On May 27, the CDE (Center for Drug Evaluation) website showed that GlaxoSmithKline (GSK) has resubmitted its marketing application for its new chronic hepatitis B drug, Bepirovirsen injection. Bepirovirsen was first submitted for marketing approval in China on March 27 this year, with the indication being limited-course treatment of chronic hepatitis B virus infection in adults with chronic hepatitis B virus infection who are currently receiving nucleoside (nucleotide) analogue therapy, have HBsAg ≤3000 IU/mL, and do not have cirrhosis. On May 21, the application received a drug notification from the National Medical Products Administration (NMPA).
Beprovirsen is an antisense oligonucleotide (ASO) therapy acquired by GSK from Ionis. It aims to inhibit the replication of hepatitis B virus DNA, thereby suppressing the level of hepatitis B surface antigen (HBsAg) in the blood and stimulating a sustained immune response. This drug is the first small nucleic acid drug in the field of chronic hepatitis B to complete Phase III trials. In May 2026, Chia Tai Tianqing Pharmaceutical Group acquired the commercialization rights for Beprovirsen in China.Two registrational Phase III studies (B-Well 1 and B-Well 2) evaluated the efficacy, safety, pharmacokinetic characteristics, and durability of beprovirsen versus placebo in achieving functional cure in patients with chronic hepatitis B who had received nucleoside analogue therapy and whose baseline HBsAg level was no higher than 3000 IU/ml. The primary endpoint was the proportion of patients with a baseline HBsAg level no higher than 3000 IU/ml who achieved functional cure, and the key secondary endpoint was the proportion of patients with a baseline HBsAg level no higher than 1000 IU/ml who achieved functional cure.The results showed that both studies met their primary endpoint: a significantly higher rate of functional cure in the beprovirone group compared to the placebo group. Furthermore, all endpoints were met, with beprovirone showing more significant efficacy in patients with baseline HBsAg levels not exceeding 1000 IU/ml. Notably , data from the Chinese subgroup showed a functional cure rate of 24% in patients with baseline HBsAg levels not exceeding 3000 IU/ml, and a functional cure rate of 35% in patients with baseline HBsAg levels not exceeding 1000 IU/ml. Hepatitis B is a viral infection that can cause both acute and chronic liver disease. Chronic hepatitis B occurs when the immune system is unable to clear the virus, leading to long-term infection and affecting more than 240 million people worldwide, including 1.7 million in the United States and 75 million in China. The disease causes approximately 1.1 million deaths annually and accounts for about 56% of all liver cancer cases worldwide. Currently, many patients often require lifelong antiviral therapy to suppress the virus, making functional cure a key goal in disease management.

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