Analysis of special approvals, major projects, and priority review varieties accepted by CDE over the years

In order to encourage the research and development of new drugs, improve the ability of independent innovation in China, strengthen the drug registration management, and accelerate the research and development of new drugs with clinical value and clinical urgently needed generic drugs, the state has opened special approval channels for drugs such as "special approval", "major special projects", "priority review" According to the statistics of drug intelligence data, the number trend of "special approval", "major special" and "priority review" varieties accepted by the National Drug Review Center (CDE) over the years is shown in Figure 1 and Figure 2 "Special examination and approval" related acceptance numbers began to appear in 2004 As of June 30, 2017, 1554 special examination and approval varieties (calculated by acceptance numbers, the same below) have been accepted in total; as of June 30, 2005, 318 major special varieties have been accepted in total; as of 2010, priority review related acceptance numbers have been accepted in total Three priority evaluation varieties In terms of the number of varieties accepted, the number of special approved varieties is much higher than that of priority evaluation and major special varieties, which is 2.5 times of the total number of accepted varieties Figure 1: "special approval", "major special", "priority review" variety quantity and combination quantity note: "Special approval + priority review": both special approval and priority review varieties; "special approval + major special": both special approval and major special varieties; "major special + priority review": both major special and priority review varieties; "special approval + priority review + major special": both special approval and priority review or major special The variety of Figure 2: after the first acceptance number of "special approval", "major special" and "priority review" varieties accepted by CDE over the years, no varieties were accepted in 2005-2007 until 2008 Before 2008-2013, the number of acceptances has been in a rapid growth stage, reaching a peak of 289 in 2013, and began to decline in the three years after 2013 146 varieties were accepted in the first half of 2017 Most of the 1554 special approved varieties are chemicals (as shown in Figure 3), accounting for 94.1% of the total, while other types of drugs only account for 5.9% The number of major special varieties accepted has shown a wave like upward trend until 2015, reaching a peak of 67 in 2015 However, only 10 varieties were accepted in 2016, and no varieties were accepted in the first half of 2017 318 major special varieties and drug types account for 6.6% as shown in Figure 4 During the five-year period when the priority review varieties began to be accepted, the number of accepted varieties has been on the rise In 2016, 122 varieties were accepted In the first half of 2017, 58 varieties were accepted According to drug types, the 303 priority evaluation varieties are still dominated by chemical drugs (as shown in Figure 5), accounting for 85.8% and biological products for 13.5% Figure 3: proportion of drug types of special approved varieties Figure 4: proportion of drug types of major special varieties Figure 5: proportion of drug types of priority review varieties Up to now, the chemical class 1 new drug "ibovetai" and preparation "ibovetai for injection" of Frontier biopharmaceutical (Nanjing) Co., Ltd are the only varieties accepted by CDE that are not only "special approval" but also "priority review" or "major special project" It was accepted in July 2016 and is still under review and approval (as shown in Table 1) It is an antiviral drug for compound treatment of HIV infection and the first long-term HIV fusion inhibitor in the world Table 1: analysis of special approval varieties accepted by CDE in the first half of 2017 for varieties that are "special approval", "major special" or "priority review" by June 30, 2017, 146 special approval varieties accepted by CDE in the first half of 2017, broken down by different classification methods as follows: drug type : 145 chemical drugs, 1 biological product, no other types such as traditional Chinese medicine; application type: 120 new drugs, 26 imported drugs, no other types such as generic drugs; registration classification: 140 chemical drugs of category 1, 3 chemical drugs of category 2.4, 2 chemical drugs of category 1.1, 1 biological product for prevention; processing status There are 132 in the review and 14 in the approval See Figure 6 for the number of enterprises and sub varieties with the number of special approved varieties ≥ 4 Most of the top ranked enterprises are domestic pharmaceutical enterprises, with Jiangsu hengruiyuan at the top There are 13 varieties accepted, and only one GlaxoSmithKline (China) is a multinational enterprise Figure 6: it is worth mentioning that among the 146 varieties, 8 are both special approval and priority evaluation varieties, among which cabotegravir suspension injection and cabotegravir tablet have been approved for clinical application, and the application types of both varieties are imported (as shown in Table 2) Table 2: analysis of 8 special approval and priority review varieties accepted by CDE in the first half of 2017 as of June 30, 58 priority review varieties accepted by CDE in the first half of 2017, broken down by different classification methods as follows: drug types: chemical drugs 46, biological products 12, no traditional Chinese Medicine and other types; application types 11 new drugs, 15 generic drugs, 29 imported drugs and 3 supplementary applications; registration classification: 8 chemical drugs of category 1, 4 chemical drugs of Category 3, 17 chemical drugs of category 5.1, 10 chemical drugs of category 6, 6 therapeutic biological products, 1 therapeutic biological product of category 15, 1 therapeutic biological product of category 9, 1 preventive biological product of category 1 and 1 preventive biological product of category 9 Task type: 14 NDA applications, 15 anda applications, 3 ind applications, 7 listing applications, 2 clinical trial applications, 2 supplementary applications (clinical), 3 confirmatory clinical applications; processing status: 53 applications are under review, and 4 applications have been approved (2 approved clinical beds, 2 approved imports, as shown in table 3) Table 3: after the completion of four certification - after the supplementary application for removal of the approved priority review varieties, the number of enterprises and sub varieties with priority review varieties ≥ 3 is shown in Figure 7, with domestic and multinational enterprises accounting for half of the total The champion and runner up are Ouyi pharmaceutical and Guangdong dongyangguang pharmaceutical Figure 7: number of enterprises and subspecies with the number of priority evaluation varieties ≥ 3