GSK(US:GSK) Zhi Tong Cai Jing·2026-01-08 00:55Core Viewpoint - GSK announced positive results from two pivotal Phase 3 clinical trials (B-Well 1 and B-Well 2) for its investigational antisense oligonucleotide therapy, bepirovirsen, aimed at treating chronic hepatitis B virus (HBV) infection, achieving significant functional cure rates and planning global regulatory submission in Q1 2026 [1][2]. Group 1: Clinical Trial Results - The B-Well 1 and B-Well 2 trials are global, multicenter, randomized, double-blind, placebo-controlled studies assessing the efficacy, safety, pharmacokinetics, and durability of functional cure of bepirovirsen in chronic HBV patients receiving nucleos(t)ide analog treatment with baseline HBsAg ≤3000 IU/ml [2]. - Both trials met their primary endpoint, demonstrating statistically and clinically significant functional cure rates for bepirovirsen compared to standard treatment alone, with significant improvements noted in patients with baseline HBsAg ≤1000 IU/ml [2]. Group 2: Disease Context - Chronic hepatitis B is a major global health challenge affecting over 250 million people and is a leading cause of liver cancer, with current standard treatments showing low functional cure rates of approximately 1% [1][2]. Group 3: Mechanism of Action - Bepirovirsen is an investigational ASO therapy with a triple mechanism of action designed to identify and destroy the genetic components of the hepatitis B virus (i.e., RNA), potentially allowing patients' immune systems to regain control over the viral infection [3].