2010-2014 approved clinical approval statistics

I The Research on the relationship between the application year and the year of approval of clinical approval can be seen from table 1 that there is a normal distribution between the application year and the total number of clinical approval documents in recent years In 2010, the number of clinical approval documents applied for clinical application is the largest, more than 1000 In the past three years, the number of clinical approvals has been hovering between 700 and 900 From 2010 to 2012, 65% of clinical approval documents were approved in the second and third years after the application of clinical approval documents From the application years of clinical approval documents in each year, from 2010 to 2012, more than 75% of clinical approval documents were applied one or two years before approval For clinical approval documents from 2013 to 2014, more than 75% of them were applied for the first, second and third years before approval 2 From table 2, we can see that the type and quantity of the top 20 drugs approved since 2010 are mainly chemicals The number of chemical approval documents has dropped from 813 in 2010 to less than 650 From 2010 to 2012, the number of approval documents of traditional Chinese medicine decreased from more than 50 to less than 40 It can be seen from table 3 that 80.9% of the top 20 drugs approved for clinical approval since 2010 are oral drugs, with only 2 injections The drug with the highest number of clinical approval documents is non bustard, which has been declared by 23 manufacturers The drugs declared and approved by more than 10 manufacturers include non Brescia, non Brescia tablets, febuxostat, febuxostat tablets, levetiracetam tablets, lamivudine tablets, clopidogrel bisulfate tablets and ornidazole tablets 3 The top 50 chemical clinical approvals approved by domestic enterprises since 2010 and their application types From table 4, we can see that the top 50 chemical clinical approvals approved by domestic enterprises since 2010 have a total of 817 clinical approvals, of which the number of three types of clinical approvals is the largest, accounting for 58.9% of the total number of clinical approvals of the top 50 enterprises; the next is the first type of clinical approvals, accounting for 20.9%; The number of six types of approvals ranked third, accounting for 14.8%
Jiangsu Hengrui Pharmaceutical Co., Ltd., Jiangsu Haosen Pharmaceutical Co., Ltd and Jinan Bainuo pharmaceutical science and Technology Development Co., Ltd rank among the top three chemical clinical approvals approved so far in 2010; enterprises with more than 10 chemical clinical approvals are Jiangsu Hengrui Pharmaceutical Co., Ltd., Jiangsu Haosen Pharmaceutical Co., Ltd and Zhejiang Haizheng pharmaceutical Co., Ltd Division, Hutchison Huangpu Pharmaceutical (Shanghai) Co., Ltd., Jiangsu Xiansheng Pharmaceutical Research Co., Ltd and Shandong xuanzhu Pharmaceutical Technology Co., Ltd are mainly concentrated in East China Among them, the clinical approvals of Hutchison Whampoa Pharmaceutical (Shanghai) Co., Ltd., Jiangsu Xiansheng Pharmaceutical Co., Ltd and Shandong xuanzhu Pharmaceutical Technology Co., Ltd are all category 1
The top scientific and technological R & D companies mainly have three types of approved clinical chemical approvals, such as Jinan Bono Pharmaceutical Technology Development Co., Ltd., Beijing Furui Kangzheng Pharmaceutical Technology Research Institute, Tianjin hankang Pharmaceutical Biotechnology Co., Ltd., Shandong innovative pharmaceutical R & D Co., Ltd., Nanjing Huawei Pharmaceutical Technology Development Co., Ltd., and Beijing rundekang Pharmaceutical Technology Co., Ltd Company, Hangzhou Rongli Pharmaceutical Technology Co., Ltd., Nanjing Haina Pharmaceutical Technology Co., Ltd., Beijing Dezhong Wanquan Pharmaceutical Technology Co., Ltd., Chongqing Libang Pharmaceutical Development Co., Ltd., Shandong terelin Pharmaceutical Technology Development Co., Ltd., Hefei Xinfeng Technology Development Co., Ltd., dadaolongda (Beijing) Pharmaceutical Technology Development Co., Ltd., Nanjing Cavendish Bioengineering Technology Co., Ltd Technology Co., Ltd and Shandong Pharmaceutical Industry Research Institute, are three types of drugs for approval.