In the mid year report of domestic clinical trials in 2019, the consistency evaluation be trial accounted for 19%

With the introduction of quality and efficacy evaluation policies of generic drugs, the attention of clinical trials has been increasing 1 Drug category in the first half of 2019, the CDE drug clinical trial registration platform publicized 961 clinical trials in total Among them, there are 745 chemical drugs, 186 biological products and 30 traditional Chinese medicine / natural drugs 2 Domestic trials and international multi center trials at present, most of the clinical trials in the drug clinical trial platform are domestic trials In the first half of 2019, a total of 47 international multi center trials, most of which are three-stage trials, mainly focus on safety and effectiveness In terms of drugs, they are basically clinical trials of new drugs It is worth mentioning that many domestic enterprises, especially innovative pharmaceutical enterprises, have begun to attach importance to international multicenter trials For example: Qingdao Baiyang Pharmaceutical Co., Ltd., Shanghai Fuhong Hanlin Biotechnology Co., Ltd., Shanghai Haihe pharmaceutical research and Development Co., Ltd., Yifang Biotechnology (Shanghai) Co., Ltd., Suzhou aimejin Pharmaceutical Co., Ltd., Yaohua Pharmaceutical Co., Ltd., Baiji Shenzhou (Beijing) Biotechnology Co., Ltd., Shanghai Hengrui Pharmaceutical Co., Ltd., Shanghai an Meisheng Material science and Technology Co., Ltd and bio Pharmaceutical Co., Ltd 3 According to the total number of clinical trials registered monthly (CTR number obtained), the number of clinical trials registered increased significantly in the first half of 2019 compared with the same period last year, among which 208 clinical trials were registered in April, which was the same as the highest value 207 in May 2018 4 Trial classification and staging there is not much analysis on trial classification and staging here, mainly because the development of consistency evaluation is different from the regular clinical trial registration rules In the first half of 2019, the most concerned drug was tqb2450 injection, followed by metformin hydrochloride sustained-release tablets Tqb2450 injection is an innovative anti-PD-L1 monoclonal antibody drug developed by Zhengda Tianqing group It is applied by Nanjing Shunxin Pharmaceutical Co., Ltd., a subsidiary of the company It is registered as a therapeutic biological product Tqb2450 injection has many independent intellectual property rights such as structure, formula and process 6 The busiest clinical trial organization simply look at the busiest clinical trial organization in the first half of 2019 Shanghai Public Health Clinical Center conducted the most trials The difference from last year is that there are more varieties of consistency evaluation last year, so the clinical trials in many hospitals have increased significantly 7 In the first half of 2019, 185 be tests have been registered in the conformity assessment of generic drugs, down 24.18% from the same period in 2018 The main pattern of be trials registered is as follows: 177 of them have been completed, and 15% of them have not yet been recruited Amoxicillin capsule (9), metformin hydrochloride sustained-release tablets (5) and Telmisartan Tablets (5) were the most frequently registered drugs in be test To sum up: looking at the published clinical trials in the first half of 2019, it can be found that bioequivalence trials account for a large proportion, and professional clinical trial institutions undertake more clinical trials Data source: CDE drug clinical trial registration and publicity platform, drug intelligence data China clinical trial database statement: this view only represents the author, not the position of drug intelligence network, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.