Weigh! TAF, the best new hepatitis B drug in history, has been approved for listing in China

On November 14, the new drug application (jxhl1700186) of Gilead's new hepatitis B drug, "fospropofol tablets" (TAF), was approved by the National Drug Administration (nmpa) for the treatment of chronic hepatitis B in adults and adolescents (over 12 years old, with a weight of more than 35kg) Gilead first submitted the application for the international multicenter clinical trial of fospronofovir tablets in China in February 2014 and went through the special approval channel In April 2015, Gilead obtained the approval document for the international multicenter clinical trial In 2015, Gilead successively registered and carried out three studies in China (ctr20150267; ctr20150268; ctr20150269) On October 9, 2017, the clinical application of Gilead "fospronofovir tablets" was accepted by CDE However, because CFDA had previously asked for the opinions on adjusting the registration and management of imported drugs, Gilead's application was not confirmatory clinical, and as an anti hepatitis drug, it was included in the priority review by CDE According to the relevant matters on adjusting the registration and management of imported drugs officially implemented on October 10, 2017, "fospronovovir tablets" was directly approved for listing by CFDA, and the steps of production reporting were omitted Fospropotenofovir (tenofovir, TAF) is a pre drug of tenofovir (TDF), which is a clinical standard drug for hepatitis B because of its high blood stability, it can be delivered to liver cells effectively, so TAF When the dosage is less than one tenth of TDF (25mg / 300mg), it can play a similar effect with the latter It can also avoid the high concentration of tenofovir in the blood, and improve the safety On November 10, 2016, TAF was approved by FDA under the trade name of vemlidy It is the first hepatitis B drug approved by FDA in the past 10 years After that, TAF was listed in Japan on December 19, 2016 and approved by European EMA on January 9, 2017 On April 20, 2017, the European Society for liver research released the latest hepatitis B management guidelines 2017, in which for the first-line preferred nucleoside (acid) analogue treatment scheme for patients with chronic hepatitis B, in addition to the original "tenofovir fumarate dipivoxil" and "entecavir", the guidelines added "phosphotenofovir" For patients with kidney disease or bone disease and / or the risk of the above diseases, especially those who have been exposed to nucleoside analogues, it is recommended that the treatment of fosbutenovir should be the first choice In the first three quarters of 2018, vemlidy's global sales revenue was US $221 million, including US $172 million In the more "money view" Chinese market, the battle between domestic generic pharmaceutical companies and Gilead, the original research manufacturer, has also started As of November 4, two domestic enterprises, Zhengda Tianqing and Qingfeng pharmaceutical, have submitted the application for imitated listing In terms of clinical trial registration, the cake of hepatitis B market has also been targeted by more domestic giants Kelun pharmaceutical's be trial has also completed patient recruitment and is close to submitting the listing application Guangshengtang and Qilu pharmaceutical have registered be test recently Source of be test registration of TAF in China: there are about 400 million hepatitis B patients in the medical magic cube clinical trial database worldwide, nearly 30 million hepatitis B patients and 7.6 million hepatitis C patients in China Each year, about 330000 people die of liver cirrhosis and primary liver cancer caused by hepatitis B virus or hepatitis C virus infection Hepatitis B is a life-threatening disease, and it can not be cured completely at present, which is a serious threat to human health Before TAF, hepatitis B drugs on the market mainly included interferon α for injection, pegylated interferon α, lamivudine, telbivudine, adefovir dipivoxil, entecavir and other common nucleoside analogues for oral use However, interferons have the disadvantages of high price and many adverse reactions Oral nucleoside drugs have the disadvantages of drug resistance, drug withdrawal and recurrence TAF is known as the best hepatitis B drug in history because of its strong efficacy and high safety.