Peginterferon alfa-2b (Pegbing®) Received Marketing Authorization for New Indication: Combined with Nucleos(t)ide Analogues for HBsAg Sustained Clearance in Adult Patients with Chronic Hepatitis B.

First Approval!

Peginterferon alfa-2b (Pegbing®) Received Marketing Authorization for New Indication: Combined with Nucleos(t)ide Analogues for HBsAg Sustained Clearance in Adult Patients with Chronic Hepatitis B.

Recently, Xiamen Amoytop Biotech Co., Ltd. (Amoytop Biotech) received the "Drug Registration Certificate" approved and issued by the National Medical Products Administration (NMPA) for the new indication of Pegbing® (Peginterferon alfa-2b Injection): "This product combined with nucleos(t)ide analogues is indicated for sustained HBsAg clearance in adult chronic hepatitis B (CHB) patients, who are nucleos(t)ide-experienced, HBsAg ≤1500 IU/mL, with sustained virological suppression, and HBeAg-negative or HBeAg ≤10 COI."

Sustained HBsAg clearance is an important clinical treatment goal and is currently recognized as a marker of functional cure for HBV. As the first drug approved for this indication, Pegbing^® will become one of the important cornerstone drugs for the functional cure of CHB. It provides a solid foundation for the continuous optimization of future combination treatment regimens, helping more CHB patients to achieve higher treatment goals.

The approval of this new indication for Pegbing^® is based on the results of a multicenter, randomized, controlled confirmatory clinical trial evaluating the safety and efficacy of Peginterferon alfa-2b Injection combined with Tenofovir Disoproxil Fumarate Tablets in chronic hepatitis B (CHB), which showed that 31.4% of patients achieved a functional cure (defined as HBsAg seroclearance with sustained undetectable HBV DNA) at 24 weeks after discontinuation of all antiviral therapy following treatment completion.

About Pegbing®

Pegbing®, the core product of Amoytop Biotech,  is the world's first 40kD pegylated interferon alfa-2b injection independently developed by the company. It is a National Class 1 New Biological Drug and China’s first domestically developed and marketed PEG-modified interferon product. Pegbing® was approved for marketing in October 2016 for the treatment of adult chronic hepatitis C, and in September 2017 for the treatment of adult chronic hepatitis B.

慢性乙型肝炎是我国面临的重要公共卫生问题，根据2024年中国肝炎防治基金会联合中国疾病预防控制中心在《The Lancet Regional Health-Western Pacific》发表的中国第四次乙肝血清流行病学调查结果显示，2020年我国1-69岁人群中HBsAg流行率从1992年的9.72%下降到2020年的5.86%，估算全国约有7500万慢性乙型肝炎感染者。感染慢性乙肝后，除对患者日常生活会造成一定影响外，还会大幅增加患者未来罹患肝衰竭、肝硬化和肝癌的风险。

In recent years, functional cure has gained significant clinical importance for its triple benefits: achieving primary treatment goals for chronic hepatitis B (CHB), reducing post-treatment relapse, and substantially lowering the risk of progression to hepatocellular carcinoma (HCC). This has led to the formal recognition of functional cure in CHB prevention and treatment guidelines across China, Europe, and the United States, where it is now established as the preferred therapeutic endpoint for future drug development.