GSK plc (GSK) Form 6-K — Oct 21, 2026
GSK announced FDA approval of Hibsago (bepirovirsen), a first-in-class antisense oligonucleotide, for chronic hepatitis B in adults without cirrhosis who have suppressed HBV DNA and HBsAg levels ≤3000 IU/ml. The approval was granted under priority review with Breakthrough Therapy Designation. Pooled B-Well phase III data showed a 19% functional cure rate in adults with HBsAg ≤3000 IU/ml (233 of 1,220), versus 0 of 614 on placebo, and a 26% cure rate in the ≤1000 IU/ml subgroup. Current standard of care typically achieves less than 1% functional cure after one year.
Key figures
- Trial countries
- 29
- Us chb patients
- approximately 1.7 million
- Treatment duration
- six months
- Functional cure rate overall
- 19% (233 of 1,220) vs 0 of 614 placebo
- Hbsag reduction to le 100 iu ml
- 49% overall, 62% in ≤1000 IU/ml subgroup
- Functional cure rate hbsag le 1000
- 26% (200 of 768) vs 0 of 393 placebo
- Global chb cases represented by le 1000 iu ml group
- approximately 45%
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