China approvals for Gilead's hepatitis and HIV drugs
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.
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