GSK’s Bepirovirsen NDA Accepted In China, Backed By Strong Phase III Results In Chronic Hepatitis B

GSK plc has announced that China’s National Medical Products Administration (NMPA) has accepted for review a new drug application for bepirovirsen, an investigational antisense oligonucleotide therapy targeting chronic hepatitis B (CHB) in adults. This marks a key regulatory milestone for the therapy in one of the largest hepatitis B patient populations globally.

Chronic hepatitis B remains a major global health burden, affecting over 250 million people worldwide, including around 75 million in China. Existing treatments, primarily nucleos(t)ide analogues, often require lifelong use and deliver very low functional cure rates, around 1%. A functional cure is defined by sustained absence of viral DNA and hepatitis B surface antigen (HBsAg) after treatment cessation, significantly lowering the risk of severe liver complications such as liver cancer.

The submission is backed by positive Phase III results from the B-Well 1 and B-Well 2 trials. In these studies, bepirovirsen combined with standard of care achieved significantly higher functional cure rates than standard of care alone. The benefit was particularly notable in patients with lower baseline HBsAg levels. The therapy also demonstrated a safety and tolerability profile consistent with earlier clinical findings.

Bepirovirsen had previously received Breakthrough Therapy designation in China, a status designed to accelerate the development and review of promising therapies. The company plans to present detailed data at upcoming scientific meetings and pursue a peer-reviewed publication in 2026, further supporting its potential as a transformative option in CHB treatment.