Consistency evaluation of first-line hepatitis B drugs

On November 23, hisilica Pharmaceutical Group Co., Ltd issued a notice that its wholly-owned subsidiary Sichuan hisilica Pharmaceutical Co., Ltd (hereinafter referred to as "Sichuan hisilica") recently received the approval document for supplementary drug application on "entecavir capsule" approved and issued by the State Drug Administration, which passed the consistency evaluation of quality and efficacy of generic drugs HISCO has invested about 4.82 million yuan in R & D for the consistency evaluation of the drug According to the domestic drug database of pharmaceutical intelligence, there are currently five enterprises holding the approval documents for the production of entecavir capsules in China, involving Fujian guangshengtang Pharmaceutical Co., Ltd., Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd., Sichuan hisico Pharmaceutical Co., Ltd., Hainan Zhonghe Pharmaceutical Co., Ltd and Jiangxi Qingfeng Pharmaceutical Co., Ltd At present, there are 4 enterprises applying for conformity evaluation, among which Jiangxi Qingfeng pharmaceutical industry is the first one to have been evaluated, and hisic has become the second one Data source: drug registration and acceptance database data source: drug consistency evaluation progress database Entecavir was developed by Bristol Myers Squibb (BMS) It was first approved by FDA on March 29, 2005, then approved by EMA on June 26, 2006, and then approved by PMDA on July 26, 2006 It is sold on the market under the name of Baraclude The drug is suitable for the treatment of chronic hepatitis B virus infection in adults and children over 2 years old with active virus replication, continuous elevation of serum transaminase ALT (ALT or AST) or liver histology showing active lesions The drug is also one of the first-line antiviral drugs recommended by the World Health Organization and guidelines of various countries According to the sales database of smart drugs, the sales volume from 2005 to 2017 is shown in the figure below In recent years, due to the mature market, the sales space has reached a certain stability, and the sales volume in 2017 was 7.103 billion yuan Data source: drug intelligence drug sales database In addition to capsules and dispersible tablets, the consistency evaluation is also being carried out in foreign countries There are 7 domestic enterprises holding the production approval documents of entecavir dispersible tablets At present, there are 4 enterprises applying for the consistency evaluation, and Jiangxi Qingfeng and Zhengda Tianqing took the lead in the evaluation The progress is shown in the following figure: data source: drug registration and acceptance database data source: drug consistency evaluation database information source: HISCO announcement data source: drug intelligence data This article is the integration content, the viewpoint only represents the author, does not represent the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.