Another four drugs have passed the consistency evaluation, and there are three first-line drugs for hepatitis B

On November 27, Dongrui pharmaceutical announced that its subsidiary Suzhou Dongrui Pharmaceutical Co., Ltd.'s anti HBV drug "entecavir dispersible tablet 0.5mg" (trade name "Lei Yi De") and antihypertensive drug "amlodipine besylate tablet 5mg" (trade name "an neizhen") were approved by the State Drug Administration to pass the quality and efficacy consistency evaluation of generic drugs Entecavir is an oral guanine nucleoside analogue for the treatment of hepatitis B virus infection It has an inhibitory effect on hepatitis B virus (HBV) polymerase At present, it is mainly used for antiviral treatment of hepatitis B, and also for the treatment of children with chronic HBV infection and compensatory liver disease between 2 and 18 years old The drug has the characteristics of rapid onset, strong resistance to hepatitis B virus and low resistance, and is the first-line antiviral treatment for chronic hepatitis B patients According to the announcement, since its listing in 2010, Toray pharmaceutical's "rexide" has been the only generic entecavir with a term of validity of 36 months in China At present, the preparations for the consistency evaluation of entecavir in China include dispersible tablets and capsules Toray pharmaceutical has been approved as the third dispersible tablet In addition, Anhui Baker biopharmaceutical Co., Ltd applied for entecavir dispersible tablets according to drug intelligence data Data source: drug registration and acceptance database data source: drug consistency evaluation progress database In addition, it was found by querying the catalogue of Chinese listed drugs that the entecavir capsule of Nanjing Zhengda Tianqing was also included in the catalogue in November So far, there are three enterprises that have passed the consistency evaluation of entecavir capsule Data source: Yao Zhi's catalogue of listed drugs in China data source: Yao Zhi's domestic drug database data source: progress database of consistency evaluation of drug intelligence amlodipine besylate amlodipine besylate is an antihypertensive drug of dihydropyridine calcium antagonists, also used to treat chronic stable angina and variant angina The company was approved for listing in 2002 According to the database of consistency evaluation progress of pharmaceutical intelligence, there are currently 17 enterprises declared according to the consistency evaluation, and now there are four enterprises that have passed the evaluation (Note: due to limited space, part of the data is intercepted If you need complete data, you can enter the "consistency evaluation progress database" for query.) data source: consistency evaluation progress database of metformin hydrochloride sustained release tablets According to the catalog of Chinese listed drugs, the metformin hydrochloride sustained-release tablets of Jiangsu Deyuan Pharmaceutical Co., Ltd have been included in the catalog in November, so far, the first metformin hydrochloride sustained-release tablets have been released through the enterprise According to the pharmaceutical intelligence data, there are 9 enterprises applying for the consistency evaluation of metformin acid sustained-release tablets Data source: drug intelligence China list of listed drugs data source: drug intelligence domestic drug database (Note: due to limited space, a part of the data is intercepted, if complete data is needed, it can be queried in the "consistency evaluation progress database" of drug intelligence) data source: drug intelligence consistency evaluation progress database In addition, in addition to the drugs that have been announced and entered the catalogue of Chinese listed drugs, there are eight drug conformity assessment applications that have been approved in November, waiting for the official approval information Data source: registration and acceptance database of smart drugs data source: registration and acceptance database of smart drugs information source: Dongrui pharmaceutical announcement data source: smart drug database