GSK announces China NMPA accepted for review NDA for bepirovirsen

GSK (GSK) announced that the China National Medical Products Administration, NMPA, has accepted for review a new drug application, NDA, for bepirovirsen, an investigational antisense oligonucleotide, for the treatment of adults with chronic hepatitis B. The regulatory submission is supported by positive results from the B-Well 1 and B-Well 2 Phase III trials, where bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. Functional cure rates were significantly higher with bepirovirsen plus standard of care compared with standard of care alone across all ranked endpoints, including in patients with lower baseline HBsAg levels where an even greater effect was observed. Bepirovirsen demonstrated an acceptable safety and tolerability profile consistent with previous studies. These data will be presented at a congress and submitted for scientific peer-reviewed publication in 2026.