When is the first-line drug TAF of hepatitis B listed in China? @State Drug Administration

Recently, the good news about the consistency evaluation of generic drugs in China keeps on going This week, the fourth batch passed the consistency evaluation list, among which the domestic modified entecavir dispersible tablets for first-line hepatitis B drugs are listed From entecavir to the beginning of consistency evaluation, Yaozhi continued to follow up During this period, many patients inquired about the progress through telephone and Yaozhi's personal wechat Secretary yaoxiaozhi After being approved by entecavir, yaoxiaozhi fell behind for a while Yaoxiaozhi received the consultation from patients' friends on TAF After a small rough Baidu query, for this drug in the domestic market time of concern is very high At present, according to European EASL guidelines and American AASLD guidelines, the first-line oral antiviral therapy for chronic hepatitis B includes entecavir, TDF and TAF Entecavir and TDF are both imported and generic in the domestic market As a new generation of antiviral drugs for hepatitis B, TAF has the same antiviral effect as tenofovir disoprofonate (TDF) The difference is that TAF has zero drug resistance, better bone and kidney safety, and it is the focus of antiviral drugs for hepatitis B all over the world Basic information of TAF domestic import information is based on the database of drug intelligence data registration and acceptance At present, the import of TAF declared by Gilead sciences has been included in the special approval, and the clinical application has been approved in 2015 According to the clinical trial database, we can see that at present, the clinical trials in China have entered into three phases The specific time when the drug can be approved for listing in China The editor will not make a forecast here, and everything is subject to the official information of the State Drug Administration However, the editor will pay real-time attention to the latest progress of the drug and share with you In recent years, considering the needs of domestic patients, various relevant departments have issued a number of policies to support the rapid arrival of good drugs and short drugs in China In 2018, the premier proposed zero tariff for anticancer drugs, and then the State Council issued a zero tariff policy for anticancer drugs since May 1 to accelerate the import of innovative drugs On May 23 yesterday, the State Drug Administration and the national health and Health Commission issued a notice on optimizing the review and approval of drug registration, further improving the speed of approval of innovative drugs on the market, simplifying the registration and application procedures for imported drugs, and pointed out that "for the prevention and control of diseases and rare diseases that are seriously life-threatening and have no effective means of treatment that have been listed abroad, If the applicant for registration of imported drugs considers that there is no ethnic difference through research, he / she may submit the clinical trial data obtained abroad to directly apply for registration of drugs on the market For the above-mentioned import drug clinical trial applications that have been accepted and put forward for clinical trial reduction or exemption before the issuance of this announcement, if they meet the requirements of the measures for the administration of drug registration and relevant documents, they can be directly approved for import " The previous "life-saving medicine", "high-quality medicine" and "high price medicine" have made patients exclaim frequently that they can't afford to wait "and" can't afford to use " Now, in the continuous attention of the state, in the continuous improvement of the review and approval system of the State Drug Administration, and in the continuous listening to the voice of patients, more and more drugs urgently needed by patients will accelerate to come to China.