Injection consistency evaluation is about to break out, 600 billion market turbulence, 11 over 1 billion varieties, who do you like best?

Highlights on June 4, the State Food and Drug Administration issued the 2018 drug tracking and inspection plan, and decided to track and inspect 201 drug manufacturers, 60 of which were newly approved for listing, the largest in all categories It can be seen that the government attaches great importance to the quality and safety of injection With the first injection passing the consistency evaluation, the consistency evaluation of injection has entered the fast lane Up to now, there are 29 chemical injections applying for the consistency evaluation (involving 14 varieties and 10 pharmaceutical companies), 11 of which have the terminal sales of public medical institutions in China exceeding 1 billion yuan in 2017 Which one do you think is the best for consistency evaluation of 14 injections?   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-size: 17px; letter-spacing: 0.544px; widows: 1; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; line-height: 25.6px; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> the first injection passed the consistency evaluation, and the market pattern will change Azithromycin for injection of Puli pharmaceutical is not only the company's first export preparation to be successfully approved in China, but also the first of all injections approved and listed according to the six categories of old chemical registration classification so far According to the data of mienei.com, in 2017, the total market of terminal injection 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) was 695.732 billion yuan, of which the sales volume of chemical injection was 593.581 billion yuan, up 5.78% year on year, accounting for 85.32% of the total injection Market Azithromycin for injection is a dual report variety that Puli pharmaceutical has applied for registration in China and the United States at the same time It has obtained the temporary approval of the U.S FDA in October 2015 and received the drug registration approval issued by the State Drug Administration in August 2017 According to the data of mid drug index comprehensive database of midnet, at present, there are 66 domestic manufacturers of azithromycin injection, involving 137 drug approvals, including 5 Import approvals Figure 1: market share of the top 3 brand of azithromycin injection in Chinese public medical institutions (click the picture to enlarge) (source: the competition pattern of Chinese public medical institutions' terminals on the Internet) according to the data of the Internet, in 2017, the market of azithromycin injection in Chinese public medical institutions was 1.903 billion yuan, an increase of 4.91% over the previous year Although there are many enterprises producing azithromycin injection, the market concentration is relatively high Top 3 brand accounts for more than 80% of the market share, among which Pfizer, the original manufacturer, and Northeast Pharmaceutical Co., Ltd share most of the market share According to the data in 2017, Northeast Pharmaceutical ranked first with 69.31% market share, followed by Pfizer, the original research manufacturer, with 8.79% From the changes of market share of major brands in recent years, Northeast Pharmaceutical basically shows a steady growth trend, while Pfizer's market share fluctuates In 2017, the sales of azithromycin for injection of Puli pharmaceutical in China's public medical institutions was only 1.74 million yuan, but through the consistency evaluation this time, it means that Puli Shuqi is expected to obtain a quality level different from other domestic enterprises, get rid of the price competition with other enterprises, and perhaps shape a new market pattern   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-size: 17px; letter-spacing: 0.544px; widows: 1; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; line-height: 25.6px; Color: rgb (62, 62, 62); border style: none none solid; text align: Center; border bottom width: 1px; border bottom color: rgb (0, 0, 0); box sizing: border box! Im portant; word wrap: break word! Im portant; "> consistency evaluation of 14 injection agent declarations, 11 sales exceeded 1 billion On December 22, 2017, CDE publicly solicited the opinions of technical requirements for conformity assessment of listed chemical generic drugs (injections), officially opening the prelude of conformity assessment of injections Although there is no official document for the consistency evaluation of chemical injection, many policies point to the quality and efficacy of chemical injection, such as May 14 In the announcement on strengthening the on-site inspection of chemical generic injection registration application issued by the State Food and Drug Administration of the people's Republic of China, there are clear and detailed regulations on the on-site inspection of chemical generic injection registration application Compared with the previous oral solid preparations which limited the scope and time limit of the first batch of conformity evaluation, the conformity evaluation of chemical injection did not limit the scope of the first batch of varieties and the window period At present, the requirements are that in addition to sodium chloride injection, glucose injection, glucose sodium chloride injection, water for injection, etc., which are not included in the scope of consistency evaluation in principle, almost all other chemical injection should carry out consistency evaluation According to the 2.0 data of medmedchina drug review database of minenet, up to now, in addition to azithromycin for injection that has passed the consistency evaluation, the State Food and drug administration has also received 29 chemical injection consistency evaluation applications, involving 14 varieties and 10 enterprises Figure 2: application of injection consistency evaluation (click the picture to enlarge) (source: Med China drug review database 2.0 on minenet) According to the review status of each acceptance number, the clinical and pharmaceutical review of cyhb1840016, cyhb1840017 and cyhb1850034 acceptance numbers has been completed, so labelor hydrochloride injection of Jiangsu desino has been reviewed Gemcitabine hydrochloride for injection of Hainan Jinrui pharmaceutical may become the next batch of injections to complete the consistency evaluation first Table 1: application for conformity assessment of injection products (click the picture to enlarge) (source: minenet database) In terms of treatment categories, 5 of the 14 varieties are antineoplastic and immunomodulators It can be seen that antineoplastic field is the focus declared by pharmaceutical companies, and there are 2 products for digestive system and metabolism, nervous system drugs and systemic anti infective drugs In terms of product declaration manufacturers, Qilu pharmaceutical and its subsidiaries declare the most products In terms of declared products, in addition to ceftriaxone sodium for injection, there are 2 products In terms of product sales, in 2017, there were 11 products with terminal sales of more than 1 billion yuan in public medical institutions (8 products with sales of more than 2 billion yuan), including pantoprazole sodium for injection of nearly 9 billion yuan, pemetrexed disodium for injection and docetaxel injection of nearly 5 billion yuan Figure 3: 2017 China's public medical institutions terminal anti-tumor and immunomodulator pattern (click the picture to enlarge) (source: China's public medical institutions terminal competition pattern of minenet) Up to now, the anti-tumor products applying for consistency evaluation are in the leading position in 2017 China's public medical institutions terminal anti-tumor and immunomodulator competition pattern, Pemetrexed disodium for injection ranked first at 4.13%, docetaxel injection at 4.09%, and thymus injection at 2.95% Lilly, the original manufacturer of pemetrexed disodium for injection, had a global sales volume of US $2283 million in 2016, while in 2017, the sales volume of pemetrexed disodium for injection was 4.816 billion yuan at the terminals of public medical institutions in Chinese cities, up 7.27% year on year In this nearly 5 billion market, Jiangsu Haosen, Qilu pharmaceutical and Lilai three major manufacturers share more than 80%, of which Jiangsu Haosen occupies 41.4% of the market share Figure 4: pantoprazole sodium for injection applied for consistency evaluation of the terminal digestive system and metabolic drug pattern of public medical institutions in China in 2017 (click the picture to enlarge) (source: the terminal competition pattern of public medical institutions in China on minenet) In 2016, the global sales volume was US $962.98 million In 2017, pantoprazole sodium for injection stood out with a market share of 5.47% At present, there are many manufacturers producing pantoprazole sodium for injection, among which Yangtze River Pharmaceutical Co., Hainan Weikang Pharmaceutical Co., Ltd and Wutian Pharmaceutical Co., Ltd account for half, and Yangtze River Co., Ltd The pharmaceutical industry takes the lead with 26.77%   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-size: 17px; letter-spacing: 0.544px; widows: 1; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; line-height: 25.6px; Color: rgb (62, 62, 62); border style: none none solid; text align: Center; border bottom width: 1px; border bottom color: rgb (0, 0, 0); box sizing: border box! Im portant; word wrap: break word! Im portant; "> injection consistency evaluation drives into the fast lane, and drug companies compete for layout According to the data published by CDE, the first batch of injection consistency evaluation varieties have been in 2018 Since April 2004, the application began, and since then, the consistency evaluation of injection will enter the fast lane Compared with the consistency evaluation of generic drugs of solid preparations, the competition of the consistency evaluation of injection will be more intense, which forces the relevant injection manufacturers to further accelerate the research speed and promotion of the consistency evaluation of injection, in order to occupy a place in the competition of injection Market Table 2: Top 5 enterprises and products for reference preparation filing of injection consistency evaluation (click the picture to enlarge) (source: minenet reference drug information base) according to the data of minenet reference drug information base, up to now, the number of injection reference preparation filing has reached 214, there are 54 enterprises for filing, and there are 71 injection varieties for consistency evaluation From the perspective of filing enterprises, Jilin Yinglian biopharmaceutical has the largest number of registered products, including 8; from the perspective of filing products, pantoprazole sodium for injection has the largest number of enterprises, including 12 Table 3: be test of injection consistency evaluation (click the picture to enlarge) (source: minenet China drug clinical trial publicity Library) Up to now, there are 5 registration numbers of injection ready to carry out / carried out / completed be test in consistency evaluation, involving 3 enterprises and 3 varieties From the perspective of the enterprises conducting the test, two products of Changzhou Qianhong Biochemical Pharmaceutical Co., Ltd and Hebei Changshan Biochemical Pharmaceutical Co., Ltd are in the test stage; from the perspective of the tested products, two pharmaceutical enterprises are conducting enoxaparin sodium injection for be test, and Shenzhen Tiandao Pharmaceutical Co., Ltd has taken the lead, and its products have been in the queue of application for conformity evaluation Note: injection consistency evaluation be test statistics since the release of document 106 If there is any omission, please correct it Source: minenet database, CDE official website, etc