Tracking and screening of phase Ⅱ and Ⅲ clinical drugs abroad

At the end of June 2015, Li Tianquan, general manager of the research and development center of yaozhi.com, made a report on the tracking and screening of foreign phase II and phase III clinical drugs for you Yaozhi compiled and edited the report, and now share the wonderful contents to you At this point, I think many people are confused about the title This has a lot to do with our domestic drug R & D background Limited by various factors, the average level of domestic R & D is lower than that of foreign R & D countries such as the United States and Japan, which is lack of innovation The R & D of new drugs depends on foreign countries to a large extent, which promotes the R & D mode based on three types of new drugs For this part of enterprises, we must focus on the research and development of foreign new drugs, especially the drugs in the clinical research stage Foreign phase I clinical drugs, with high failure rate and high R & D risk, are not suitable for research and development In foreign countries, the safety and efficacy of phase II and phase III clinical drugs have been evaluated accordingly, so it is particularly important to collect information in this field when setting up a project for investigation New drug research and development is a war without gunpowder, a contest between time and money The domestic new drug R & D market is relatively chaotic, which also adds a lot of difficulties to our strategic planning So, in this war, what should we do to know ourselves and the enemy and win every battle? 1、 How to determine the direction of new drug R & D focus on confidants is the key factor to obtain the priority of this war First of all, we need to make clear our own combat value, the chips in hand, in short, the balance of financial and material resources, as well as the choice of the most suitable combat mode for enterprises 1 According to A enterprise strategic positioning B enterprise resource allocation: matching with the existing product portfolio; matching with the existing sales network and mode; matching with the existing production and R & D conditions; matching with the market strategy; C external factors: considering the market, hot spots and policies Significant policy changes also have a great impact on new drug R & D, and even directly affect the R & D decisions of enterprises 2 Specific direction A technical category: biological medicine, chemical medicine, traditional Chinese medicine, monoclonal antibody, etc B new drug type: original, innovative, imitation C Market: large variety, orphan medicine; domestic and overseas D treatment field: cardiovascular, psychiatric, diabetes, etc Enterprises need to weigh their own advantages and the pharmaceutical environment to choose the best R & D field Enterprises need to consider the current hot direction, such as McAb? Is the choice based on cost imitated or innovated on the basis of foreign original? 2、 How to effectively screen the targets of foreign countries II, After phase III clinical drugs, there are two directions First, research and development should be carried out according to class I drugs Almost all class I new drugs in China follow this path to develop so-called "me better" and "me too" new drugs Second, class III drugs, all application materials are ready to be continued As long as the drugs are listed in foreign countries, they should be immediately imitated At present, the R & D of three kinds of drugs is more in line with the market, because no matter whether they are listed in China or not, domestic enterprises can declare as three kinds of new drugs, only need to do confirmatory clinical Even if it is listed in China and has domestic standards, it is more convenient for domestic generic pharmaceutical enterprises to directly declare according to six categories, which is more time-saving, labor-saving and money saving Figure 1: according to the statistics of the registration and acceptance database of pharmaceutical intelligence, the declaration of each registration type of chemical drugs from January 1, 2005 to now (July 1, 2015), excluding the five new drugs of the modified dosage form, category 3.1 drugs are far away from other declaration types, especially in the past two years, the number of declaration has increased in a straight line All the major pharmaceutical companies have taken a good look at this cake, so how can we take the lead in selecting the most promising drugs from a large number of drugs? It is better to talk about war than to fight 1 Global drug under research / on the market: master the current situation of global R & D; 2 Treatment field / clinical stage / technology category: lock in series of potential varieties; 3 Patent / Market: variety comparison, selection of advantage candidate varieties; 4 Target varieties: determine the target, and suggestions for product project development Next, we will explain the specific screening methods for you Screening Route 1: WHO clinical trial registration platform retrieval defects: inaccurate positioning; lack of clinical stage screening methods, can not exclude "non new drug research and development projects" Screening approach 2 The global clinical trial database contains the information of clinical trial registration centers of all countries in the world, and the clinical trials are divided into trial stages, which can be screened for important information such as research type, disease field, intervention measures, test results and country According to the global clinical trial database of the relevant statistics on the number of trials in various test centers around the world (as of June 2015) are carried out The results are as follows: Figure 2 Statistics on the number of trials in various test centers around the world (as of June 2015) the database covers more than 95% of the global clinical trial information of new drugs under research, among which the U.S clinical trial registration center can be seen（ CT Gov) accounted for about 2 / 3 of clinical trials Figure 3 Screening methods for the statistics of phase II and phase III clinical trials of ct.gov in the United States from 2011 to 2015 3 Focus on tracking specific companies to obtain relevant information by logging into the websites of major pharmaceutical companies The following is part of the information obtained on Roche's website Defect: incomplete information, trouble in search and screening, only one company can be targeted Screening pathway 4 The information of new drugs under research is mainly obtained through literature / reports, various databases, etc For example, through the global new drug R & D variety Library of Yaozhi, basic screening of global new drug R & D varieties can be carried out Take delafloxacin as an example, and get the following search results: after the variety screening, we have to conduct a comprehensive analysis of the selected varieties, such as patents, which is a big and difficult problem To know the details of the breakdown, please pay close attention to our pharmaceutical intelligence lecture "according to the map: the application of patent map in the field of biopharmaceutical" held at 8:00 p.m on 23 this month! 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