The 12 first batch of products that passed the consistency evaluation, 8 sales exceeded one billion, and more than 50 acceptance numbers are on the way to review...

On December 29, CFDA released the first batch of drugs that passed the consistency evaluation of quality and efficacy of generic drugs After statistics, minenet found that this batch of drugs involved 12 products and 7 enterprises, among which Zhejiang Huahai Pharmaceutical Co., Ltd contracted 7 products In addition, it is worth noting that two enterprises with the specification of 75mg of irbesartan tablets have been approved at the same time, namely, Huahai pharmaceutical and Haizheng Pfizer Table 1: the first batch of drugs evaluated by the quality and efficacy consistency of generic drugs (unit: 100 million yuan) (data source: minenet database; data source: CFDA official website) According to the data of mienei.com, among the 12 products mentioned above, in 2016, there was one product with a total sales volume of more than 10 billion in China's urban public hospitals, county-level public hospitals, urban community centers, township health centers (referred to as China's public medical institutions) terminals and China's urban retail drugstores terminals, which was clopidogrel sulfate tablets, while there were products with a total sales volume of more than 1 billion yuan Paroxetine hydrochloride tablets, cefuroxime ester tablets, gefitinib tablets, irbesartan hydrochlorothiazide tablets, rosuvastatin calcium tablets, irbesartan tablets, and losartan potassium tablets   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; "> clopidogrel bisulfate tablets Figure 1: the competition of clopidogrel bisulfate tablets in the terminals of Chinese public medical institutions in 2016 (data source: minenet China public medical institutions terminal competition pattern) Clopidogrel is a classic anticoagulant in the field of cardio cerebrovascular, with a huge market scale According to the data of minenet, in 2016, the terminal sales of clopidogrel bisulfate tablets in public medical institutions in China reached 10.084 billion yuan, and the terminal sales of urban retail pharmacies in China reached 1.860 billion yuan At present, there are only three enterprises producing, Sanofi, xinlitai and Lepu pharmaceutical industry are in the situation of "three parts of the world" In 2000, clopidogrel of xinlitai was first approved to be registered for production, with the trade name of Taijia In September of the same year, clopidogrel of Sanofi Aventis and Bristol Myers Squibb was granted administrative protection in China In 2001, clopidogrel of Sanofi Aventis was approved to be listed in China under the trade name of Plavix It is worth mentioning that xinlitai is the first enterprise in China that has passed the EU certification for clopidogrel preparation and raw materials Taijia is listed and sold in more than 10 countries in the EU   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; "> rsuvastatin calcium tablet Figure 2: enterprise competition of rsuvastatin calcium tablet in China's public medical institutions in 2016 (data source: minenet China's public medical institutions terminal competition pattern) Statins are the first choice of drugs in the treatment of hypercholesterolemia Rosuvastatin calcium has high selectivity to liver, obvious lipid-lowering effect, and significantly reduced the side effects on central nervous system compared with other statins According to the data of minenet, in 2016, the terminal sales of rosuvastatin calcium tablets in public medical institutions in China reached 4.206 billion yuan, and the terminal sales of retail pharmacies in cities in China reached 696 million yuan In recent years, AstraZeneca's market share has been declining, from 63.5% in 2014 to 55.47% in 2016 This time, rosuvastatin calcium tablets of Nanjing Zhengda Tianqing pharmaceutical passed the consistency evaluation successfully, and its sales revenue will be greatly increased in the future In 2016, the sales volume of this variety in China's public medical institutions reached 657 million yuan, a year-on-year increase of 19.29% Jingxin Pharmaceutical Co., Ltd is one of the enterprises for the consistency evaluation of rosuvastatin calcium tablets On December 26, the information column of the consistency evaluation task on CDE website showed that the review of its rosuvastatin calcium tablets was suspended, and the reason for suspension is unknown On the afternoon of December 27, the information of CDE website was queried again, and the information of review suspension of rosuvastatin calcium tablets of the company was deleted On December 28, Beijing New Pharmaceutical Co., Ltd issued a notice on the supplement of rosuvastatin calcium tablets from CDE, saying that it needs to provide additional information     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; "> irbesartan tablet Figure 3: enterprise competition of irbesartan tablet in the terminals of public medical institutions in China in 2016 (data source: China's public medical institutions terminal competition pattern of minenet) Irbesartan tablet is mainly used for the treatment of primary hypertension, type 2 diabetic nephropathy with hypertension In 2016, the terminal sales of irbesartan tablets in public medical institutions in China exceeded 2.4 billion yuan, and the terminal sales of retail pharmacies in cities in China also exceeded 600 million yuan At the end of China's public medical institutions, the leading enterprise of the product is Sanofi, the original research enterprise The enterprises that have passed the consistency evaluation this time include Zhejiang Huahai Pharmaceutical Co., Ltd and Haizheng Pfizer Pharmaceutical Co., Ltd Among them, both enterprises of 75mg products have successfully passed the consistency evaluation In 2016, among the terminals of public medical institutions in China, the sales of irbesartan tablets of 75mg in Huahai Pharmaceutical Co., Ltd was 74.14 million yuan, while the sales of irbesartan tablets of 75mg in haizhenghuirui Co., Ltd was only 11.56 million yuan On November 10 this year, Haizheng pharmaceutical announced the completion of the 49% equity disposal of Haizheng huirui Pfizer officially withdrew and Hillhouse capital took over After the disposal of Pfizer's equity, Pfizer and the joint venture will continue to cooperate at various levels, including directly or indirectly transferring the technology of designated Pfizer products to Haizheng Pfizer, licensing the intellectual property rights of designated Pfizer products, and continuing to supply designated Pfizer products Through the consistency evaluation this time, it has also brought benefits to the company   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; "> Figure 4: the enterprise competition of losartan potassium tablets in the terminals of public medical institutions in China in 2016 (data source: minernet China public medical institutions terminal competition pattern) Losartan potassium tablet is mainly used in the treatment of essential hypertension, but also can be used in the treatment of chronic heart failure in adults who are not suitable for the treatment of ACE inhibitors (especially when there is cough or contraindications) In 2016, the terminal sales of losartan potassium tablets in public medical institutions in China exceeded 1.7 billion yuan, and the terminal sales of retail pharmacies in cities in China also exceeded 300 million yuan At the end of China's public medical institutions, the leading enterprise of the product is the original research enterprise MSD, and the enterprise passing the consistency evaluation this time is Zhejiang Huahai Pharmaceutical Co., Ltd Losartan potassium tablet is one of the important products of Zhejiang Huahai pharmaceutical industry In 2016, the sales contribution rate of losartan potassium tablet to enterprises in China's public medical institutions was 18.33%, while the sales contribution rate of irbesartan tablet was 6.13% In China's urban retail drugstore terminals, the sales contribution of losartan potassium tablets and irbesartan tablets are more than 10% Table 2: more than 50 acceptance numbers on the review Road