A Phase 2a Randomized, Double-blinded, Placebo-controlled, Multi Center, Dose Ranging Study of the Safety and Efficacy of ATI-2173 and Vebicorvir in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection

This is a randomized, double-blinded, placebo-controlled, multi center, dose ranging study of safety and efficacy in volunteers with chronic hepatitis B virus infection. Volunteers will be administered multiple oral doses of ATI-2173 vebicorvir in combination with tenofovir disoproxil fumarate and assessed for safety and efficacy including blood tests to show how the body metabolizes and eliminates the investigational drug as well as how the drug effects the virus infection.

开始日期2022-04-11

申办/合作机构

Antios Therapeutics, Inc.

NCT04820686

/ Terminated临床2期

A Randomized Phase 2a, Multicenter, Open-Label, Multiple-Cohort Study Evaluating Regimens Containing Vebicorvir in Subjects With Chronic Hepatitis B Virus Infection

The purpose of this study is to determine if vebicorvir (VBR, ABI-H0731) in combination with AB-729 is safe and effective in participants with chronic hepatitis B infection (cHBV) receiving a standard of care nucleos(t)ide/reverse transcriptase inhibitor (SOC NrtI).

开始日期2021-05-07

申办/合作机构

Assembly Biosciences, Inc.

[+1]

NCT04781647

/ Terminated临床2期

A Randomized Phase 2a, Multicenter, Open-label Study Evaluating ABI-H0731-Containing Regimens in Patients With Chronic Hepatitis B

The purpose of this study is to evaluate the safety, antiviral activity, and pharmacokinetics of ABI-H0731 in combination with entecavir (ETV) and with ETV plus pegylated-interferon alpha (Peg-IFNα) in Chinese participants with chronic hepatitis B virus infection (cHBV)

开始日期2021-02-18

申办/合作机构

Assembly Biosciences, Inc.

100 项与 Vebicorvir 相关的临床结果

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100 项与 Vebicorvir 相关的转化医学

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100 项与 Vebicorvir 相关的专利（医药）

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项与 Vebicorvir 相关的文献（医药）

2024-04-01·JHEP reports : innovation in hepatology

Long-term open-label vebicorvir for chronic HBV infection: Safety and off-treatment responses

Article

作者: Weilert, Frank ; Schiff, Eugene R ; Bonacini, Maurizio ; Nguyen, Tuan T ; Han, Steven-Huy ; Agarwal, Kosh ; Gane, Edward J ; Kwo, Paul Yien ; Bennett, Michael ; Stamm, Luisa M ; Hassanein, Tarek ; Hann, Hie-Won ; Fung, Scott ; Ayoub, Walid S ; Yuen, Man-Fung ; Ma, Julie ; Zomorodi, Katie ; Ramji, Alnoor ; Ravendhran, Natarajan ; Sulkowski, Mark S ; Park, James S ; Chan, Sing ; Jacobson, Ira M ; Ma, Xiaoli ; Dieterich, Douglas T ; Nahass, Ronald G ; Bae, Ho S ; Lalezari, Jacob ; Knox, Steven J ; Elkhashab, Magdy ; Yan, Ran

Background & Aims:

The investigational first-generation core inhibitor vebicorvir (VBR) demonstrated safety and antiviral activity over 24 weeks in two phase IIa studies in patients with chronic HBV infection. In this long-term extension study, patients received open-label VBR with nucleos(t)ide reverse transcriptase inhibitors (NrtIs).

Methods:

Patients in this study (NCT03780543) previously received VBR + NrtI or placebo + NrtI in parent studies 201 (NCT03576066) or 202 (NCT03577171). After receiving VBR + NrtI for ≥52 weeks, stopping criteria (based on the treatment history and hepatitis B e antigen status in the parent studies) were applied, and patients either discontinued both VBR + NrtI, discontinued VBR only, or continued both VBR + NrtI. The primary efficacy endpoint was the proportion of patients with HBV DNA <20 IU/ml at 24 weeks off treatment.

Results:

Ninety-two patients entered the extension study and received VBR + NrtI. Long-term VBR + NrtI treatment led to continued suppression of HBV nucleic acids and, to a lesser extent, HBV antigens. Forty-three patients met criteria to discontinue VBR + NrtI, with no patients achieving the primary endpoint; the majority of virologic rebound occurred ≥4 weeks off treatment. Treatment was generally well tolerated, with few discontinuations due to adverse events (AEs). There were no deaths. Most AEs and laboratory abnormalities were related to elevations in alanine aminotransferase and occurred during the off-treatment or NrtI-restart phases. No drug-drug interactions between VBR + NrtI and no cases of treatment-emergent resistance among patients who adhered to treatment were observed.

Conclusions:

Long-term VBR + NrtI was safe and resulted in continued reductions in HBV nucleic acids following completion of the 24-week parent studies. Following treatment discontinuation, virologic relapse was observed in all patients. This first-generation core inhibitor administered with NrtI for at least 52 weeks was not sufficient for HBV cure.

Clinical trial number:

NCT03780543.

Impact and implications:

Approved treatments for chronic hepatitis B virus infection (cHBV) suppress viral replication, but viral rebound is almost always observed after treatment discontinuation, highlighting an unmet need for improved therapies with finite treatment duration producing greater therapeutic responses that can be sustained off treatment. First-generation core inhibitors, such as vebicorvir, have mechanisms of action orthogonal to standard-of-care therapies that deeply suppress HBV viral replication during treatment; however, to date, durable virologic responses have not been observed after treatment discontinuation. The results reported here will help researchers with the design and interpretation of future studies investigating core inhibitors as possible components of finite treatment regimens for patients with cHBV. It is possible that next-generation core inhibitors with enhanced potency may produce deeper and more durable antiviral activity than first-generation agents, including vebicorvir.

2022-11-01·Journal of hepatology

Safety and efficacy of vebicorvir administered with entecavir in treatment-naïve patients with chronic hepatitis B virus infection

Article

作者: Ayoub, Walid S ; Hann, Hie-Won L ; Nguyen, Tuan T ; Hassanein, Tarek ; Evanchik, Marc ; Weilert, Frank ; Alves, Katia ; Ma, Julie ; Chan, Sing ; Lalezari, Jacob P ; Ramji, Alnoor ; Knox, Steven J ; Gane, Edward J ; Yuen, Man-Fung ; Schiff, Eugene R ; Agarwal, Kosh ; Bae, Ho S ; Bonacini, Maurizio ; Lopatin, Uri ; Han, Steven-Huy B ; Elkhashab, Magdy ; Park, James S ; Kwo, Paul Yien ; Ravendhran, Natarajan ; Ma, Xiaoli ; Huang, Qi ; Jacobson, Ira M ; Stamm, Luisa M ; Nahass, Ronald G ; Fung, Scott K ; Colonno, Richard ; Bennett, Michael ; Yan, Ran ; Sulkowski, Mark S ; Dieterich, Douglas T

BACKGROUND & AIMS:

Nucleos(t)ide reverse transcriptase inhibitors do not completely suppress HBV DNA in chronic HBV infection (cHBV). Vebicorvir (VBR) is an investigational core inhibitor that interferes with multiple aspects of HBV replication. This phase II trial evaluated the safety and efficacy of VBR in combination with entecavir (ETV) in treatment-naïve patients with cHBV.

METHODS:

HBeAg-positive, treatment-naïve patients without cirrhosis were randomised 1:1 in a double-blind manner to once-daily VBR 300 mg+ETV 0.5 mg or placebo (PBO)+ETV 0.5 mg for 24 weeks. The primary endpoint was change in mean log₁₀ HBV DNA from Baseline to Week 12 and 24.

RESULTS:

All patients in both treatment groups (PBO+ETV: 12/12; VBR+ETV: 13/13) completed the study. At Week 12, VBR+ETV led to a greater mean (SD) reduction from Baseline in log₁₀ IU/ml HBV DNA (-4.45 [1.03]) vs. PBO+ETV (-3.30 [1.18]; p = 0.0077). At Week 24, VBR+ETV led to a greater reduction from Baseline in log₁₀ IU/ml HBV DNA (-5.33 [1.59]) vs. PBO+ETV (-4.20 [0.98]; p = 0.0084). Greater mean reductions in pregenomic RNA were observed at Week 12 and 24 in patients receiving VBR+ETV vs. PBO+ETV (p <0.0001 and p <0.0001). Changes in viral antigens were similar in both groups. No drug interaction between VBR and ETV was observed. Two patients experienced HBV DNA rebound during treatment, with no resistance breakthrough detected. The safety of VBR+ETV was similar to PBO+ETV. All treatment-emergent adverse events and laboratory abnormalities were Grade 1/2. There were no deaths, serious adverse events, or evidence of drug-induced liver injury.

CONCLUSIONS:

In this 24-week study, VBR+ETV provided additive antiviral activity over PBO+ETV in treatment-naïve patients with cHBV, with a favourable safety and tolerability profile.

CLINICAL TRIAL NUMBER:

NCT03577171 LAY SUMMARY: Hepatitis B is a long-lasting viral infection of the liver. Current treatments can suppress hepatitis B virus but do not offer the opportunity of cure, hence, new treatment approaches are required. Herein, we show that the combination of the novel core inhibitor vebicorvir with an existing antiviral (entecavir) in treatment-naïve patients chronically infected with hepatitis B virus demonstrated greater antiviral activity than entecavir alone. Additionally, vebicorvir was safe and well tolerated. Thus, further studies evaluating its potential role in the treatment of chronic hepatitis B are warranted.

2022-10-01·Perfusion4区 · 医学

Oxygenator impact on meropenem/vaborbactam in extracorporeal membrane oxygenation circuits

4区 · 医学

Article

作者: Cies, Jeffrey J ; Giliam, Nadji ; Chopra, Arun ; Low, Tracy ; Marino, Daniel ; Deacon, Jillian ; Moore, Wayne S ; Nikolos, Peter ; Enache, Adela

Introduction::

To determine the oxygenator impact on alterations of meropenem (MEM)/vaborbactam (VBR) in a contemporary neonatal/pediatric (1/4-inch) and adolescent/adult (3/8-inch) extra corporeal membrane oxygenation (ECMO) circuit including the Quadrox-i® oxygenator.

Methods::

1/4-inch and 3/8-inch, simulated closed-loop ECMO circuits were prepared with a Quadrox-i pediatric and Quadrox-i adult oxygenator and blood primed. Additionally, 1/4-inch and 3/8-inch circuits were also prepared without an oxygenator in series. A one-time dose of MEM/VBR was administered into the circuits and serial pre- and post-oxygenator concentrations were obtained at 5 minutes, 1, 2, 3, 4, 5, 6, 8, 12, and 24-hour time points. MEM/VBR was also maintained in a glass vial and samples were taken from the vial at the same time periods for control purposes to assess for spontaneous drug degradation.

Results::

For the 1/4-inch circuit, there was an approximate mean 55% MEM loss with the oxygenator in series and a mean 33%–40% MEM loss without an oxygenator in series at 24 hours. For the 3/8-inch circuit, there was an approximate mean 70% MEM loss with the oxygenator in series and a mean 30%–38% MEM loss without an oxygenator in series at 24 hours. For both the 1/4-inch circuit and 3/8-inch circuits with and without an oxygenator, there was <10% VBR loss for the duration of the experiment.

Conclusions::

This ex-vivo investigation demonstrated substantial MEM loss within an ECMO circuit with an oxygenator in series with both sizes of the Quadrox-i oxygenator at 24 hours and no significant VBR loss. Further evaluations with multiple dose in-vitro and in-vivo investigations are needed before specific MEM/VBR dosing recommendations can be made for clinical application with ECMO.

项与 Vebicorvir 相关的新闻（医药）

2026-01-22

·今日头条

2026乙肝新药迎来突破！临床治愈不再是梦，这些人群优先受益

近年来，乙肝治疗领域确实取得了一系列重要进展，特别是新型治疗药物的研发为临床治愈带来了新的希望。然而，医学进步需要客观、严谨地呈现，任何夸大宣传或误导性信息都可能对患者造成伤害。本文基于截至2026年1月的权威医学文献、临床试验数据和官方发布信息，系统梳理乙肝治疗的真实进展、临床治愈的现状与挑战、新药研发的客观情况，旨在帮助患者和家属科学认识当前治疗水平，避免不切实际的期望，合理规划治疗方案。需要特别强调的是：本文所有数据、信息均标注明确来源或说明假设条件，不夸大疗效，不虚构数据，不承诺无法确定的时间表。医学发展有其客观规律，新药研发、审批、上市、普及需要时间，患者应基于当前可及的治疗方案进行规范管理，而非盲目等待"突破性新药"。第一章：临床治愈——定义、现状与客观认知一、什么是乙肝临床治愈？医学定义：根据《慢性乙型肝炎防治指南（2022年版）》和国内外肝病学共识，乙肝临床治愈（functional cure，也称功能性治愈）是指：停药后24周以上，乙肝表面抗原（HBsAg）持续阴性，HBV DNA检测不到，肝功能指标正常。需要澄清的关键点： 1. 不是病毒完全清除：临床治愈不等于病毒从体内彻底清除。肝细胞内的cccDNA（病毒复制模板）可能仍存在，但处于非活动状态，不会造成肝脏损伤。 2. 不是"根治"：医学上不使用"根治"这一表述，因为存在极低概率的远期复发风险（约1%-2%）。 3. 停药后需持续监测：达到临床治愈标准后，仍需定期复查（建议每6-12个月），监测HBsAg、HBV DNA和肝功能。临床意义：达到临床治愈后，患者可停止抗病毒治疗，肝硬化、肝癌的发生风险显著降低（接近健康人群水平），生活质量明显改善。这是目前乙肝治疗的最高目标，但并非所有患者都能实现。二、当前临床治愈的真实水平（截至2026年1月）现有治疗方案下的治愈率：目前临床实践中，主要采用核苷（酸）类似物（如恩替卡韦、替诺福韦）联合或不联合聚乙二醇干扰素治疗。根据大规模临床研究和真实世界数据： - 总体人群：经现有方案治疗，停药后24周HBsAg清除率约5%-10%（不同研究数据略有差异） - 优势人群：对于基线HBsAg≤1500 IU/mL、HBeAg阴性、无肝硬化的患者，通过优化治疗（如延长干扰素疗程、个体化调整方案），临床治愈率可达15%-30% - 长期随访数据：停药后3-5年，维持临床治愈状态的比例约80%-90%，复发风险主要发生在停药后1年内重要提醒：上述数据基于严格筛选的患者群体、规范的治疗方案和长期随访。实际临床实践中，因患者依从性、个体差异等因素，真实世界的治愈率可能略低于研究数据。三、临床治愈的获益与局限主要获益： - 停止长期服药，减轻经济负担和心理压力 - 肝硬化、肝癌风险显著降低（非肝硬化患者肝癌年发生率从0.5%-1.0%降至接近健康人群水平） - 生活质量改善，社会心理负担减轻客观局限： - 并非所有患者都能达到：目前仍有约70%-90%的患者无法通过现有方案实现临床治愈 - 存在个体差异：年龄、性别、基因型、免疫状态等因素影响治疗效果 - 治疗过程可能伴随副作用：干扰素治疗可能出现流感样症状、骨髓抑制等不良反应 - 费用问题：部分治疗方案（如长期干扰素）费用较高，且医保报销比例因地区而异第二章：新药研发进展——客观现状与时间表一、新药研发的基本流程与时间周期从研发到上市的关键阶段： 1. 临床前研究（1-3年）：实验室研究、动物实验 2. I期临床试验（1-2年）：安全性、耐受性、药代动力学研究 3. II期临床试验（1-3年）：初步有效性、剂量探索 4. III期临床试验（2-4年）：大规模有效性、安全性验证 5. 上市申请与审批（0.5-2年）：向药监部门提交申请，等待审批 6. 上市后监测（持续）：IV期临床研究、真实世界数据收集关键事实：一个创新药从研发到上市，通常需要8-12年甚至更长时间，成功率不足10%。即使完成III期试验，仍有约20%的药物在审批阶段失败。二、当前在研乙肝新药的真实情况（截至2026年1月）以下信息基于公开的临床试验注册信息、学术会议摘要和药企官方发布，所有数据均为截至2026年1月的客观状态： 1. 小核酸药物（siRNA/ASO）代表药物：bepirovirsen（GSK836，葛兰素史克研发） - 研发阶段：已完成两项III期临床试验（B-Together和B-Well研究），计划2026年第一季度提交上市申请（注意：是"提交申请"，不是"获批上市"） - 作用机制：靶向HBV RNA，降低HBsAg水平 - 关键数据：2025年公布的IIb期研究显示，在HBsAg≤1000 IU/mL的优势人群中，24周治疗后的HBsAg清除率约9%-10%（停药后24周数据）。III期完整数据尚未在学术期刊发表，具体疗效和安全性需等待同行评审。 - 客观评估：该药是进展最快的在研新药之一，但2026年上市可能性极低（从提交申请到获批通常需6-12个月，且存在审批失败风险）。即使获批，初期可能仅限特定人群使用。其他siRNA药物：如VIR-2218、JNJ-3989等，多数处于II期或早期III期，2026年上市无望。 2. 口服表面抗原抑制剂代表药物：GST-HG131（广生堂研发） - 研发阶段：仅完成II期临床试验（2025年公布初步结果），计划2026年启动III期试验（注意：是"启动"，不是"完成"或"上市"） - 作用机制：口服小分子药物，降低HBsAg水平 - 关键数据：II期研究显示，12周治疗使HBsAg平均下降0.9 log IU/mL。该数据反映的是HBsAg下降幅度，而非临床治愈率。临床治愈需要停药后持续清除，而该研究尚未完成停药随访。 - 客观评估：该药处于相对早期阶段，从启动III期到完成、提交上市申请，通常需要2-3年。2026年上市完全不可能。其他类似药物：如GST-HG141、贺普拉肽等，均处于更早期阶段（I期或临床前）。 3. 衣壳抑制剂、免疫调节剂等 - 衣壳抑制剂（如ABI-H0731、JNJ-6379）：部分完成II期，但疗效数据有限，2026年上市可能性极低 - 治疗性疫苗：多数处于早期临床阶段，距离上市遥远 - 新型免疫检查点抑制剂：安全性问题尚未完全解决，研发进展缓慢三、关于"2026年新药上市"的客观判断核心结论： - 唯一可能提交上市申请：bepirovirsen（GSK836）计划2026年Q1提交申请，但获批时间不确定（可能2026年底或2027年） - 其他药物：所有其他在研药物（包括GST-HG131、siRNA药物等）2026年不可能上市，多数处于II期或更早阶段 - "多款新药上市"是虚假表述：截至2026年1月，没有任何一款在研乙肝新药获得上市批准，更不存在"多款同时上市"的情况重要提醒：药物研发存在高度不确定性。即使完成III期试验，也可能因安全性问题、疗效不足、审批标准变化等原因失败。患者应基于当前已上市的药物制定治疗计划，而非等待未确定的新药。第三章：医保政策与治疗费用——真实情况与合理预期一、2025-2026年乙肝药物医保现状 2025年国家医保目录（2026年1月1日执行）： - 新增药物：甲磺酸普雷福韦（新舒沐）被纳入，这是2025年唯一新增的乙肝抗病毒药物 - 已纳入药物：恩替卡韦、替诺福韦、丙酚替诺福韦等一线核苷（酸）类似物均已纳入，报销比例因地区而异（职工医保通常70%-85%） - 干扰素：聚乙二醇干扰素α-2a/2b在多数地区纳入医保，但报销比例可能低于口服药关键事实核查： - bepirovirsen、GST-HG131等新药：均未纳入2025年医保目录（因为它们尚未获批上市） - "已纳入乙类医保"是虚假表述：新药需先获批上市，再通过医保谈判程序（通常每年一次）才有可能纳入。文章将"未来可能纳入"表述为"已纳入"，严重误导读者 - 报销比例：不存在全国统一的"80%"标准。实际报销比例由各地医保政策决定，且新药纳入后需通过谈判确定支付标准二、新药纳入医保的时间表与不确定性医保纳入流程： 1. 药物获批上市（国家药监局批准） 2. 企业申请纳入医保目录（通常在每年7-8月） 3. 医保谈判（9-11月） 4. 谈判成功，次年1月1日执行客观评估： - 即使bepirovirsen2026年获批上市，最早也要2027年1月才能进入医保（如果谈判成功） - 其他在研药物因上市时间更晚，医保纳入时间更不确定 - 不存在"2026年新药就能医保报销"的情况三、治疗费用的合理预期当前可及方案的费用（以职工医保为例）： - 恩替卡韦/替诺福韦：每月费用约200-300元，医保报销后自付约50-100元 - 丙酚替诺福韦：每月费用约300-400元，医保报销后自付约100-150元 - 干扰素治疗：费用较高（每月1000-2000元），医保报销后自付比例因地区而异新药费用预期（如果未来上市）： - 创新药上市初期价格通常较高（可能每月数千元） - 即使纳入医保，自付部分可能仍高于现有药物 - 价格会随时间下降，但初期可及性有限建议：患者应基于当前可及、医保覆盖的治疗方案进行规划，而非寄希望于未确定的新药降价或医保覆盖。第四章：哪些患者可能从新治疗中获益？——科学评估而非简单分类一、影响治疗效果的客观因素根据现有临床研究和专家共识，以下因素可能影响临床治愈的可能性： 1. 基线HBsAg水平：HBsAg≤1500 IU/mL的患者，临床治愈率相对较高。这是目前最重要的预测因素。 2. HBeAg状态：HBeAg阴性患者（非活动性携带或治疗后血清学转换）的治愈率高于HBeAg阳性患者。 3. 肝脏基础：无肝硬化或代偿期肝硬化患者优于失代偿期肝硬化患者。 4. 年龄与免疫状态：年轻患者（<40岁）、免疫功能正常者可能获益更多。 5. 既往治疗反应：对核苷（酸）类似物治疗反应良好（HBV DNA持续检测不到）的患者，后续联合治疗可能更有效。重要提醒：上述因素是统计学趋势，而非绝对标准。个体差异很大，不能简单地对号入座。是否适合某种治疗方案，必须由肝病专科医生综合评估。二、关于"优势人群"的客观解读原文将患者分为"5类优势人群"并给出具体治愈率数据，这种表述存在严重问题：问题1：数据来源不明 - 文章声称"bepirovirsen优势患者治愈率25%""联合干扰素治愈率47%"，但这些数据缺乏任何公开发表的文献支持 - 已发表的IIb期研究显示，在严格筛选的HBsAg≤1000 IU/mL人群中，HBsAg清除率约9%-10%（停药后24周）。"25%"数据可能来自更早期的探索性研究，样本量小，不具代表性。 - "47%"这一数字完全虚构，没有任何研究报道过如此高的治愈率。问题2：分类过于简化 - 临床治愈受多因素影响，不能仅凭HBsAg水平或年龄简单分类 - 即使在同一"优势人群"中，个体差异仍很大 - 这种简化分类可能误导患者自我判断，忽视专业评估的重要性正确认知：不存在绝对的"优势人群"或"非优势人群"。每个患者都应接受个体化评估，由医生根据完整临床资料（病毒载量、肝功能、肝脏影像、既往治疗史等）制定方案。第五章：规范治疗的核心原则——避免误区，科学管理一、当前治疗的基本原则对于需要治疗的患者（符合抗病毒治疗指征）： 1. 首选一线核苷（酸）类似物：恩替卡韦、替诺福韦、丙酚替诺福韦是国内外指南推荐的一线治疗药物，能有效抑制病毒复制，延缓疾病进展。 2. 定期监测：每3-6个月复查HBV DNA、肝功能、HBsAg定量；每6-12个月做肝脏影像学检查（B超或FibroScan

2024-08-08

·同写意

一家抗病毒明星Biotech的溃逃

本次以“突破瓶颈打造健康产业新引擎”为主题，设一场主论坛和八场主题论坛，从前沿创新突破、临床应用拓展、工艺技术优化、商业化开发等多个全新视角推动CGT技术开发与应用，成就健康产业未来。差不多十年前，著名风投公司ARCH Venture Partners联合创始人Robert Nelsen，萌生了想要创办一家药企，以应对世界上最为严重的病原体。 “这是一个疯狂的想法。”曾在渤健和Vertex从事艾滋病毒和丙肝药物开发工作的Vicki Sato，在接到Nelsen的电话时评价道。虽然传染病一直存在，但在彼时，越来越多的药企正撤出传染病领域。然而，对于以疯狂的想法发家致富的Nelsen，这没有什么值得大惊小怪的。毕竟，有时科学听起来也很疯狂：通过改造细胞来治疗癌症，找到延缓衰老的药物。凭借“用免疫系统解决病原体”的独特想法，Nelsen收获了肯定，2016年成功组建Vir Biotechnology。戏剧性的是，信誓旦旦，言犹在耳，这家Biotech却在前不久宣布停止肝炎之外的传染病项目研究，引入抗癌产品。 Vir并不孤单，曾经因抗病毒药物而声名鹊起的吉利德和Vertex，也已将不少精力转向癌症、神经学、罕见疾病和自身免疫。传染病药企发展的宿命注定如此吗？相较于行业，这更是准备重组的Vir需要回答的问题。 1 创造没有传染病的世界多年来，生物技术公司一直想要攻克传染病。但由于技术、投入产出不成比例等原因，这个领域的进展缓慢。 Nelsen获得信赖的想法是，与其试图为每种病原体想出解药，不如像研究癌症的科学家那样，利用免疫系统做这项工作。成立之初，Vir的目标是“创造一个没有传染病的世界”，并请来渤健前首席执行官George Scangos，担任Vir CEO。在一年的时间里，Vir收购了Humabs，获得5亿美元融资，并和斯坦福大学、哈佛大学等知名科研机构达成合作。 Vir开局顺利，但当时的大环境对传染病领域并不友好。 2014年，诺华几乎用整个传染病部门交换了GSK的相关癌症项目；Achaogen在2018年成功在美国推出自研的新型抗生素普拉佐米星（Zemdri），却因销售惨淡而在次年宣布破产。因而，在2019年10月IPO时，Vir股价以低于发行价18％的16.50美元开盘，并以14.02美元收盘（下跌29.9%）的表现，就并没有太让人感到意外。这种困扰并未持续多久。因为很快，COVID-19就来了。在此前，Vir就从埃博拉幸存者体内分离出了高效的中和抗体MAb114，疗效媲美再生元的REGN-EB3（三种抗体鸡尾酒），且明显优于美国另一家公司Mapp研发的ZMapp。2020年下旬，REGN-EB3、MAb114先后获得FDA批准。 COVID-19期间，在传染病领域已经有了一些积淀的Vir，从SARS康复患者体内分离出可以交叉识别COVID-19病毒的中和抗体，在此基础上开发了VIR-7831和VIR-7832两款中和抗体。 Vir抓住了风口，而MNC选择抓住了Vir。2020年4月，GSK宣布对Vir进行2.5亿美元的股权投资，共同开发上述两款产品。 2021年1月，Vir与礼来、GSK达成合作，在低风险的轻中度COVID-19患者中评估两种中和抗体疗法的组合。彼时，礼来已扩展其正在进行的BLAZE-4试验，以评估bamlanivimab与VIR-7831构成的组合疗法的效果。这次联盟，让Vir的股价飙升，一度达到141美元。 VIR-7831没有辜负期待。2021年5月，它获得FDA的紧急使用授权（EUA），通用名为sotrovimab，商品名为Xevudy，成为礼来、再生元之后第3款获得EUA的中和抗体，半年时间里取得了超10亿美元的销售额。即使面对“神兵”mRNA疫苗，中和抗体也有一战之力。数据显示，2021年COVID-19中和抗体试产规模达到110亿美元。在2022年，由于sotrovimab的贡献，Vir的营收超过16亿美元，在COVID-19期间的营收增长率一度达到1334%。Sotrovimab在40多个国家获得上市批准、临时授权或紧急使用授权，Vir市值水涨船高，一度接近200亿美元。 2 Biotech，起落落落随着COVID-19消退，相关红利也逐渐消失。据GSK年报，在2022年，sotrovimab销售额为23亿英镑，增长100%。到了2023年，销量下滑幅度直逼去年涨幅，达到98%，仅有4400万英镑。而在此前，由于病毒不断变异，sotrovimab的效力已经逐渐减弱。2021年3月，Vir宣布sotrovimab一项针对住院患者的III期临床ACTIV-3停止入组，原因是独立数据和安全监察委员会经分析认为对获益可能较小。 2022年4月，卫生保健提供者情况说明书中包含的数据显示，sotrovimab的授权剂量不太可能对BA.2亚型有效，sotrovimab在美国任何州或地区授权均被撤销。时来天地皆同力，运去英雄不自由。随后，REGEN-COV（再生元）、Evusheld（阿斯利康）等COVID-19中和抗体也相继撤出美国市场。2023年2月，GSK宣布不再与Vir就COVID-19相关项目进行继续合作。 COVID-19像是Vir发展的一个分界线，一边是泛着金光的光明未来，一边是迷雾笼罩的原始丛林。在剔除COVID-19项目后，当时Vir管线中走在前面的只有两个处在临床II期的肝炎项目，分别是单抗VIR-3434（Tobevibart）和siRNA药物VIR-2218（Elebsiran），均引进自Alynlam。 Tobevibart旨在抑制乙肝病毒和丁肝病毒进入肝细胞，中和乙肝病毒和丁肝病毒病毒体，并降低血液中的病毒体和亚病毒颗粒水平；Elebsiran可降解乙肝病毒RNA转录本并限制乙肝表面抗原的产生，可能对乙肝病毒和丁肝病毒具有直接的抗病毒活性。数据显示，2022年约有130万⼈死于病毒性肝炎，与结核病并列成为当年传染病中第二大死亡原因，仅次于COVID-19。但需要指出的是，乙肝市场并不是一个容易吃上的“饼”。就目前来说，乙肝病毒形成的cccDNA（共价闭合环状DNA）难以被清除，导致乙肝很难被彻底治愈，即使现在追求的功能性治愈也存在诸多问题，停药后容易复阳，中途放弃探索的药企也不在少数。比如，同样获得快速通道资格的在研乙肝新药ABI-H0731、ABI-H2158（Assembly Biosciences）均已折戟沙场。本身的技术难度之外，如何追赶并超越“前辈”，甚至抢占已上市产品的市场份额，也是颇不容易。 GSK、吉利德等巨头都有处在中后期的肝炎在研药物。GSK用于慢性乙肝治疗的Bepirovirsen在今年2月获得FDA“快速通道”资格；3月，吉利德Vemlidy扩充适应症，获得FDA批准治疗六岁及以上乙肝患者。尴尬的是，Vir能否在肝炎领域杀出一片天尚有待观察，该公司关注的另一重点领域流感也出了岔子。 2023年7月，Vir用于预防症状性甲型流感的VIR-2482在II期研究中未达到主要或次要疗效终点，股价大跌近45%。到年底，Vir宣布进行重组，裁员12%，并关闭位于密苏里州圣路易斯和俄勒冈州波特兰的研发设施。 3 选择更具性价比的路 8月1日，Vir宣布了一项战略性改革，透露将不再继续COVID-19和流感方面的工作，叫停基于T细胞的病毒载体平台，并把病毒学业务限制在其乙型和丁型肝炎项目中，专注于“近期的高价值机会”。具体来看，管线中的下一代COVID单克隆抗体VIR-7229、针对流感A和B的神经氨酸酶靶向单克隆抗体VIR-2981、临床前治疗性癌症疫苗VIR-1949，以及进入I期试验的HIV疫苗VIR-1388，都将不复存在。同时，Vir还披露了一项与赛诺菲达成的许可协议，获得后者三个临床阶段的条件激活CD3双抗，以及可切割蛋白酶掩蔽平台的独家使用权。 3款产品分别为： • SAR446309，一种双掩蔽HER2xCD3分子，目前正在I期开发中，用于治疗转移性、治疗抵抗性HER2阳性肿瘤，如乳腺癌和结直肠癌。 • SAR446329，一种双掩蔽PSMAxCD3候选物，处于I期临床试验阶段，针对患有转移性、去势抵抗性前列腺癌的患者。 • SAR446368，针对EGFR的双重掩蔽CD3 TCE，其IND已获得批准。预计1期临床试验将在2025年第一季度或更早启动，用于各种EGFR阳性癌症。不难看出，Vir新的重点锚定了癌症。 Vir的选择也许对标了赛诺菲、礼来、辉瑞等起初也是“传染病”起家的巨头，在某款产品中获得巨额利润后转向更大的疾病领域。需要指出的是，这些巨头已经拥有了巨大的资本积累。与Vir基本退出传染病领域形成对比的是，今年6月，吉利德预防HIV的III期试验取得积极结果，一年两针，100%有效。欢呼声掩盖了失意者的落寞，但现实困境确实横亘在前。囿于传染病的患者群体、地区、患病率、付费能力等现实因素，产品市场并不稳定，在大多数拥有支付能力的国家，癌症、自身免疫性疾病、神经退化才是“主要矛盾”。此外，药企公共沟通的不足可能也进一步加深传染病药物研发的困境。根据Endpoints数据，从2010年到2020年，风险资本向癌症投入的现金是传染病的5倍多。回望Vir的来时路，很遗憾一个为传染病而生的公司还是走向了更“稳妥”的选择。丁肝成了“最后的倔强”。6月初，Vir更新了在研项目的利好进展。 II期试验SOLSTICE的初步数据显示，tobevibart单药或与elebsiran联用治疗丁型肝炎病毒感染中耐受性良好，受试者在第12周和第24周实现了高病毒学应答率，且病毒学应答持久至48周，患者丙氨酸转氨酶（ALT）水平正常化的比率高。完整的24周治疗数据有望在2024年第四季度报告。FDA已授予tobevibart和elebsiran组合药物快速通道资格，用于治疗慢性丁型肝炎病毒感染。接受tobevibart与elebsiran联合疗法的HDV患者快速达到病毒学抑制和ALT水平正常化，图源：药明康德 2024年第二季度，Vir的收入为310万美元，低于去年同期的380万美元。截至2024年6月30日，Vir拥有14.3亿美元的现金、现金等价物和投资。在战略重组的工作中，Vir将裁员25%，在其运营中取消大约140个职位。年底时，员工人数将降至约435人，比去年的峰值减少了约200人。而作为与赛诺菲协议的一部分，Vir将从后者引进一些“具有丰富的T细胞接合剂科学和开发专业知识的关键员工”。这些调整预计将节省5000万美元，直至2025年底，Vir计划将这些资金重新投资于从赛诺菲获得的候选药物。未来，这家Biotech计划利用PRO-XTEN技术在多个领域进行创新开发，加强在癌症治疗领域的产品线，也将拓展至抗感染领域。不可否认，传染病仍是一个巨大的潜在市场。GlobalData预计，传染病市场将以每年5.7%的速度增长，2029年达到年销售额1500亿美元。问题是，这条赛道上，对于“脱胎换骨”的Vir能跑到什么位置，或许就不是那么乐观了。参考文献： 1、Vir Lays Off 25% of Staff, Abandons Most Virus Work and Pivots to Cancer in Sanofi Deal；biospace 2、Can investing in infectious disease pay off? Vir Biotechnology’s tightrope walk shows it’s a struggle；statnews 3、Vir Biotechnology官网 4、100%肝炎患者病毒持久抑制近1年！创新疗法亮眼结果公布；药明康德 5、After Big Pharma abandoned infectious diseases, 5 biotech contrarians decided to go all in. Then Covid-19 changed everything；endpoints 同写意媒体矩阵，欢迎关注↓↓↓

IPO并购

2024-05-08

·GlobeNewswire-Health Care

Assembly Biosciences Reports First Quarter 2024 Financial Results and Recent Highlights

Clinical trial application clearances received for a Phase 1a/1b trial for ABI-5366 targeting recurrent genital herpes, and a Phase 1b trial for ABI-4334 in chronic HBV infection; both studies on track to initiate by mid-2024 ABI-5366 interim Phase 1a first-in-human data expected in Q3 2024 and ABI-4334 interim Phase 1b data expected by end of year SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results and recent highlights for the first quarter ended March 31, 2024. “We are pleased that we now have regulatory clearance to initiate trials evaluating our promising investigational therapies ABI-5366 and ABI-4334 and look forward to sharing interim data from these studies later this year,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “These clearances are a significant step toward our goal of reaching key clinical inflection points for multiple programs in our antiviral pipeline by year end. Our continued clinical progress reflects the strength and agility of our highly experienced team and our singular focus of improving treatment options for those living with serious viral diseases.” First Quarter 2024 and Recent Highlights Two clinical trial applications received clearance to proceed: ABI-5366, a long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate, for initiation of Phase 1a/1b clinical studies in both healthy volunteers and in individuals with recurrent genital herpesABI-4334, a next-generation, highly potent capsid assembly modulator candidate, for initiation of a Phase 1b study in individuals with chronic hepatitis B virus (HBV) infection An abstract highlighting preclinical data for ABI-6250, an oral, small molecule HBV/hepatitis delta virus (HDV) entry inhibitor candidate, has been accepted for poster presentation at the European Association for the Study of the Liver (EASL) CongressTM 2024, June 5-8, 2024 Anticipated 2024 Milestones ABI-5366 and ABI-4334 studies expected to initiate by mid-2024: ABI-5366 Phase 1a interim clinical data expected in Q3 2024 and interim Phase 1b data expected in the first half of 2025ABI-4334 Phase 1b interim clinical data expected by the end of 2024 Two additional candidates are anticipated to enter the clinic by the end of 2024: ABI-1179, a long-acting HSV helicase-primase inhibitor contributed by Gilead Sciences, Inc. (Gilead) under the collaboration between Assembly Bio and GileadABI-6250, a small molecule orally-bioavailable HDV entry inhibitor First Quarter 2024 Financial Results Cash, cash equivalents and marketable securities were $113.0 million as of March 31, 2024, compared to $130.2 million as of December 31, 2023. Assembly Bio’s cash position is projected to fund operations into the second half of 2025.Revenues from collaborative research were $5.8 million for the three months ended March 31, 2024. There was no revenue recognized for the same period in 2023. Revenue for the three months ended March 31, 2024 consists of amounts recognized under the collaboration with Gilead.Research and development expenses were $11.9 million for the three months ended March 31, 2024, compared to $14.5 million for the same period in 2023. Increased expenses related to the development of ABI-1179 and ABI-6250 were more than offset by savings from the discontinuation of ABI-H3733 and vebicorvir as well as reduced employee and contractor-related expenses.General and administrative expenses were $4.6 million for the three months ended March 31, 2024, compared to $5.0 million for the same period in 2023. The decrease is primarily due to a decrease in non-cash stock-based compensation expense.Net loss attributable to common stockholders was $9.1 million, or $1.66 per basic and diluted share, for the three months ended March 31, 2024, compared to $19.0 million, or $4.46 per basic and diluted share, for the same period in 2023. The investigational products and investigational product candidates referenced here have not been approved anywhere globally, and their safety and efficacy have not been established. About Assembly BiosciencesAssembly Biosciences is a biotechnology company dedicated to the development of innovative small-molecule therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide. Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. For more information, visit assemblybio.com. Forward-Looking StatementsThe information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead Sciences, Inc., including all financial aspects of the collaboration and equity investments; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio’s product candidates from other companies’ candidates; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. More information about Assembly Bio’s risks and uncertainties are more fully detailed under the heading “Risk Factors” in Assembly Bio’s filings with the SEC, including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts Investor and Corporate: Shannon Ryan SVP, Investor Relations, Corporate Affairs and Alliance Management (415) 738-2992 investor_relations@assemblybio.com Media: Sam Brown Inc.  Hannah Hurdle  (805) 338-4752  ASMBMedia@sambrown.com ASSEMBLY BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands except for share amounts and par value) March 31, December 31, 2024 2023 (Unaudited) ASSETS Current assets Cash and cash equivalents $18,749 $19,841 Marketable securities 94,227 110,406 Accounts receivable from collaboration 43 43 Prepaid expenses and other current assets 4,149 3,497 Total current assets 117,168 133,787 Property and equipment, net 367 385 Operating lease right-of-use assets 2,036 2,339 Other assets 312 312 Total assets $ 119,883 $ 136,823 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $727 $461 Accrued research and development expenses 2,059 885 Other accrued expenses 2,051 5,744 Deferred revenue from a related party - short-term 32,771 30,915 Operating lease liabilities - short-term 1,145 1,220 Total current liabilities 38,753 39,225 Deferred revenue from a related party - long-term 47,738 55,379 Operating lease liabilities - long-term 791 1,122 Total liabilities 87,282 95,726 Commitments and contingencies Stockholders' equity Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding — — Common stock, $0.001 par value; 150,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 5,482,752 shares issued and outstanding as of March 31, 2024 and December 31, 2023 5 5 Additional paid-in capital 827,660 826,921 Accumulated other comprehensive loss (239) (81) Accumulated deficit (794,825) (785,748) Total stockholders' equity 32,601 41,097 Total liabilities and stockholders' equity $ 119,883 $ 136,823 ASSEMBLY BIOSCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands except for share and per share amounts) (Unaudited) Three Months Ended March 31, 2024 2023 Collaboration revenue from a related party $5,785 $— Operating expenses Research and development 11,879 14,547 General and administrative 4,635 5,012 Total operating expenses 16,514 19,559 Loss from operations (10,729) (19,559) Other income Interest and other income, net 1,652 609 Total other income 1,652 609 Net loss $ (9,077) $ (18,950) Other comprehensive loss Unrealized (loss) gain on marketable securities (158) 290 Comprehensive loss $ (9,235) $ (18,660) Net loss per share, basic and diluted $(1.66) $(4.46) Weighted average common shares outstanding, basic and diluted 5,483,313 4,251,037

财报临床1期临床申请临床2期

100 项与 Vebicorvir 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12054	-	-	-

研发状态

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
慢性乙型肝炎	临床2期	澳大利亚	Assembly Biosciences, Inc.	2017-06-15
慢性乙型肝炎	临床2期	韩国	Assembly Biosciences, Inc.	2017-06-15
乙型肝炎	临床2期	-	Indiana University	-

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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


NCT04781647 (CTgov)	临床2期	慢性乙型肝炎	54	ETV+ABI-H0731 (ABI-H0731 + ETV)	構壓網選醖築積廠範淵 = 積鬱積選築繭選選遞範網鹹廠觸醖鑰廠願獵鑰 (襯選鹹膚鑰獵獵簾蓋遞, 鏇築窪簾鹽簾蓋觸蓋構 ~ 憲繭夢齋襯鏇蓋夢積鹽) 更多	-	2023-10-06
				Peg-IFNα+ETV+ABI-H0731 (ABI-H0731 + ETV + Peg-IFNα)	構壓網選醖築積廠範淵 = 積製餘顧壓糧醖範襯網網鹹廠觸醖鑰廠願獵鑰 (襯選鹹膚鑰獵獵簾蓋遞, 願願艱淵衊膚餘襯淵憲 ~ 範簾鑰顧顧築鏇艱醖製) 更多
NCT04454567 (CTgov)	临床2期	慢性乙型肝炎	2	NrtI+ABI-H0731 (ABI-H0731 + SOC NrtI)	網艱選範簾醖餘衊顧簾 = 遞鹹鏇範網願繭獵窪襯積淵蓋醖膚遞顧醖壓醖 (蓋顧觸網獵鑰顧醖鑰製, 鹹構餘壓遞憲鏇繭憲觸 ~ 顧鹹構鏇壓製鏇遞鑰蓋) 更多	-	2022-10-20
				NrtI+ABI-H0731 (Placebo + SOC NrtI)	網艱選範簾醖餘衊顧簾 = 窪鑰糧憲夢鏇繭願願鏇積淵蓋醖膚遞顧醖壓醖 (蓋顧觸網獵鑰顧醖鑰製, 鏇淵選窪艱構艱鏇簾衊 ~ 鑰鹽壓淵鹹蓋艱壓壓艱) 更多
NCT03577171 (Study 202, EASL2022)	临床2期	慢性乙型肝炎	25	Vebicorvir 300 mg + Entecavir 0.5 mg	鏇齋餘獵繭獵糧鬱製壓(衊製壓築餘顧願衊願鏇) = 遞鹹淵壓選觸廠窪獵餘繭襯鏇築鑰願膚鹽窪築 (鬱獵鬱顧鹽窪繭製艱構 )	-	2022-06-25
				Placebo + Entecavir 0.5 mg	鏇鑰鬱獵顧選鏇遞糧夢(製廠顧獵顧鹹範蓋蓋築) = 鑰醖顧蓋憲繭鹽網鬱餘廠構鑰顧夢衊選憲鑰製 (觸餘觸選範艱鹹觸憲衊 ) 更多
NCT03577171 (Study 202, EASL2022)	临床2期	乙型肝炎 HBeAg positive \| HBcrAg \| HBV DNA ... 更多	-	Vebicorvir+Entecavir	鹹衊選窪願網築構遞築(願顧窪網選憲淵廠襯鹽) = 製觸鏇夢鑰夢積憲積鏇願齋廠顧廠繭窪廠願鏇 (醖願願選遞壓積蓋衊夢 )	-	2022-06-23
NCT03577171 (Pubmed)	临床2期	慢性乙型肝炎	25	Vebicorvir 300 mg+Entecavir 0.5 mg	遞構積齋網範糧鬱積獵(觸艱蓋襯艱遞鏇淵齋衊) = 積積範構觸艱簾繭願簾艱憲築淵廠鬱顧夢網窪 (淵鑰構艱淵窪窪顧簾窪 ) 更多	-	2022-06-10
				Placebo+Entecavir 0.5 mg	遞構積齋網範糧鬱積獵(觸艱蓋襯艱遞鏇淵齋衊) = 鑰繭壓選鬱鏇膚鹹構顧艱憲築淵廠鬱顧夢網窪 (淵鑰構艱淵窪窪顧簾窪 ) 更多
Study 211 (EASL2021)	N/A	慢性乙型肝炎 eAg positive \| sAg \| crAg	41	Vebicorvir	簾觸繭鹹齋鹹夢襯齋醖(壓獵齋鏇齋膚窪構膚鏇) = ALT elevation in 4/41 (10%) pts 遞鏇鏇夢夢構積網觸鹽 (鏇觸獵繭襯選鑰齋襯蓋 ) 更多	-	2021-06-23
				Placebo+NrtI
NCT03577171 (ABI-H0731-202 \| Study 202, CTgov)	临床2期	慢性乙型肝炎	25	SOC ETV+ABI-H0731 (ABI-H0731 + SOC ETV)	鹹範糧鹽醖顧網淵齋遞(鹽餘糧觸齋膚網廠獵獵) = 餘蓋獵鹽遞憲膚構願遞窪衊鹽窪餘鏇壓鏇艱廠 (艱網淵願衊獵積繭觸鑰, 0.890) 更多	-	2021-01-28
				Placebo Oral Tablet+SOC ETV (Placebo + SOC ETV)	鹹範糧鹽醖顧網淵齋遞(鹽餘糧觸齋膚網廠獵獵) = 餘鹹觸淵壓廠窪醖繭糧窪衊鹽窪餘鏇壓鏇艱廠 (艱網淵願衊獵積繭觸鑰, 0.999) 更多
NCT03576066 (ABI-H0731-201, CTgov)	临床2期	慢性乙型肝炎	73	SOC NUC+ABI-H0731 (ABI-H0731 + SOC NUC)	鹽壓觸積醖願觸製膚衊 = 夢艱衊構繭衊糧顧鹽憲淵鹹餘膚夢鹽鹹製夢鑰 (廠憲醖餘繭餘襯憲繭遞, 範壓壓製醖餘觸觸構觸 ~ 膚網鏇鹹窪鹽繭壓願壓) 更多	-	2021-01-28
				Placebo Oral Tablet (Placebo + SOC NUC)	鹽壓觸積醖願觸製膚衊 = 窪鑰餘願願廠餘醖遞遞淵鹹餘膚夢鹽鹹製夢鑰 (廠憲醖餘繭餘襯憲繭遞, 淵網窪鹹選衊鏇鹽築膚 ~ 醖遞膚鏇淵憲獵繭膚醖) 更多
ABI-H0731-211 (EASL2020)	临床2期	慢性乙型肝炎	-	ABI-H0731	鑰願糧憲淵淵簾繭糧艱(窪廠願餘遞網夢鹹網繭) = 廠鹽範壓憲觸夢製糧鹹構製鹽夢艱鹽艱鑰鑰築 (願壓選壓簾遞觸製遞鏇 ) 更多	-	2020-08-27