China approvals for Gilead's hepatitis and HIV drugs .




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US biotech major Gilead Sciences (Nasdaq: GILD) has received approval from China’s National Medical Products Administration (NMPA) for Harvoni (ledipasvir 90mg/sofosbuvir 400mg) for the treatment of chronic hepatitis C virus (HCV) genotype 1-6 infection in adults and adolescents aged 12 to 18 years.

Hepatitis C is a significant public health challenge. Nearly 10 million people in China are estimated to have chronic HCV, with around 58% having HCV genotype 1 infection.

"The multicenter clinical trials in China have shown that the once-daily single tablet treatment regimen of Harvoni achieved a 100% SVR12 (defined as undetectable HCV RNA 12 weeks after completing therapy) rate in treatment patients with genotype 1 HCV infection," said Professor Lai Wei, Peking University People's Hospital and Institute of Hepatology, Beijing.

Descovy also approved

Also, the China NMPA has approved Descovy (emtricitabine 200mg/tenofovir alafenamide 10mg and emtricitabine 200mg/tenofovir alafenamide 25mg, F/TAF), a fixed-dose combination for the treatment of HIV.

In China, Descovy is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) in adults and adolescents (aged 12 years and older with body weight at least 35kg).