Only 13 of the 600 billion injections have been reviewed! 125 varieties are under examination, with Hengrui, Qilu, etc

According to data from minenet, in 2018, the total sales volume of terminal chemical drugs and Chinese patent medicines in public medical institutions in China reached 692 billion yuan, of which chemical injection accounted for more than 85% At present, there are 13 injection varieties that have passed or are deemed to have passed the consistency evaluation, while 125 injection varieties that are being reviewed for supplementary application of consistency evaluation, among which, there are 3 or more enterprises applying for 37 varieties such as parrixib sodium for injection, ambroxol hydrochloride injection, involving Jiangsu Hengrui pharmaceutical, Qilu pharmaceutical, Jiangsu aosaikang pharmaceutical and other enterprises Recently, at the 2019 national pharmaceutical economic information conference, Zhou Chunxuan, director of minenet Hospital Center, interpreted the market characteristics and development trend of China's Injection Market According to the data of minenet, in 2018, the total sales volume of injection of chemical drugs and Chinese patent medicines in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) reached 692 billion yuan, and the injection accounted for a large proportion of China's public medical institutions, but its market share has declined in recent years, while oral preparations have grown steadily Proportion of total drug use routes of public medical institutions in China in 2017-2018 Zhou Chunxuan pointed out that there are many kinds of injections in the chemical medicine, and the sales volume accounts for a large proportion The number of varieties reaches 1371, involving 1179 manufacturers, involving nearly 8000 brands, among which 162 varieties with sales volume exceeding 1 billion; while the number of injections in the Chinese patent medicine is small, only 143, accounting for 2% of the total number of Chinese patent medicine varieties, but the sales volume accounts for the total sales volume of Chinese patent medicine 30% of the total, including 32 varieties with sales of more than 1 billion, is one of the areas where large varieties are achieved Top 10 terminal drug injection products of public medical institutions in China in 2018 (unit: 100 million yuan) In 2018, the sales of top 10 products exceeded 80 billion yuan, with a total market share of 14% In the top 10 products, the sales volume of sodium chloride injection and human albumin exceeded 10 billion, and the sales volume of the other eight products exceeded 5 billion yuan Top 10 of China's public medical institutions' terminal drug injection brands in 2018 (unit: 100 million yuan) Among the top 10 brands, except for dizosin injection of Yangzijiang Pharmaceutical Group, ceftazidime for injection of Hainan Hailing Chemical Pharmaceutical Co., Ltd and sodium chloride injection of Sichuan Kelun Pharmaceutical Co., Ltd., the remaining seven are foreign pharmaceutical enterprises It is worth mentioning that there are only 5 billion varieties of dizoxin injection from Yangzijiang Pharmaceutical Group, which is the exclusive variety At present, Tianjin Pharmaceutical Research Institute, Jiangsu Enhua pharmaceutical and other pharmaceutical companies have also submitted the listing application of this variety; cephalosporin for injection of Hainan Hailing chemical pharmaceutical increased from 2.258 billion yuan in 2013 to 3.805 billion yuan in 2018; chloridization of Sichuan Kelun Pharmaceutical Co., Ltd The sales volume of sodium injection kept steady growth Top 10 terminal traditional Chinese medicine injection products of public medical institutions in China in 2018 (unit: 100 million yuan) In 2018, the sales of top 10 products exceeded 40 billion yuan, with a total market share of 43%, and a high market concentration Among them, the sales volume of Xueshuantong for injection (freeze-drying) and Xuesaitong for injection (freeze-drying) exceeded 5 billion yuan Top 10 Chinese traditional medicine injection brands in public medical institutions in 2018 (unit: 100 million yuan) The sales volume of top 10 brands is more than 2.5 billion yuan, including 7 exclusive varieties, such as Xueshuantong for injection (freeze-drying) of Wuzhou Pharmaceutical (Group) and Danhong injection of Shandong Danhong pharmaceutical As the main force of injection Market, chemical injection increased from 400.9 billion in 2013 to nearly 600 billion in 2018 In October this year, the State Food and Drug Administration issued the technical requirements for conformity assessment of quality and efficacy of generic chemical injection (Draft for comments) and the application data requirements for conformity assessment of quality and efficacy of generic chemical injection (Draft for comments), among which, the technical requirements are clear, sodium chloride injection, glucose injection and glucose chlorination There is no need to carry out consistency evaluation for sodium injection, water for injection and some radioactive drugs (such as technetium [99mTc]), but quality improvement research is needed Sterilization process, filter and packing material selection (including compatibility research) should meet relevant technical requirements According to Zhou Chunxuan, excluding the above varieties, the sales volume of chemical injection is 570.3 billion yuan, while more than 1 billion varieties are concentrated in five categories: systemic anti infective drugs, blood and hematopoietic system drugs, digestive system and metabolic drugs, anti-tumor and immunomodulator drugs, and nervous system drugs In the future, these will be the hot categories for consistency evaluation, especially systemic anti infective drugs, Among them, there are more than 50 varieties with a sales volume of more than 1 billion Supplementary application for consistency evaluation of injections under review (3 or more) According to the data of minenet, there are 125 injection varieties under review, involving more than 400 acceptance numbers Among them, there are 3 or more enterprises applying for 37 varieties, such as ceftriaxone sodium for injection, parecoxib sodium for injection, ambroxol hydrochloride injection, ropivacaine hydrochloride injection, and the application for ceftriaxone sodium for injection and parecoxib sodium for injection It has the largest number of enterprises, including Jiangsu Hengrui pharmaceutical, Qilu pharmaceutical, Yangzi River Guangzhou Hairui pharmaceutical, Jiangsu aosaikang pharmaceutical, Hunan Kelun pharmaceutical and Zhengda Tianqing pharmaceutical.