- Participants achieving HBsAg loss with pegylated interferon alfa (PEG-IFNα) ± elebsiran or BRII-179 demonstrated favorable off-treatment clinical outcomes, with most HBsAg rebounds <10 IU/mL and HBV DNA rebound infrequent and not associated with clinically significant ALT elevation. These findings indicate durable post.

- 使用聚乙二醇干扰素α（PEG-IFNα）± elebsiran 或 BRII-179 实现 HBsAg 消失的参与者展示了良好的停药后临床结果，大多数 HBsAg 反弹 <10 IU/mL，HBV DNA 反弹少见且未伴随有临床意义的 ALT 升高。这些发现表明其具有持久的疗效。

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treatment immunological control, supporting the potential for safe nucleos(t)ide reverse transcriptase inhibitor (NRTI) discontinuation in regimens combining PEG-IFNα with novel therapeutic modalities.

治疗性免疫控制，支持在PEG-IFNα与新型治疗模式结合的方案中安全停用核苷（酸）逆转录酶抑制剂（NRTI）的潜力。

- Shorter NRTI consolidation was not associated with higher HBsAg rebound rates, suggesting that shortening or potentially eliminating the NRTI consolidation period may be feasible in these combination regimens.

- 较短的NRTI巩固治疗并未伴随更高的HBsAg反弹率，这表明在这些联合治疗方案中缩短或可能消除NRTI巩固期是可行的。

DURHAM, N.C. and BEIJING

杜伦（美国北卡罗来纳州）和北京

,

，

April 26, 2026

2026年4月26日

/PRNewswire/ --

/PRNewswire/ --

Brii Biosciences Limited

腾盛博药有限公司

('Brii Bio,' 'Brii,' or the 'Company,' stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet medical need, presented a cross-study analysis of post-treatment hepatitis B surface antigen (HBsAg) rebound profiles at the 35.

（“腾盛博药”、“Brii”或“公司”，股票代码：2137.HK）是一家致力于开发改善患者健康和选择的疗法的生物技术公司，针对高度未满足医疗需求的疾病，在第35届会议上展示了治疗后乙型肝炎表面抗原（HBsAg）反弹特征的跨研究分析。

th

th

Annual Meeting of Asian Pacific Association for the Study of the Liver (APASL 2026), taking place from April 22-25, 2026 in Istanbul, Turkey.

2026年亚太肝病研究协会（APASL 2026）年会，将于2026年4月22日至25日在土耳其伊斯坦布尔举行。

This analysis evaluated post-end-of-treatment (EOT) HBsAg rebound in NRTI-experienced participants with chronic hepatitis B virus (HBV) infection who achieved HBsAg loss in the Phase 2 ENSURE study or the Phase 2 BRII-179-002 study. The Phase 2 ENSURE study is designed to assess the safety and efficacy of combination approaches aimed at improving functional cure outcomes.

本分析评估了在2期ENSURE研究或2期BRII-179-002研究中，曾接受过NRTI治疗并实现HBsAg消失的慢性乙型肝炎病毒（HBV）感染者在治疗结束（EOT）后HBsAg反弹的情况。2期ENSURE研究旨在评估组合方法的安全性和有效性，以改善功能性治愈结果。

Cohorts 1-3 evaluate elebsiran in combination with PEG-IFNα compared to PEG-IFNα monotherapy, while Cohort 4 evaluates the potential role of BRII-179 in identifying immunologically responsive patients and improving HBsAg loss rate. BRII-179-002 is a multicenter, randomized, double-blind, proof-of-concept Phase 2 study that evaluates BRII-179 as an add-on therapy to PEG-IFNα..

队列1-3评估了elebsiran联合PEG-IFNα与PEG-IFNα单药治疗的比较，而队列4则评估了BRII-179在识别免疫响应患者和提高HBsAg清除率方面的潜在作用。BRII-179-002是一项多中心、随机、双盲、概念验证的2期研究，评估BRII-179作为PEG-IFNα的附加疗法。

Data from the two studies were pooled to assess the incidence, magnitude and clinical relevance of HBsAg rebound following EOT in participants treated with PEG‑IFNα alone or in combination with elebsiran or BRII‑179. Across studies, participants demonstrated favorable off‑treatment clinical outcomes.

两项研究的数据被汇总起来，以评估接受PEG‑IFNα单独治疗或与elebsiran或BRII‑179联合治疗的参与者在治疗结束（EOT）后HBsAg反弹的发生率、幅度和临床相关性。在各项研究中，参与者表现出良好的非治疗期临床结果。

All HBsAg rebounds remained below 100 IU/mL with most rebounds remaining below 10 IU/mL. HBV DNA rebound was infrequent and not associated with clinically meaningful alanine aminotransferase (ALT) elevations following NRTI discontinuation. Together, these results suggest durable post‑treatment immunological control and further support the potential for safe discontinuation of NRTIs in PEG‑IFNα-based combination with novel therapeutic modalities.

所有HBsAg反弹均保持在100 IU/mL以下，且大多数反弹保持在10 IU/mL以下。HBV DNA反弹不常见，并且在停止NRTI治疗后未伴随有临床意义的丙氨酸氨基转移酶（ALT）升高。这些结果共同表明治疗后持久的免疫控制，并进一步支持在基于PEG-IFNα的联合治疗中安全停用NRTI的潜力，特别是结合新型治疗方式时。

Notably, shorter NRTI consolidation periods (12 to 20 weeks versus 24 weeks) were not associated with higher HBsAg rebound rates, suggesting that shortening—and potentially eliminating—the NRTI consolidation period may be feasible in future treatment strategies..

值得注意的是，较短的NRTI巩固期（12至20周对比24周）并未伴随更高的HBsAg反弹率，这表明在未来的治疗策略中，缩短甚至可能消除NRTI巩固期是可行的。

'We are encouraged by the growing evidence showing that our novel therapeutic combinations can achieve not only rapid HBsAg loss, but also durable immunological control after treatment withdrawal,' said David Margolis, M.D., Chief Medical Officer of Brii Bio. 'These findings strengthen our confidence in the potential of BRII‑179 and elebsiran as components of next‑generation HBV cure strategies, and we look forward to additional readouts from our ongoing studies throughout 2026.'.

“我们受到越来越多证据的鼓舞，这些证据表明我们的新型治疗组合不仅能够实现乙肝表面抗原（HBsAg）的快速消失，还能在治疗结束后实现持久的免疫控制，”腾盛博药首席医疗官David Margolis博士表示。“这些研究结果增强了我们对BRII-179和elebsiran作为下一代乙肝治愈策略组成部分潜力的信心，我们期待在2026年期间从正在进行的研究中获得更多数据。”

Additional details of the oral presentation are as follows:

口头报告的更多细节如下：

Title:

标题：

Cross-study Analysis of HBsAg Rebound Following Treatments of Elebsiran/BRII-179 in Combination with Peginterferon Alfa

Elebsiran/BRII-179联合聚乙二醇干扰素α治疗后HBsAg反弹的跨研究分析

Session/Presentation Type:

会议/演示类型：

Oral Presentation Session 58

口头报告会议 58

Date and time:

日期和时间：

13:40 - 15:10 on April 25 (UTC+3)

4月25日13:40 - 15:10（UTC+3）

Presenter:

主持人：

Jidong Jia, M.D., Ph.D., Professor of Medicine at the Liver Research Centre, Beijing Friendship Hospital, Capital Medical University in Beijing, China

中国北京首都医科大学附属北京友谊医院肝病研究中心医学教授贾继东，医学博士，哲学博士

Post‑EOT HBsAg rebound was observed in 24 of 55 participants (43.6%) with similar rates during NRTI consolidation (13/55, 23.6%) and after NRTI discontinuation (11/41, 26.8%).

在55名参与者中有24人（43.6%）观察到EOT后HBsAg反弹，NRTI巩固期间（13/55，23.6%）和NRTI停药后（11/41，26.8%）的反弹率相似。

Shorter NRTI consolidation was not associated with higher HBsAg rebound rates after NRTI withdrawal, with 15.0% (3/20) of participants receiving 12–20 weeks of NRTI consolidation and 23.8% (5/21) of those receiving 24 weeks experiencing HBsAg rebound by 24 weeks after NRTI discontinuation.

较短的NRTI巩固治疗与NRTI停药后较高的HBsAg反弹率无关，在接受12-20周NRTI巩固治疗的参与者中有15.0%（3/20）出现HBsAg反弹，而接受24周治疗的参与者中则有23.8%（5/21）在NRTI停药后24周内出现HBsAg反弹。

The magnitude of HBsAg rebound was limited, with all rebounds <100 IU/mL and 75.0% (18/24) remaining <10 IU/mL. HBV DNA rebound after NRTI discontinuation was infrequent, with >90% (38/41) of participants maintaining HBV DNA <LLOQ at the last available visit. No ALT flares were observed; one participant exceeded the normal range and received NRTI retreatment at investigator discretion..

HBsAg 的反弹幅度有限，所有反弹均 <100 IU/mL，且 75.0% (18/24) 的反弹保持在 <10 IU/mL。停止 NRTI 治疗后 HBV DNA 的反弹较少见，在最后一次随访中，超过 90% (38/41) 的参与者维持 HBV DNA <LLOQ。未观察到 ALT 爆发；一名参与者超出正常范围，并由研究者决定重新接受 NRTI 治疗。

About Hepatitis B

关于乙型肝炎

Hepatitis B virus (HBV) infection is one of the world's most significant infectious disease threats with more than 254 million people infected globally.

乙型肝炎病毒（HBV）感染是全球最严重的传染病威胁之一，全球感染人数超过2.54亿。

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[

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Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV infection each year.

慢性乙型肝炎感染是肝脏疾病的主要原因，据估计，每年有82万人死于慢性乙型肝炎感染的并发症。

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HBV is of exceptional concern in China, where 87 million people are chronically infected.

在中国，乙型肝炎病毒尤为令人担忧，有8700万人受到慢性感染。

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About BRII-179

关于BRII-179

BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, designed to induce enhanced and broad B-cell and T-cell immunity. In November 2023, the Center for Drug Evaluation (the 'CDE') of China's National Medical Products Administration (the 'NMPA') granted BRII-179 Breakthrough Therapy Designation..

BRII-179 是一种新型的基于重组蛋白的乙肝病毒（HBV）免疫治疗候选药物，可表达 Pre-S1、Pre-S2 和 S 乙肝病毒表面抗原，旨在诱导更强和广泛的 B 细胞和 T 细胞免疫反应。2023 年 11 月，中国国家药品监督管理局（NMPA）药品审评中心（CDE）授予 BRII-179 突破性疗法认定。

About

关于

Elebsiran

埃莱布西兰

Elebsiran is an investigational subcutaneously administered HBV-targeting siRNA designed to degrade HBV RNA transcripts and limit the production of hepatitis B surface antigen. It has the potential to have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index.

Elebsiran 是一种研究性皮下给药的靶向乙型肝炎病毒（HBV）的小干扰 RNA（siRNA），旨在降解 HBV 的 RNA 转录本并限制乙型肝炎表面抗原的产生。它对 HBV 和丁型肝炎病毒（HDV）具有直接抗病毒活性的潜力。这是首个在临床中应用增强稳定化学 Plus 技术的 siRNA，该技术可提高稳定性并减少脱靶活性，从而可能提高治疗指数。

Brii Bio licensed exclusive rights to develop and commercialize elebsiran for the Greater China territory from Vir Biotechnology, Inc. in 2020. In May 2024, the CDE of China's NMPA granted elebsiran Breakthrough Therapy Designation..

2020年，腾盛博药从Vir生物技术公司获得了在大中华地区开发和商业化elebsiran的独家权利。2024年5月，中国国家药品监督管理局药品审评中心授予elebsiran突破性疗法认定。

About Brii Bio

关于腾盛博药

Brii Biosciences Limited ('Brii Bio', stock code: 2137.HK) is a biotechnology company developing therapies to improve patients' health by addressing high unmet medical needs with limited treatment options. The Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection.

腾盛博药生物科技有限公司（“腾盛博药”，股票代码：2137.HK）是一家生物技术公司，致力于通过解决治疗选择有限的高未满足医疗需求来改善患者健康。公司正在推进一系列独特的治疗候选药物，其中针对乙型肝炎病毒（HBV）感染的项目处于领先地位。

The Company is led by a visionary and experienced leadership team and has operations in both China and the United States. For more information, visit .

公司由富有远见且经验丰富的领导团队带领，并在中国和美国均设有业务。欲了解更多信息，请访问。

www.briibio.com

www.briibio.com

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。

1

1

World Health Organization. (April 2024). Global hepatitis report 2024: action for access in low- and middle-income countries. World Health Organization. Retrieved from

世界卫生组织（2024年4月）。《2024年全球肝炎报告：在低收入和中等收入国家采取行动促进可及性》。世界卫生组织。检索自

https://www.who.int/publications/i/item/9789240091672

https://www.who.int/publications/i/item/9789240091672

2

2

World Health Organization. Hepatitis. World Health Organization. Retrieved from

世界卫生组织。肝炎。世界卫生组织。检索自

https://www.who.int/china/health-topics/hepatitis#:~:text=There%20are%2087%20million%20people,living%20with%20chronic%20hepatitis%20C.

https://www.who.int/china/health-topics/hepatitis#:~:text=中国有8700万人,感染慢性丙型肝炎。

SOURCE Brii Biosciences Limited

来源：腾盛博药生物科技有限公司

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