[heavyweight] 2017 list of domestic chemical drug registration and Application

Inscription: The acceptance of drug registration can reflect many problems, such as "the current state of the national drug industry", "the reliable guarantee of people in drug use" and other macro problems; at the same time, it can also reflect "which domestic drug companies are in the front end of the industry", "which varieties are concerned by these drug companies", "which varieties reflect the current state of drug use in China" So it's necessary for people in the industry to summarize the acceptance of drug registration every year and get some experience through data! Clinical application of class 1 new drug ind in 2017, the number of class 1 new drug ind applications undertaken by the State Food and drug administration was nearly 120, among which, Jiangsu Hengrui was the domestic pharmaceutical enterprise with the largest number of applications, with a total of 9 varieties; followed by Zhengda Tianqing, with 6 varieties; thirdly, Guangdong dongyangguang, with 5 varieties The enterprises with 3 ind application varieties are Nanjing Shenghe, Chenxin pharmaceutical and Jiangsu Kangyuan See Table 1 for specific varieties At the same time, in addition to the enterprises with a relatively large number of applications, about 10 domestic pharmaceutical enterprises have 1-2 varieties of ind applications, which shows that under the guidance of national policies, the application of class 1 new drugs is booming Table 1: clinical application of class 1 new drug ind in China in 2017 (data source: intelligence data) listing application of class 2 new drug NDA In 2017, a total of 8 NDA chemicals were administered by the State Administration of drug administration, namely, Silver Valley pharmaceutical, phequine bromide nasal spray, geoli pharmaceutical, Dan nrofi sodium tablets, Hutchison Whampoa fukuquinii capsule, Jiangsu hausen polyethylene glycol lusinitin injection, PheBo in rosalitin capsule, Jiangsu Heng Rui maleate pyrrolidone tablet, Zhejiang medicine - nimrofloxacin maleate sodium chloride injection Ejaculation, Zhengda Tianqing ~ enrotinib hydrochloride capsule, details are shown in Table 2 (in no order) Table 2: application for NDA listing of class 1 new drugs in China in 2017 (data source: intelligence data) 3 clinical application of class 2 new drugs In the whole year of 2017, the application for class II new drugs in China was still relatively stable and tepid Nearly 30 pharmaceutical companies in China filed clinical applications to the drug administration However, the research and development direction of most products is still around the point of dosage form, constantly looking for a better drug See table 3 for details Table 3: clinical application of class 2 new drugs in 2017, anda application of class 43 generic drugs, as a large country of generic drugs, was once the place for most pharmaceutical enterprises in China, and also the most crowded point for registration applications However, since the country began to issue a series of relevant policies in 2015, many pharmaceutical companies' attitude towards the three types of drugs, after a short vacuum and wandering, the number of natural application registration is much less (after all, it is real gold and silver...) In 2017, the enterprises with the largest number of application for three kinds of drugs were Zhengda Tianqing, with a total of 10 varieties; secondly, Jiangsu Haosen (6 varieties), Nanjing Youke (5 varieties), Sichuan xinkaiyuan (5 varieties), Jiangsu Hengrui (4 varieties), Yangtze River Pharmaceutical (4 varieties) and Shiyao group (4 varieties); see Table 4 for details Table 4: Declaration of Anda of 3 types of generic drugs in China in 2017 (data from pharmaceutical intelligence data) declaration of Anda of 54 types of generic drugs declaration of 4 types of chemical drugs usually shows strong market development ability and control ability Relatively speaking, large pharmaceutical companies have more declarations In the whole year of 2017, Zhejiang Huahai had the largest number of application for 4 kinds of generic drugs, with a total of 12 varieties; afterwards, Qilu Pharmaceutical (10 varieties), Jiangsu Haosen (7 varieties), Zhengda Tianqing (5 varieties), Shijiazhuang No.4 Pharmaceutical (4 varieties) and so on See table 5 for details Table 5: summary of Anda declaration of 4 domestic generic drugs in 2017 (data from pharmaceutical intelligence data) For class 1 new drug ind application, Jiangsu Hengrui and Zhengda Tianqing are the leading domestic innovative drug R & D enterprises, and the number of applications is high, which is a normal phenomenon It is expected that in recent years, there has been a significant output of dongyangguang in this area, which really makes the industry bright and look forward to more; for class 1 new drug NDA application, in the application list in 2017, some products have been removed at present Yingruo believes that among the listed varieties, it will inevitably bring surprises to the industry; category 2 drugs were once the "points" favored by many enterprises With the deepening of drug registration reform and the redefinition of category 2 drugs, the products on this point will be further "baptism" If some enterprises can bear their temper, they will have great potential Yes, there is no need to say more about the three kinds of drugs The consistency evaluation of "persistence" and the continuous output of the n-th batch of approved list have been achieved by the state in this area Enterprises also have a clearer idea of drug development in the future However, the supporting policies of some local governments really need to be kept up in time, otherwise it will hurt a large number of priority enterprises' investment and confidence; 4 There are many registered varieties of generic drugs, Huahai and Qilu, which show their market capabilities For many small and medium-sized enterprises, they are very envious To know that a good variety really needs a good platform.. For 2017's annual drug registration, let's first say here, the small summary is just a small miniature, and each one in the list Specific varieties are more worthy of our further research and thinking! ◆◆◆◆ From June 29 to 30, under the guidance of China Pharmaceutical University, Chongqing Economic and Information Technology Commission, the third China Pharmaceutical R & D Innovation Summit and 2018 top 100 list of China's pharmaceutical R & D strength will be launched in Chongqing under the guidance of yaozhi.com and China Pharmacy magazine, and the high-profile 2018 China Pharmaceutical R & D strength list (including the "general list") will be solemnly released , chemical medicine list, traditional Chinese medicine list and biological medicine list), and awarded awards and medals to the award-winning enterprises The release of the list aims to encourage and flaunt those leading enterprises that have made great contributions to pharmaceutical research and development, and further enhance the attention of the whole industry to pharmaceutical research and development innovation As a leading force in the pharmaceutical industry, listed enterprises represent the highest level of Chinese pharmaceutical R & D innovation! I hope that in the future, under the leadership of these leading enterprises, Chinese pharmaceutical enterprises can break the traditional R & D, production and business model, Chinese medicine can push the old to the new into the international market, Chinese pharmaceutical people can be brave to be the leader of innovation and development in the new era, and common breakthrough belongs to the road of self-improvement in our era!