GlaxoSmithKline (GSK.US) chronic hepatitis B treatment reached a major end point or hit a peak sales of £2 billion

The Zhitong Finance App learned that British pharmaceutical giant GlaxoSmithKline (GSK.US) said on Wednesday local time that its experimental drug to treat chronic hepatitis B infection has reached major goals in two major clinical studies that have attracted market attention, which will also bring the functional cure of this disease affecting more than 250 million people around the world one step closer. Furthermore, this high-profile new drug may strongly help GlaxoSmithKline achieve its ambitious revenue goals.

These positive figures mark an early victory for GlaxoSmithKline under new CEO Luke Miels. Miels replaced Emma Walmsley at the beginning of the year. Investors expect Miels to lead GlaxoSmithKline's ambitious target of over £40 billion (US$54 billion) in annual revenue by 2031.

The formal regulatory approval for the drug, bepirovirsen — the market unanimously expects its peak annual sales to exceed £2 billion, which could bring GlaxoSmithKline closer to achieving this goal. Before the drug reaches its main target, analysts expect GlaxoSmithKline's total revenue to be around £35 billion by 2031.

Despite the existence of safe and effective hepatitis B virus vaccines — including prophylactic injections such as those produced by GlaxoSmithKline, and significant advances in treatment, the disease is still widespread around the world. Furthermore, most of the current mainstream treatments require long-term or even lifelong medication, and the proportion that can actually achieve functional cure has been low for a long time, so any project that reads a “functional cure” signal in large-scale and critical research will receive great attention.

Currently, standard treatments are mainly nucleoside (acid) analogues (NAs), which can effectively inhibit HBV DNA, but it is often difficult to remove cccDNA and virus fragments integrated into the host genome, resulting in HBsAg (surface antigen) clearance being low even after long-term treatment.

Current standard treatments (nucleosides/nucleotide analogs such as tenofovir, entecavir; and polyethylene glycol interferon for some people) can generally inhibit HBV DNA and reduce the risk of liver cirrhosis/liver cancer in the long term, but it is necessary to achieve the “functional cure” defined by the research community — that is, continuous loss of HBsAg for at least 24 weeks after discontinuation of the drug and unquantifiable/undetectable HBV DNA, which is rare under existing treatments.

For GlaxoSmithKline, this latest research data will be used to submit regulatory approval applications globally.

In this latest study, the bepirovirsen treatment developed by GlaxoSmithKline achieved a statistically significant and clinically significant functional cure rate, which means that the treatment helped maintain two of the most critical biomarkers at such a significantly reduced level that testing was unable to detect them.

GlaxoSmithKline's test report showed that patients in both studies were monitored for continued significant declines in their viral DNA and surface antigen levels. If the level reduction lasts for 6 months or more, it indicates a functional comprehensive cure.

GlaxoSmithKline has not yet disclosed the final proportion of patients who achieved functional cure after receiving bepirovirsen treatment, but said full data will be announced at the upcoming scientific conference. The company stressed that the latest test data will also be used to submit official regulatory approval applications internationally in the first quarter of 2026.

The main reason why bepirovirsen is “in the spotlight” is that it targets the recognized “holy grail” in the field of chronic hepatitis B treatment — achieving functional cure (functional cure) after a limited course of treatment, rather than just suppressing the virus.

bepirovirsen is a class of antisense oligonucleotides (ASO). The design goal is to identify and degrade HBV, reduce the production of viral proteins (including HBsAg) at the source, and is described by GSK as possibly helping the immune system “regain control”; its early tests (IIb reported by NEJM) have observed continued loss of HBsAg and HBV DNA after discontinuation in some populations. At the same time, the latest phase III clinical trial further confirms that “functional cure rate” is both statistically and clinically significant and clinically significant At Standard treatment comparison, this is the most critical “implementation point” compared to similar research plans.