China's NMPA approves Vemlidy for chronic hepatitis B

The China National Medical Products Administration (NMPA) has approved Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35kg), marking the fourth major regional clearance for the drug.

US biotech major Gilead Sciences’ (Nasdaq: GILD) Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to Gilead's Viread (tenofovir disoproxil fumarate, TDF) 300mg but at one-tenth of the dose. Data show that because Vemlidy has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to Viread, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. In clinical trials, Vemlidy demonstrated improved renal and bone laboratory safety parameters compared to Viread.

The hepatitis B market is estimated to be worth up to $25.8 billion by 2025, according to a report from Grand View Research. The Asia Pacific is anticipated to witness the maximum growth with a compound annual growth rate (CAGR) of 5.8% over the forecast period owing to rapidly increasing healthcare expenditure, compared with 2.7% globally.