The growth rate of imitation application slows down, the Yangtze River has the most applications, and the levansaban is the hottest

In 2019, CDE undertook 1051 copy applications, with the growth rate slowing down Yangzijiang Pharmaceutical Group has the largest number of applied varieties, and Zhengda Tianqing has reduced by nearly half year on year Rivaroxaban tablet is a popular imitation and declaration variety 54 varieties were officially included in the priority review, with Yichang humanwell Pharmaceutical Co., Ltd having the most A total of 140 new registration and classification approvals and 27 first imitations of generic drugs were approved by nmpa According to the statistics of medchina drug review database 2.0 of midnet, in 2019, CDE undertook 1051 imitations (including 5.2 categories of imports), involving 395 varieties, with a year-on-year growth of 7.24%, and the growth slowed down With the continuous promotion of centralized drug procurement, general generic drugs will enter the era of meager profit, and enterprises will be more cautious when setting up generic drug projects Applications for generic drugs undertaken by CDE in 2016-2019 (according to acceptance number) From the perspective of registration classification, the imitation application of import category 5.2 has rebounded in 2019, and the proportion of the imitation application of new category 3 and new category 4 has stabilized Changes in the proportion of copy application registration categories in 2016-2019 In 2019, there are 18 enterprises applying for more than 6 varieties of generic drugs, among which Yangzijiang Pharmaceutical Group is the most active one, and Zhengda Tianqing pharmaceutical group applied for 17 generic drugs in 2019, nearly half of which is lower than that in 2018 Under the influence of centralized drug purchase, many enterprises have turned the research and development of generic drugs to high-end generic drugs with high technical barriers, and the research and development pattern of generic drugs will face reconstruction Application of generic drugs by major enterprises in 2018-2019 (by product name) Detailed application of top 3 enterprises in 2019 In 2019, there are 21 varieties with more than 6 companies applying for imitation, among which the largest number of enterprises applying for imitation of rivaroxaban tablets is 18 There are 10 clopidogrel bisulfate tablets, 9 levofloxacin tablets, pramipexole hydrochloride sustained-release tablets and entecavir tablets Declaration of major varieties of enterprises in 2019 Specific application enterprises of rivaroxaban tablets in 2019 In 2019, 54 varieties of generic drugs undertaken by CDE were officially included in the priority review, among which the same production line produced the most varieties, 24 From the perspective of enterprises, four varieties of Yichang humanwell Pharmaceutical Co., Ltd were included in the priority review (three same production lines and one child drug) Priority review of generic drugs undertaken by CDE in 2019 In 2019, the imitation application filed according to the new registration classification entered the intensive harvest period In 2019, nmpa approved 140 generic approval documents declared according to the new registration classification (including the old 6 generic applications reviewed according to the new classification standard), involving 67 varieties Among them, 27 varieties (40 approvals) are the first imitations in China Approval of new registered generic drugs in 2017-2019 (according to approval number) (according to nmpa approval date) Details of approval of new registered generic drugs in 2019