Special News

Tenofovir Alafenamide Fumarate Tablets obtains Drug Registration Certificate

Recently, “tenofovir alafenamide fumarate tablets” (Brand name: Qinglide (晴力得)), a new drug developed by the Group for the treatment of hepatitis B, has obtained drug registration certificate granted by the National Medical Products Administration of the People’s Republic of China. This product was filed as a Chemicals Category 3 drug, and is deemed to have passed the Consistency of Quality and Efficacy Evaluation for Generic Drugs. The approved indication is: for the treatment of adults with compensated chronic hepatitis B virus infection.

Tenofovir alafenamide fumarate is a new type of nucleoside reverse transcriptase inhibitor, an upgraded version of tenofovir disoproxil fumarate (“TDF”). It requires only one-tenth the dosage of TDF to achieve the same effect and has better skeletal and renal safety than TDF. With its proven and stable efficacy, tenofovir alafenamide fumarate has been recommended by the American Association for the Study of Liver Diseases (AASLD), the European Association for the Study of the Liver (EASL), and the domestic “Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 Edition)” as a first-line drug for antiviral treatment of chronic hepatitis B.

Hepatitis B is a global public health problem. It is a necrosis and inflammation of liver cells caused by hepatitis B virus (“HBV”) infection, which may lead to a series of complications such as liver failure, cirrhosis and hepatocellular carcinoma. China is an area with a high incidence of chronic hepatitis B, with huge market and demand for hepatitis B drugs. Qinglide’s approval for launch will further improve the layout of anti-HBV products of the Group and help reduce the financial burden of patients.