GSK's Hepatitis B Drug Bepirovirsen Receives FDA Priority Review and Breakthrough Therapy Designation

▎Armstrong

On April 28, 2026, GSK China announced that the FDA had accepted the marketing application for its new hepatitis B ASO drug, Bepirovirsen, granting it Priority Review status as well as Breakthrough Therapy Designation (BTD). The PDUFA date is October 26, 2026.

Bepirovirsen demonstrated a clinically meaningful functional cure rate in the two Phase III clinical trials, B-WELL 1/2. Specific data will be disclosed at this year's EASL conference and simultaneously published in an academic journal.

GSK China expects the sales peak of Bepirovirsen to exceed 2 billion pounds.

At the 2025 AASLD Conference, AusperBio Announced New ASO Drug for Hepatitis BAHB-137 Week 24 Post-Treatment Data. Strong and sustained antiviral response demonstrated at 24 weeks post-treatment (i.e., Week 48), including complete response (HBsAg<0.05 IU/mL and HBV DNA

Summary

As a major country with a high prevalence of hepatitis B, China has also seen an explosion in domestically produced innovative drugs for hepatitis B. Huahui Health's FIC Libivirumab has achieved breakthrough efficacy in patients with both hepatitis B and hepatitis D, and has been approved for marketing. It has simultaneously received Breakthrough Therapy Designation in both China and the United States.AusperBio's AHB-137 achieved HBsAg clearance in 62% of patients after 12 weeks of treatment, far surpassing GSK China's Bepirovirsen, and marking the best historical data for hepatitis B treatment drugs, providing a better tool for functional cure of hepatitis B. In addition, Hepa Thera's hepatitis B siRNA + hepatitis B neutralizing antibody, and CGE HEALTHCARE's therapeutic hepatitis B vaccine have also demonstrated excellent efficacy potential in different scenarios.