4 billion varieties "pass" consistency evaluation! Is the Yangtze River not fast enough for this pharmaceutical company?

Highlights recently, CFDA food and drug audit and Inspection Center (CFDI) released the news of the first batch of consistency evaluation varieties due to on-site inspection work, with securities companies predicting that the inspection involved 13 varieties of 9 pharmaceutical enterprises in 6 provinces Four neurologicals, antitumor drugs, anti hepatitis B drugs, anti epileptic drugs and statins have been analyzed by minenet Today, we will analyze another 4 billion cardiovascular drugs (amlodipine besylate tablets) that are expected to pass the consistency evaluation   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; 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 4 billion varieties" breaking through "data source of cardiovascular system drug product pattern of public medical institutions in China in 2016: minenet terminal competition pattern of public medical institutions in China According to the data of mienei.com, in 2016, 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) terminal chemical drug market, the sales of amlodipine besylate tablets exceeded 4 billion yuan, accounting for 3.92% of the market share, ranking sixth The sales volume of amlodipine besylate tablets in Chinese public medical institutions (unit: 10000 yuan) data source: the terminal competition pattern of Chinese public medical institutions on the intranet none = "shifumousedownstyle ('shifu bus')" style = "margin: 1em Auto; padding: 0px; max width: 100%; color: RGB (62, 62, 62); font family:" hiragino sans GB "," Microsoft YaHei ", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; 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; "> fierce competition in China Data source: the terminal competition pattern of China's public medical institutions Currently, there are 65 domestic approval numbers for amlodipine besylate tablets, including 58 for 5mg, 4 for 2.5mg and 3 for 10mg The competition is quite fierce Pfizer, as the original research and development enterprise of amlodipine besylate tablets (trade name: luohuoxi), has always ranked the top in terms of sales In 2016, Pfizer exceeded 3 billion yuan, ranking the third in the brand pattern of cardiovascular system drugs, with a market share of 3.02% However, in recent years, its market share has gradually declined, 3.35% in 2013, 3.28% in 2014 and 3.06% in 2015   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; 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 enterprise that has passed the consistency evaluation will be the first to apply for the consistency evaluation of amlodipine besylate tablets Data source: midnet Med China drug evaluation database 2.0 According to the data of minenet, CDE has accepted the application for consistency evaluation of amlodipine besylate tablets from Jiangsu Huanghe Pharmaceutical Co., Ltd and Yangzi Pharmaceutical Group Shanghai haini Pharmaceutical Co., Ltd In the prediction of securities companies, only Jiangsu Huanghe Pharmaceutical Co., Ltd is expected to become the first enterprise to pass the consistency evaluation of amlodipine besylate tablets The estimated approval time of amlodipine besylate tablets comes from CFDA, CDE and Guotai Junan Securities research According to the securities analysis, it is estimated that the actual inspection time will be about 3-5 days After the completion of the sampling review, opinions will be formed and fed back to CDE for subsequent review If no additional information is needed in the future, the first batch of consistent varieties may be officially approved at the beginning of 2018 at the earliest   none="shifuMouseDown('shifu_t_002')" style="margin: 1em auto; padding: 0.5em 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border: none; text-align: center; width: 670px; box-sizing: border-box !im portant; Word wrap: break word! Im assistant; "> conclusion: This is a breakthrough for consistency evaluation, which starts the on-site inspection of consistency evaluation varieties In the future, with the promotion of consistency evaluation, the development of China's pharmaceutical industry will be accelerated, the market competition pattern will be optimized, and the era of "the leftover" will be the king.