AMOYTOP(SH:688278) Shang Hai Zheng Quan Bao·2025-10-12 17:35Core Viewpoint - The approval of the expanded indication for Pegbiv, a drug developed by Xiamen Tebao Biological Engineering Co., Ltd., marks a significant advancement in the treatment of chronic hepatitis B, enhancing its market competitiveness and potential for clinical cure [1][5]. Drug Basic Information - Drug Name: Pegbiv - Generic Name: Pegylated Interferon α-2b Injection - Application: Drug registration (domestic production) - Approval Conclusion: The drug is approved for use in adults with chronic hepatitis B for HBsAg clearance when used in combination with nucleos(t)ide analogs [1][2]. Drug Background - Pegbiv is the company's core product and the world's first 40kD pegylated long-acting interferon α-2b injection, classified as a Category 1 new drug in China. It was first approved for chronic hepatitis C in October 2016 and for chronic hepatitis B in September 2017 [2]. Chronic Hepatitis B Context - Chronic hepatitis B is a significant public health issue in China, with an estimated 75 million infected individuals as of 2020. The prevalence of HBsAg has decreased from 9.72% in 1992 to 5.86% in 2020 [3]. The disease poses risks of liver failure, cirrhosis, and liver cancer [3]. Clinical Cure Concept - The 2022 Chronic Hepatitis B Prevention and Treatment Guidelines in China emphasize the pursuit of clinical cure, defined as sustained HBsAg clearance and HBV DNA suppression after stopping all treatment for six months or longer [4]. The approval of Pegbiv's expanded indication is based on clinical trial results demonstrating its efficacy in achieving these treatment goals [4][5]. Clinical Trial Results - In a clinical trial, 31.4% of patients achieved HBsAg clearance and sustained HBV DNA suppression 24 weeks after treatment cessation, providing strong evidence for Pegbiv's role in achieving clinical cure for chronic hepatitis B [5].