What's Happening?
China's National Medical Products Administration has granted conditional approval for libevitug, a drug developed by Huahui Health to treat chronic hepatitis D virus (HDV) infections. This marks a significant advancement in treatment options for HDV,
which co-infects with hepatitis B virus (HBV) and affects around 5% of the global population with chronic hepatitis B. Libevitug targets the PreS1 domain of the large envelope protein of HBV and HDV, blocking the viruses' entry into liver cells. Previously, the only approved drug for HDV was Gilead Sciences' Hepcludex, which was approved in Europe but rejected by the FDA in the U.S.
Why It's Important?
The approval of libevitug addresses a critical need for effective HDV treatments, particularly in China, which has the highest burden of chronic HBV infections globally. This development could significantly impact public health by reducing the risk of liver disease-related deaths and liver cancer associated with HDV and HBV co-infections. The approval also highlights the growing role of Chinese pharmaceutical companies in developing innovative treatments and the potential for international collaboration in addressing global health challenges.
