GSK's Hepatitis B Functional Cure Drug Bepirovirsen Denied First-Time Approval in China

On May 25, 2026, the NMPA published delivery information for 35 drug notification documents (i.e., indicating non-approval), the last of which pertains to GSK's Bepirovirsen injection.

The highly anticipated novel drug for the functional cure of hepatitis B was not approved in its initial marketing authorization application in China.

This is a highly anticipated drug. For a long time, hepatitis B has remained incurable; medications such as entecavir and tenofovir alafenamide can only potently inhibit viral replication but cannot completely eradicate the virus.

Therefore, innovative drugs targeting the functional cure of hepatitis B are being actively developed worldwide, and the most advanced among them is Bepirovirsen injection (Bepirovirsen, GSK836).

Bepirovirsen injection is a first-in-class antisense oligonucleotide (ASO) therapy with a triple mechanism of action, designed to inhibit hepatitis B virus (HBV) DNA replication, thereby reducing hepatitis B surface antigen (HBsAg) levels in the blood, and stimulating the immune system to elicit a durable response.

The drug was submitted for marketing approval in China in March 2026, was included in the priority review and approval program, and obtainedFollowing the Breakthrough Therapy designation, GSK believes this drug has the potential to become the world's first approved therapy for a functional cure of hepatitis B.

Provenge Injection（Bepirovirsen Solution for Injection）is a drug developed by IonisASO Therapy, featuring a triple mechanism of action capable of recognizing and degrading the genetic material (i.e., RNA) of the hepatitis B virus responsible for chronic infection, thereby inhibiting viral DNA replication in vivo, reducing hepatitis B surface antigen (HBsAg) levels in the blood, and stimulating the immune system to increase the likelihood of a durable response.

In August 2019, GSK licensed the development and commercialization rights to the product from Ionis, with an upfront and milestone payment of $262 million.

On January 7 this year, GSK announced that bepirovirsen'sBoth pivotal Phase III B-Well 1 and B-Well 2 studies met their primary endpoints.. These two studies enrolled a total of more than 1,800 subjects and were conducted in 29 countries.

The results showed that, in the B-Well study,`Bepirovirsen`demonstrated a statistically and clinically significant functional cure rate, and the functional cure rate of the combination with standard therapy was significantly higher than that of standard therapy alone.

Currently, bepirovirsen has been submitted for marketing approval in Japan. If approved, the product is expected to become the first finite six-month treatment option for chronic hepatitis B and serve as a cornerstone drug for future sequential therapies.

Globally, multiple antisense oligonucleotide (ASO) and small interfering RNA (siRNA) candidate drugs for the clinical cure of hepatitis B are currently undergoing clinical trials.

In addition to bepirovirsen, GSK has multiple other small nucleic acid therapies for hepatitis B in development, such as:GSK5637608(Former development code: JNJ-3989 (ARO-HBV) is currently undergoing Phase II clinical trials. siRNA drug co-developed by Roche and DicernaXalnesiran, capable of targeting conserved regions of the hepatitis B virus (HBV) genome, thereby silencing multiple HBV transcripts, and may be effective in patients with chronic HBV infection with or without immunomodulators.

Significant progress has also been made in the research and development of domestically produced small nucleic acid drugs, with drugs under development including Brii Biosciences' hepatitis B siRNA candidate drug.BRII-835（Elebsiran）, Ascletis'sASC22（Envafolimab）、Xingyao Kunze's HBV siRNA Candidate DrugHT-101, a Hepatitis B siRNA Candidate Drug by Chia Tai TianqingTQA-3038。

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