GSK’s Bepirovirsen accepted for review as a potential first functional cure for chronic hepatitis B in China

GSK has recently announced that the China National Medical Products Administration has accepted for review a new drug application for bepirovirsen, an investigational antisense oligonucleotide, for the treatment of adults with chronic hepatitis B.

Chronic hepatitis B is a major public health challenge, affecting more than 250 million people worldwide and an estimated 75 million people in China¹. The current standard of care – typically nucleoside analogues, which often requires lifelong therapy and the functional cure rates remain low, typically only 1%.³ Functional cure occurs when the hepatitis B virus DNA and viral protein – hepatitis B surface antigen – are undetectable in the blood for at least 24 weeks after stopping all treatment, indicative of the disease being controlled by the immune system without medication.

Note that 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.

In addition, Bepirovirsen was granted Breakthrough Therapy designation in China in August 2021, which is intended to expedite the review of investigational drugs with potential for substantial improvement over available therapies.

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Related Topics and Keywords

bepirovirsen, chronic hepatitis b