Enterprises and varieties that benefit most from special approval

Source: on December 17, 2014, when everyone complained about the long waiting period for approval, they all focused on special approval, but so far, the biggest winner from special approval is Hengrui system 1、 As of December 7, 2014, the list of special approved varieties published by the drug approval center of the State Food and drug administration has 884 records Through data analysis, there are 2 duplicate records, and there are 882 records in fact According to Article 2 of the regulations on the administration of special examination and approval of new drug registration, only new drugs that treat diseases such as AIDS, malignant tumors, rare diseases and have obvious clinical treatment advantages, and new drugs that treat diseases without effective treatment means can enjoy special examination and approval treatment when applying for production, and the effective ingredients extracted from plants, animals, minerals and other substances that are not marketed in China The newly discovered medicinal materials and their preparations, as well as the chemical APIs and their preparations and biological products that have not been approved for marketing at home and abroad, can enjoy special approval when applying for clinical application According to the visual inspection, this rule limits the difficulty of taking the special approval channel for drug application and production Therefore, the number of clinical approval applications for special approval varieties accounts for 90.8%, and the number of production approval applications only accounts for 7.4% , the proportion of clinical application and production application is too large If the special approval belongs to the clinical category, there are 363 import applications, accounting for 45.3% of the total number of clinical approvals There are 8 imports of production approval documents, accounting for 12.3% Imports accounted for 42.3% of the total approvals It can be seen that in order to speed up the examination and approval of imported manufacturers, they are also very competitive Figure 1 the number of different types of special approval varieties (data source: XD database of drug approval center of State Food and Drug Administration) from the perspective of enterprise ranking, from the perspective of total number of special approval varieties, clinical application number and production application number, Hengrui ranks first Hengrui has a strong grasp of the trend of R & D policy In other words, Hengrui Department has made great efforts in the field of cancer in recent years If Beijing Novartis Pharma Ag and Novartis Pharma AG are combined, Novartis ranks first in the total number of special approved varieties and clinical applications Table 1 top ten special approved varieties Table 2 clinical application top ten special approved varieties Table 3 production application top five special approved varieties (data source: XD database of drug approval center of State Food and Drug Administration) 2 Overall approval of special approved varieties from table 4 Yes, in the clinical application of special approved varieties, the overall disapproval rate of clinical application (the overall disapproval rate of clinical application = the number of clinical application disapproval / the total number of clinical application) is 6.5%, of which the disapproval rate of domestic new drugs (the disapproval rate of domestic new drugs = the number of domestic new drugs disapproval / the number of clinical application of domestic new drugs) is 8.4% The rate of non approval of imports (the rate of non approval of imports = the number of non approval of imports / the number of clinical applications of imports) is 4.1%; the rate of termination of approval procedures of clinical applications (the rate of termination of approval procedures of clinical applications = the number of termination of approval procedures of clinical applications / the total number of clinical applications) is 2.6%, of which the rate of termination of approval procedures of domestic new drugs (the rate of termination of approval procedures of domestic new drugs)= The number of domestic new drug termination approval procedures / the total number of domestic new drug clinical applications) was 2.3%, and the rate of import termination approval procedures (the rate of import termination approval procedures = the number of import termination approval procedures / the total number of import clinical applications) was 3.0% The final number of clinical application with production approval for special approved varieties is 21, accounting for only 2.6% of the total number of applications This is probably related to the period from clinical application to approval After all, the special approval policy was only implemented in 2009 Among the 21 approval numbers obtained, there is no approval for traditional Chinese medicine, and 20 are import approval, accounting for 95.3%, only one approval for new drugs Among the 363 import applications, there are 20 production approval documents, and the 438 domestic applications only obtain the final production of gemcitabine from Jiangsu Hengrui, which is more efficient in clinical application Table 4 data source of overall approval of production application and clinical application of special approved varieties: of 65 applications submitted for approval by XD database of drug approval center of State Food and drug administration, 6 obtained import approval documents, 18 obtained production approval documents, and the rate of obtaining approval documents temporarily was 36.9% Among them, 8 import applications, 6 were approved; 57 domestic applications, 18 were approved Imports are also more efficient It can be seen from table 5 that Hengrui is the first domestic manufacturer among the special approved varieties It can also be seen from the side that the current situation of R & D in China, most pharmaceutical companies' grasp of national policies, their ability to screen R & D projects and control key links are not so good In the face of the low-level repeated application for approval, when drugs need to return to the therapeutic value, the product competitiveness of enterprises is seriously not qualified Table 5 list of approved enterprises and varieties for production and import approval of special approved varieties (data source: XD database of drug approval center of State Food and Drug Administration) 3 Are special approved varieties really fast? According to Ding Xiangyuan's "how long is the examination and approval time for all kinds of new drugs?" data, from 2011 to 2014, the average examination and approval time of 1.1 newly declared clinical application was 14 months, the average examination and approval time of declared production was 29 months, and the examination and approval time in 2014 increased to 42 months The average time of clinical evaluation of special approved class 1 new drugs is 13 months, and the production is 25 months It can be seen that the acceleration of special approval is mainly reflected in the approval of production approval Summary: when everyone complained about the long waiting period for approval, they all focused on special approval, but so far, the biggest winner from special approval is Hengrui Recently, there is a popular saying that talking about feelings without products is like a eunuch talking about climax It's better to reflect on your overall R & D strategy to talk about how to get approval faster Attached with background knowledge: the administrative measures for special approval of new drug registration (hereinafter referred to as the "measures") was officially promulgated and implemented on January 7, 2009 Enjoy "special treatment" There are four kinds of drugs: (1) the effective ingredients and preparations extracted from plants, animals, minerals and other substances that are not marketed in China, as well as the newly discovered medicinal materials and preparations; (2) the chemical raw materials and preparations and biological products that are not approved to be marketed in China and abroad; (3) the drugs are used to treat AIDS, malignant tumors, rare diseases and other diseases and have obvious clinical treatment advantages New drugs for diseases without effective treatment The innovative drugs in these four situations will establish a separate channel, priority review and approval, a mechanism for timely intervention and communication at key stages, a variety of channels for supplementary information, a clear link with the special approval process, and other incentives The priority of examination and approval greatly shortens the registration time of new drugs and avoids the detour of enterprises in the development process: the new drugs whose main treatment syndrome is not included in the national approved Chinese patent medicine [functional main treatment] can be regarded as the new drugs for diseases without effective treatment means In the case of (1) and (2), the applicant for drug registration (hereinafter referred to as the applicant) may apply for special examination and approval when submitting the application for clinical trial of new drugs The drug evaluation center of the State Food and drug administration shall review and determine the application within 5 days after receiving the application for special examination and approval In the case of (3) and (4), the applicant can apply for special examination and approval only when applying for production The drug evaluation center of the State Food and drug administration shall organize an expert meeting to review and determine the application within 20 days after receiving the application for special examination and approval.