GSK Resubmits Bepirovirsen NDA in China and Secures Priority Review Designation

▎Armstrong

May 27, 2026: GSK Resubmits Marketing Application for Hepatitis B ASO Drug Bepirovirsen, Accepted by NMPA

On June 1, the marketing application for Bepirovirsen was proposed for inclusion in the priority review program, indicated for adult patients with chronic hepatitis B virus infection who are currently receiving nucleos(t)ide analogue therapy, have HBsAg levels ≤3000 IU/mL, and do not have cirrhosis.

On May 28, 2026, GSK China announced data from the Phase III B-WELL 1 and B-WELL 2 trials of its novel antisense oligonucleotide (ASO) drug for hepatitis B, bepirovirsen, showing a functional cure rate of 19% at 24 weeks after discontinuation following 48 weeks of treatment.For patients with baseline HBsAg ≤1000 IU/mL, the functional cure rate was 26%.

Summary

After years of exploration, hepatitis B is on the verge of entering a new era of functional cure. In addition to GSK’s pioneering research, efforts by Chinese biotech companies are leading to a flourishing development of novel drugs for hepatitis B. Huahui Health’s first-in-class Pre-S1 antibody HH-003 has been approved for the treatment of patients with hepatitis B co-infected with hepatitis D. AusperBio’s AHB-137, Xingyao Kunze’s HT-101 + HT-102, Yuanda Saiweixin’s therapeutic vaccine for hepatitis B, and siRNA candidates from Bowang Pharmaceutical and Hengrui Medicine have all achieved phased clinical breakthroughs, holding promise to raise the functional cure rate for hepatitis B to higher levels.