The National Medical Products Administration (NMPA) has granted market approval for pradefavir, a Category 1 drug developed by Xi’an Xintong Pharmaceutical Research Co., Ltd., for the treatment of adult chronic hepatitis B virus (HBV) infection under the trade name XinShuMu.
Pradefavir, a nucleoside liver-targeting drug, functions by inhibiting HBV DNA polymerase, thereby preventing the virus’s replication. The drug exhibits good stability in the bloodstream and gastrointestinal tract and is capable of releasing the active metabolite adefovir monophosphate in the liver through the action of the CYP3A4 enzyme. This metabolite is further converted to adefovir diphosphate by cellular kinases, which inhibits HBV DNA reverse transcription by competing with the natural substrate deoxyadenosine triphosphate.
Clinical studies have demonstrated that pradefavir is as effective as current first-line therapies in inhibiting HBV DNA replication, clearing hepatitis B e antigen (HBeAg), and restoring liver function. Pradefavir is noted for its overall safety profile, with no observed adverse effects on the kidneys or bones, which are common with other nucleoside drugs, and it carries a low cardiovascular risk for long-term use.- Flcube.com
