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更新于：2025-10-22

Imdusiran

更新于：2025-10-22

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)

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

齐鲁制药有限公司

Arbutus Biopharma Corp.

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-

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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。

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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

/ Active, not recruiting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）

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.

AIDS reviews4区 · 医学

Hepatitis B Gene Therapy Coming to Age.

4区 · 医学

Review

作者: Soriano, Vicente

The major pandemics caused by chronic viral infections is produced by HIV, hepatitis C virus (HCV), and hepatitis B virus (HBV), with estimates of 38, 70, and 250 million people worldwide, respectively (Fig. 1). During the last couple of years, the advent of direct oral antivirals has allowed pursuing global HCV eradication. In an unprecedented manner, these drugs cure more than 95% of hepatitis C patients when given for only 2-3 months. The enthusiasm on HCV has renewed the interest for curative strategies for both HIV and HBV. However, important biological differences between all three viruses may preclude envisioning a similar rapid success for either HIV or HBV than for HCV infection. As shown in figure 1, once infection of targeted cells has occurred, the viral genetic material only replicates in the cytosol for HCV whereas it enters the nucleus and integrates into the chromosomes as provirus for HIV or is converted in a circular covalently closed form (cccDNA) for HBV (Fig. 1). Blocking viral nucleic acid replication for a minimum lag of time allows definitive clearance of HCV infection, with degradation of residual cytoplasmic HCV-RNA strands. In contrast, blocking viral replication has only a transient effect on HIV or HBV, as mRNA expression resumes following treatment discontinuation, given the stability of the HIV provirus or the HBV cccDNA, respectively. The European Liver meeting took held in Paris on April 2018. A relatively large number of presentations addressed distinct new hepatitis B therapeutic strategies. Table 1 summarizes some of the molecules that have been investigated so far with more promising results, grouping them into distinct drug classes (Soriano et al. Exp Op Inv Drugs 2017;26:843-51), based on their distinct mechanism of action and targeted steps in the HBV life cycle (Fig. 2). Considering the pros and cons of novel HBV therapeutic candidates, it has become apparent new HBV gene therapies among the most attractive. Several advances have contributed to position gene therapy in front within the experimental HBV armamentarium. First, progresses in delivery systems, including the use of polymers and nanoformulations have allowed developing easier forms of administration that now are becoming subcutaneous and monthly. Second, the synthetic production of oligonucleotide formulations has reduced costs. Third, the specificity against HBV is higher than for other experimental agents, as immune modulators that enhance innate immunity, such as TLR agonists (i.e., GS-9620) or checkpoint inhibitors (i.e., nivolumab). Fourth, significant declines in serum hepatitis B surface antigen (HBsAg) are demonstrated during gene therapy, which have never been seen using the most potent polymerase inhibitors (i.e., tenofovir or entecavir). Finally, unanticipated significant reductions in cccDNA are seen with HBV gene therapy, most likely as prove of an indirect benefit of waning the immunosuppressive effect of large over amounts of HBsAg released by infected hepatocytes that contributes to T-cell exhaustion. In a pioneering study, Roche was the first to publish the potent effect of an oral small molecule that blocked HBV gene expression (Mueller et al. J Hepatol 2018;68:412-20). The drug belonged to the dihydroquinolizinone class, and directly or indirectly modified viral RNAs, promoting their degradation. This posttranscriptional silencing was accompanied by rapid drops in HBV-DNA and more importantly in serum HBsAg in the humanized mice. However, Roche decided to discontinue any further clinical development of the drug. Nowadays, two major groups of agents are being developed as HBV gene therapies. At this time, interference RNA (iRNA) molecules and nucleic acid polymers (NAPs) are the most promising. Overall, iRNA is double-stranded RNA molecules, 20 nucleotides long. One strand matches a segment of specific HBV mRNA and induces its degradation. Several iRNA molecules have entered into Phase II clinical trials (Flisiak et al. Exp Op Biol Ther, in press), including ARB-1467 and AB-729 (Arbutus), ARO-HBV (Arrowhead), ALN-HBV (Alnylam), and IONIS-HBVRx (Ionis). In most cases, they are tested as part of combination therapy with nucleos(t)ide analogs and/or peginterferon. NAPs are phosphorothioate 40 length oligonucleotides that no map any HBV sequence. However, they interact with a liver host target protein (apolipoprotein-like) and result in specific inhibition of HBV mRNAs. This is followed by rapid suppression of HBsAg release (Roehl et al. Mol Ther Nuc Acids 2017;8:1-12). In a pilot study with intravenous REP-2139, investigators from Replicor demonstrated strong reductions in HBV-DNA along with significant drops in HBsAg and seroconversion in some patients. More interestingly was the recognition of significant reductions in hepatic cccDNA, most likely a result of an indirect effect following the removal of large amounts of HBsAg from the bloodstream that contributes to impaired T-cell responses in chronic hepatitis B patients (Bazinet et al. EASL, Paris 2018; abstract FRI-343). An improved NAP, named REP-2165 and subcutaneous administration are currently being tested.

153

项与 Imdusiran 相关的新闻（医药）

2025-10-07

·GlobeNewswire-Health Care

Arbutus Announces Four Abstracts Accepted for Presentation at AASLD - The Liver Meeting® 2025

Multiple abstracts accepted featuring imdusiran clinical data – highlighting progress toward a potential functional cure for chronic hepatitis B virus AB-101 clinical data abstract recognized as a Poster of Distinction WARMINSTER, Pa., Oct. 07, 2025 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company focused on infectious disease, today announced that three abstracts featuring imdusiran data and one abstract featuring AB-101 data, have been accepted for poster presentations at the American Association for the Study of Liver Diseases (“AASLD”) – The Liver Meeting 2025, taking place November 7–11 in Washington, DC. Notably, the AB-101 abstract has been selected as a Poster of Distinction. Regular Abstracts Accepted as Poster Presentations: Publication Number: 1160Presentation Title: Imdusiran (AB-729) is safe and well-tolerated after repeat dosing in chronic hepatitis B patients: An integrated safety analysis of Phase 1 and 2 imdusiran clinical trialsPresenter: Tilly Varughese, MD, Medical Director, Clinical Development, Arbutus BiopharmaDate and Time: November 7, 2025, 8:00 am - 5:00 pm ETKey Findings: Imdusiran therapy in patients with chronic hepatitis B virus (“cHBV”) was safe and well tolerated when administered at both 60 mg and 90 mg dose levels every 8 weeks for 4 – 6 doses (24 – 48 weeks) and through up to 48 weeks of follow up after imdusiran dosing. Publication Number: 1244Presentation Title: IM-PROVE I: Hepatitis B virus (“HBV”) genotype responsiveness to pegylated interferon alfa-2a may be enhanced with imdusiran combination treatmentPresenter: Emily Thi, Senior Director, Immunobiology and Biomarkers Research, Arbutus BiopharmaDate and Time: November 7, 2025, 8:00 am - 5:00 pm ETKey Findings: In this limited dataset, the majority of subjects who achieved HBsAg response during pegylated interferon alfa-2a (“IFN”) treatment with or following imdusiran dosing were genotype B or C. These findings contrast with historical data from IFN therapy and suggest that imdusiran may enhance IFN responsiveness in cHBV patients with specific HBV genotypes. Further studies in larger cohorts are warranted to confirm these observations. Publication Number: 1184Presentation Title: Elevated soluble immune biomarkers in subjects with HBsAg loss after treatment with imdusiran and immunotherapeutic agents in the IM-PROVE I and IM-PROVE II studies Presenter: Emily Thi, Senior Director, Immunobiology and Biomarkers Research, Arbutus BiopharmaDate and Time: November 7, 2025, 8:00 am - 5:00 pm ETKey Findings: Imdusiran treatment is associated with increases in soluble immune biomarkers in both IM-PROVE I and IM-PROVE II studies. In subjects who lost HBsAg and had anti-HBs antibodies, a greater breadth and magnitude of immune biomarker increases were observed in IM-PROVE I subjects compared to IM-PROVE II. In both studies, subjects who showed increases in soluble immune biomarkers on-treatment met nucleos(t)ide analogue (“NA”) therapy discontinuation criteria and had baseline HBsAg ≤1000 IU/mL. Poster of DistinctionPublication Number: 1123Presentation Title: Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of AB-101, a small-molecule PD-L1 inhibitor, in chronic hepatitis B patientsPresenter: Tilly Varughese, MD, Medical Director, Clinical Development, Arbutus BiopharmaDate and Time: November 7, 2025, 8:00 am - 5:00 pm ET. The poster will remain available for the full duration of the conference.Key Findings: Oral doses of AB-101 up to 30 mg QD for 28 days were generally well tolerated in NA-suppressed cHBV patients. Preliminary interim pharmacodynamic data indicate dose-related increases in PD-L1 receptor occupancy, with 83% mean maximal receptor occupancy at the 30 mg dose. Cohort 3B is ongoing and all available data, including safety, PK, receptor occupancy and HBV biomarkers, will be presented. The regular accepted abstracts are available to the public on the AASLD website and will be published in the October supplement of HEPATOLOGY. The poster presentations will be available on the AASLD website beginning November 7, 2025 at 8:00 am ET and will also be found on Arbutus’ website in the Publications section at https://www.arbutusbio.com/publications/. About Imdusiran (AB-729) Imdusiran is an RNAi therapeutic specifically designed to reduce all hepatitis B viral proteins and antigens including HBsAg, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to control the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (“GalNAc”) delivery technology enabling subcutaneous delivery. To date, Arbutus has reported a total of eight patients with cHBV who have achieved a functional cure following treatment with imdusiran and NA therapy in combination with either IFN or low dose nivolumab plus an immunotherapeutic. Clinical data generated thus far has shown imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in HBsAg and hepatitis B virus DNA. About AB-101 AB-101 is an oral PD-L1 inhibitor candidate that is designed to allow for controlled checkpoint blockade while minimizing the systemic safety issues typically seen with checkpoint antibody therapies. Immune checkpoints such as PD-1/PD-L1 play an important role in the induction and maintenance of immune tolerance and in T-cell activation, for example against HBV. In Arbutus’ ongoing Phase 1a/1b clinical trial, AB-101 has been generally safe and well-tolerated with evidence of high receptor occupancy. About HBV Hepatitis B is a potentially life-threatening liver infection caused by HBV. HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. cHBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from cHBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from cHBV infection. Approximately 1.1 million people die every year from complications related to cHBV infection despite the availability of effective vaccines and current treatment options. About Arbutus Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company focused on infectious disease. The Company is currently developing imdusiran (AB-729) and an oral PD-L1 inhibitor (AB-101) for the treatment of cHBV infection. The Company is also consulting closely with and supporting its exclusive licensee, Genevant Sciences, to protect and defend its intellectual property, which is the subject of on-going lawsuits against Moderna and Pfizer/BioNTech for use of Arbutus’s patented LNP technology in their COVID-19 vaccines. For more information, visit www.arbutusbio.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include statements about: the potential to lead to a functional cure for HBV; the potential for Arbutus’ product candidates to achieve success in clinical trials; and Arbutus’ pipeline and development plans for its cHBV programs. With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of clinical trials, and the usefulness of the data; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies. Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: ongoing and anticipated clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested product candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ product candidates; economic and market conditions may worsen; and market shifts may require a change in strategic focus. A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law. Contact: Arbutus Biopharma Corporation / ir@arbutusbio.com

临床结果疫苗临床研究免疫疗法

2025-09-04

·研发客

中国小核酸药物赛道崛起，这些黑马公司值得关注

Citeline首席分析师周淑华发言圆桌现场研发客主编毛冬蕾与张江全互动张金晶威斯津生物合伙人商务发展总监李安康腾盛博药CFO 尹思远传信生物首席运营官王松立星核迪赛研发总监陈进维亚臻生物临床药理&转化医学副总裁高璐圆因生物CEO 张震徕博科亚太商务开发高级总监 Simon Yu 徕博科中国中心实验室运营总监研讨会现场图片分享舶望制药近日与诺华制药就4款小核酸药物达成1.6亿美元预付款的消息，再次证明小核酸药物成为备受关注的热门赛道。全球众多企业布局，中国一批“黑马”公司正凭借独特的技术平台和差异化的管线布局悄然崭露头角。在由研发客与徕博科联合举办的“中国分子，世界引擎”研讨会上，该领域的发展前景成为焦点。拓展阅读舶望再度授权诺华siRNA药物，总交易价值达52亿美元！李勇：在心血管疾病领域前景广阔复旦大学华山医院心脏科李勇教授认为，小核酸药物在心血管疾病防治领域正展现出较大潜力。英克司兰（Inclisiran）的成功获批，验证了这一领域的重要性。小核酸药物在递送系统方面取得了进展。除了目前已经广泛应用的肝细胞递送系统外，通过优化递送载体，科学家已实现了对卵巢细胞、肾脏细胞及脑细胞的有效靶向递送。李勇教授认为，针对脑细胞的靶向递送技术有望在短期取得突破，这为小核酸药物在心血管神经系统疾病的应用提供了可能。复旦大学华山医院心脏科李勇教授心血管疾病如高血压、血脂异常和糖尿病等，多为慢性病，不仅在中国，在全球也有数以亿计的大量患者，而且需要长期维持治疗。李勇教授指出：“糖尿病患者中45%的死亡与心血管疾病相关，而非高血糖本身。慢性肾脏病患者进入透析后，无论在是否已经接受透析治疗，心血管事件也是其首要死因，占比超40%。近10年来越来越受关注的脂肪肝，已经超越消化系统，与糖尿病及慢性炎症密切关联，也会导致心血管疾病风险增高。因此，维护心血管健康是内科疾病防控预防和管理的关键策略。” “心血管事件链”概念于1991年由美国医学科学院院长魏德照Victor Dzao提出，强调从危险因素发展为冠心病、心衰的连续过程中的全程疾病管理及危险因素控制。李勇教授解释，高血压、糖尿病和血脂异常是三大主要危险因素，它们通过激活体内RAAS、炎症、能量/线粒体代谢等某些系统，促使动脉粥样硬化斑块形成和发展、以及心肌、肾脏、血管的纤维化加速进展。关于高血压，他表示：“高血压不仅造成物理损伤，还会激活某些系统，引起左心室肥厚和舒张功能障碍。中国高血压患者众多，每年约260万人因高血压而此死亡，我国的高血压人口数和死亡人数均居全球之首。目前美国诊断标准为130/80 mmHg，而中国仍采用140/90 mmHg，这在一定程度上影响了防控效果。” 在血脂方面，他说：“LDL-C是动脉粥样硬化的主要致病性危险因素，根据我国著名心血管流行病学家北京安贞医院赵冬教授团队15年的队列研究数据，其升高对心肌梗死风险的贡献达77%。大量随机对照临床试验证实，显著降低LDL-C水平不仅能是防治心血管病的关键，还能降低全因死亡，延长寿命。”对于糖尿病与脂肪肝，他强调这两类患者的心血管风险增加，脂肪肝患者尤其易合并心血管疾病，导致临床结局恶化，建议心血管医生应更多关注这类人群的心血管健康。在血脂管理方面，他特别提到英克司兰（Inclisiran）：“作为一种靶向PCSK9的小干扰RNA药物，英克司兰通过阻断PCSK9与LDL受体的结合，增加肝细胞表面LDL受体的数量，提升肝细胞清除LDL-C的能力，从而降低血中的LDL-C水平。其独特之处在于，一次注射可维持长达6个月的疗效，大大提高了患者的治疗依从性。临床试验表明，英克司兰单药治疗或与他汀联用，均可降低LDL-C幅度高达水平60%，且安全性良好。” 他还介绍了其他小核酸药物的研究进展：“除了英克司兰外，针对甘油三酯（TG）和脂蛋白(a) [Lp(a)]的小核酸药物也展现出广阔的应用前景。例如，针对ApoC-III的小核酸药物Plozasiran、针对ANGPLT-3的Zodasiran可降低TG水平，并减少急性胰腺炎的发作风险；除了Plecarsen外、多个针对Lp(a)的小核酸药物如Olpasiran、Lepodisiran则可降低其水平达90%以上，有望减少心血管事件的发生。” 在强化降压与降脂治疗的临床意义方面，李勇教授表示：“近年来，多项大规模临床试验表明，将血压控制在更低水平（如收缩压<120 mmHg）可降低心血管事件和死亡率。然而，中国的高血压管理目标值仍为140/90 mmHg，这在一定程度上限制了降压治疗的获益。因此，推动高血压管理目标的下调，对于改善中国心血管疾病防治现状具有重要意义。”小核酸药物在降压领域也有明显的进展，Zilebesiran的II期临床试验显示，每6月一次皮下注射，可获得令人相当满意的降压效果，针对高血压患者的心血管结局随机对照临床试验（CVOT）ZENITH研究已经启动。他还强调了早期降脂治疗的重要性：“LDL-C的累积暴露时间与动脉粥样硬化的发展密切相关。因此，越早启动降脂治疗并维持较低水平，对心血管的保护作用越大。小核酸药物的出现，为实现长期、稳定的降脂治疗提供了新的手段。” 最近，Lancet发表了小核酸药物用于治疗脂肪肝的II期临床试验结果，ION224-CS2试验表明，采用肝活检来评估，寡核苷酸制剂抑制DGAT-2，能够有效逆转脂肪肝，安全性良好。展望未来，李勇教授认为小核酸药物在一级预防和多靶点治疗方面具有广阔前景。然而，李勇教授也指出了小核酸药物面临的挑战：例如，如何进一步提高递送效率、降低脱靶效应、优化给药方案等。此外，加强医生和患者对小核酸药物的认知也是推动其应用的关键。最后，他总结道：“小核酸药物为心血管疾病防治带来了新希望。通过不断优化技术、拓展适应症和加强临床应用研究，相信小核酸药物将在未来心血管疾病防治中发挥越来越重要的作用。” 周淑华：全球核酸药物研发持续活跃 Citeline首席分析师周淑华博士介绍了2025年全球核酸药物研发持续活跃的态势。 Citeline首席分析师周淑华博士截至2025年，全球处于活跃开发阶段的药物总数达23,875种，较上一年度增长4.6%，新增药物1,050种，其中4,546种为新加入研发管线的药物。新增药物中，抗癌药占比38.8%，神经系统疾病药物占13.8%。各临床阶段药物数量均增长，Ⅰ期增长6.8%，Ⅱ期增长6.3%，Ⅲ期增长8.8%，临床前研究阶段增长1.8%（低于2024年的5.5%），显示全球研发活跃但临床前研究增速放缓。核酸药物研发管线中，肿瘤学仍是最大治疗领域，2025年有9,746种药物在研，增长3.7%，占所有在研药物的39.7%（略低于2024年的40.1%）。神经系统疾病药物研发增长率低于平均水平（2024-2025年仅增长4.2%）。顶尖企业中，辉瑞重新夺回研发管线规模榜首，罗氏和诺华紧随其后。前十家企业贡献5.4%的在研药物，前25家贡献10.0%，剩余19.4%来自仅有一两种药物在研的公司。疾病聚焦方面，乳腺癌仍是研发重点，管线规模增长9.5%，领先于非小细胞肺癌（NSCLC，增长10.0%）。非癌症领域中，新冠病毒退出前十，阿尔茨海默病仍是唯一进入前十的非肿瘤疾病。肥胖治疗药物研发增长43.3%（受Wegovy和Mounjaro等药物影响）。热门药物蛋白靶点中，免疫疗法（I-O）相关靶点主导，CD3e连续第二年位居榜首，EGFR取代Her-2成为第二位热门靶点（应用于多种癌症治疗）。全球及中国研发合作趋势显示，全球范围内16%的在研药物处于合作研发状态（抗癌药物领域16%，神经系统疾病药物16%，抗感染药物14%，消化/代谢系统疾病药物17%）。2017-2025年,中国合作交易数量和总金额2025年分别达16.4%和33.7%，但首付款比例普遍低于全球水平。 “未来，全球核酸药物研发将持续活跃，中国企业增长势头强劲。中国企业需提升创新效率、加强全球市场洞察、完善内部管理并构建健全的资本体系，以实现可持续发展。”周淑华说。张江全：小核酸药物非临床安全评价要点徕博科中国区早期研发负责人张江全剖析了小核酸药物非临床安全评价要点。在结构与修饰上，siRNA药物可进行多种修饰，这会影响其药代动力学，免疫原性特性和毒性表现，介绍了非临床监管、药代动力学以及免疫原性三个方面的内容。徕博科中国区早期研发负责人张江全小核酸药物的非临床监管主要遵循 ICH M3（R2）原则，标准遗传毒组合试验，一般毒性、DART、致癌性研究使用两种种属，同时需考虑ICH S6 指南部分终点。考虑到siRNA的临床给药周期，重复给药毒性研究周期较长，啮齿类动物 6 个月、非人灵长类 9 个月，对此，多国监管机构有相关原则。在药代动力学方面，siRNA血浆半衰期短，快速被肝脏摄取，导致PK/PD分离现象。siRNA主要分布于肝脏且在肝组织中半衰期较长，肝脏药代动力学和RNA诱导沉默复合体（RISC）药代动力学是决定药效动力学及其持续时间的关键因素。免疫原性的潜在来源包括有序列依赖性免疫激活、递送系统影响等。对于动物研究的毒性特征，包括免疫原性相关毒性，通过非 Toll 样受体途径触发促炎细胞因子释放；杂交依赖性毒性有靶点效应、脱靶效应、RNAi 机制饱和等；递送载体毒性方面，各种载体存在各自不同的毒性特征。此外，张江全还分享了两个案例。一是已报道的SLN360案例，GalNAc结合的siRNA，靶向脂蛋白a mRNA，用于心血管疾病。研究通过GalNAc- 去唾液酸糖蛋白受体（ASGPR）结合实现肝脏特异性递送，旨在降低PLA，进行体外特异性和效力研究、体内生物分布研究（大鼠/食蟹猴）以及29天GLP毒性研究。结果显示，大鼠在不同剂量下，高剂量雌性大鼠体重略有下降，其他方面如食物摄入等无显著变化，观察到的非不良反应在停药8周后可恢复；食蟹猴在不同剂量下，体重等一般观察无SLN360相关影响，无补体激活或细胞因子释放，预期效果良好，非不良反应停药后也可恢复。案例二是AAA（GalNAc结合的siRNA，用于非酒精性脂肪性肝炎（NASH）），研究每月1次皮下注射给大鼠和食蟹猴，持续12周，评估毒性并确定毒代动力学，观察停药12周后的恢复或持续情况。结果表明，系统暴露量与剂量成正比或高于剂量比，无药物蓄积和性别差异，临床观察未观察到AAA相关影响。临床病理主要为肝脏相关指标改变，镜检观察可见肝脏、淋巴结、胸腺、脾脏、肾脏、注射部位等出现色素沉着、空泡化、淋巴细胞减少等改变。所有病理发现均为轻度，认为是non-adverse，因此两个种属的NOAEL均为高剂量。与会者表示这些全面的要点和案例分享，为小核酸药物非临床安全评价领域的研究提供了极具价值的参考。徐中南：正大天晴进军小核酸药物领域正大天晴药业集团的高级临床总监徐中南分享了正大天晴在小核酸药物开发中的技术演进路径，尤其聚焦TQA3038这一创新药的临床开发策略。正大天晴药业集团的高级临床总监徐中南徐中南分析了慢乙肝治疗领域的严峻现状：中国慢乙肝患者诊断率仅22%，治疗率17%，市场需求迫切。尽管已有NUC和IFN等抗病毒药物，但抗病毒时间长、临床治愈率低的问题依旧突出，因此，针对HBV复制环节开发新药成为研究热点。在介绍TQA3038时，徐中南阐述了其作为GalNAc偶联修饰siRNA药物的独特机制：“通过皮下注射特异性靶向HBV ORF-X区，有效抑制HBV复制。GalNAc配体与肝脏细胞的高亲和力和迅速内化能力，确保了siRNA的高效作用。” 临床试验方面，TQA3038一期健康受试者SAD研究共设置了6个剂量组，采用递增剂量设计确保安全。TQA3038给药后快速吸收，血浆浓度约4小时达峰，半衰期8.7至9.34小时，24小时内药物基本消除。6个剂量组安全性良好，未发生严重不良事件。需要重点关注ECG的改变情况。 TQA3038与同靶点药物相比的优势：同剂量下，TQA3038体内抗HBV活性优于Vir-2218，包括HBsAg、HBeAg、HBV RNA的下降比例；与ETV单药组相比，TQA3038和ETV联合给药组对小鼠血浆中HBV DNA的降低更明显。在介绍同靶点药物联合干扰素治疗方案时，他分享了VIR-2218与PEG-IFNα联合治疗的研究成果，显示联合用药的受试者HBsAg下降幅度更大，部分受试者实现HBsAg转阴和血清学转换。同时，他也提及了AB-729与IFN联合治疗的研究进展。针对TQA3038 Ⅱ期研究，评价TQA3038注射液联合NUC治疗经治慢乙肝患者的初步疗效及安全性。研究显示无严重不良事件发生，TQA3038可快速降低HBsAg水平，高剂量组效果更明显。最后，他总结了TQA3038的技术演进路径和临床应用前景。TQA3038用药后在外周血浓度快速下降，48小时后检测不到，且GalNAc-siRNA可在肝脏中蓄积并缓慢释放，单次给药即可维持长期疗效，使其成为慢乙肝治疗领域的潜力创新药物。毕吕存：生物分析策略从方法开发到全球一致性验证徕博科执行总监及中国生物分析与亚太LCMS实验室负责人毕吕存博士探讨了小核酸药物的生物分析策略包括：药代动力学（PK）生物分析策略和生物标志物（BM）生物分析策略。徕博科执行总监及中国生物分析与亚太LCMS实验室负责人毕吕存博士小核酸药物的基本结构是由20至30个核苷酸基团组成的短线性链，通过磷酸二酯键连接，具有强亲水性和高度负电荷性。在生物分析方法上，毕博士展示了定量分析小核酸药物的各技术手段，特别是液相色谱-质谱联用技术（LC-MS/MS）和高分辨率质谱（LC-HRMS）的应用。通过案例研究，可以利用这些技术对小核酸药物及其代谢物进行精确的定量分析。针对小核酸药物的生物标志物分析，毕博士强调了评估药效动力学（PD）标志物或其他测量指标的重要性。小核酸药物在脏器组织中具有很长半衰期，能够保持很长疗效，因此评估其药效响应时需考虑组织分布和药效动力学特点。此外，他还介绍了小核酸药物递送技术的创新，特别是GalNAc（N-乙酰半乳糖胺）递送技术能将小核酸递送至肝细胞，并通过化学修饰改善小核酸药物，很多生物科技公司更专注于肝外递送技术。优秀的生物分析技术能够提供答案，这些修饰后的小核酸药物能否有选择性地递送到达目标器脏，以及这些小核酸药物的体内分布和药效。在方法开发方面，他介绍了小核酸药物生物分析中的各种困难，以及解决这些困难的方法，特别是针对组织样品的处理和分析中的经验。通过案例研究，毕博士介绍了如何优化提取条件、色谱分离和质谱检测参数，以提高分析的灵敏度和准确性。最后，毕博士总结了徕博科在小核酸药物生物分析的经验和成果，强调了多种生物分析工具（如LC-MS、qPCR、Simoa、ELISA、MSD和免疫捕获LC-MS）在支持小核酸药物PK/PD评估中的作用。“这些分析工具为药物设计和决策提供了关键数据，推动了小核酸药物的持续发展。”他说。李海涛：炫景生物的创新实践炫景生物联合创始人及CTO李海涛博士介绍了小核酸药物领域的全球研发环境、关键决策点和炫景生物的创新实践。炫景生物联合创始人及CTO 李海涛博士他认为，小核酸药物正迎来前所未有的机遇。全球范围内已有超过20款药物成功上市，且市场规模保持高速增长。在中国，小核酸药物开始显示出巨大潜力。然而，小核酸Biotech公司也面临严峻的生存环境，一级市场融资金额大幅下滑，国内小核酸药热门靶点扎堆，siRNA领域内卷严重，进一步压缩了Biotech的生存空间。李海涛博士强调，Biotech公司是License-out交易项目的主要来源，其创新性在全球合作中发挥着关键作用。在研发路径与关键决策维度上，李海涛认为，产品差异化和技术创新是小核酸Biotech企业在严苛生存环境中脱颖而出的关键。靶点选择需综合临床需求、竞争格局和审评需求，梯度开发扩展适应症以分散风险。平台适配方面，需权衡自主研发与授权引进的利弊，选择合适的平台（如ASO或siRNA）和技术路线。临床试验则需考虑不同临床方案的优劣、全球多中心的必要性和紧迫性等。此外，商业化准备也是关键一环。对于小核酸药物的发展趋势，李海涛认为，在经历过第一轮“踩踏式”的肝靶点同质化开发后，越来越多的小核酸企业会转向新靶点新机制的研究，一方面实现真正的产品管线差异化、多元化，另一方面也能满足人们对小核酸药物解决不可成药靶点和真正面向未满足临床需求的期待和愿景。此外，多靶向新结构和组合疗法的应用将迅速兴起、强效保障并长效维持治疗效果。递送技术将突破人体主要组织器官的靶向递送，实现更加精准、高效和安全的药物递送。同时，生产成本降低和规模扩大将提高药物可及性，而AI/ML技术将从辅助工具转变为决策支持。在介绍炫景生物时，李海涛提到，作为国家高新技术企业和国家级科技型中小企业，炫景生物致力于成为小核酸制药领域的深耕者和变革者。公司自2022年成立以来，已获得近3亿元融资，得到多家知名投资机构的支持。炫景生物拥有自主研发的药物设计筛选平台RIHOST®、化学修饰平台RICMO®和体内递送平台LICOD®等核心技术平台，形成了独特的技术壁垒。药物设计筛选平台实现了智能化序列设计和高通量筛选，大大缩短了研发周期。化学修饰平台通过新单体、新模式、新结构的三层次突破，建立了“通式”修饰模式，提高了药物的稳定性、有效性、长效性和安全性。递送技术平台则涵盖了肝内和肝外递送技术，肝靶向载体具有高效的组织靶向性和成本优势等。此外，炫景生物还建立了7个肝外组织的递送技术，其中肾脏靶向递送载体率先完成食蟹猴体内验证，研发进度全球领先。在管线开发方面，首发管线RG002已启动临床Ⅱ期研究，安全性有效性优于同靶点竞品。谈及创业感悟时，李海涛表示，自己出身于科学家背景，在技术上的挑战并非最为棘手，真正困难在于如何实现从科学家到企业家的角色转变。会议最后，来自国内小核酸药物领域的企业代表，包括炫景生物、瑞博生物、腾盛博药、思合基因、浩博医药、圣诺医药、海昶生物、传信生物、伽进生物、圆因生物、高田生物、星核迪赛以及维亚臻生物等公司，分享了各自公司的平台技术、研发管线布局、融资进展情况及BD计划等。他们认为，当前是中国小核酸药物行业发展的黄金时机，但同时也指出，递送技术、靶向范围拓展、稳定性提升及免疫原性降低等技术瓶颈仍亟待突破。编辑 | 姚嘉 yao.jia@PharmaDJ.com 总第2565期访问研发客网站，深度报道和每日新闻抢鲜看 www.PharmaDJ.com

siRNA核酸药物引进/卖出

2025-06-25

·investor.arbutusbio.com

Arbutus Reacquires Greater China Rights to Imdusiran and Announces Scientific Advisory Board with Late-Stage Clinical Focus

Qilu Pharmaceutical and Arbutus mutually agree to conclude strategic partnership for imdusiran in Greater China Drs. Jordan Feld, Ed Gane, Anna Lok, Mark Sulkowski and Man-Fung Yuen join Arbutus Scientific Advisory Board WARMINSTER, Pa., June 25, 2025 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company focused on infectious disease, today announced that it has reacquired China rights to its lead compound, imdusiran, from Qilu Pharmaceutical, one of the leading pharmaceutical companies in China. The parties have mutually agreed to conclude the strategic partnership entered into in 2021 for development, manufacturing and commercialization of imdusiran in mainland China, Hong Kong, Macau and Taiwan markets. “I would like to express our deepest thanks to the executive leadership and team at Qilu for the collaborative and fruitful partnership we have enjoyed over the last several years,” said Lindsay Androski, President and Chief Executive Officer of Arbutus. “In light of Qilu’s pipeline reprioritization efforts and Arbutus’ renewed focus on advancing our pipeline efficiently, the parties have agreed to terminate our strategic partnership for Greater China. We are thrilled to once again hold global rights for imdusiran, which to date has achieved functional cure in eight patients in combination therapy in two Phase 2a trials.” Dr. Weikang Tao, the global R&D head of Qilu Pharmaceutical commented: “We greatly appreciate the collaboration, efforts and support of both Arbutus and Qilu's project teams for the development of imdusiran in the Greater China area and we wish Arbutus every success in further advancing the development of imdusiran.” Arbutus has also launched a new Scientific Advisory Board (SAB) consisting of globally recognized leaders in the treatment of chronic hepatitis B virus (cHBV) with extensive experience in late-stage clinical trials. SAB members will advise Arbutus on its strategic evaluation of its cHBV pipeline. Members of Arbutus’ Scientific Advisory Board include: Jordan J. Feld, MD, MPH, Professor of Medicine at the University of Toronto and Director of the Toronto Centre for Liver Disease at the Toronto General Hospital, where he holds the R. Phelan Chair in Translational Liver Research as a clinician-scientist and leads a large clinical and translational research program focused primarily on viral hepatitis and its complications. Edward J. Gane, MBChB, MD, FRACP, FAASLD, MNZM, Professor of Medicine at the University of Auckland, New Zealand; Hepatologist and Deputy Director of the New Zealand Liver Unit at Auckland City Hospital. Dr. Gane was involved in early phase development of the first oral cure for hepatitis C and is now focused on developing a finite cure for hepatitis B. He has published over 450 papers and has received many research awards including the Health Research Council Beaven and Liley Medals. Anna Suk-Fong Lok, MD, DSc (Hon), FAASLD, AGAF, Dame Sheila Sherlock Distinguished University Professor of Hepatology and Internal Medicine, Alice Lohrman Andrews Research Professor of Hepatology in the Department of Internal Medicine, at the University of Michigan. Dr. Lok’s research focuses on hepatitis B, and she has published more than 600 scientific articles including guidelines on hepatitis B. Mark Sulkowski, MD, Professor of Medicine, Senior Associate Dean for Clinical Trials, and Founding Director of the Office of Clinical Trials at the Johns Hopkins University School of Medicine. Professor Sulkowski also serves as the Director of the Division of Infectious Diseases at the Johns Hopkins Bayview Medical Center and the Medical Director of the Viral Hepatitis Center in the Divisions of Infectious Diseases and Gastroenterology/Hepatology in the Department of Medicine. Professor Sulkowski has been the principal investigator for more than 200 clinical trials on managing viral hepatitis B and C. Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair Professor of The University of Hong Kong; Li Shu Fan Medical Foundation Professor in Medicine and Chief of the Division of Gastroenterology and Hepatology, Queen Mary Hospital, Hong Kong. Professor Yuen is a world-renowned researcher who has been leading most of the international trials examining novel agents for the treatment of chronic hepatitis B. As previously reported, to date, across all Phase 2a clinical trials (IM-PROVE I and IM-PROVE II) conducted with imdusiran, Arbutus has reported a total of 8 patients who have been functionally cured and were able to discontinue all therapies including nucleos(t)ide analogue (NA) therapy. Two of the patients who achieved functional cure received no interferon (IFN) as part of their treatment, and seven of the eight patients had baseline hepatitis B surface antigen (HBsAg) levels less than 1000 IU/mL. About Imdusiran (AB-729) Imdusiran is an RNAi therapeutic specifically designed to reduce all HBV viral proteins and antigens including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to control the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. To date, Arbutus has reported a total of eight patients with cHBV who have achieved functional cure following treatment with imdusiran and NA therapy in combination with either IFN or low dose nivolumab plus an immunotherapeutic. Clinical data generated thus far has shown imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in HBsAg and hepatitis B virus DNA. About HBV Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 1.1 million people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options. About Arbutus  Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company focused on infectious disease. The company is currently developing imdusiran (AB-729) and an oral PD-1 inhibitor (AB-101) for the treatment of chronic HBV infection. The Company is also consulting closely with and supporting its exclusive licensee, Genevant Sciences, to protect and defend its intellectual property, which is the subject of on-going lawsuits against Moderna and Pfizer/BioNTech for use of Arbutus’s patented LNP technology in their COVID-19 vaccines. For more information, visit www.arbutusbio.com. Forward-Looking Statements and Information This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include statements about: the potential to lead to a functional cure for HBV; the potential for Arbutus’ product candidates to achieve success in clinical trials; and Arbutus’ pipeline and development plans for its cHBV programs. With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies. Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: ongoing and anticipated clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested product candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; and market shifts may require a change in strategic focus. A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law. Arbutus Biopharma Corporation / ir@arbutusbio.com

临床2期临床结果疫苗

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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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


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	網淵餘範構鑰顧鏇窪餘(襯襯餘艱鹽齋憲餘廠窪) = 網艱構繭獵選夢繭餘簾製蓋顧淵蓋窪製製觸蓋 (憲廠餘醖鏇選齋艱夢淵 )	积极	2025-05-07
				imdusiran + VTP-300 + nivolumab	網淵餘範構鑰顧鏇窪餘(襯襯餘艱鹽齋憲餘廠窪) = 鹽醖窪簾選襯鹽襯範願製蓋顧淵蓋窪製製觸蓋 (憲廠餘醖鏇選齋艱夢淵 ) 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	築簾製襯簾壓鬱積簾鑰(鬱鹹願糧襯簾鹽醖鹽繭) = 鹽齋襯願遞簾鹽顧範顧醖廠觸築醖構夢積襯築 (壓廠廠鏇艱窪網鬱糧觸 )	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)	廠窪獵壓餘憲範憲夢簾(積襯壓餘獵繭鏇窪鹹餘) = 遞築蓋餘選廠願獵壓壓鹹構窪顧廠蓋鑰廠淵壓 (繭鹹鏇憲鏇鹹顧窪鑰範 ) 更多	积极	2024-06-01
				imdusiran (A2: 24 wks IFN + NA)	廠窪獵壓餘憲範憲夢簾(積襯壓餘獵繭鏇窪鹹餘) = 廠壓淵齋遞築醖選艱憲鹹構窪顧廠蓋鑰廠淵壓 (繭鹹鏇憲鏇鹹顧窪鑰範 ) 更多
ACTRN12622000317796 (AB-729-202, GlobeNewswire) 人工标引	临床2期	乙型肝炎	40	imdusilan+VTP-300	鏇構餘願鬱鏇選願顧壓(範遞鹹積遞憲淵繭淵鑰) = There were no serious adverse events, Grade 3 or 4 adverse events or treatment discontinuations. 淵範簾壓艱繭餘壓夢簾 (壓鹽鏇遞遞顧繭淵鬱窪 ) 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	醖遞簾遞艱壓網遞鹽廠(廠範夢鹹壓壓廠顧製繭) = 築繭衊壓鏇鹹膚糧願艱襯糧鬱願獵壓簾獵簾範 (鏇網鑰夢願顧觸選艱顧 )	积极	2022-06-25
				Control GalNAc siRNA	醖遞簾遞艱壓網遞鹽廠(廠範夢鹹壓壓廠顧製繭) = 膚憲構繭繭壓糧願窪夢襯糧鬱願獵壓簾獵簾範 (鏇網鑰夢願顧觸選艱顧 )
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	鹽膚簾鹹簾鏇齋簾艱淵(鑰醖鬱憲夢範鏇願憲顧) = 製餘選醖鏇網鏇鹽顧鏇繭積糧廠鹹衊艱鹹鏇範 (獵鑰積製鏇網鹹鑰築構 )	积极	2022-06-22