Production approval of adefovir dipivoxil tablets, a new hepatitis B drug of Fangsheng pharmaceutical

Recently, the State Food and Drug Administration learned that a new chemical drug of Fangsheng pharmaceutical has obtained the birth permit The drug registration shows that the drug handling status with the acceptance number of "cxhs1000312xiang" is "approved - to be prepared" The reporter further learned that this kind of 1.1 chemical new drug adefovir dipivoxil is mainly used for the treatment of chronic hepatitis B Adefovir dipivoxil, a drug originally developed by GlaxoSmithKline for the treatment of hepatitis B, is a nucleoside analogue currently used for the treatment of hepatitis B, which is more suitable for long-term antiviral treatment due to its low incidence of drug resistance, late time of drug resistance and good long-term drug safety At present, 120 million people in China carry hepatitis B virus In 2012, the total scale of hepatitis B drug market in China has reached 29.6 billion yuan, including 11.6 billion yuan of antiviral hepatitis B drugs Adefovir dipivoxil, lamivudine and entecavir are the three main nucleoside anti HBV drugs According to the public information, adefovir dipivoxil was listed in China in 2005, with two dosage forms of tablet and capsule According to CFDA website data, there are no less than 20 pharmaceutical companies in China that have obtained the approval documents of adefovir dipivoxil preparation, including Zhengda Tianqing, Jiangsu Wuzhong (600200 SH), Shuanglu Pharmaceutical (002038), Guangji Pharmaceutical (000952 SZ), Tishi Pharmaceutical (600535 SH) subsidiary company Diyi pharmaceutical, etc It is worth mentioning that Fangsheng pharmaceutical has obtained the production approval of adefovir dipivoxil tablets and capsules before, and the dispersive tablet type approved by Fangsheng pharmaceutical is the first one in China Compared with other solid preparations such as tablets and capsules, dispersible tablets have the advantages of convenient administration, rapid disintegration, fast absorption and high bioavailability Fangsheng pharmaceutical is mainly engaged in Chinese patent medicine of cardio cerebrovascular, orthopedic medicine, paediatric medicine, anti infective medicine, etc In 2014, the company realized an operating revenue of 416 million yuan, and the net profit attributable to the shareholders of the listed company was 80.99 million yuan.