and their CDMO and other high-quality industrial chain companies has highlighted the priority of allocation, such as ****, ***, ***, ***, ***, ***, ***, and ***. ***, ***, **** and so on.
Second, a sound national emergency management system, we believe that the new crown epidemic on the domestic medical system to do a medical test, exposed a certain degree of short boards, local financial and national level to increase investment will be an inevitable trend, especially the Internet + medical service project technology will be promoted, the public health care institutions of the Internet + health care services industry companies will be given the opportunity to focus on the company: **** and so on.
Third, Kang Xino new crown vaccine will cooperate with the National Research Council of Canada to promote clinical trials, May 13 Kang Xino biological announcement that the company and the National Research Council of Canada to start cooperation, *** with the advancement of recombination of the public *** health incident vaccine (adenovirus vector) in Canada's clinical trials. Vaccine-related ***** companies have opportunities.
Third, with the advancement of the consistency evaluation of injections, there will be more and more varieties of injections to participate in the bandwagon procurement, the industry pattern is about to be reorganized, similar to the consistency evaluation of chemical pharmaceuticals, the next two years is expected to injections bandwagon procurement will also be launched, the injections market will usher in the huge change.
Fourth, excipients and packaging Due to the limitations of space, private letter to receive complete information.
Lv Changshun (Cairns) Certificate No.: A0150619070003. The above represents only personal investment advice, the stock market is risky, investment should be cautious!
Cairns
Good man good stock high-end trader business school honorary dean, visiting professor at the University of International Business and Economics, the People's University of China manipulation of senior lecturer, Tsinghua University manipulation of special training lecturers, CCTV2 "trading time" special experts, "manipulation of the Lecture Hall" special professor.
In 2013, he once publicly explained how to choose three years of ten times the bull stock on Beijing TV, and the case cited eventually realized ten times the profit at the end of 2015. Cairns is currently the only domestic value investment in the field of quantifiable real-world scholars.