Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy

To learn if giving immune checkpoint therapy (such as atezolizumab) and bevacizumab to patients who have HCC and are receiving DAAs may help to control HCC and hepatitis C.

开始日期2023-03-17

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT06180590

/ RecruitingN/AIIT

A Prospective Cohort Study: the Efficacy of Vosevi in Treating Direct Antiviral Agent Therapy Failure Patients

Hepatitis C virus (HCV) infection remains a significant health problem in our country. The World Health Organization estimated that 71 million people worldwide had chronic HCV infection in 2015. And 399,000 people died from cirrhosis or primary hepatocellular carcinoma caused by HCV infection. In 2006, the positive rate of HCV antibody in the population aged 1-59 was 0.43%. Therefore, it was estimated that there were about 5.6 million HCV infected people in the general population, and about 10 million cases of HCV infected people in high-risk groups and high incidence areas.
Universal genotype direct antiviral agent (DAA) is the preferred antiviral therapy for hepatitis C. Sofosbuvir/velpatasvir are direct antiviral agents for hepatitis C. The results of Asian clinical trials mainly in Chinese population showed that the sustained virologic response (SVR) rates of sofosbuvir/velpatasvir at 12 weeks in genotype 1a, 1b, 2, 3a, 3b and 6 were 100%, 100%, 100%, 95%, 76% and 99%, respectively. Limited data showed that the SVR rate of sofosbuvir/velpatasvir at 12 weeks was 96% in Chinese genotype 3b patients without cirrhosis and 50% in patients with cirrhosis.
After standard antiviral therapy for hepatitis C, there are still some patients who cannot obtain SVR, and these patients are defined as DAA-experienced patients. The guidelines recommend that Sofosbuvir/Velpatasvir combined with ribavirin be used as salvage therapy for patients with DAA-experienced failure. Vosevi is a new generation of antiviral therapy for hepatitis C, which contains three components, (Sofosbuvir, Velpatasvir and Voxilaprevir. It was a salvage treatment plan for DAAs-experienced patients which was recommended by the Chinese hepatitis C prevention and treatment guidelines in 2019. However, there are insufficient data on the proportion of SVR acquired in Vosevi treated DAAs-experienced patients in Asian populations and the effectivity of antiviral therapy between Vosevi and Sofosbuvir/Velpatasvir combined with ribavirin.
In the present study, the investigators enroll DAAs-experienced hepatitis C patients. The participants are randomly divided into two groups. Then the participants are treated with Vosevi or Sofosbuvir/Velpatasvir combined with ribavirin respectively. All enrolled participants are followed-up for 3 years. Objectives of the present study are as follows:
A. To clarify the sustained virologic response rate after Vosevi therapy for DAAs-experienced patients.
B. To clarify the safety and efficacy between the Vosevi therapy and the Sofosbuvir/Velpatasvir combined with ribavirin therapy.
C. To clarify the changes of biochemistry indexes in DAAs-experienced patients after Vosevi therapy.
D. To clarify the virological relapse rate at 12 weeks after Vosevi therapy. E. To clarify the rate of cirrhosis and liver cancer during the follow-up.

开始日期2023-02-28

申办/合作机构

广州医科大学附属第三医院（广州重症孕产妇救治中心、广州柔济医院）

NCT05467826

/ Not yet recruiting临床4期IIT

Efficacy and Safety of Sofosbuvir/Velpatasvir Plus Ribavirin for 12 Weeks or Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks in DAA Treatment Naïve HCV Subjects With GT3b, Compensated Cirrhosis in China

Direct-acting antiviral agents (DAAs) targeting HCV have revolutionized the treatment of HCV. The efficacy of DAA-based therapy can depend on patient-related factors such as treatment experience, cirrhosis, but also on viral genotype. The high prevalence of genotype 3, which is considered difficult to cure, remains a challenge because many oral DAAs are less effective for this genotype, particularly subtype 3b than for others. Current guidance generally recommends sofosbuvir (SOF)/velpatasvir (VEL) ± ribavirin (RBV), glecaprevir/pibrentasvir and SOF/VEL/voxilaprevir (VOX) as first-line therapy for genotype 3, and an interferon-based regimen - SOF plus pegylated interferon and ribavirin is still recommended as an alternative treatment option. These recommendations are based on clinical data generated in regions where genotype 3a predominates. Our recent study indicated that sofosbuvir plus ribavirin for 24 weeks in subjects with HCV genotype 3 infection resulted in high rates of SVR. However, the SVR12 rate among subjects with genotype 3b was lower than that observed in subjects with genotype 3a infection, particularly among treatment-experienced subjects with cirrhosis.
Our study aimed to investigate the efficacy and safety of SOF/VEL plus RBV for 12 weeks or SOF/VEL/VOX for 12 weeks in DAAs treatment naïve HCV subjects with GT3b, compensated cirrhosis in China.

开始日期2022-09-01

申办/合作机构

北京大学人民医院

100 项与索磷维伏相关的临床结果

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100 项与索磷维伏相关的转化医学

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100 项与索磷维伏相关的专利（医药）

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项与索磷维伏相关的文献（医药）

2023-08-01·Journal of hepatology

A randomized-controlled trial of SOF/VEL/VOX with or without ribavirin for retreatment of chronic hepatitis C

Article

作者: Lee, Samuel S ; Emadeldeen, Mohammed ; Hassany, Mohamed ; Congly, Stephen E ; Liu, Hongqun ; El-Kassas, Mohamed ; Esmat, Gamal ; El-Raey, Fathiya ; Gomaa, Ahmed Ali

BACKGROUND & AIMS:

The combination of sofosbuvir, velpatasvir and voxilaprevir (SOF/VEL/VOX) is recommended for the retreatment of patients with HCV infection in whom previous direct-acting antiviral (DAA) treatment failed. However, whether ribavirin further increases the therapeutic efficacy of SOF/VEL/VOX retreatment remains unclear. We aimed to test this hypothesis in a randomized-controlled trial.

METHODS:

We randomly assigned 315 patients with DAA treatment failure from five Egyptian sites into two groups. Group A (n = 158) received SOF/VEL/VOX for 12 weeks, and group B (n = 157) received SOF/VEL/VOX + weight-based ribavirin for 12 weeks. Therapeutic efficacy was defined as SVR12 (sustained virologic response 12 weeks after treatment end). Safety and tolerability were evaluated by monitoring treatment-related adverse events (AEs) and laboratory abnormalities.

RESULTS:

Males comprised 53.9% of group A and 57.1% of group B (p = 0.58); mean ages were 51.8 and 47.3 years in group A and B, respectively. Seventeen patients in each group were lost to follow-up. SVR12 rates were 87.3% (138/158) by intention-to-treat analysis and 97.8% (138/141) by per-protocol analysis in group A; and 87.9% (138/157) and 98.5% (138/140), respectively, in group B (p = n.s. for intention-to-treat and per-protocol analyses). Both regimens were well-tolerated, with no deaths and only one serious AE (anemia) in group B, which required ribavirin discontinuation. Fifty-five patients in group A vs. 77 in group B experienced any AE (p = 0.002).

CONCLUSION:

This randomized-controlled trial showed equal, high efficacy of both regimens for the retreatment of previous DAA failures, although ribavirin was associated with more AEs. Therefore SOF/VEL/VOX monotherapy should be the preferred retreatment strategy. CLINCIALTRIALS.

GOV NUMBER:

NCT04695769.

IMPACT AND IMPLICATIONS:

HCV treatment guidelines recommend retreatment of direct-acting antiviral (DAA) treatment failures with the combination of sofosbuvir, velpatasvir and voxilaprevir (SOF/VEL/VOX) for 12 weeks. However, whether ribavirin exerts an additional/synergistic effect remains unclear. The present study confirmed that SOF/VEL/VOX without ribavirin is the best regimen for retreatment of DAA treatment failures, and thus will help guide clinicians caring for patients who are not cured with a first course of DAA therapy.

2022-06-01·The lancet. Gastroenterology & hepatology1区 · 医学

Safety and efficacy of sofosbuvir–velpatasvir–voxilaprevir for re-treatment of chronic hepatitis C virus infection in patients with previous direct-acting antiviral treatment failure in Rwanda (SHARED-3): a single-arm trial

1区 · 医学

Article

作者: Grant, Philip M ; Serumondo, Janvier ; Manirambona, Linda ; Musabeyezu, Emmanuel ; Shumbusho, Fabienne ; Kateera, Fredrick ; Murangwa, Anthere ; Nsanzimana, Sabin ; Mukabatsinda, Constance ; Kabihizi, Jules ; Makuza, Jean Damascene ; Muvunyi, Claude Mambo ; Gupta, Neil ; Camus, Gregory

BACKGROUND:

Hepatitis C virus (HCV) genotype 4 non-a/d subtypes, which frequently have NS5A resistance-associated substitutions, are highly prevalent in sub-Saharan Africa. These subtypes, particularly genotype 4r, have been associated with higher rates of failure of treatment regimens containing the NS5A inhibitors ledipasvir or daclatasvir, which are the most accessible direct-acting antivirals in low-income countries. Clinical evidence regarding the efficacy of re-treatment options for these subtypes is limited. We aimed to evaluate the safety and efficacy of sofosbuvir-velpatasvir-voxilaprevir for the treatment of adults in Rwanda with chronic HCV infection, predominantly of genotype 4, and a history of direct-acting antiviral treatment failure.

METHODS:

In this single-arm prospective trial, we enrolled adults (aged ≥18 years) with a HCV RNA titre of at least 1000 IU/mL, and a documented history of direct-acting antiviral failure. Patients were assessed for eligibility at a single study site after referral from hospitals with HCV treatment programmes throughout Rwanda, and participants for whom sofosbuvir-ledipasvir treatment had failed in the previous SHARED trial were also included. Participants with decompensated liver disease or hepatitis B virus co-infection were excluded. Participants were treated once daily with an oral fixed-dose combination tablet containing sofosbuvir (400 mg), velpatasvir (100 mg), and voxilaprevir (100 mg) for 12 weeks. The primary endpoint was the proportion of participants with a sustained virological response 12 weeks after completion of treatment (SVR12) in the intention-to-treat population. Viral sequencing of NS3, NS5A, and NS5B genes was done at baseline in all participants and at end of follow-up (week 24) in participants with treatment failure. The study is registered with ClinicalTrials.gov (NCT03888729) and is completed.

FINDINGS:

Between Sept 23, 2019, and Jan 10, 2020, 49 individuals were screened and 40 participants were enrolled. 20 (50%) were female, 20 (50%) were male, median age was 63 years (IQR 56-68), and median HCV viral load was 6·2 log₁₀ IU/mL (5·8-6·5) at baseline. The genotype subtypes identified were 4r (18 [45%] participants), 4k (six [15%]), 4b (five [13%]), 4q (four [10%]), 4l (two [5%]), 4a (one [3%]), 4m (one [3%]), and 3h (one [3%]). One (3%) genotype 4 isolate could not be subtyped, and one (3%) isolate was of unknown genotype. All successfully sequenced isolates (33 [83%]) had at least two NS5A resistance-associated substitutions and 25 (63%) had three or more. 39 (98% [95% CI 87-100]) participants had SVR12. Seven (18%) participants had a total of ten grade 3, 4, or 5 adverse events, including three (8%) cases of hypertension, and one (3%) case each of cataract, diabetes, gastrointestinal bleeding, joint pain, low back pain, vaginal cancer, and sudden death. Four of these events were categorised as serious adverse events resulting in hospitalisation. The one sudden death occurred at home from an unknown cause 4 weeks after the completion of treatment. No serious adverse event was determined to be related to the study drug or resulted in treatment discontinuation.

INTERPRETATION:

A 12 week course of sofosbuvir-velpatasvir-voxilaprevir is safe and efficacious for the re-treatment of individuals infected with HCV genotype 4 non-a/d subtypes with frequent baseline NS5A resistance-associated substitutions, following failure of previous direct-acting antiviral treatment. Improved affordability and access to sofosbuvir-velpatasvir-voxilaprevir in regions with these subtypes is crucial.

FUNDING:

Gilead Sciences.

2020-09-28·Journal of Clinical and Translational Hepatology

Review of Clinically Relevant Drug Interactions with Next Generation Hepatitis C Direct-acting Antiviral Agents

Review

作者: Yoshida, Eric M ; Wright, Robert C ; Partovi, Nilu ; Hong, Jenny ; Hussaini, Trana

In this review, we examine the pharmacokinetics and clinically relevant drug interactions of the newer generation direct-acting antivirals (DAAs) for the treatment of chronic hepatitis C, specifically sofosbuvir/velpatasvir (Epclusa^®), sofosbuvir/velpatasvir/voxilaprevir (Vosevi^®), glecaprevir/pibrentasvir (Maviret^®), and elbasvir/grazoprevir (Zepatier^®). We searched MEDLINE (1948-January 2020), Embase (1964-January 2020), Google, and GoogleScholar using the terms pharmacokinetics, drug interaction, drug metabolism, sofosbuvir, velpatasvir, Epclusa, voxilaprevir, Vosevi, glecaprevir, pibrentasvir, Maviret, elbasvir, grazoprevir, and Zepatier, from inception to January 13, 2020. The search was limited to randomized controlled trials, in vitro studies, prospective and retrospective human studies, drug monographs, abstracts, and conference proceedings. All relevant published literature on pharmacokinetic and pharmacodynamic interactions involving DAAs were reviewed and the data extracted. Numerous clinically relevant drug-drug interactions (DDIs) were identified with the newer generation DAAs and commonly prescribed drugs. NS3/4A protease inhibitors are more likely to be involved in DDIs, followed by NS5A inhibitors and NS5B polymerase inhibitor. The majority of clinically relevant DDIs are predictable, according to known pharmacokinetic, pharmacodynamics, and physicochemical properties of DAAs; however, in select cases, unpredictable DDIs do occur. As expected, many drug interactions exist between newer generation DAAs and commonly prescribed medications. While the majority of clinically relevant interactions are predictable, many require therapeutic dose adjustment or careful selection of non-interacting drugs. In select cases, severe and unpredictable drug interactions can occur. Clinicians should consult hepatitis C virus pharmacotherapy experts and tertiary drug interaction resources when initiating DAA therapy in patients taking other medications.

项与索磷维伏相关的新闻（医药）

2026-09-02

·硅谷VC圈

硅谷华人创立乙肝医药公司Ausper获1.2亿美元C轮融资

9月6日全球美股投资者线上交流会扫码报名👆👆 AusperBio（中文“浩博医药”）是一家专注于慢性乙型肝炎功能性治愈的寡核苷酸药物公司，采用美国硅谷进行研发与中国临床开发相结合的运营模式。公司宣布完成1.2亿美元C轮融资，投资机构包括RA Capital Management、HanKang Capital、Sherpa Capital、InnoPinnacle Fund、Qiming Venture Partners、YuanBio Venture Capital、CDH Investments。 AusperBio的两位联合创始人分别是CEO程国锋博士和CSO Chris Yang博士。两人的共同背景是曾在吉利德科学公司Gilead Sciences从事抗病毒药物研发。程国锋博士拥有微生物学与免疫学博士背景，毕业于伊利诺伊大学芝加哥分校，并曾在斯克里普斯研究所进行博士后研究，接受乙肝与病毒免疫领域著名科学家Frank Chisari指导。进入Gilead后，他长期负责抗病毒新药研发，曾担任高级总监及核心生物学负责人，并参与了Harvoni、Epclusa和Vosevi等丙肝治愈性疗法的开发与监管申报过程。这些药物的意义在于，它们改变了丙肝治疗范式：患者可通过有限疗程取得极高治愈率，而非长期控制感染。 Chris Yang博士同样来自Gilead体系，曾担任药物代谢与药代动力学，即DMPK方向的负责人或高管。他参与过丙肝药物开发，并因相关贡献获得美国化学会“Heroes of Chemistry”奖项。与程国锋侧重病毒学、药理和临床转化不同，Yang的经历强化了AusperBio在寡核苷酸分子设计、体内暴露、组织分布、药代动力学与递送优化方面的能力。 AusperBio的成立，源自一个明确的产业判断：丙肝已经在直接抗病毒药物时代实现了高比例治愈，但乙肝的生物学机制更复杂，现有药物大多只能长期压制病毒，极少能让患者在停药后持续维持表面抗原消失与病毒学控制。因此，乙肝仍是抗病毒药物领域最重要、也最具技术挑战的“未解难题”之一。公司于2019年在美国硅谷创立，并逐步形成AusperBio Therapeutics, Inc.与Ausper Biopharma Co., Ltd.共同运营的结构，在美国和中国均有业务布局。其早期战略并非从传统小分子抗病毒路线切入，而是押注核酸药物，尤其是反义寡核苷酸，也就是ASO，以及后续的siRNA和肝靶向递送技术。公司希望以药物化学、递送系统和临床开发相结合的方式，直接干预HBV RNA及相关病毒蛋白表达。 2024年开始，AusperBio进入融资与临床推进加速期。从发展阶段看，AusperBio已由早期研发型biotech转向接近商业化的临床后期公司。它的核心任务不再只是验证概念，而是要完成III期注册研究、扩大生产能力、建立商业化准备体系，并验证第二代核酸药物与联合疗法的可扩展性。 AusperBio为何特别关注HBsAg，即乙肝表面抗原。长期以来，乙肝治疗难以实现功能性治愈的一个关键原因，是持续存在的表面抗原会造成免疫耐受或免疫耗竭。若药物能快速、深度且持久地降低HBsAg，便可能为患者免疫系统重新控制病毒创造条件。 AusperBio的产品布局以AHB-137为核心，并向新一代siRNA候选药物AHB-171及组合治疗方案扩展。公司主要依托两项平台：Med-Oligo™ ASO平台和Au-HALO™靶向递送平台。 AHB-137是公司的旗舰项目，也是在临床和商业价值上最重要的资产。它是一种非偶联型反义寡核苷酸药物，旨在靶向乙肝病毒相关RNA，从而减少HBsAg产生、抑制HBV DNA复制，并帮助恢复患者对病毒的免疫控制。与传统核苷或核苷酸类似物不同，AHB-137并非仅仅压制病毒复制，而是同时瞄准病毒蛋白表达与功能性治愈所需的免疫学转变。所谓“非偶联型”，意味着AHB-137并未采用某些核酸药物常见的配体偶联策略，而是依靠其自身的化学修饰、分子设计和组织分布特征发挥作用。AusperBio将这类能力归入Med-Oligo™平台。公司的技术主张是，在不牺牲药效和耐受性的前提下，构建能在肝脏中实现有效暴露的反义寡核苷酸药物，并使之具备快速降低HBsAg的潜力。 AHB-137已经完成全球I期研究及多项II期研究，目前正在中国开展III期注册临床试验。慢性乙肝的最大临床痛点，是现有主流治疗能够控制、却很难清除或长期关闭感染。核苷（酸）类似物如恩替卡韦、替诺福韦等可有效抑制HBV DNA复制，降低肝硬化和肝癌风险，但多数患者需要长期甚至终身服药；干扰素虽然有机会带来更高的表面抗原清除概率，却受限于疗效差异、不良反应和适用人群有限。世界卫生组织估计，全球约有2.54亿慢性乙肝感染者，每年约110万人死于主要由肝硬化和肝癌造成的乙肝相关疾病。对于这样一个患者基数巨大的疾病领域，“终身抑制”意味着医疗体系、患者依从性、长期支付和肝癌风险管理都面临长期负担。 AusperBio瞄准的是其中三个层面的核心难题。第一，是降低HBsAg。HBsAg长期存在不仅是病毒活跃的重要标志，也是免疫系统难以有效清除感染的重要原因之一。传统NA类药物对HBsAg下降的作用有限，而AHB-137的设计目标就是直接抑制相关病毒RNA和表面抗原生成，从而创造免疫恢复窗口。第二，是实现有限疗程治疗。若患者可以在数月疗程后持续维持HBsAg消失和HBV DNA受控，治疗就有可能从“无限期服药”变成“有限疗程后停药观察”。这对患者生活质量、长期用药负担和医保支付逻辑都有潜在意义。功能性治愈并不等于彻底根除患者体内所有HBV遗传物质，例如cccDNA或整合病毒DNA，但它通常意味着血液中HBsAg与HBV DNA长期不可检测，并显著改善临床结局。第三，是解决患者异质性。慢乙肝患者在HBeAg状态、基线HBsAg、病毒复制水平、既往NA治疗史以及免疫状态上差异很大。单一药物未必能覆盖所有人群，因此AusperBio不仅开发ASO，也布局siRNA、递送平台和联合治疗策略。其真正想建立的，不只是一个药物，而是一套面向乙肝功能性治愈的核酸药物平台。总体而言，AusperBio代表了中国创新药公司和美国生物科技生态融合的一种典型路径：以国际化研发团队切入重大未满足医疗需求，以核酸药物平台建立技术壁垒，再以中美临床开发和资本市场资源推动全球化。若AHB-137能够顺利完成III期并证明其停药后的功能性治愈具有稳定性，它有机会成为慢乙肝治疗从长期抑制走向有限疗程治愈的重要参与者；若AHB-171及Au-HALO™平台也得到临床验证，公司则可能从一家单品驱动企业成长为覆盖多种核酸药物机制的肝病治疗平台型公司。 - End - ======================= Startup/VC投融资服务初创公司融资服务 WeDeal位于美国硅谷，专注于为北美种子轮及A轮阶段创业公司提供融资服务，帮助创始人在超5000家美国VC和PE中找到合适的投资人。投资人Deal Sourcing服务 WeDeal位于美国硅谷，专注为全球全球天使投资人、VC、PE、家办、国际化企业提供硅谷及北美优质早期项目资源。如有需求，请私信后台咨询。 =================== 美股二级市场数据服务 StockFan App - 用户覆盖全球60个国家的美股大数据和社区平台扫码下载StockFan App

2026-08-28

·平哥慢谈

浩博医药1.2亿美元C轮融资的底气

8月28日，杭州浩博医药（AusperBio）宣布完成1.2亿美元C轮融资，由全球知名战略投资机构领投，RA Capital入局，老股东启明创投、汉康资本、夏尔巴、鼎晖VGC、元生创投、元生资本、InnoPinnacle等全部跟投。自2024年以来累计融资3.6亿美元。在Biotech融资整体收紧的当下，这笔钱砸向一家还没产品上市的小核酸公司，底气是什么？一、事件：C轮1.2亿美元，全部押注乙肝功能性治愈浩博医药成立于2019年8月，总部位于杭州滨江天和高科技产业园，中美双总部运作，是一家临床阶段的寡核苷酸创新药公司。本轮融资将重点投向三件事： 1. 核心产品AHB-137 III期注册临床试验及商业化准备； 2. AHB-171（siRNA）临床推进及下一代联合疗法布局； 3. Med-Oligo™ ASO与Au-HALO™递送平台向其他重大疾病领域拓展。从融资节奏看，浩博医药2024年完成A轮3700万美元、B轮7300万美元；2025年又完成B+轮5000万美元、B2轮6300万美元；2026年再拿C轮1.2亿美元——两年七轮、累计3.6亿美元，且老股东复购率极高，这在当下一级市场极为罕见。二、赛道：乙肝功能性治愈，千亿美金蓝海慢性乙肝是全球公共卫生难题。中国约有8600万乙肝病毒携带者，全球感染者约2.96亿。现有核苷（酸）类似物需终身服药，临床治愈率不到3%，治疗率仅15%-20%。据弗若斯特沙利文测算，中国乙肝抗病毒药物市场规模将从2023年的24.3亿元增至2030年的723亿元，七年近30倍。 2026年8月24日，GSK的反义寡核苷酸（ASO）药物Bepirovirsen获日本厚生劳动省批准，成为全球首个慢乙肝功能性治愈药物。这一里程碑彻底坐实了ASO/siRNA路线在乙肝治愈领域的核心地位，也让跟在身后的浩博医药估值逻辑陡然清晰——AHB-137是全球第二个进入临床阶段的同类ASO，且临床数据更具差异化。小核酸药物（ASO/siRNA）是继小分子、抗体之后的"第三类药物"，通过直接靶向mRNA从源头抑制致病蛋白。全球已有十余款产品上市，2025年市场规模突破百亿美元。国内歌礼、拓创、瑞博、舶望等多家公司布局乙肝赛道，但临床进度和数据质量上，浩博目前处于国产第一梯队。三、管线：AHB-137单药16周，70%临床治愈浩博的核心底气来自AHB-137在2026年EASL（欧洲肝病学会）年会上公布的II期随访数据，这是一组让投资人愿意掏钱的数字：试验由浙大一院领衔，随机双盲安慰剂对照，初治慢乙肝患者每周一次AHB-137（300mg）治疗16周，停药后随访24周。结果显示： • 基线HBsAg 100-1000 IU/mL人群，临床治愈率达70%； • 整体人群临床治愈率32%（传统疗法<3%）； • 治疗结束时68%患者达完全应答； • 停药24周后病毒学应答和抗原清除持久维持； • 安全性与耐受性良好。 "16周有限疗程→停药持久治愈"，这正是乙肝治疗梦寐以求的范式——把终身服药变成"打疫苗式"的短程治愈。AHB-137已获CDE突破性治疗品种认定，正在推进多项全球II期及中国III期试验。第二张牌AHB-171是基于Au-HALO™肝靶向递送平台开发的siRNA候选药，已完成慢乙肝患者首例给药，未来将与AHB-137形成ASO+siRNA序贯联合方案，进一步抬升治愈率天花板。公司还布局了治疗性乙肝疫苗和鼻喷中和抗体，形成"基石药+联合疗法"矩阵。四、团队：吉利德丙肝治愈"梦之队" 浩博医药的团队底色，是中国Biotech中极少见的"真正做过治愈药"的班子。 CEO程国锋博士：美国伊利诺伊大学芝加哥医学院微生物及免疫学博士，Scripps研究所博士后（师从病毒学泰斗Frank Chisari）。在吉利德工作十余年，官至抗病毒新药高级研发总监、乙肝治愈新药研发核心领导人，作为首席生物学家共同主导研发了三款FDA批准的丙肝治愈药——夏帆宁（Harvoni）、丙通沙（Epclusa）、沃士韦（Vosevi）。这三款药合计销售额峰值超200亿美元，直接把丙肝从"难治"变成"可治愈"。 CSO杨成勇博士：联合创始人，寡核苷酸药物研发资深专家，与程国锋搭档多年，主导Med-Oligo™ ASO平台从零搭建。核心团队多有吉利德、Alnylam、Ionis等小核酸和抗病毒领域顶级公司背景。"做过丙肝治愈→再做乙肝治愈"，这是浩博区别于其他Biotech最硬的信用背书——团队证明过自己能把一款治愈药从实验室推到FDA批准。五、机构加持：顶级美元基金+产业资本全明星阵容 C轮领投的"全球知名战略投资机构"虽未具名，但结合入局者和老股东名单，浩博的股东表堪称医疗投资圈"全家福"：几个信号值得注意：第一，RA Capital入局。这家长期专注生物医药的纽约对冲基金，以严格的临床和科学尽调著称，通常只投有全球竞争力的资产，其入局常被视为国际资本对中国Biotech资产质量的"盖章"。第二，老股东全部复购。从Pre-A到C轮，启明、汉康、夏尔巴、鼎晖、元生等核心股东一轮不落地跟投，说明每一轮临床数据都在持续验证最初的投资逻辑。第三，信达生物创始人俞德超的InnoPinnacle连续加码。作为中国创新药产业最成功的创业者科学家之一，俞德超对浩博的持续背书具有强烈的产业信号意义。结语：底气来自"数据+团队+资本"三重共振浩博医药1.2亿美元C轮的底气，不是故事，而是三重确定性的叠加：AHB-137用70%临床治愈率的数据，证明了ASO路线在乙肝治愈上的潜力；程国锋团队用三款丙肝治愈药的履历，证明了自己能把药做出来；顶级机构七轮3.6亿美元的持续押注，证明了资本市场愿意为这个组合买单。 GSK的Bepirovirsen已经在日本撞线，浩博是身后最有力的中国追赶者。III期临床如果复刻II期数据，中国乙肝功能性治愈的第一款国产ASO，可能就在这家杭州公司手里。本文仅为行业信息整理与个人观点分享，不构成任何投资建议或投资依据。瑞博生物：国内小核酸药物第一股只要半年注射一次Zilebesiran就可以控制高血压了吗？--浅谈小核酸药的投资要点

2026-08-28

·融中社

杭州生物制药公司融资8亿，开创乙肝治愈变革性疗法

融中社8月28日报道，生物制药公司浩博医药（AusperBio）今日宣布完成1.2亿美元（约8.06人民币）C轮融资。本轮融资由全球知名战略投资机构领投，新投资者RA Capital Management参与投资，汉康资本、夏尔巴投资、InnoPinnacle Fund、启明创投、元生创投和鼎晖VGC等现有投资者继续跟投。该公司自2024年以来累计融资已达3.6亿美元。资金用途方面，本轮资金将重点支持核心产品AHB-137的III期注册临床试验及商业化准备，加速推进HBV siRNA候选药物AHB-171以及以AHB-137为基石的下一代联合疗法研发，并进一步拓展公司寡核苷酸创新产品管线。浩博医药是一家即将进入商业化阶段的生物制药公司，专注于开发差异化的寡核苷酸治疗药物及靶向递送技术，初期聚焦慢性乙型肝炎的功能性治愈。该公司依托自主研发的Med-Oligo™ ASO和Au-HALO™靶向递送平台，推进多种寡核苷酸创新疗法的开发。 AHB-137已在临床研究中展现出积极的临床疗效，有望成为慢性乙型肝炎功能性治愈的基石疗法。围绕这一核心产品，该公司正持续布局下一代慢性乙型肝炎治疗方案。该公司联合创始人、CEO及董事长程国锋博士在抗病毒药物研发领域拥有深厚经验。他曾担任Gilead公司抗病毒新药研发高级总监，期间共同主导研发FDA获批的三个丙型肝炎治愈创新药物Harvoni、Epclusa和Vosevi，并曾担任Gilead乙肝治愈新药研发核心负责人，全方位引领cccDNA抑制剂和HBsAg抑制剂的新药开发。 ▲ 浩博医药联合创始人、CEO及董事长程国锋博士程国锋拥有美国伊利诺伊大学芝加哥分校微生物学及免疫学博士学位，博士后师从Scripps研究所Frank Chisari院士。联合创始人、CSO及董事会成员杨成勇博士拥有丰富的药物发现和开发经验。他曾在Gilead公司担任DMPK总监14年，共同主导研发前述三个丙肝治愈药物，并任Epclusa的临床研究、开发和监管申报核心领导，因在丙肝药物开发方面的贡献于2015年获美国化学学会"化学英雄"奖。 ▲ 浩博医药联合创始人、CSO及董事会成员杨成勇博士杨成勇还曾担任Gilead多个HIV药物研发领导团队的核心成员，在加入Gilead之前曾任Sugen公司抗癌药物Sutent的DMPK负责人。他拥有普渡大学药物化学及分子药理学博士学位。

100 项与索磷维伏相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10900	索磷维伏	J05A	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
丙型肝炎	中国	Gilead Sciences Ireland UC	2019-12-03
慢性丙型肝炎	美国	Gilead Sciences, Inc.	2017-07-18

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性丙型肝炎基因型 3	临床3期	美国	Gilead Sciences, Inc.	2015-12-23
慢性丙型肝炎基因型 3	临床3期	澳大利亚	Gilead Sciences, Inc.	2015-12-23
慢性丙型肝炎基因型 3	临床3期	加拿大	Gilead Sciences, Inc.	2015-12-23
慢性丙型肝炎基因型 3	临床3期	法国	Gilead Sciences, Inc.	2015-12-23
慢性丙型肝炎基因型 3	临床3期	德国	Gilead Sciences, Inc.	2015-12-23
慢性丙型肝炎基因型 3	临床3期	新西兰	Gilead Sciences, Inc.	2015-12-23
慢性丙型肝炎基因型 3	临床3期	英国	Gilead Sciences, Inc.	2015-12-23

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临床结果

适应症

分期

评价

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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


NCT05717400 (CTgov)	临床4期	晚期肝细胞癌 \| 慢性丙型肝炎	2	sofosbuvir+velpatasvir+atezolizumab+voxilaprevir+bevacizumab	齋顧鹽餘鹽鹽獵憲積繭 = 憲繭膚醖憲憲蓋糧窪鏇壓蓋觸獵膚築遞膚鬱鏇 (鹹積蓋齋襯醖顧鹹糧遞, 製憲繭膚鏇壓淵鹽製選 ~ 蓋鬱構衊鏇窪膚醖餘壓) 更多	-	2024-12-10
NCT04695769 (Pubmed \| J Hepatol)	临床4期	慢性丙型肝炎	315	SOF/VEL/VOX	壓遞鹽襯鏇築艱齋艱獵(壓餘膚築構積膚繭範糧) = 鹹鹹醖糧糧糧夢觸範窪鹽築觸構壓廠積鏇積壓 (壓鏇積遞獵襯壓鑰願構 )	积极	2023-04-21
NCT04695769 (Pubmed \| J Hepatol)	临床4期	慢性丙型肝炎	315	SOF/VEL/VOX + ribavirin	壓遞鹽襯鏇築艱齋艱獵(壓餘膚築構積膚繭範糧) = 齋夢餘鏇鏇鹹齋獵醖選鹽築觸構壓廠積鏇積壓 (壓鏇積遞獵襯壓鑰願構 )	积极	2023-04-21
NCT03888729 (SHARED-3, Pubmed \| Lancet Gastroenterol Hepatol)	临床4期	慢性丙型肝炎	40	Sofosbuvir-velpatasvir-voxilaprevir	鬱範簾鑰獵壓襯齋積簾(醖簾鏇鏇鏇壓蓋餘簾襯) = 構鑰齋鹹願憲淵觸觸簾製構鬱醖簾蓋願淵鏇鏇 (淵醖製網鬱鹽積襯選觸, 87 ~ 100)	积极	2022-03-03
NCT04211909 (CTgov)	临床3期	慢性丙型肝炎	87	SOF/VEL (SOF/VEL)	糧窪衊壓淵鬱繭壓築簾 = 遞網餘窪餘鏇淵簾憲齋淵鹽積糧壓顧淵鑰鬱鹽 (鑰鏇繭構鹽壓餘襯餘窪, 範簾憲積願製鬱顧憲簾 ~ 網製顧顧艱艱繭艱鬱觸) 更多	-	2021-10-27
NCT04211909 (CTgov)	临床3期	慢性丙型肝炎	87	SOF/VEL/VOX (SOF/VEL/VOX)	糧窪衊壓淵鬱繭壓築簾 = 範糧齋遞網鏇網憲構齋淵鹽積糧壓顧淵鑰鬱鹽 (鑰鏇繭構鹽壓餘襯餘窪, 窪憲構繭製製積選簾顧 ~ 蓋鹽壓窪壓夢鬱遞襯願) 更多	-	2021-10-27
NCT03619837 (PRO-ACT:, CTgov)	临床4期	丙型肝炎	122	Sofosbuvir/Velpatasvir+Sofosbuvir/Velpatasvir/Voxilaprevir	簾醖鏇製製願獵憲遞願 = 範憲願襯觸衊襯鬱遞衊糧鏇鬱鹹醖齋鹽糧鹹顧 (積鬱製膚獵積窪鏇觸廠, 憲壓膚鏇鏇夢夢鹹糧獵 ~ 願淵選鑰壓憲壓鹽範鏇) 更多	-	2021-03-03
NCT02938013 (deLIVER, CTgov)	临床4期	HIV感染 \| 丙型肝炎	15	Sofosbuvir/Velpatasvir/Voxilaprevir [SOF/VEL/VOX] (Group A)	鑰壓鹽艱築鑰蓋顧廠範 = 窪選積網製夢選繭壓獵醖淵鑰鏇鹹鏇築艱餘壓 (築襯夢襯鑰糧淵積鏇願, 繭鬱構網簾築簾選窪構 ~ 襯遞選憲積鑰襯齋夢憲) 更多	-	2020-11-16
NCT02938013 (deLIVER, CTgov)	临床4期	HIV感染 \| 丙型肝炎	15	Sofosbuvir/Velpatasvir (SOF/VEL) (Group B)	鑰壓鹽艱築鑰蓋顧廠範 = 憲鹽觸簾選觸鹹鏇簾糧醖淵鑰鏇鹹鏇築艱餘壓 (築襯夢襯鑰糧淵積鏇願, 遞鬱餘製鑰鑰襯艱艱鏇 ~ 襯簾壓壓廠鑰衊顧範觸) 更多	-	2020-11-16
NCT03820258 (CTgov)	临床2期	慢性丙型肝炎	21	SOF+VEL+VOX	壓鬱齋簾構鬱淵願築願(蓋獵窪顧顧簾觸鏇積窪) = 鹹範醖憲鬱簾鹹網積鹹糧願廠廠餘艱鹹夢構鑰 (齋觸餘簾顧餘襯憲淵襯, 1247.28) 更多	-	2020-08-31
NCT03118843 (CTgov)	临床3期	丙型肝炎	31	SOF/VEL/VOX	膚觸衊齋鹹鑰構網鏇餘 = 繭築繭憲願鹹願繭遞壓醖製衊範膚衊鹽夢鏇廠 (範襯願網襯膚遞襯獵範, 壓廠憲齋艱廠網齋窪選 ~ 鹹願顧遞夢艱鏇齋觸齋) 更多	-	2019-04-03
NCT02745535 (RESOLVE, CTgov)	临床2期	慢性丙型肝炎	77	Sofosbuvir/Velpatasvir/Voxilaprevir	範簾構淵壓糧壓鑰蓋構 = 壓鑰願製鹹鏇構蓋憲淵獵壓壓壓積淵顧夢選壓 (網艱鬱艱廠壓夢齋繭夢, 壓襯願襯鏇壓憲觸齋鹹 ~ 簾壓遞衊鹹壓壓憲膚觸) 更多	-	2019-03-27
NCT02607735 (POLARIS-1, CTgov)	临床3期	慢性丙型肝炎	416	SOF/VEL/VOX (SOF/VEL/VOX (Primary Study))	選蓋醖簾鹽夢觸鏇膚構 = 艱製製夢淵窪糧壓築願齋鏇蓋繭積顧製鏇鑰鹽 (壓選觸齋鑰艱壓蓋鏇鹽, 構願廠鏇顧鹹積糧築鏇 ~ 鬱積積膚醖鏇遞衊觸衊) 更多	-	2017-12-13
NCT02607735 (POLARIS-1, CTgov)	临床3期	慢性丙型肝炎	416	Placebo (Placebo (Primary Study))	繭膚遞糧範鹽糧襯廠選 = 憲膚壓觸艱製蓋鏇網糧餘構鹽網鏇醖糧醖築襯 (壓衊繭鏇願簾鏇選獵膚, 獵遞鹽鏇廠夢壓觸窪鑰 ~ 顧鹽餘襯廠簾襯糧網齋) 更多	-	2017-12-13