[good medicine record] three new 289 catalog varieties will be added this week, and the consistency evaluation of Shiyao, Qilu and Cr heavyweight products will be passed

Up to now, there are 271 application acceptance numbers of conformity assessment, involving 112 varieties of 115 enterprises, 60 of which have passed the conformity assessment What's the new trend of this week's consistency evaluation? Let's take a look at it with the editor The first two varieties passed the consistency evaluation, and another two varieties passed soon This week (July 26 to August 2), the passion of consistency evaluation was released Three varieties passed the consistency evaluation The export of Ouyi's metformin hydrochloride tablets to domestic market was approved as the first to pass the consistency evaluation The first one of Qilu's terbinafine hydrochloride tablets passed the evaluation, and the first one of China Resources SECCO amlodipine besylate tablets passed the evaluation Another two varieties have been approved and will soon pass the evaluation It includes bisoprolol fumarate tablets in the 289 catalogue of Yuandong biology in Chengdu The details are as follows: Table 1 review and approval status of this week's consistency evaluation details of Ouyi metformin hydrochloride tablet recently, Ouyi said that its metformin hydrochloride tablet was listed in the United States and submitted to the domestic market application for approval The drug is deemed to have passed the consistency evaluation and become the first enterprise to pass the consistency evaluation of metformin hydrochloride tablet Metformin Hydrochloride Tablets is a kind of biguanide oral hypoglycemic drug, which is recommended by many countries and health organizations as the first line drug and the basic drug in the combination of diabetes patients to control hyperglycemia In 1922, scientists synthesized metformin for the first time In 1957, Squibb was put on the market under the trade name of "gehuazhi" In 1958, it was listed in the UK, and in 1972, it was listed in Canada In 1994, the metformin hydrochloride produced by Squibb pharmaceutical was approved to be listed in the United States According to the public information, the sales volume of metformin sample hospitals in 2017 was about 280 million yuan According to experts' estimates, the annual market size of metformin can reach 3.5 billion yuan, including the retail market However, most of the market belongs to the original research drug gehuazhi, and the sales proportion of domestic enterprises is very small According to the pharmaceutical intelligence data, at present, there are 120 domestic approvals for metformin hydrochloride tablets, with a large number of manufacturing enterprises and 5 enterprises applying for conformity assessment, which have not yet passed the conformity assessment See Table 2 for details Table 2 acceptance details of metformin hydrochloride tablets consistency evaluation amlodipine besylate tablets On July 30, China Resources SECCO Pharmaceutical Co., Ltd., a wholly-owned subsidiary of China Resources Shuanghe Pharmaceutical Co., Ltd., received the approval document for supplementary application of amlodipine besylate tablets (5mg) (approval document No.: 2018b03437) issued by the State Food and drug administration, which formally passed the consistency evaluation of quality and efficacy of generic drugs In addition, on July 26, the consistency evaluation of amlodipine besylate tablets of Zhejiang Weikang Pharmaceutical Co., Ltd was undertaken by CDE, and new competitors were added According to the pharmaceutical intelligence data, at present, there are 78 domestic approvals for amlodipine besylate tablets in China, with many manufacturers There are 9 enterprises applying for conformity assessment, among which Yangzi River and Jiangsu Huanghe pharmaceutical industry have passed the conformity assessment, Shanghai Novartis has issued documents, and Shanghai haini pharmaceutical industry has announced that its products have passed the conformity assessment not long ago This time, China Resources Secco has passed the conformity assessment, and the market competition is more fierce See Table 3 for details Table 3 acceptance details of the consistency evaluation of amlodipine besylate tablets on July 27, the approval results of the consistency evaluation of terbinafine hydrochloride tablets of Qilu pharmaceutical show that it is "approved production", and it has passed the conformity evaluation officially Terbinafine hydrochloride tablet is the first oral acrylamine antifungal drug in the world The original research company is Novartis, Switzerland It was first listed in Japan in September 1997 It is clinically used for various skin and nail infections caused by superficial fungi The drug has broad-spectrum antifungal effect, strong bactericidal power, can significantly shorten the course of treatment of chronic mycosis and can effectively reduce the recurrence rate The clinical efficacy has been unanimously recognized by medical institutions and the majority of patients According to the pharmaceutical intelligence data, there are only 10 domestic market approvals for terbinafine hydrochloride tablets, the main manufacturers are Beijing Novartis, Qilu pharmaceutical, Haizheng Pfizer, etc., and only Qilu pharmaceutical has applied for the consistency evaluation This time, Qilu pharmaceutical is the first one to obtain policy dividend through consistency evaluation, while occupying a larger market share Ambroxol hydrochloride tablets on July 27, Jiangsu Hengrui ambroxol hydrochloride tablets consistency evaluation review and approval status shows "issued", passing soon Ambroxol is a new active metabolite of bromhexin; it can promote the formation of pulmonary surfactant, it is a new phlegm dissolving drug, it can relieve cough and dyspnea, it is conducive to the discharge of airway secretion, ambroxol hydrochloride tablet is its tablet product According to the data released on the Internet, the ambroxol market of public hospitals in key cities in 2016 was 774 million yuan Ambroxol sales in public hospitals in China have exceeded 6 billion yuan At present, domestic ambroxol accounts for 54% of the total According to the pharmaceutical intelligence data, at present, there are 14 domestic approvals for ambroxol hydrochloride tablets in China, including Jiangsu Hengrui, sanders (China) pharmaceutical and Shandong Yuxin pharmaceutical Among them, Jiangsu Hengrui and Shandong Yuxin pharmaceutical have applied for conformity assessment, and Jiangsu Hengrui will be the first to pass, and Shandong Yuxin pharmaceutical is currently under review and approval Table 4 acceptance details of ambroxol hydrochloride tablets consistency evaluation on bisoprolol fumarate tablets on July 27, Chengdu Yuandong biological bisoprolol fumarate tablets consistency evaluation review approval status is "approval completed - to be verified", passing soon Bisoprolol fumarate tablets, 289 catalogue varieties, is a highly selective β l receptor blocker, which can reduce the toxic effect of catecholamine on the heart Its original research company is Merck According to the pharmaceutical intelligence data, bisoprolol fumarate tablets have 5 domestic approvals Domestic manufacturers include Beijing HuaSu Pharmaceutical Co., Ltd., Chengdu Yuandong bio Pharmaceutical Co., Ltd and Yueyang Xinhua Pharmaceutical Co., Ltd At present, Chengdu Yuandong bio Pharmaceutical Co., Ltd and Shanghai Novartis Trading Co., Ltd have applied for the consistency evaluation of bisoprolol fumarate tablets Among them, the consistency declaration of Chengdu Yuandong was handled on November 13, 2017, and the status of handling on July 27, 2018 has been shown as "approved pending certification" If there is no accident, Chengdu Yuandong will become the first one to pass the consistency evaluation of bisoprolol fumarate tablets Enterprise Table 5 acceptance details of bisoprolol fumarate tablets consistency evaluation II 10 acceptance No 9 varieties have been undertaken, and several 289 catalog varieties are listed This week, 10 new conformity assessment acceptance numbers were undertaken, involving 9 varieties of 9 enterprises, among which 5 varieties were the first ones to be declared, namely, tegacyclin for injection of Zhengda Tianqing, parixib sodium for injection of Hunan Kelun, cetirizine hydrochloride tablets of Xinhua Pharmaceutical, fluconazole tablets of Sichuan Kelun pharmaceutical and propranolol hydrochloride tablets of Jiangsu Yabang Epson pharmaceutical, Three 289 catalogue varieties are also involved, namely, cefuroxime ester tablets of Jiangsu Sinochem, propranolol tablets of Jiangsu Yabang epsomic acid and fluconazole tablets of Sichuan Kelun pharmaceutical See the following table for details: Table 6 acceptance details of consistency evaluation this week The following small edition will briefly introduce some varieties of parexib sodium for injection this week On July 30, the consistency rating of parecoxib sodium for injection was accepted by CDE Parecoxib sodium for injection is the only selective cyclooxygenase-2 (COX-2) inhibitor available for injection in the world It is mainly used for the treatment of postoperative pain and is one of the basic drugs for clinical multimodal analgesia Developed jointly by Pfizer and famasia, it was first listed in Europe in 2002, with the trade name of dynastat and specifications of 20mg and 40mg It has been listed in at least 15 countries, such as Germany, France and the United Kingdom It was approved to be listed in China in 2008, with the trade name of Trane, which is a national class B medical insurance product In 2016, the sales volume of TNT China was about RMB 765 million Relevant data shows that in 2016, the sales volume of parecoxib sodium for injection in China was about 765 million yuan From 2012 to 2017, the sales volume of parecoxib sodium in sample hospitals in key cities increased year by year In 2017, the amount of drugs used in Chinese hospitals reached 1 billion yuan According to industry forecasts, the generic drug is expected to become a 1 billion class of large varieties According to the pharmaceutical intelligence data, the domestic enterprises of parixib sodium for injection are only Hunan Kelun and Qilu pharmaceutical, and the drug is the first imitated product of Hunan Kelun The first application for conformity assessment is accepted If it passes the assessment successfully, it will be more conducive to expanding its market share while seizing the dividend of conformity assessment policy On July 30, the consistency evaluation of fluconazole tablets of Sichuan Kelun Pharmaceutical Co., Ltd was undertaken by CDE Fluconazole tablets, 289 catalog varieties, broad-spectrum antifungal agents, with a variety of fungal infections Developed by Pfizer, it was first listed in the United Kingdom in 1988, in Japan and Italy in 1989, and in the United States in 1990 The Spanish market is licensed by Pfizer to Vita Cientifica, a subsidiary of Procter & Gamble According to the pharmaceutical intelligence data, there are 24 domestic approvals for fluconazole tablets, including Yangzi River, Sichuan Kelun, Lepu pharmaceutical and other enterprises The enterprises applying for conformity assessment are only Sichuan Kelun, and the product is exempt from be test, which will accelerate its passing the conformity assessment On July 27, gemcitabine hydrochloride for injection, Jiangsu Haosen Pharmaceutical Co., Ltd obtained gemcitabine hydrochloride for injection from CDE as pyrimidine anti-tumor drugs The clinical indications are: local advanced or metastatic non-small cell lung cancer; local advanced or metastatic pancreatic cancer; unresectable, local recurrent or metastatic breast cancer, etc According to data statistics of 400 public hospitals in 16 key cities, gemcitabine hydrochloride for injection sold 348 million yuan in the first three quarters of 2017 The largest market share is Jiangsu Haosen, 58.52%; the second is original research Lilai, 37.73%; the total market volume of the two enterprises is more than 95% According to the pharmaceutical intelligence data, there are 26 domestic approvals for gemcitabine hydrochloride for injection, involving multiple manufacturers Up to now, Jiangsu Haosen and Hainan Jinrui pharmaceutical have applied for the consistency evaluation, and their evaluation status has been shown as "issued" Table 7 acceptance details of the consistency evaluation of gemcitabine hydrochloride for injection propranolol hydrochloride tablets on July 26, the consistency evaluation of propranolol hydrochloride tablets of Jiangsu Yabang Epson Pharmaceutical Co., Ltd was undertaken by CDE Propranolol hydrochloride, 289 catalogue and BCS classification, is a non selective β - receptor blocker It blocks β - receptor of myocardium and has antagonistic effect on β 1 and β 2 receptor Originally developed by AstraZeneca in 1966 According to the pharmaceutical intelligence data, there are 75 domestic approvals for propranolol hydrochloride tablets in China, with many manufacturers Jiangsu Yabang Epson Pharmaceutical Co., Ltd is the first to apply for conformity assessment and has been accepted Data source: drug intelligence database information source: drug intelligence network, enterprise announcement and other network public information