China Biopharmaceutical (01177) announced that the new drug "propofol tenofovir fumarate tablets" (trade name: Qinglide) developed by the group for the treatment of hepatitis B has been issued a drug registration certificate by the State Drug Administration of the People's Republic of China. This variety is declared according to 3 categories of chemical drugs, and is deemed to have passed the consistency evaluation of the quality and efficacy of generic drugs; Approved indications are for the treatment of compensatory chronic hepatitis B virus infection in adults.
Propofol tenofovir fumarate is a novel nucleoside reverse transcriptase inhibitor that is an upgraded version of tenofovir disoproxil fumarate (TDF); The dosage only takes one-tenth of TDF to achieve the same effect, and it has better bone safety and kidney safety than TDF. With its precise and stable properties, propofol tenofovir fumarate has been recommended as a first-line drug for the antiviral treatment of chronic hepatitis B by the American Society for The Study of Liver Diseases (AASLD), the European Society for the Study of Liver Diseases (EASL), and the domestic Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 Edition).
Hepatitis B is a global public health problem. It is hepatocellular necrosis and inflammation caused by hepatitis B virus (HBV) infection, which can cause a range of complications such as liver failure, cirrhosis and hepatocellular carcinoma. China is a high incidence of chronic hepatitis B, and the hepatitis B market size and drug demand are huge. Qinglide's approval for listing will further improve the layout of the Group's anti-HBV product line, and at the same time help reduce the economic burden on patients.