Overview of clinical trials of breast cancer drugs in China

Breast cancer is a malignant tumor of ductal epithelium and terminal ductal epithelium Breast cancer occurs in 99% of the female population and only 1% of the male population According to statistics, women's breast cancer is the first malignant tumor in European and American countries, and China's is the second There is an upward trend in recent years The author searched the database of Chinese clinical trials, and summarized the clinical trials of breast cancer drugs For reference According to the statistics of drug intelligence data, as of December 19, 2016, there were 229 test records, including 85 drug clinical trial registration records (deleted duplicates) published by CFDA and 144 ones registered by China clinical trial registration center Taking the data published by CFDA clinical trial registration platform as an example, this paper analyzes the clinical trials of breast cancer drugs in China from the following aspects: the first publication date of 85 clinical trial registration records is from July 24, 2013 to December 9, 2016 Drug type: from the perspective of drug type, 85 clinical trial records include two categories: 61 chemical drugs, accounting for 72%; 24 biological products for treatment, accounting for 28% Trial classification: from the perspective of registered clinical trial classification, 9 (11%) were safe; 44 (52%) were safe and effective; 8 (9%) were bioequivalent / bioavailability tests; 11 (13%) were pharmacokinetics / pharmacodynamics; 7 (8%) were effective; 6 (7%) were other From the above data, we can see that the safety and effectiveness test (71%) of drugs is the most concerned Test status: from the perspective of test status, 18 (21%) have been completed; 9 (11%) have not been recruited; 20 (24%) have been recruited; 36 (42%) have been recruited, and 2 (2%) have been suspended actively Half (53%) of the total number of clinical trials have not yet been recruited and recruited, and interested partners can pay more attention Trial stage: from the perspective of trial stage: 28 in phase I (33%); 6 in phase II (7%); 29 in phase III (34%); 6 in phase IV (7%); 16 in other phases (19%) As can be seen from the above data, phase III clinical trials are the most, followed by phase I Enterprise analysis: there are 26 clinical trials in foreign enterprises (31% of the total) In terms of the number of clinical trials, Roche ranked first, Novartis (4) and AstraZeneca (4) tied second, Pfizer (3) and Bayer (3) tied third Other enterprises are as follows: one is bringer Ingelheim, one is Lilly, one is Weicai, and one is yingchuangyuan A total of 59 clinical trials (69% of the total) were conducted by domestic enterprises, with Qilu Pharmaceutical (8) ranking first, Jiangsu Hengrui (6) second, and tiger (4) third The number of clinical trial registration records of other enterprises is between 1-3 More concerned companies and drugs are: Roche: patozumab injection, trastuzumab-mcc-dm1 for injection, bevacizumab injection; Novartis: Rad001, bkm120, gw572016 tablets; AstraZeneca: olaparib, fluvectorgroup injection; Pfizer: palbociclib capsule, exemestane tablets; Bayer: sorafenib (dogimer, Bay43-9006), radium chloride [223ra] injection; Qilu pharmaceutical: recombinant anti HER2 humanized monoclonal antibody for injection, seratinib toluenesulfonate tablets; Jiangsu Hengrui: Paclitaxel for injection (albumin binding type), pyrrolidine maleate tablets; tag: patozumab injection solution, vinblastine tartrate concentrated solution for injection Note: This article is the original manuscript of the author of yaozhi.com, welcome to reprint, please indicate the source when reprint, thank you!