近期，厦门特宝生物工程股份有限公司自主研发的1类创新药派格宾

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（聚乙二醇干扰素α-2b注射液）的新增适应症获得国家药品监督管理局正式批准——派格宾

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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，成为全球首个获批该适应症的药物，标志着慢乙肝临床治愈进入新篇章，是乙肝治疗领域的划时代突破。

HBV相关肝癌的破局之策

据世界卫生组织数据显示，2022年，中国原发性肝癌的新发人数为36.8万，死亡人数为31.7万

[1]

，均占全球近一半。目前我国肝癌最主要的病因仍是HBV

[2]

，肝癌患者中的感染比例高达75.09%

[3]

，HBV相关肝癌发病数占全球总数的69%

[4]

。可见我国HBV相关肝癌的负担依然沉重。此外，我国超50%的肝癌新发患者处于进展期和终末期

[5]

，5年生存率较低。《中国防治病毒性肝炎行动计划（2025 - 2030年）》总目标中提到：持续夯实免疫屏障，持续降低新发感染，有效控制病毒性肝炎流行，减少病毒性肝炎相关肝硬化和肝癌的发生及其导致的死亡。因此，将肝癌防治的关口前移，强化预防工作，是降低其发病率和死亡率的根本策略。

慢乙肝患者是肝癌发生的高危人群，其肝癌相对风险是正常人群的14 - 223倍

[6]

，且随着慢乙肝疾病阶段的进展，肝癌发生风险越来越高，非肝硬化HBV感染者的肝癌年发生率为0.2% - 1.0%，肝硬化患者则高达3% - 6%

[7]

。国内外多项指南均强调了，慢乙肝治疗的最终目标是延缓和减少患者肝癌的发生

[7-9]

。目前，乙肝完全治愈仍较难实现，临床治愈已成为当前国内外认可的最理想的治疗目标，指的是停止治疗后HBsAg持续阴性，且HBV DNA检测不到，伴或不伴HBsAb出现

[10,11]

。

临床治愈改写慢乙肝患者远期结局

实现HBsAg持续清除意味着HBV病毒复制趋于静止，对改善慢乙肝患者的远期预后具有重大临床意义。获得HBsAg清除的患者可能更易实现肝组织学改善

[12]

，且在长期随访期间仍可持续获益

[13,14]

，进而降低肝硬化、肝功能失代偿、肝癌等肝脏不良事件的发生率

[15,16]

。

既往研究数据显示，未经治疗的慢乙肝患者5年肝癌累积发生率约15%左右

[17,18]

，肝硬化患者甚至高达38%

[17]

；接受抗病毒治疗可降低40% - 60%的肝癌发生风险，且干扰素α效果更佳

[19]

；而获得HBsAg清除的患者肝癌发生率显著低于HBsAg阳性的患者，5年肝癌累积发生率低至1%左右

[15,20-22]

。一项香港研究

[23]

显示，获得HBsAg清除的患者12年肝癌累积发生率为2.2%，非肝硬化患者仅1.5%，表明慢乙肝患者获得HBsAg清除后12年内，肝癌发生率依然较低。此外，获得HBsAg清除的年龄可能与肝癌风险相关

[24,25]

，50岁前获得HBsAg清除的非肝硬化患者肝癌发生率与普通人群无显著差异

[26]

。

乙肝临床治愈开启新纪元

派格宾

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3期确证性注册临床研究证实派格宾

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联合核苷（酸）类似物治疗可实现停止所有药物后24周的HBsAg清除且HBV DNA检测不到的比例达31.4%

[27]

，实现真正的临床治愈，是目前全球首个达到该临床治愈率的乙肝药物。此次派格宾

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联合核苷（酸）类似物用于成人慢性乙型肝炎患者HBsAg持续清除新适应症的获批，标志着慢乙肝临床治愈正式开启了新纪元，将进一步推动慢乙肝治疗向着更高的治愈目标迈进，从而大幅降低HBV相关肝硬化、肝癌的发生率和死亡率，为消除病毒性肝炎公共卫生危害奠定坚实基础，为实现“健康中国”贡献力量。 

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