每经AI快讯，10月13日，特宝生物(688278.SZ)公告，公司产品派格宾联合核苷(酸)类似物用于成人慢性 乙型肝炎患者HBsAg持续清除的增加适应症已获国家药监局批准。此次获批基于临床试验结果，显示 31.4%患者在停药24周后实现HBsAg转阴且HBVDNA持续抑制。该适应症拓展显著提升派格宾市场潜 力，强化其在慢乙肝临床治愈领域的地位。 ...

受理号：CXSS2400023、CXSS2400024、CXSS2400025、CXSS2400026 证书编号：2025S03097、2025S03098、2025S03099、2025S03100 本公司董事会及全体董事保证公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容的 真实性、准确性和完整性依法承担法律责任。 近日，厦门特宝生物工程股份有限公司（以下简称"公司"）收到国家药品监督管理局核准签发的《药品 注册证书》，公司产品派格宾联合核苷（酸）类似物用于成人慢性乙型肝炎患者的HBsAg持续清除的增 加适应症（以下简称"增加适应症"）上市许可申请获得批准。现将有关情况公告如下： 一、药品基本情况 药品名称：派格宾? 通用名称：聚乙二醇干扰素α-2b注射液 申请事项：药品注册（境内生产） 我国2022版《慢性乙型肝炎防治指南》中指出："对于部分适合条件的患者，应追求临床治愈（又称功 能性治愈）"，即停止所有治疗药物6个月或更长时间HBsAg持续清除伴HBV DNA持续抑制。HBsAg持 续清除是一个重要的临床治疗目标，目前被认为是获得HBV功能性治愈的标志。本次派格宾获批增加 适应症是基于一 ...

Core 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].