GlaxoSmithKline plc Sponsored ADR(GSK.US) chronic hepatitis B therapy reaches primary endpoint or hits peak sales of 2 billion.

British pharmaceutical giant GlaxoSmithKline plc Sponsored ADR (GSK.US) announced on Wednesday local time that its experimental drug for treating chronic hepatitis B infection has achieved primary goals in two major clinical trials that are closely watched by the market, bringing functional cure closer for this disease affecting over 250 million people worldwide. In addition, this promising new drug may also strongly support GlaxoSmithKline plc Sponsored ADR in achieving its ambitious revenue targets. These positive data mark an early victory for GlaxoSmithKline plc Sponsored ADR under the leadership of new CEO Luke Miels, who took over from Emma Walmsley earlier this year. Investors expect Miels to lead GlaxoSmithKline plc Sponsored ADR to achieve annual revenues exceeding 40 billion ($54 billion) by 2031. For the drug, bepirovirsen, formal regulatory approvalmarket analysts expect peak annual sales to exceed 2 billioncould bring GlaxoSmithKline plc Sponsored ADR closer to reaching this goal. Analysts predict that by 2031, GlaxoSmithKline plc Sponsored ADR's total revenue will be around 35 billion before the drug reaches its primary goal. Although there are safe and effective hepatitis B virus vaccines available, including preventive injections produced by GlaxoSmithKline plc Sponsored ADR, and significant progress has been made in treatment, the disease remains prevalent globally. Furthermore, existing mainstream therapies often require long-term or lifelong medication, and the proportion of achieving functional cure remains low in the long term, making any project that shows a "functional cure" signal in large, critical studies highly significant. The current standard treatment primarily uses nucleos(t)ide analogues (NAs) to effectively suppress HBV DNA, but it often struggles to eliminate cccDNA and viral fragments integrated into the host genome, leading to a low clearance rate of HBsAg (surface antigen) under long-term treatment. Current standard treatments (nucleoside/nucleotide analogues such as entecavir, tenofovir, and pegylated interferon for some populations) can overall suppress HBV DNA and reduce the risk of liver fibrosis/liver cancer long-term. However, achieving a "functional cure" as defined by the research communitymeaning HBsAg loss for at least 24 weeks after stopping medication and sustained undetectable levels of HBV DNAis rare under existing therapies. For GlaxoSmithKline plc Sponsored ADR, these latest research data will be used to submit regulatory approval applications worldwide. In this latest study, the bepirovirsen treatment developed by GlaxoSmithKline plc Sponsored ADR achieved statistically significant and clinically meaningful rates of functional cure, helping to maintain two key biomarkers at significantly reduced levels to the point of undetectability. GlaxoSmithKline plc Sponsored ADR's trial reports show that patients in both studies saw a sustained significant decrease in their viral DNA and surface antigen levels. If this decrease persists for 6 months or longer, it indicates an achievement of functional overall cure. GlaxoSmithKline plc Sponsored ADR has not yet disclosed the final proportion of patients achieving functional cure after bepirovirsen treatment but stated that complete data will be presented at an upcoming scientific conference. The company emphasized that the latest trial data will also be used to formally submit regulatory approval applications internationally in the first quarter of 2026. What makes bepirovirsen "promising" is its targeting of the chronic hepatitis B treatment field's widely recognized "holy grail"achieving functional cure after a limited course of treatment, rather than just suppressing the virus. Bepirovirsen is an antisense oligonucleotide (ASO) designed to identify and degrade HBV, reducing the production of viral proteins (including HBsAg) from the source, described by GSK as potentially helping the immune system "regain control." Early trials (reported by NEJM in IIb) have observed sustained absence of HBsAg and HBV DNA after stopping treatment in some populations, while the latest Phase III clinical trial further confirms the statistically and clinically significant "functional cure rate," surpassing standard treatment controls, proving to be the most critical "fulfillment point" relative to similar ongoing programs.