New drug gap: list of new drugs that have been listed in the United States but not in China

CDE recently organized a symposium on accelerating the review and approval of imported drugs, in which it mentioned that "we should speed up the review and approval of some imported drugs in an orderly manner", and listed the scope of application - the new drugs that have not been listed in China in Europe, the United States and Japan in the past decade, which are in line with one of the "rare diseases" or "drugs to prevent and control serious life-threatening diseases" Based on the basic database of medicine Rubik's cube, the author sorts out the new drugs that have not been listed in China in the past 10 years in the United States for reference 1 The data processing method is to export the first approved American drugs in the past 10 years (2008 / 1 / 1-2018 / 7 / 27) from the US Library of medicine magic cube, excluding the following varieties: 1) the varieties with the market status of the United States showing "discontinue"; 2) the varieties with the highest progress of "listed" in China; 3) the varieties that China has asked for delisting; 4) oxygen, purified water and other varieties Manually verify the possible problems of the above data 2 According to statistics, there are 361 new drugs approved in the United States in the past 10 years (including new compound) which are not listed in China, including 287 chemical drugs, accounting for 80% Among these new drugs that are not listed in China, 35 drugs contain rare disease indications, and 148 generic names have obtained the priority evaluation qualification of FDA Note: 1) for compounds with the same molecule, different acid radical and base, two different common names are calculated, such as fumarate demethyl venlafaxine and succinate demethyl venlafaxine 2) Solvate is not calculated as a generic name alone, and darunavir hydrate is included in the previously approved darunavir ethanol complex 3) The chemicals mentioned in this article do not include enzymes, insulin, monoclonal antibodies and other synthetic biological products synthesized by chemical methods Among the above varieties, 191 have no patent protection in China (no compound patent, or the patent has expired), 63 of them have obtained the priority evaluation qualification, and 12 of them have rare disease indications 300, 640" data-src="https://mmbiz.qpic.cn/mmbiz_png/Hy3TVVMMWe1qhg0CGSr5PjAAQ9fYwibuxdYBLwrmiclwibE5iabMwtDicC8evSEzMh8RvAJxlMJs9oibVgClc7eDJyHQ/640?wx_fmt=png" data-type="png" data-w="537" _width="558.125px" src="http://" class="lazy" original="http://" data-fail="0" style="margin: 0px; padding: 0px; height: auto !im portant; max-width: 100%; box-sizing: border-box !im portant; word-wrap: break-word !im portant; width: 558.125px !im portant; visibility: visible !im portant; "ALT =" wechat picture "width =" 537 "height =" 663 "/ > for these varieties without patent protection in China, we rank them according to the sales data disclosed in the financial report of the original research company, and list the top 10 varieties here for your reference