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更新于：2026-08-29

Imdusiran

更新于：2026-08-29

概要

概要

基本信息

药物类型

siRNA

别名

Imdusiran Sodium、AB 729、AB-729

+ [1]

靶点

HBsAg

作用方式

抑制剂

作用机制

HBsAg抑制剂(HBV表面抗原抑制剂)、RNAi(RNA干扰)

治疗领域

感染消化系统疾病

在研适应症

慢性乙型肝炎乙型肝炎

非在研适应症-

原研机构

Arbutus Biopharma Corp.

在研机构

Arbutus Biopharma Corp.

齐鲁制药有限公司

非在研机构

Assembly Biosciences, Inc.

权益机构

齐鲁制药有限公司

Barinthus Biotherapeutics (UK) Ltd.

Antios Therapeutics, Inc.

+ [2]

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)临床申请

特殊审评快速通道 (美国)

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结构/序列

使用我们的RNA技术数据为新药研发加速。

或

查看完整样例数据

Sequence Code 453110990

来源: *****

Sequence Code 453110991

来源: *****

关联

项与 Imdusiran 相关的临床试验

NCT06154278

/ Recruiting临床2期IIT

Pilot Study to Evaluate Intrahepatic and Peripheral Responses to Small Interfering RNA, Imdusiran (AB-729), Among People With Chronic Hepatitis B

The goal of this clinical trial is to learn about the action of Imdusiran (AB-729) in the liver of people with chronic hepatitis B. The main questions it aims to answer are:
* how well is it working in the liver
* how does Imdusiran affect the hepatitis B virus
Participants will receive injections of Imdusiran, one injection every 8 weeks, for a total of 4 doses. They will also undergo 2 liver biopsies: one with the first dose of Imdusiran, and the second 8 weeks after the last dose of Imdusiran.

开始日期2024-07-25

申办/合作机构

University of Maryland Baltimore

[+1]

NCT06245291

/ Withdrawn临床2期

A Phase 2a, Open-Label Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab, a PD-L1 Monoclonal Antibody, in Subjects With Chronic HBV Infection

This is a phase 2a, open-label, multicenter study investigating the safety, tolerability, and antiviral activity of durvalumab administered at targeted times during a 48-week treatment period of imdusiran in virologically-suppressed CHB subjects

开始日期2024-05-01

申办/合作机构

Arbutus Biopharma Corp.

ACTRN12622000317796

/ Completed临床2期

A Phase 2a, Randomized, Blinded, Multicenter Study Investigating a Combination of AB-729 and VTP-300 to evaluate their safety and reactogenicity in Virologically-Suppressed Chronic Hepatitis B Participants.

开始日期2022-06-02

申办/合作机构

Arbutus Biopharma Corp.

100 项与 Imdusiran 相关的临床结果

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100 项与 Imdusiran 相关的转化医学

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100 项与 Imdusiran 相关的专利（医药）

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项与 Imdusiran 相关的文献（医药）

2026-07-01·The Lancet Gastroenterology & Hepatology

The small interfering RNA imdusiran as single and multiple doses in healthy, randomised individuals and non-randomised individuals with chronic hepatitis B (AB-729–001): a phase 1a/b trial

Article

作者: Sevinsky, Heather ; Pamulapati, Ganapati Reddy ; Thi, Emily P ; Sims, Karen D ; Kim, Yoon Jun ; Fortney, Tiffany ; Leerapun, Apinya ; Berliba, Elina ; Picchio, Gastón ; Lee, Amy C H ; Ganchua, Sharie C ; Cloherty, Gavin A ; Iott, Christina ; Sukeepaisarnjaroen, Wattana ; Gray, Kevin R ; Lim, Young-Suk ; Strasser, Simone I ; Espiritu, Christine ; Sharma, Varun ; Yuen, Man-Fung ; Gane, Edward ; Paratala, Bhavna S ; Eley, Timothy ; Holmes, Jacinta A ; Jucov, Alina ; Anderson, Mark ; Sofia, Michael J ; Tangkijvanich, Pisit ; Medvedeva, Elina

BACKGROUND:

Functional cure of chronic hepatitis B requires a sustained loss of HBsAg and hepatitis B virus (HBV) DNA, which is unlikely with current therapies. We aimed to investigate the safety, antiviral activity, and anti-HBV immune responses of the N-acetylgalactosamine-conjugated, small interfering RNA imdusiran, a therapeutic strategy designed to reduce viral antigens on the path to achieving immune control.

METHODS:

AB-729-001 was a phase 1a/b trial conducted at 11 centres and hospitals: three in Australia, one in New Zealand, three in Thailand, one in Hong Kong, two in South Korea, and one in Moldova. In part 1, which had a double-blinded, single ascending dose design consisting of four sequential dose groups, healthy individuals aged 18-45 years were randomly assigned (2:1), using fixed block randomisation (block number of two for 1:1 active:placebo sentinel dosing, followed by block number of four for 3:1 active:placebo for the next four participants), into three equal-sized cohorts and received subcutaneous imdusiran or placebo as a single dose of 60 mg, 180 mg, or 360 mg. Participants and investigators were masked to treatment assignment until part 1 was complete. Parts 2 and 3 were open-label and enrolled individuals aged 18-65 years with chronic hepatitis B, who were HBeAg-positive or HBeAg-negative and were taking or not taking nucleoside or nucleotide (nucleos[t]ide) analogue therapy (continued during the imdusiran treatment period), and who had HBsAg concentrations of at least 250 international units per mL, no clinically significant abnormalities on liver ultrasound, and an absence of cirrhosis. These participants received subcutaneous imdusiran as a single dose of 60 mg, 90 mg, or 180 mg (part 2) or as repeat doses of 60 mg or 90 mg every 4, 8, or 12 weeks for up to 48 weeks (part 3). The primary endpoint for all parts of the study was to evaluate the frequency and severity of treatment-emergent adverse events, discontinuations due to adverse events, and laboratory abnormalities following the administration of single doses to healthy participants (evaluated until day 29 after dosing) and of single and multiple doses of imdusiran to participants with chronic hepatitis B (evaluated until week 48 of follow-up and until month 36 of follow-up for participants who discontinued nucleos[t]ide analogue therapy after completing imdusiran treatment and meeting eligibility criteria). All individuals who received at least one dose of study drug comprised the safety population and were included in safety analyses. This study was registered with the Australia New Zealand Clinical Trials Registry-ACTRN12619000954123 (part 1), ACTRN12619001197123 (part 2), and ACTRN12620000295943 (part 3)-and is complete.

FINDINGS:

Between July 16 and Aug 30, 2019, 18 individuals (18 [100%] male) were enrolled in part 1 and randomly assigned (12 [67%] to imdusiran and six [33%] to placebo). Between Sept 3, 2019, and June 11, 2020, of 43 individuals assessed for eligibility, 22 (51%) were enrolled in part 2, of whom 15 (68%) were male and seven (32%) were female. 78 individuals were assessed for eligibility in part 3 between April 30, 2020, and June 26, 2021, of whom 43 (55%) were enrolled (26 [60%] male and 17 [40%] female). All 83 enrolled participants received at least one dose of imdusiran or placebo and were included in the safety analyses. Across all parts, no participants discontinued imdusiran owing to an adverse event and no dose-related trends in reported treatment-emergent adverse events were observed across groups. There were no deaths. The most commonly reported treatment-emergent adverse events occurring in two or more participants in part 1 were an increase in alanine aminotransferase concentration (n=2; both reported as treatment-related), dizziness (n=2), medical device site reaction (n=3), headache (n=2), and oropharyngeal pain (n=2). The most commonly reported treatment-emergent adverse events in part 2 were transient injection-site pain (n=5; all reported as treatment-related), headache (n=4; two treatment-related), an increase in alanine aminotransferase (n=3; two treatment-related) and aspartate aminotransferase (n=2; one treatment-related) concentrations, and dizziness (n=2). The most commonly reported treatment-emergent adverse events in part 3 were coronavirus infection (n=18), injection-site pain (n=8; all of which were reported to be treatment-related), injection-site erythema (n=4; all treatment-related), headache (n=4), upper respiratory tract infection (n=4), pyrexia (n=4), fatigue (n=3; one treatment-related), and injection-site bruising (n=3; all treatment-related). All were reported as grade 1. No clinically relevant changes in clinical laboratory, vital signs, and electrocardiogram values over time were noted in any part of the study.

INTERPRETATION:

Single and multiple doses of imdusiran were safe and well tolerated in healthy individuals and in individuals with chronic hepatitis B, supporting drug development of imdusiran as a future treatment targeting functional cure for chronic hepatitis B.

FUNDING:

Arbutus Biopharma.

2024-10-11·ACS Infectious Diseases

Control of Hepatitis B Virus with Imdusiran, a Small Interfering RNA Therapeutic

Article

作者: Cuconati, Andrea ; Paratala, Bhavna ; Thi, Emily P. ; Graves, Ingrid E. ; Ye, Xin ; McClintock, Kevin ; Rijnbrand, Rene ; Micolochick Steuer, Holly M. ; Espiritu, Christine ; Sofia, Michael J. ; Lee, Amy C. H. ; Harasym, Troy ; Jarosz, Agnes ; Snead, Nicholas M. ; Teng, Xiaowei ; Abbott, Cory ; Ardzinski, Andrzej ; Lam, Angela M.

Chronic hepatitis B is a global health concern with a high risk of end-stage liver disease. Current standard-of-care agents have low cure rates, and new therapies are needed. Small interfering RNAs (siRNAs) that target viral RNAs fulfill a gap not addressed by standard-of-care agents and may contribute to a functional cure. Here, we describe the preclinical characterization of imdusiran (AB-729), a novel, pan-genotypic siRNA therapeutic that effectively reduces HBsAg, viral antigens, and viral replication in chronic hepatitis B patients and is currently in Phase 2 clinical studies. In hepatitis B virus (HBV) cell-based systems, imdusiran possessed pan-genotypic nanomolar potency and retained activity against HBV target site polymorphisms. Imdusiran was active against nucleos(t)ide analogue- and capsid assembly modulator-resistant HBV isolates, and combination with standard-of-care agents was additive. In an HBV adeno-associated virus mouse model, HBsAg was reduced up to 3.7 log₁₀ after a single imdusiran dose, with sustained suppression for 10 weeks. Imdusiran did not intrinsically stimulate cytokine release in healthy donor human whole blood, supportive of its mechanism of action as a direct acting RNA interference antiviral. Taken together, these data support imdusiran in combination treatment approaches toward chronic hepatitis B functional cure.

Hepatology communications

Measuring hepatitis B pgRNA stability using an updated automated HBV pgRNA assay with increased sensitivity

Article

作者: Anderson, Mark ; Thi, Emily P. ; Stec, Michael ; Mbanya, Dora ; Picchio, Gaston ; Cloherty, Gavin

Background::

HBV pregenomic RNA (pgRNA) is a circulating biomarker for covalently closed circular DNA activity in HBV-infected individuals and has been studied for treatment efficacy, disease staging, and off-therapy outcomes; however, data on the stability are scarce. Increasing HBV pgRNA assay sensitivity may improve its predictive value and provide additional insights at low viral levels.

Methods::

Modifications to a fully automated first (v1) generation HBV pgRNA assay improved sensitivity up to 15-fold over the previous assay. Flexible sample input volumes yielded lower limits of quantitation of 10 and 22 copies/mL for 0.6 and 0.2 mL assays, respectively. Results are standardized to secondary standards that are traceable to the WHO HBV DNA standard, and internal and external controls are included.

Results::

Comparison between v1 and modified v2 assays showed increased sensitivity from 152 copies/mL with v1 to 10 (0.6 mL) and 22 (0.2 mL) copies/mL with v2, respectively. Quantitated v2 results were indistinguishable from v1, indicating that comparisons can be made to previous studies. Single timepoint treatment-naive blood donors or longitudinal draws from patients with chronic hepatitis B on AB-729, an investigational siRNA therapy, showed improved detection and quantifiable pgRNA with v2 compared with v1. Stability testing demonstrated excellent HBV pgRNA plasma stability after 3 freeze-thaw cycles, for at least 7 days at 25–37 °C and at least 30 days at 4°C, with ≤0.25 Log U/mL decrease.

Conclusion::

HBV pgRNA v2 assays with increased sensitivity and flexible input volumes demonstrated increased detection and quantitation of low viral titer samples. Highly sensitive HBV pgRNA assays may be useful in refining predictive treatment outcomes based on this marker. HBV pgRNA was stable under multiple conditions, which increases the reliability of this marker.

215

项与 Imdusiran 相关的新闻（医药）

2026-08-26

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一针改写乙肝历史：全球首款功能性治愈药重构治疗格局

2026年8月24日，葛兰素史克（GSK）反义寡核苷酸（ASO）药物贝普若韦生（Bepirovirsen，商品名 Hibsago）在日本获批上市，用于核苷（酸）类似物经治、HBsAg≤3000 IU/mL的成人慢性乙肝功能性治愈。这是全球首个获批的乙肝功能性治愈疗法，标志着全球乙肝治疗正式从“终身抑制”迈入“有限疗程治愈”的全新阶段。我国是乙肝高发大国，存量乙肝病毒感染者约 7500 万。长期以来，核苷酸类似物能有效抑制病毒复制，却无法清除病毒、实现表面抗原转阴，患者需终身用药，肝硬化与肝癌远期风险无法根除。功能性治愈——即停药后HBsAg持续转阴、病毒DNA持续阴性——正是千万患者的核心诉求。三管齐下：中国亚组疗效更优贝普若韦生由GSK与Ionis联合开发，通过ASO序列互补结合HBV pgRNA与mRNA，经RNase H降解阻断病毒蛋白合成；同步压低血清HBsAg，解除病毒对T细胞、NK细胞的抗原耐受；末端修饰激活TLR8，唤醒固有免疫。简单说，就是阻断病毒蛋白源头、打破免疫抑制、激活自身清除能力——三路并进实现功能性治愈。临床试验结果显示，在基线乙肝表面抗原≤3000 IU/mL 的适用人群中，24 周完整疗程治疗后功能性治愈率达 19%；在更优质的低抗原人群（≤1000 IU/mL）中，治愈率提升至 26%，安慰剂组无治愈案例。值得关注的是，试验中国亚组数据表现更优，优势人群功能性治愈率可达 35%。安全性方面，以注射部位反应、一过性肝酶升高为主，无新信号。该药物采用每周一次皮下注射、24 周固定疗程的治疗方案，无需终身服药，极大改善患者长期治疗依从性。但必须说明的是，目前贝普若韦生获批的适用人群为核苷类似物经治+HBsAg≤3000、无肝硬化患者，高抗原活动期患者、未治初治者暂不在内。贝普若韦生已提交中国上市申请并获得优先审评资格，正大天晴持有国内独家商业化权益，行业普遍预测2027年上半年国内获批。美国FDA将于2026年10月完成审评，该药即将实现全球多地同步上市。在研管线：小核酸领跑，多机制分层竞速贝普若韦生把赛道“对照基准”提到了19%—26%。全球在研170余条管线中，中国占近60%，进度呈清晰阶梯： · ASO方阵：浩博医药AHB-137IIa期显示基线HBsAg 100-1000 IU/mL的NAs经治人群经24周单药治疗且停药后48周临床治愈率达30%。目前Ⅲ期入组以完成，治疗效果待持续验证。 · siRNA方阵：恒瑞HRS-5635（GalNAc-siRNA）2026年7月启动Ⅲ期（540例HBeAg阴性经治），为全球首个进入Ⅲ期的乙肝siRNA药物；瑞博RBD1016、舶望BW-20507、星曜坤泽HT-101（联用HT-102单抗）、正大天晴TQA3038处于Ⅱ期；海外Vir/Alnylam VIR-2218、Arbutus AB-729、GSK/JNJ-3989做序贯联用探索。 · 非小核酸路径：广生堂GST-HG141（衣壳抑制剂）Ⅲ期、远大赛威信TVAX-008（治疗性疫苗）Ⅲ期首例入组；腾盛博药Elebsiran+PEG-IFNα+BRII-179序贯Ⅱ期治愈率25.8%，抗-HBs应答人群36.8%。目前，国产管线多处于临床中后期，亮眼的 II 期数据仍需在大规模 III 期试验中持续兑现，且多为单区试验，相较起贝普若韦生的全球多中心 III 期临床证据仍有差距。从研发趋势来看，“Nas（核苷酸类似物）压制+小核酸降抗原+干扰素/疫苗免疫巩固”三步联用是通向更高治愈率的必然架构。市场重构：从百亿存量博弈到千亿治愈增量中康开思CHIS数据显示，2025 年中国整体肝炎治疗用药市场约 147亿元，同比增长7.9%，等级医院销售额同比增长13.5%，市场权重从57%升至60%，贡献了增量市场的主要部分。普华有策预测，我国乙肝药物市场2034年将增长至770.4亿元。图1 2024-2025肝炎治疗用药市场多渠道占比数据来源：中康开思CHIS 市场内部品种结构分化显著，化学药和生物制品占据七成以上份额；以聚乙二醇干扰素α2b、丙酚替诺福韦和艾米替诺福韦为代表的生物药/创新药同比增长超20%，成为驱动市场增长的动力；传统大品种如恩替卡韦则面临规模收缩压力。从价格来看，乙肝常用药物除恩替卡韦外单价均超百元，由于乙肝用药长处方的特点，叠加定期检测等费用，经医保报销后每年治疗费用仍可达3000-20000元/人。表1 2025年肝炎治疗用药TOP5品种市场表现数据来源：中康开思CHIS 因此，定价成为贝普若韦生能否惠及患者的关键因素。目前贝普若韦生的官方定价尚未公布，据行业内推测，若贝普若韦生在国内上市，初期无医保加持下完整疗程自费可能达30 万 - 40 万元，若能纳入国家医保，疗程费用有望降至10 万 - 15 万元，经医保报销后有望低至5万以下。相较于终身服用、常年累积的传统药物费用，治愈型疗法具备长期成本优势，但短期单次治疗费用仍高于大众预期，未来需依托医保、惠民保、患者援助项目构建多层次支付体系，降低患者负担。贝普若韦生入局后，结合正大天晴多年深耕肝病用药市场的渠道和资源优势，有望激活需求增量。2020年第四次全国乙肝血清流行病学调查数据显示，我国7500万乙肝病毒感染者中，已确诊且符合抗病毒治疗指征的人群中仅17.33%（约300万人）正在接受抗病毒治疗的数据，推测未来乙肝治疗药物市场规模有望突破千亿。整体而言，GSK 新药的获批，正式宣告全球乙肝功能性治愈时代来临，乙肝治疗用药市场格局将面临重构。国产药企唯有依托更优的给药方案、更可控的安全性、更亲民的定价体系，才能抓住市场机遇，为千万慢乙肝患者带来福祉。参考资料：网络公开信息，包括新闻资讯、企业官网、政府文件等。精彩回顾：医保“十五五”规划出炉：“双轮驱动”重构创新药支付路径 DRG/DIP 3.0 改革纵深推进：“同病同付”破局支付壁垒，“药随病走”补齐基层用药短板谁是2026上半年全球最强药企？原研复活赛，10款原研药刷新纪录：第12批集采中选结果公布点击关注新康界，获取更多热点分析/行研报告/蓝皮书。【免责声明】 1.“新康界”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。 2.“新康界”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。 3.“新康界”所有信息仅供参考，不做任何商业交易及或医疗服务的根据，如自行使用“新康界”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。 4.本声明未涉及的问题参见国家有关法律法规，当本声明与国家法律法规冲突时，以国家法律法规为准。

2026-08-26

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一针改写乙肝历史：全球首款功能性治愈药重构治疗格局

2026年8月24日，葛兰素史克（GSK）反义寡核苷酸（ASO）药物贝普若韦生（Bepirovirsen，商品名 Hibsago）在日本获批上市，用于核苷（酸）类似物经治、HBsAg≤3000 IU/mL的成人慢性乙肝功能性治愈。这是全球首个获批的乙肝功能性治愈疗法，标志着全球乙肝治疗正式从“终身抑制”迈入“有限疗程治愈”的全新阶段。我国是乙肝高发大国，存量乙肝病毒感染者约 7500 万。长期以来，核苷酸类似物能有效抑制病毒复制，却无法清除病毒、实现表面抗原转阴，患者需终身用药，肝硬化与肝癌远期风险无法根除。功能性治愈——即停药后HBsAg持续转阴、病毒DNA持续阴性——正是千万患者的核心诉求。三管齐下：中国亚组疗效更优贝普若韦生由GSK与Ionis联合开发，通过ASO序列互补结合HBV pgRNA与mRNA，经RNase H降解阻断病毒蛋白合成；同步压低血清HBsAg，解除病毒对T细胞、NK细胞的抗原耐受；末端修饰激活TLR8，唤醒固有免疫。简单说，就是阻断病毒蛋白源头、打破免疫抑制、激活自身清除能力——三路并进实现功能性治愈。临床试验结果显示，在基线乙肝表面抗原≤3000 IU/mL 的适用人群中，24 周完整疗程治疗后功能性治愈率达 19%；在更优质的低抗原人群（≤1000 IU/mL）中，治愈率提升至 26%，安慰剂组无治愈案例。值得关注的是，试验中国亚组数据表现更优，优势人群功能性治愈率可达 35%。安全性方面，以注射部位反应、一过性肝酶升高为主，无新信号。该药物采用每周一次皮下注射、24 周固定疗程的治疗方案，无需终身服药，极大改善患者长期治疗依从性。但必须说明的是，目前贝普若韦生获批的适用人群为核苷类似物经治+HBsAg≤3000、无肝硬化患者，高抗原活动期患者、未治初治者暂不在内。贝普若韦生已提交中国上市申请并获得优先审评资格，正大天晴持有国内独家商业化权益，行业普遍预测2027年上半年国内获批。美国FDA将于2026年10月完成审评，该药即将实现全球多地同步上市。在研管线：小核酸领跑，多机制分层竞速贝普若韦生把赛道“对照基准”提到了19%—26%。全球在研170余条管线中，中国占近60%，进度呈清晰阶梯：· ASO方阵：浩博医药AHB-137IIa期显示基线HBsAg 100-1000 IU/mL的NAs经治人群经24周单药治疗且停药后48周临床治愈率达30%。目前Ⅲ期入组以完成，治疗效果待持续验证。· siRNA方阵：恒瑞HRS-5635（GalNAc-siRNA）2026年7月启动Ⅲ期（540例HBeAg阴性经治），为全球首个进入Ⅲ期的乙肝siRNA药物；瑞博RBD1016、舶望BW-20507、星曜坤泽HT-101（联用HT-102单抗）、正大天晴TQA3038处于Ⅱ期；海外Vir/Alnylam VIR-2218、Arbutus AB-729、GSK/JNJ-3989做序贯联用探索。 · 非小核酸路径：广生堂GST-HG141（衣壳抑制剂）Ⅲ期、远大赛威信TVAX-008（治疗性疫苗）Ⅲ期首例入组；腾盛博药Elebsiran+PEG-IFNα+BRII-179序贯Ⅱ期治愈率25.8%，抗-HBs应答人群36.8%。目前，国产管线多处于临床中后期，亮眼的 II 期数据仍需在大规模 III 期试验中持续兑现，且多为单区试验，相较起贝普若韦生的全球多中心 III 期临床证据仍有差距。从研发趋势来看，“Nas（核苷酸类似物）压制+小核酸降抗原+干扰素/疫苗免疫巩固”三步联用是通向更高治愈率的必然架构。市场重构：从百亿存量博弈到千亿治愈增量中康开思CHIS数据显示，2025 年中国整体肝炎治疗用药市场约 147亿元，同比增长7.9%，等级医院销售额同比增长13.5%，市场权重从57%升至60%，贡献了增量市场的主要部分。普华有策预测，我国乙肝药物市场2034年将增长至770.4亿元。图1 2024-2025肝炎治疗用药市场多渠道占比数据来源：中康开思CHIS市场内部品种结构分化显著，化学药和生物制品占据七成以上份额；以聚乙二醇干扰素α2b、丙酚替诺福韦和艾米替诺福韦为代表的生物药/创新药同比增长超20%，成为驱动市场增长的动力；传统大品种如恩替卡韦则面临规模收缩压力。从价格来看，乙肝常用药物除恩替卡韦外单价均超百元，由于乙肝用药长处方的特点，叠加定期检测等费用，经医保报销后每年治疗费用仍可达3000-20000元/人。表1 2025年肝炎治疗用药TOP5品种市场表现数据来源：中康开思CHIS因此，定价成为贝普若韦生能否惠及患者的关键因素。目前贝普若韦生的官方定价尚未公布，据行业内推测，若贝普若韦生在国内上市，初期无医保加持下完整疗程自费可能达30 万 - 40 万元，若能纳入国家医保，疗程费用有望降至10 万 - 15 万元，经医保报销后有望低至5万以下。相较于终身服用、常年累积的传统药物费用，治愈型疗法具备长期成本优势，但短期单次治疗费用仍高于大众预期，未来需依托医保、惠民保、患者援助项目构建多层次支付体系，降低患者负担。贝普若韦生入局后，结合正大天晴多年深耕肝病用药市场的渠道和资源优势，有望激活需求增量。2020年第四次全国乙肝血清流行病学调查数据显示，我国7500万乙肝病毒感染者中，已确诊且符合抗病毒治疗指征的人群中仅17.33%（约300万人）正在接受抗病毒治疗的数据，推测未来乙肝治疗药物市场规模有望突破千亿。整体而言，GSK 新药的获批，正式宣告全球乙肝功能性治愈时代来临，乙肝治疗用药市场格局将面临重构。国产药企唯有依托更优的给药方案、更可控的安全性、更亲民的定价体系，才能抓住市场机遇，为千万慢乙肝患者带来福祉。参考资料：网络公开信息，包括新闻资讯、企业官网、政府文件等。【免责声明】

2026-08-26

·QQ浏览器

一针改写乙肝历史：全球首款功能性治愈药重构治疗格局

2026年8月24日，葛兰素史克（GSK）反义寡核苷酸（ASO）药物贝普若韦生（Bepirovirsen，商品名 Hibsago）在日本获批上市，用于核苷（酸）类似物经治、HBsAg≤3000 IU/mL的成人慢性乙肝功能性治愈。这是全球首个获批的乙肝功能性治愈疗法，标志着全球乙肝治疗正式从“终身抑制”迈入“有限疗程治愈”的全新阶段。我国是乙肝高发大国，存量乙肝病毒感染者约 7500 万。长期以来，核苷酸类似物能有效抑制病毒复制，却无法清除病毒、实现表面抗原转阴，患者需终身用药，肝硬化与肝癌远期风险无法根除。功能性治愈——即停药后HBsAg持续转阴、病毒DNA持续阴性——正是千万患者的核心诉求。三管齐下：中国亚组疗效更优贝普若韦生由GSK与Ionis联合开发，通过ASO序列互补结合HBV pgRNA与mRNA，经RNase H降解阻断病毒蛋白合成；同步压低血清HBsAg，解除病毒对T细胞、NK细胞的抗原耐受；末端修饰激活TLR8，唤醒固有免疫。简单说，就是阻断病毒蛋白源头、打破免疫抑制、激活自身清除能力——三路并进实现功能性治愈。临床试验结果显示，在基线乙肝表面抗原≤3000 IU/mL 的适用人群中，24 周完整疗程治疗后功能性治愈率达 19%；在更优质的低抗原人群（≤1000 IU/mL）中，治愈率提升至 26%，安慰剂组无治愈案例。值得关注的是，试验中国亚组数据表现更优，优势人群功能性治愈率可达 35%。安全性方面，以注射部位反应、一过性肝酶升高为主，无新信号。该药物采用每周一次皮下注射、24 周固定疗程的治疗方案，无需终身服药，极大改善患者长期治疗依从性。但必须说明的是，目前贝普若韦生获批的适用人群为核苷类似物经治+HBsAg≤3000、无肝硬化患者，高抗原活动期患者、未治初治者暂不在内。贝普若韦生已提交中国上市申请并获得优先审评资格，正大天晴持有国内独家商业化权益，行业普遍预测2027年上半年国内获批。美国FDA将于2026年10月完成审评，该药即将实现全球多地同步上市。在研管线：小核酸领跑，多机制分层竞速贝普若韦生把赛道“对照基准”提到了19%—26%。全球在研170余条管线中，中国占近60%，进度呈清晰阶梯：· ASO方阵：浩博医药AHB-137IIa期显示基线HBsAg 100-1000 IU/mL的NAs经治人群经24周单药治疗且停药后48周临床治愈率达30%。目前Ⅲ期入组以完成，治疗效果待持续验证。· siRNA方阵：恒瑞HRS-5635（GalNAc-siRNA）2026年7月启动Ⅲ期（540例HBeAg阴性经治），为全球首个进入Ⅲ期的乙肝siRNA药物；瑞博RBD1016、舶望BW-20507、星曜坤泽HT-101（联用HT-102单抗）、正大天晴TQA3038处于Ⅱ期；海外Vir/Alnylam VIR-2218、Arbutus AB-729、GSK/JNJ-3989做序贯联用探索。 · 非小核酸路径：广生堂GST-HG141（衣壳抑制剂）Ⅲ期、远大赛威信TVAX-008（治疗性疫苗）Ⅲ期首例入组；腾盛博药Elebsiran+PEG-IFNα+BRII-179序贯Ⅱ期治愈率25.8%，抗-HBs应答人群36.8%。目前，国产管线多处于临床中后期，亮眼的 II 期数据仍需在大规模 III 期试验中持续兑现，且多为单区试验，相较起贝普若韦生的全球多中心 III 期临床证据仍有差距。从研发趋势来看，“Nas（核苷酸类似物）压制+小核酸降抗原+干扰素/疫苗免疫巩固”三步联用是通向更高治愈率的必然架构。市场重构：从百亿存量博弈到千亿治愈增量中康开思CHIS数据显示，2025 年中国整体肝炎治疗用药市场约 147亿元，同比增长7.9%，等级医院销售额同比增长13.5%，市场权重从57%升至60%，贡献了增量市场的主要部分。普华有策预测，我国乙肝药物市场2034年将增长至770.4亿元。图1 2024-2025肝炎治疗用药市场多渠道占比数据来源：中康开思CHIS市场内部品种结构分化显著，化学药和生物制品占据七成以上份额；以聚乙二醇干扰素α2b、丙酚替诺福韦和艾米替诺福韦为代表的生物药/创新药同比增长超20%，成为驱动市场增长的动力；传统大品种如恩替卡韦则面临规模收缩压力。从价格来看，乙肝常用药物除恩替卡韦外单价均超百元，由于乙肝用药长处方的特点，叠加定期检测等费用，经医保报销后每年治疗费用仍可达3000-20000元/人。表1 2025年肝炎治疗用药TOP5品种市场表现数据来源：中康开思CHIS因此，定价成为贝普若韦生能否惠及患者的关键因素。目前贝普若韦生的官方定价尚未公布，据行业内推测，若贝普若韦生在国内上市，初期无医保加持下完整疗程自费可能达30 万 - 40 万元，若能纳入国家医保，疗程费用有望降至10 万 - 15 万元，经医保报销后有望低至5万以下。相较于终身服用、常年累积的传统药物费用，治愈型疗法具备长期成本优势，但短期单次治疗费用仍高于大众预期，未来需依托医保、惠民保、患者援助项目构建多层次支付体系，降低患者负担。贝普若韦生入局后，结合正大天晴多年深耕肝病用药市场的渠道和资源优势，有望激活需求增量。2020年第四次全国乙肝血清流行病学调查数据显示，我国7500万乙肝病毒感染者中，已确诊且符合抗病毒治疗指征的人群中仅17.33%（约300万人）正在接受抗病毒治疗的数据，推测未来乙肝治疗药物市场规模有望突破千亿。整体而言，GSK 新药的获批，正式宣告全球乙肝功能性治愈时代来临，乙肝治疗用药市场格局将面临重构。国产药企唯有依托更优的给药方案、更可控的安全性、更亲民的定价体系，才能抓住市场机遇，为千万慢乙肝患者带来福祉。参考资料：网络公开信息，包括新闻资讯、企业官网、政府文件等。【免责声明】

100 项与 Imdusiran 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
慢性乙型肝炎	临床2期	澳大利亚	Assembly Biosciences, Inc.	2021-05-07
慢性乙型肝炎	临床2期	保加利亚	Assembly Biosciences, Inc.	2021-05-07
慢性乙型肝炎	临床2期	加拿大	Assembly Biosciences, Inc.	2021-05-07
慢性乙型肝炎	临床2期	新西兰	Assembly Biosciences, Inc.	2021-05-07
乙型肝炎	临床申请	中国	齐鲁制药有限公司	2022-05-10
乙型肝炎	临床申请	中国	Arbutus Biopharma Corp.	2022-05-10

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适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04980482 (AB-729-201, CTgov)	临床2期	慢性乙型肝炎	43	imdusiran (Lead-In Treatment)	顧鬱鏇窪繭廠襯觸壓積 = 簾蓋衊糧衊積觸壓壓衊壓構網願蓋製憲齋蓋構 (顧襯鑰廠鹹範鏇窪築膚, 構醖醖窪選壓顧蓋壓選 ~ 觸遞艱衊繭夢糧網夢窪) 更多	-	2026-04-29
				Peg-IFNα-2a+AB-729 (Cohort A1)	顧鬱鏇窪繭廠襯觸壓積 = 憲觸觸衊構鹽衊淵築淵壓構網願蓋製憲齋蓋構 (顧襯鑰廠鹹範鏇窪築膚, 襯遞廠鹹簾選膚淵壓範 ~ 構蓋簾獵餘願糧窪觸構) 更多
ACTRN12622000317796 (IM-PROVE II \| AB-729-202, Company_Website) 人工标引	临床2期	乙型肝炎	62	imdusiran + VTP-300	膚糧範獵夢構簾衊淵鹹(鏇齋艱淵願蓋淵齋願餘) = 艱壓膚餘簾選繭選憲鑰繭膚鏇艱鑰築積窪襯鑰 (襯構選夢憲網蓋鬱鑰繭 )	积极	2025-05-07
				imdusiran + VTP-300 + nivolumab	膚糧範獵夢構簾衊淵鹹(鏇齋艱淵願蓋淵齋願餘) = 糧夢築齋顧顧顧繭憲齋繭膚鏇艱鑰築積窪襯鑰 (襯構選夢憲網蓋鬱鑰繭 ) 更多
ACTRN12622000317796 (IM-PROVE II \| AB-729-202, GlobeNewswire) 人工标引	临床2期	慢性乙型肝炎	22	Imdusiran, VTP-300, low-dose nivolumab	齋觸鹹構餘獵繭夢憲淵(選廠簾壓顧鬱鬱網廠觸) = 鏇鑰築觸簾憲觸淵齋襯繭鏇鹽構夢餘網壓窪鏇 (膚鏇簾願蓋築願糧夢糧 )	积极	2024-11-15
NCT04980482 (AB-729-201, EASL2024) 人工标引	临床2期	慢性乙型肝炎	43	imdusiran (A1: 24 wks IFN + 2 imdusiran doses + NA)	壓簾網獵觸遞艱糧選鏇(獵淵壓壓願構廠網衊夢) = 膚醖淵鹹鹽獵範鹽鏇範衊齋顧積憲鬱艱鏇淵遞 (獵積艱齋網壓網艱製壓 ) 更多	积极	2024-06-01
				imdusiran (A2: 24 wks IFN + NA)	壓簾網獵觸遞艱糧選鏇(獵淵壓壓願構廠網衊夢) = 蓋觸鏇鑰糧觸範網鹹淵衊齋顧積憲鬱艱鏇淵遞 (獵積艱齋網壓網艱製壓 ) 更多
NCT04820686 (AB-729-001, CTgov)	临床2期	慢性乙型肝炎	65	tenofovir+Entecavir+AB-729+VBR (VBR + AB-729 + SOC NrtI)	衊醖鑰網鬱窪獵齋製衊 = 選憲構衊簾淵醖觸範獵蓋蓋鹹廠醖選遞鹽構鏇 (鬱遞製壓獵夢繭夢糧鏇, 鏇醖顧餘襯夢積壓築膚 ~ 憲憲醖膚糧夢鑰鹹鹹顧) 更多	-	2023-11-14
				tenofovir+Entecavir+VBR (VBR + SOC NrtI)	衊醖鑰網鬱窪獵齋製衊 = 夢餘構艱鑰選鏇蓋願顧蓋蓋鹹廠醖選遞鹽構鏇 (鬱遞製壓獵夢繭夢糧鏇, 範窪觸顧襯鏇願夢積襯 ~ 鑰膚範觸艱鹹淵獵積觸) 更多
ACTRN12622000317796 (AB-729-202, GlobeNewswire) 人工标引	临床2期	乙型肝炎	40	imdusilan+VTP-300	齋鬱鬱鏇壓憲艱壓壓積(積鬱廠築獵夢夢鹽憲繭) = There were no serious adverse events, Grade 3 or 4 adverse events or treatment discontinuations. 膚築淵製繭廠襯鏇範壓 (鹽簾築構艱醖顧齋簾築 ) 更多	积极	2023-11-09
				imdusilan+placebo
Phase 2a (EASL2022)	临床2期	HBV RNA transcripts \| HBV DNA \| hepatitis B surface antigen (HBsAg)	-	AB-729 siRNA	淵願獵齋鑰構膚範糧積(鹽繭糧網獵鏇艱鹹鹹顧) = 顧鬱鏇鏇襯製鏇獵範衊廠鹹襯蓋齋齋蓋獵鹹願 (顧觸鏇製繭醖淵鑰壓憲 )	积极	2022-06-25
				Control GalNAc siRNA	淵願獵齋鑰構膚範糧積(鹽繭糧網獵鏇艱鹹鹹顧) = 醖鑰構餘鏇獵衊襯壓簾廠鹹襯蓋齋齋蓋獵鹹願 (顧觸鏇製繭醖淵鑰壓憲 )
NCT04820686 (AB-729-001, EASL 12022 \| EASL 22022) 人工标引	临床2期	慢性乙型肝炎	27	AB-729	餘構製鹽壓襯鬱鬱網廠(窪窪餘顧獵蓋餘淵餘觸) = 顧顧鬱觸選鑰憲蓋糧餘鬱醖糧壓遞顧製壓鏇繭 (廠艱鹽衊淵憲鬱餘鑰顧 )	积极	2022-06-22