[list] top 100 enterprises applying for generic drugs in 2016

2016 is the year with the strictest policy regulation in the pharmaceutical industry, and it is also a year when many pharmaceutical enterprises are dying The whole industry has not fully awakened from the nightmare of self-examination and verification of drug clinical trial data in 2015, followed by the policy of consistency evaluation and new classification of chemical drug registration, which caught the pharmaceutical industry by surprise In 2016, both the declaration of new drugs and generic drugs dropped sharply, and the declaration of generic drugs was lower than that of new drugs for three consecutive years The declaration structure of drug R & D in China is undergoing fundamental changes What is the situation of the declaration of generic drugs when the domestic pharmaceutical enterprises are carrying out radical reform and innovation? The answer can be found in the 2016 generic declaration! 1 In 2016, the number of generic drug applications dropped sharply Although the number of generic drug applications in 2016 was lower than that in the past, there were still 647 (2 traditional Chinese medicine, 638 chemical drugs, and 7 others), with 196 approved From the chart, only the first quarter of the year reported a relatively high volume (ignoring the impact of the Spring Festival holiday in February), reaching a peak of 109 in March Affected by the two policies of conformity evaluation of generic drugs and new registration and classification of chemicals, the annual declaration trend has remained low since March, resulting in less than half of the annual declaration volume in previous years Although the reporting situation in November has been reviewed, compared with 1905 bases in 2015, the reporting volume dropped 66% year on year 2 the return of the king of Shandong has become the champion in 2016 In 2016, the regions and provinces with the largest amount of generic drugs declaration mainly concentrated in Jiangsu, Shandong, Hebei and Sichuan It is worth noting that Jiangsu Province, which has the first declaration volume in two consecutive years from 2014 to 2015, has lost, and Shandong Province, the declaration champion in 2013, once again won the championship in 2016 with 136 But in general, in recent years, the declaration volume of the top regions is on the decline, from 290 in 2014 and 231 in 2015 in Jiangsu, to 136 in 2016 in Shandong, a year-on-year decrease of 41.1% 3 most of the new enterprises have become the main force of generic application in the field of generic application Ruiyang pharmaceutical is the most representative Since it won the first place in 2015, it still can't be replaced in 2016, although the number of applications is 9 less than that of previous years 4 in 2016, the number of generic drug applications reached a four-year low From 2013 to 2015, 6098 applications and 2178 approvals were filed The most declared years are mainly from 2013 to 2014 The number of annual declarations is more than 2000 By 2015, the number of declarations decreased slightly, falling below 2000 In 2016, the total annual declaration volume was only 647, a year-on-year decrease of 66%, a record low The reason for the sharp drop in the application volume of generic drugs in 2016 is closely related to the consistency evaluation of the two major policies and the new classification of chemical drug registration in that year For the industry, the combination of consistency evaluation and new classification of chemical registration will fundamentally wash the whole generic drug market In order to survive, pharmaceutical enterprises will gradually change the old concept of weight and quality, and accelerate the realization of real consistency between generic drugs and original research drugs In addition, the reduction of declaration volume can also effectively alleviate the backlog problem of CDE Generally speaking, 2016 is the watershed of the pharmaceutical industry, and a more efficient and high-quality pharmaceutical era is coming.