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更新于：2025-08-05

Imdusiran

更新于：2025-08-05

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.

151

项与 Imdusiran 相关的新闻（医药）

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

2025-06-17

·PRNewswire

Chronic Hepatitis B Market--The US to Have the Lion's Share Among the 7MM, Predicts DelveInsight

The chronic hepatitis B market size is predicted to surge owing to the increasing prevalence of the disease globally and rising awareness about early diagnosis and treatment. Advances in antiviral therapies and the development of novel treatment options are fueling market expansion. LAS VEGAS, June 17, 2025 /PRNewswire/ -- Hepatitis B is the most widespread serious liver infection globally, caused by the hepatitis B virus (HBV), which targets and damages the liver. Millions of individuals worldwide are affected by chronic hepatitis B. The virus spreads through contact with infected blood and bodily fluids, including transmission via unprotected sex, sharing of contaminated needles, use of illegal drugs, and exposure to unsterilized medical equipment. In most cases, hepatitis B resolves on its own within 1 to 2 months. However, if the infection persists beyond six months, it can become chronic, potentially leading to ongoing liver inflammation, cirrhosis (liver scarring), liver cancer, or liver failure. As of 2024, around 5 million people across the 7MM were living with chronic hepatitis B. Among these, 85% had compensated liver function, while the remaining 15% had progressed to decompensated liver disease. Currently, there is no definitive cure for hepatitis B. Antiviral medications and interferon injections can help manage the disease by reducing viral activity and easing symptoms, but they do not eliminate the virus entirely. If the infection persists beyond six months, it is classified as chronic, making patients eligible for drug therapy, particularly those with active liver disease. Learn more about the chronic hepatitis B virus market @ New Treatment for Chronic Hepatitis B The US FDA has approved seven medications for treatment: two injectable interferons and five oral antiviral drugs. These treatments must be taken daily and work by suppressing viral replication, thereby reducing liver inflammation and potential damage. VEMLIDY (tenofovir alafenamide), developed by Gilead Sciences, is an innovative, targeted prodrug of tenofovir formulated as an oral tablet. In March 2024, Gilead announced that the FDA had approved a supplemental New Drug Application (sNDA) for VEMLIDY 25 mg, allowing its once-daily use in pediatric patients aged 6 years and older and weighing at least 25 kg who have chronic hepatitis B (CHB) infection with compensated liver disease. Earlier, in November 2022, the FDA approved the same 25 mg dose for once-daily use in children aged 12 and above with CHB and compensated liver disease. The initial FDA approval came in November 2016 for adult patients with CHB and compensated liver function. In January 2017, Gilead announced that the European Commission (EC) had granted marketing authorization for VEMLIDY 25 mg to treat CHB in adults and adolescents aged 12 and older who weigh at least 35 kg. Additionally, in December 2016, Japan's Ministry of Health, Labour and Welfare (MHLW) approved VEMLIDY for the treatment of chronic hepatitis B in patients showing active viral replication and abnormal liver function. Find out more on FDA-approved chronic hepatitis B drugs @ Chronic Hepatitis B (CHB) Market The chronic hepatitis B treatment drug market is continuously evolving. Several pharma companies are evaluating their lead assets in different phases of development. Many potential therapies are being investigated to manage chronic hepatitis B. Some of the drugs in the pipeline include Imdusiran (AB-729) (Arbutus Biopharma), GSK3228836 (bepirovirsen) (GlaxoSmithKline), Tobevibart (VIR-3434) + elebsiran (VIR-2218) ± PEG-IFN-a (Vir Biotechnology), and others. Even though it is too soon to comment on the above-mentioned promising candidate to enter the market during the forecast period (2025–2034), it is safe to assume that the future of this market is bright. Discover which therapies are expected to grab major chronic hepatitis B treatment drug market @ Chronic Hepatitis B Market Report Daplusiran (also known as tomligisiran, formerly JNJ-3989/GSK5637608) is an experimental siRNA-based therapy targeting hepatitis B virus (HBV). It is being studied in combination with bepirovirsen in a sequential regimen for adult patients with chronic hepatitis B who are non-cirrhotic and receiving nucleos(t)ide analogue (NA) therapy. In October 2023, GSK and Arrowhead Pharmaceuticals announced an agreement with Janssen Pharmaceuticals to acquire the exclusive global rights to further develop and commercialize JNJ-3989. Janssen had originally licensed the drug (then called ARO-HBV) from Arrowhead in 2018. Imdusiran is an RNA interference (RNAi) therapy designed to suppress all HBV viral proteins and antigens, including HBsAg, which is believed to be critical for restoring the immune system's ability to fight the virus. It uses Arbutus' proprietary GalNAc-conjugated delivery platform to specifically target liver cells (hepatocytes), allowing for subcutaneous administration. Arbutus plans to launch a Phase IIb clinical trial in the first half of 2025 to evaluate imdusiran in combination with interferon (IFN) and NA therapy. Discover more about drugs for chronic hepatitis B in development @ Chronic Hepatitis B Clinical Trials The anticipated launch of these emerging therapies for chronic hepatitis B are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the chronic hepatitis B market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for chronic hepatitis B is expected to grow at a significant CAGR by 2034. In 2024, the United States dominated the CHB market among the 7MM, capturing approximately 72% of the total market share. The market size of chronic hepatitis B is expected to grow due to several factors, including rising global prevalence of hepatitis B virus infection and increasing awareness about the disease. Advances in antiviral therapies and growing screening initiatives also boost market growth by enabling early diagnosis and improved disease management. DelveInsight's latest published market report, titled as Chronic Hepatitis B Market Insight, Epidemiology, and Market Forecast – 2034 , will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the chronic hepatitis B country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The chronic hepatitis B market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Chronic Hepatitis B Total Diagnosed Cases of Chronic Hepatitis B Chronic Hepatitis B Cases by Age Group Chronic Hepatitis B Cases by Gender Treated Cases of Chronic Hepatitis B Chronic Hepatitis B Cases by Impact on Liver The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM chronic hepatitis B market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this chronic hepatitis B market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the chronic hepatitis B market. Also, stay abreast of the mitigating factors to improve your market position in the chronic hepatitis B therapeutic space. Related Reports Chronic Hepatitis B Epidemiology Chronic Hepatitis B Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and the CHB epidemiology trends. Chronic Hepatitis B Pipeline Chronic Hepatitis B Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CHB companies, including Vedanta Biosciences, Gilead Sciences, Dong-A ST Co, Assembly Biosciences, Arbutus Biopharma, Vir Biotechnology, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Romark Laboratories, Qilu Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Henlix, Enyo Pharma, Tasly Tianjin Biopharmaceutical, Brii Biosciences, Vaxine Pty Ltd, Vaccitech Limited, Zhejiang Palo Alto Pharmaceuticals, Suzhou Ribo Life Science, PharmaEssentia, Nucorion Pharmaceuticals, Jiangsu HengRui Medicine, Enanta Pharmaceuticals, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, VenatoRx Pharmaceuticals, Zhimeng Biopharm, among others. Hepatitis A Market Hepatitis A Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key hepatitis A companies, including Boryung Pharmaceutical, Cadila Healthcare, Indian Immunologicals, Biological E Limited, among others. Hepatitis C Market Hepatitis C Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key hepatitis C companies, including AbbVie, Gilead Sciences, Atea Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准引进/卖出临床2期

2025-06-05

·CPHI制药在线

收藏 | 现有管线与上市RNA疗法汇总

关注并星标CPHI制药在线RNA疗法正迅速成为现代医学中最具变革性的治疗策略之一。从反义寡核苷酸（ASO）和小干扰RNA（siRNA）等精准调控基因表达的工具，到mRNA疫苗和肿瘤免疫疗法等前沿应用，RNA技术已在多个疾病领域展现出巨大潜力。近年来，随着递送系统、生物偶联技术和修饰化学的不断进步，RNA疗法的临床管线迅速扩展，涵盖了罕见病、神经系统疾病、代谢性疾病以及肿瘤等多个领域。目前，RNA疗法的临床开发全景涵盖了ASO、siRNA、mRNA、核酸适体（aptamer）等主要技术路径，在不同适应症中布局广泛，关键企业的研发动态频繁，已获批上市的代表性药物不断涌现。本文总结了现有管线和上市的 RNA疗法，将这一新兴领域的开发全景呈现出来。1. ASO类 RNA资产梳理 1.1 I期ASO资产 • Praxis ASO资产：Elsunersen（PRAX-222）靶点：SCN2A基因适应症：由SCN2A基因的功能获得性突变引起的早发性SCN2A发育性和癫痫性脑病。 • PYC Therapeutics ASO资产：VP-001 靶点：PRPF31基因适应症：由PRPF31基因突变引起的视网膜色素变性11型 ASO资产：PYC-001 靶点：OPA1基因适应症：由OPA1基因突变引起的常染色体显性视神经萎缩（ADOA） ASO资产：PYC-003 靶点：PKD1基因适应症：常染色体显性多囊肾病（ADPKD） • Bio-Path Holdings ASO资产：BP1002（Liposomal Grb2 ASO）适应症：急性髓性白血病（AML）、B细胞淋巴瘤（B-cell lymphoma）技术特点：使用独特的中性脂质体递送系统（DNAbilize® Platform）递送ASO。1.2 II期ASO资产 • Stoke Therapeutics ASO资产：Zorevunersen（STK-001）靶点：SCN1A基因适应症：Dravet综合征（一种严重癫痫） ASO资产：STK-002 靶点：OPA1基因适应症：常染色体显性视神经萎缩（ADOA） • Entrada Therapeutics ASO资产：ENTR-601-44 适应症：Duchenne肌营养不良（DMD）靶点：DMD中的Exon 44跳跃技术特点：使用Entrada独有的分子穿透技术（Endosomal Escape Vehicle, EEV）提高细胞内递送效率。 ASO资产：ENTR-601-45 靶点：DMD基因的外显子45（Exon 45）适应症：适用于外显子45跳跃的杜氏肌营养不良症（DMD）患者 • Dyne Therapeutics ASO资产：DYNE-251 适应症：Duchenne肌营养不良（DMD），针对DMD中的Exon 51跳跃。技术特点：使用抗体-寡核苷酸结合平台（FORCE platform）进行肌肉组织特异性递送。 ASO资产：DYNE-101 适应症：肌强直性营养不良症1型（DM1）靶点：DMPK基因的异常CTG重复序列 • Ribomic ASO资产：Umedaptanib Pegol（原RBM-007，严格来说是核酸适体aptamer，而不是典型ASO) 靶点：FGF2（成纤维细胞生长因子2）。适应症：湿性年龄相关性黄斑变性（wAMD），软骨发育不全症 • Wave Life Sciences ASO资产： WVE-N531：DMD（杜氏肌营养不良症）治疗，靶向Exon 53跳跃 WVE-003：亨廷顿舞蹈症（Huntington's Disease, HD），靶向HTT基因突变 • PepGen ASO资产：PGN-EDO51 适应症：Duchenne肌营养不良（DMD）技术特点：结合增强型细胞穿透肽（Enhanced Delivery Oligonucleotide, EDO）技术，提高ASO进入肌肉细胞的效率。 ASO资产：PGN-EDODM1 靶点：DMPK基因的异常CUG重复序列适应症：肌强直性营养不良症1型（DM1） • 罗氏 ASO资产：Tominersen（RG6042）靶点：Huntingtin（HTT）基因适应症：亨廷顿病（Huntington's Disease, HD） ASO资产：IONIS-FB-LRx（RO7434656 / RG6299）靶点：补体因子B（Factor B）适应症：IgA肾病（IgAN） • Ultragenyx ASO资产：GTX-102 靶点：UBE3A-AS（UBE3A反义转录本）适应症：天使综合征（Angelman Syndrome）1.3 ASO类3期资产 • Oncotelic Therapeutics ASO资产：OT-101（也叫Trabedersen）靶点：转化生长因子β2（TGF-β2）适应症：胶质母细胞瘤（GBM）、胰腺癌、恶性黑色素瘤机制：抑制TGF-β2，有望减轻肿瘤免疫抑制，增强抗肿瘤免疫反应 • 阿斯利康 ASO资产：ION449（亦称AZD8233），与Ionis合作开发的ASO疗法靶点：PCSK9（一种影响低密度脂蛋白胆固醇LDL-C水平的蛋白质）适应症：高胆固醇血症（hypercholesterolemia）备注：主要竞争对手包括小分子抑制剂和PCSK9单抗（如Repatha、Praluent） • GSK ASO资产：bepirovirsen 靶点：乙型肝炎病毒（HBV）的前基因组RNA和mRNA 适应症：慢性乙型肝炎（chronic hepatitis B, CHB），通过抑制HBV基因表达，帮助病毒清除或实现功能性治愈（functional cure）。 • 诺华 ASO资产：Pelacarsen 靶点：LPA基因（编码脂蛋白(a)）作用机制：Pelacarsen通过抑制LPA基因的mRNA，降低血液中脂蛋白(a)(Lp(a))水平，从而降低心血管疾病风险。Lp(a)是目前被认为的重要但尚无针对性治疗手段的心血管风险因子。适应症：主要用于治疗动脉粥样硬化性心血管疾病高危患者中，血脂异常（特别是Lp(a)升高）的情况。临床阶段：正在进行III期临床试验（Lp(a)HORIZON）。Pelacarsen可能成为首个专门针对Lp(a)升高治疗获批的药物。1.4 ASO类上市药物 • 渤健 Spinraza（nusinersen）靶点：SMN2前体mRNA（促进功能性SMN蛋白表达）适应症：脊髓性肌萎缩症（SMA）获批时间：2016年12月（美国FDA批准）备注：全球首个获批的SMA治疗药物。由Ionis开发，Biogen负责商业化。 • Sarepta Therapeutics Exondys 51（eteplirsen）靶点：DMD基因的Exon 51 适应症：Duchenne肌营养不良（DMD）获批时间：2016年9月（FDA加速批准） Vyondys 53（golodirsen）靶点：DMD基因的Exon 53 适应症：DMD 获批时间：2019年12月 Amondys 45（casimersen）靶点：DMD基因的Exon 45 适应症：DMD 获批时间：2021年2月（FDA加速批准） • Ionis Pharmaceuticals Tegsedi（inotersen）靶点：TTR（转甲状腺素蛋白）适应症：遗传性转甲状腺素蛋白淀粉样变性多发性神经病（hATTR-PN）获批时间：2018年10月（FDA，EMA批准） Waylivra（volanesorsen）靶点：APOC3（载脂蛋白C-III）适应症：家族性乳糜微粒血症综合征（FCS）获批时间：2019年5月（欧洲EMA批准；未获美国FDA批准） • NS Pharma Viltepso（viltolarsen）靶点：DMD基因的Exon 53 适应症：Duchenne肌营养不良（DMD）获批时间：2020年8月（FDA加速批准）2.RNAi类 RNA资产2.1 I期RNAi资产 • Aligos Therapeutics RNAi资产：ALG-125755 靶点：乙型肝炎病毒（HBV）RNA 适应症：慢性乙型肝炎（CHB） • Regulus Therapeutics RNAi资产：RGLS8429 靶点：microRNA-17（miR-17家族）适应症：常染色体显性多囊肾病（ADPKD） • Phio Pharmaceuticals RNAi资产：PH-762 靶点：程序性死亡受体1（PD-1）适应症：癌症免疫疗法（通过下调T细胞表面PD-1，增强免疫杀伤）技术特点：采用其自有的INTASYL✓平台，优化了siRNA的稳定性和局部递送。 • TransCode Therapeutics RNAi资产：VIR-2218 TTX-MC138 靶点：microRNA-10b（miR-10b）适应症：针对转移性实体肿瘤（如乳腺癌、胰腺癌、脑肿瘤等）技术特点：使用纳米颗粒系统高效递送siRNA药物，特别适合针对深部转移灶。2.2 II期RNAi资产 • Arbutus Biopharma RNAi资产：AB-729 靶点：乙型肝炎病毒（HBV）表面抗原（HBsAg）适应症：慢性乙型肝炎（CHB）备注：AB-729是Arbutus当前最重要的核心资产之一。 • OliX Pharmaceuticals RNAi资产：OLX703A 靶点：HBV病毒相关RNA 适应症：慢性乙型肝炎（CHB）机制：抑制HBV病毒蛋白表达 • Silence Therapeutics RNAi资产：SLN360 靶点：LPA基因（编码脂蛋白Lp(a)）适应症：高脂蛋白(a)血症（Lp(a)过高相关的心血管疾病）机制：通过降低血液中Lp(a)水平，减少动脉粥样硬化风险。备注：SLN360是Silence在心血管RNA疗法领域的主力项目。 • Sirnaomics RNAi资产：STP705 靶点：双靶点siRNA药物，靶向TGF-β1和COX-2。适应症：瘢痕治疗（皮肤纤维化）、非黑色素瘤皮肤癌（如基底细胞癌、鳞状细胞癌）机制：抑制纤维化、降低肿瘤微环境免疫抑制。备注：Sirnaomics的特点是双靶点siRNA联合递送。 • GSK RNAi资产：GSK4532990 靶点：靶向HSD17B13基因适应症：代谢功能障碍相关脂肪性肝炎（MASH） • 礼来 RNAi项目：LY3561774 靶点：SERPINA1基因适应症：α1-抗胰蛋白酶缺乏症（AATD）机制：降低异常α1-抗胰蛋白酶（AAT）积聚 • VIR Biotechnology RNAi项目：VIR-2218 靶点： HBV RNA 适应症：慢性乙型肝炎（CHB）。机制：抑制HBV表面抗原表达 • 罗氏 RNAi资产：Zilebesiran 靶点：肝脏表达的血管紧张素原（AGT）基因。适应症：高血压，特别是高心血管风险患者。2.3 III期RNAi资产 • Arrowhead Pharmaceuticals RNAi资产：ARO-APOC3 靶点：APOC3（载脂蛋白C-III），适应症：高甘油三酯血症和罕见脂代谢异常 • 武田 RNAi资产：Fazirsiran 靶点：SERPINA1（编码α1-抗胰蛋白酶）适应症：α1-抗胰蛋白酶缺乏症（AATD）引起的肝病 • 安进 RNAi资产：Olpasiran 靶点：LPA基因（脂蛋白(a)）适应症：高脂蛋白(a)血症及其引发的心血管疾病风险备注：这是一款非常重磅的RNAi项目，对心血管领域意义重大。 • Avidity Biosciences RNAi资产：AOC 1001 靶点：DMPK基因（导致肌强直性营养不良症1型DM1）适应症：肌强直性营养不良症1型（DM1）技术特点：AOC（Antibody Oligonucleotide Conjugate，抗体-寡核苷酸偶联体），用于肌肉靶向递送siRNA。 • 赛诺菲 RNAi资产：Fitusiran 靶点：AT（抗凝血酶）适应症：血友病A或B患者的出血预防 • VIR Biotechnology RNAi资产：VIR-2218 靶点：HBV RNA 适应症：慢性乙型肝炎（CHB）2.4 上市RNAi资产 • Alnylam Pharmaceuticals Alnylam是全球RNAi疗法先锋，拥有最多已上市RNAi药物。 Onpattro（Patisiran）靶点：TTR 适应症：遗传性转甲状腺素蛋白淀粉样变性引起的多发性神经病（hATTR-PN）批准情况：2018年FDA/EMA批准 Givlaari（Givosiran）靶点：ALAS1 适应症：急性肝卟啉症（AHP）批准情况：2019年FDA/EMA批准 Oxlumo（Lumasiran）靶点：HAO1 适应症：原发性高草酸尿症1型（PH1）批准情况：2020年FDA/EMA批准 Amvuttra（Vutrisiran）靶点：TTR 适应症：遗传性转甲状腺素蛋白淀粉样变性引起的多发性神经病（hATTR-PN）（长效皮下注射版）批准情况：2022年FDA批准 • 诺华 RNAi资产：Leqvio（Inclisiran）靶点：PCSK9 适应症：高胆固醇血症，动脉粥样硬化性心血管疾病风险降低批准情况：2020年欧洲EMA批准；2021年底美国FDA批准 • 诺和诺德 RNAi资产：Rivfloza (nedosiran) 靶点：肝脏中乳酸脱氢酶（LDH）mRNA 适应症：治疗9岁及以上、肾功能相对良好的原发性高草酸尿症1型（PH1）患者。作用机制：抑制LDH蛋白表达，减少草酸过度生成，缓解PH1疾病过程，减少肾脏损害风险。批准情况：2023年9月29日FDA正式批准Rivfloza上市。成为继Alnylam的Oxlumo（Lumasiran）之后，全球第二款获批用于PH1治疗的RNAi药物。3.mRNA类 RNA药物资产3.1 1期mRNA资产 • 赛诺菲 SP0237: 季节性流感 mRNA 疫苗适应症：针对 A/H3N2 毒株的季节性流感。 SP0256 – RSV mRNA 疫苗（老年人群）适应症：用于预防老年人群中的呼吸道合胞病毒（RSV）感染。 SP0268 – mRNA 痤疮疫苗适应症：针对痤疮（Acne）的 mRNA 疫苗。 SP0291 – 多价呼吸道病毒 mRNA 疫苗适应症：针对 RSV、人类偏肺病毒（hMPV）和副流感病毒 3 型（PIV3）的组合疫苗，主要用于老年人群。沙眼衣原体（Chlamydia）mRNA 疫苗候选适应症：预防沙眼衣原体感染，主要针对 18 至 29 岁的成人。 • Vertex mRNA资产：VX-522：用于囊性纤维化（CF）的mRNA疗法靶点：CFTR基因（囊性纤维化跨膜电导调节因子）。适应症：无法通过CFTR调节剂治疗的CF（囊性纤维化）患者，尤其是那些由于CFTR基因突变导致CFTR蛋白缺失的患者。作用机制：VX-522是一种mRNA疗法，通过脂质纳米颗粒（LNP）递送CFTR mRNA至肺部细胞，促使其合成功能性CFTR蛋白，从而恢复氯离子通道的功能。3.2 II期mRNA资产 • Gritstone Bio GRANITE（GRT-C901/GRT-R902）个体化肿瘤新抗原疫苗，采用腺病毒（ChAd68）和自扩增mRNA（samRNA）组成的异源prime-boost策略。适应症：用于治疗转移性微卫星稳定型结直肠癌（MSS-CRC）。 CORAL 基于自扩增mRNA（samRNA）的COVID-19疫苗，诱导广泛且持久的中和抗体和T细胞免疫反应。 • CureVac/GSK 季节性流感mRNA疫苗候选该疫苗候选基于CureVac的第二代mRNA平台，针对流感病毒株，包括A型和B型毒株。 COVID-19 mRNA疫苗候选CV0601和CV0701 CV0601为单价疫苗，编码Omicron BA.4/5变异株的刺突蛋白；CV0701为二价疫苗，编码Omicron BA.4/5变异株和原始SARS-CoV-2毒株的刺突蛋白。3.3 III期mRNA资产 • 第一三共 DS-5670a（原始毒株单价疫苗）适应症：Covid-19疫苗，作为加强针用于已完成初始疫苗接种的成人和老年人。 DS-5670a/b（原始毒株与Omicron BA.4/5二价疫苗）适应症：Covid-19疫苗，作为加强针用于12岁及以上已完成初始疫苗接种的人群。 DS-5670d（Omicron XBB.1.5单价疫苗）适应症：Covid-19疫苗，作为季节性加强针用于12岁及以上人群，包括未接种疫苗者。 • 默沙东 mRNA资产：V940（mRNA-4157）类型：肿瘤疫苗（个体化mRNA疫苗）适应症：手术切除后的高风险黑色素瘤患者辅助治疗靶点：个体化新抗原（根据患者肿瘤突变特异设计）3.4上市mRNA资产 • Arcturus Therapeutics mRNA资产：KOSTAIVE（ARCT-154 / Zapomeran）类型：自扩增mRNA（sa-mRNA）疫苗适应症：用于预防COVID-19，适用于18岁及以上人群靶点：SARS-CoV-2病毒刺突蛋白（Spike protein） • BioNTech/辉瑞 Comirnaty 类型：mRNA疫苗适应症：用于预防COVID-19，适用于6个月及以上人群靶点：SARS-CoV-2病毒刺突蛋白（Spike protein）获批时间：✓2020年12月获得FDA紧急使用授权，2021年8月获得美国FDA完全批准 • 莫德纳 Spikevax 类型：mRNA疫苗适应症：用于预防COVID-19，适用于6个月及以上人群靶点：SARS-CoV-2病毒刺突蛋白（Spike protein）获批时间：2020年12月18日，美国FDA授予紧急使用授权；2022年1月31日，获得FDA完全批准Ref. TD Cowen. Pharmaceuticals’ websitesEND【企业推荐】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

临床2期寡核苷酸上市批准信使RNA临床1期

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	Arbutus Biopharma Corp.	2022-05-10
乙型肝炎	临床申请	中国	齐鲁制药有限公司	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	構構鑰範簾壓獵遞鬱衊(壓齋醖鑰繭觸觸鬱築齋) = 膚齋齋構鹹醖積憲繭艱淵膚構鑰積鹽蓋鏇膚觸 (夢獵鏇鹹願夢積蓋範夢 )	积极	2025-05-07
				imdusiran + VTP-300 + nivolumab	構構鑰範簾壓獵遞鬱衊(壓齋醖鑰繭觸觸鬱築齋) = 廠糧憲鹽廠鏇鏇製憲積淵膚構鑰積鹽蓋鏇膚觸 (夢獵鏇鹹願夢積蓋範夢 ) 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	鹹觸製蓋蓋繭廠蓋憲蓋(襯齋鑰鹽窪獵鬱鹽築顧) = 製獵淵構製憲簾製範艱廠鬱夢鬱網襯襯鏇醖願 (遞衊範鹽窪製鹽鏇願網 )	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)	鹹夢遞獵範顧膚鑰齋蓋(醖醖築築壓鑰積艱觸繭) = 構願獵鬱淵鑰膚襯窪觸積願膚積鹹蓋鏇壓廠膚 (獵襯蓋網選淵顧鬱構鑰 ) 更多	积极	2024-06-01
				imdusiran (A2: 24 wks IFN + NA)	鹹夢遞獵範顧膚鑰齋蓋(醖醖築築壓鑰積艱觸繭) = 鹽艱糧壓積鬱築觸膚鑰積願膚積鹹蓋鏇壓廠膚 (獵襯蓋網選淵顧鬱構鑰 ) 更多
ACTRN12622000317796 (AB-729-202, GlobeNewswire) 人工标引	临床2期	乙型肝炎	40	imdusilan+VTP-300	膚積願鏇襯壓積鬱壓鬱(膚糧簾壓淵獵鹹廠糧範) = There were no serious adverse events, Grade 3 or 4 adverse events or treatment discontinuations. 憲範糧衊夢壓鹹壓製鑰 (壓網醖膚鬱齋齋鹹醖鏇 ) 更多	积极	2023-11-09
				imdusilan+placebo
EASL2022	临床2期	HBV RNA transcripts \| HBV DNA \| hepatitis B surface antigen (HBsAg)	-	AB-729 siRNA	範艱構簾願願壓製獵壓(積顧襯窪衊簾簾積簾築) = 蓋襯壓淵餘膚範憲製簾淵鏇壓觸夢鬱憲繭廠憲 (淵衊糧構憲獵繭積襯憲 )	积极	2022-06-25
				Control GalNAc siRNA	範艱構簾願願壓製獵壓(積顧襯窪衊簾簾積簾築) = 鹽觸窪觸網觸繭鑰膚艱淵鏇壓觸夢鬱憲繭廠憲 (淵衊糧構憲獵繭積襯憲 )
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	餘鏇網範鹽構簾鑰憲糧(廠繭鏇糧簾廠構顧蓋醖) = 願願蓋網醖願艱齋鬱膚簾範憲憲遞襯醖蓋艱廠 (襯窪獵繭衊蓋遞鏇範膚 )	积极	2022-06-22