Historic Approval for Hepatitis B Treatment
China's National Medical Products Administration (NMPA) announced on October 13, 2025, the approval of Pegbing, an injectable drug developed by Amoytop Biotech. This landmark decision marks Pegbing as the world's first domestically developed drug specifically designed to achieve a functional cure for chronic hepatitis B, representing a significant stride in addressing the widespread liver infection.
Understanding Pegbing's Role in Functional Cure
Pegbing is approved for use in combination with existing antiviral medication. Its primary aim is to achieve the sustained clearance of the hepatitis B surface antigen in adults suffering from chronic hepatitis B. The Chinese Foundation for Hepatitis Prevention and Control emphasized that this approval signifies the 'world's first market authorization for a drug aimed at achieving functional cure for hepatitis B,' heralding a new phase in the global battle against the infectious disease. Developed by Amoytop Biotech, based in Xiamen, Fujian province, Pegbing's introduction is expected to offer a new and effective treatment pathway for millions of patients.
The Global and National Burden of Hepatitis B
Hepatitis B remains a critical global health challenge, affecting approximately 254 million people worldwide and contributing to over 1 million related deaths annually. China bears a substantial portion of this burden, with an estimated 75 million chronic hepatitis B patients. The chronic nature of the infection can lead to severe liver damage, including cirrhosis and liver cancer, underscoring the urgent need for more effective treatments and curative options.
Paving the Way for Future Treatments
The approval of Pegbing is seen as a pivotal moment, not only for China but for the international medical community. It highlights the potential for innovative domestic research and development to deliver groundbreaking solutions to complex health issues. This development offers renewed hope for patients seeking a functional cure, moving beyond mere viral suppression to a state where the virus is effectively controlled by the body's immune system.
5 Comments
Donatello
Chinese approvals can be rushed. I'm wary of 'first-in-the-world' claims.
Michelangelo
It's exciting to see such innovation from China in tackling a major global health burden like Hepatitis B. Yet, the article's focus on a 'cure' drug while the primary topic is 'Vaccines' highlights the ongoing importance of prevention, which shouldn't be overshadowed by treatment advancements.
Raphael
Combination therapy? Sounds complicated and potentially more side effects.
Africa
Another expensive treatment for a disease that should be prevented by vaccines.
Coccinella
Amazing news! A functional cure is a game-changer for so many.