The consistency evaluation has entered the harvest period, and 13 varieties have been evaluated by pharmaceutical companies

[industry trends of pharmaceutical network] data shows that as of October 24, the acceptance number of CDE acceptance consistency evaluation reached 1523, involving 425 varieties of 440 enterprises, and the number of acceptance has reached 264 Most of the mainstay varieties of enterprises have passed the evaluation or entered the application stage, and the domestic imitated varieties and quality are increasing Recently, some institutional data show that the top 10 enterprises that have passed the consistency evaluation are Qilu pharmaceutical, Zhengda Tianqing, Zhejiang Huahai, Sichuan Kelun, Shiyao Ouyi, Jiangsu Haosen, Jiangsu Hengrui, Shenzhen xinlitai, Chongqing Yaoyou and Zhejiang Jingxin Among them, 3 pharmaceutical enterprises have passed the consistency evaluation more than 10 Qilu Pharmaceutical Co., Ltd.: there are 13 varieties passed At present, Qilu Pharmaceutical Co., Ltd is in the first place in terms of variety declaration and quantity passed Among them, 30 varieties have been applied for and 13 varieties have passed the consistency evaluation The first varieties that have passed the consistency evaluation are gefitinib tablets (the supplementary application approval document for consistency evaluation was obtained on December 2017); subsequently, Qilu pharmaceutical varieties, such as tenofovir dipivoxil fumarate tablets, terbinafine hydrochloride tablets and solina succinate new tablets, have passed the consistency evaluation Among them, warfarin sodium tablets developed by Qilu pharmaceutical began to be listed in China in 1995 According to data, the sales volume of domestic sample hospitals of warfarin sodium tablets reached 22.6982 million yuan in 2018, and Qilu pharmaceutical accounted for 35.97% of the top 10 hospital sales volume At present, the consistency evaluation of warfarin sodium tablets is only accepted and evaluated by Qilu pharmaceutical, which is expected to rapidly occupy a larger share of the sales market by virtue of the advantages of the evaluation Zhengda Tianqing: 11 varieties passed the consistency evaluation for the first time The first variety passed the consistency evaluation was tenofovir fumarate dipivoxil tablets (2017 / 12) The first declared variety was entecavir dispersible tablets (the second approved variety of the company), all of which were antiviral After that, 11 varieties of metformin hydrochloride sustained-release tablets, imatinib mesylate capsules, alisentan tablets, gefitinib tablets, apixaban tablets and rivaroxaban tablets passed / deemed to pass Among them, rivaroxaban tablets entered the domestic market in March 2009, and was included in the national health insurance catalog in the same year The original research of the drug dominated the domestic market for the next decade On August 5, this year, Zhengda Tianqing obtained the approval of nmpa for the listing application of "rivaroxaban tablets" submitted by the new 4 categories, which is the manufacturer that obtained the listing qualification of this kind of generic drugs in the early stage in China Some industry insiders said that it is expected to quickly break the monopoly of the original research in China and provide more drug options for patients Huahai pharmaceutical: 11 varieties passed Huahai pharmaceutical has previously declared the consistency evaluation of 18 varieties Currently, there are 11 kinds of losartan potassium tablets, irbesartan hydrochlorothiazide tablets, irbesartan tablets, fosinopril sodium tablets, voriconazole tablets, donepezil hydrochloride tablets, valsartan tablets, risperidone tablets, nevirapine tablets, paroxetine hydrochloride tablets and lisinopril tablets Previously, Huahai pharmaceutical said in the semi annual report that it is rapidly promoting the 4 + 7 market, about 2 / 3 of the annual collection has been completed In the future, we will strengthen the dynamic analysis of non centralized mining areas and actively explore a new marketing model under the 4 + 7 belt volume collection It can be seen from the enterprises involved in the passed varieties that at present, the top ranked pharmaceutical enterprises are all pharmaceutical enterprises with strong R & D strength in China However, according to the application of acceptance number, the phenomenon of clustering of popular varieties in conformity evaluation is serious As of October 21, 2019, the top ten varieties of application acceptance number are amlodipine besylate tablets, Amoxicillin Capsules, metformin hydrochloride tablets, ceftriaxone sodium for injection, ranitidine hydrochloride capsules, montmorillonite powder, Cefalexin Capsules, paracetamol tablets, captopril tablets and parecoxib sodium for injection In the face of this situation, enterprises should make more rational judgments when setting up projects, prefer to choose varieties with better consistency evaluation pattern, and avoid "clustering" competition.