On January 7th local time, the British pharmaceutical company GlaxoSmithKline...GSK announced that its investigational chronic hepatitis B therapy, Bepirovirsen, met its primary endpoints in two pivotal Phase 3 clinical trials. If approved, this would mean the world's first antiviral therapy that can achieve functional cure of hepatitis B with only a limited 6-month treatment course.

Bepirovirsen is a novel antisense oligonucleotide (ASO) antiviral therapy for hepatitis B that directly inhibits viral replication. GSK plans to formally initiate global regulatory approval applications for Bepirovirsen in the first quarter of this year.

The term "functional cure" refers to a condition where, after discontinuing medication, the patient remains negative for hepatitis B surface antigen (HBsAg) and has undetectable hepatitis B virus (HBV) DNA for six months or longer. Analysts believe that even if only 15% to 20% of hepatitis B patients achieve functional cure, it will have significant implications for changing global hepatitis B treatment outcomes.

Currently, no other treatment has achieved a significant functional cure rate after discontinuation of the drug. Michael Leuchten, an analyst at investment bank Jefferies, stated, "GSK's announcement suggests that Bepirovirsen has the potential to become a blockbuster drug."

GSK predicts that if Bepirovirsen is approved, its peak annual sales could exceed £2 billion (approximately $2.7 billion), bringing the company closer to its goal of achieving annual revenue of over £40 billion by 2031.

Chronic hepatitis B (CHB) is a long-term infection and a persistent global public health challenge, affecting more than 250 million people worldwide. It is also a leading cause of liver cancer. According to the latest estimates from the World Health Organization (WHO), chronic hepatitis B caused more than one million deaths in 2022.

Currently, the standard treatment for chronic hepatitis B primarily involves nucleoside (acid) analogs (NAs). While these effectively suppress viral replication, they are ineffective at eliminating the virus, often requiring lifelong medication. Data shows that standard treatment only enables 1% to 4% of patients to clear the virus over a period of time. Furthermore, these drugs may cause related complications.

"Theoretically, hepatitis B patients who have achieved functional cure do not need lifelong medication," said Lu Fengmin, professor of Pathogenic Biology at Peking University School of Medicine, who has long been engaged in HBV virus research. However, he also pointed out that if the anti-HBV immune reconstitution in functionally cured hepatitis B patients is not sufficiently consolidated, relapse is still possible. Furthermore, the use of strong immunosuppressants may also cause viral reactivation.

The "Guidelines for the Prevention and Treatment of Hepatitis B Virus Reactivation in High-Risk Groups in China (2026 Edition)," recently compiled by Professor Zhang Wenhong and other experts from the Department of Infectious Diseases at Huashan Hospital Affiliated to Fudan University, cites data showing that the prevalence of hepatitis B surface antigen (HBsAg) in the general population of my country is 6.1%, with approximately 86 million chronic HBV infections.

If the new treatment is approved, the outcomes of hepatitis B treatment in China are expected to undergo a fundamental change in the coming years. Besides GSK, other companies including Roche and Johnson & Johnson also have other options.Multinational pharmaceutical giants are also actively developing related therapies.

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