DURHAM, N.C. and BEIJING, May 13, 2024 /PRNewswire/ -- Brii Biosciences Limited ('Brii Bio' or the 'Company', stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet need, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designations for BRII-877 (tobevibart), an investigational broadly neutralizing monoclonal antibody targeting hepatitis B virus (HBV) and BRII-835 (elebsiran), an investigational HBV-targeting small interfering ribonucleic acid (siRNA).

北卡罗来纳州达勒姆和北京，2024年5月13日/PRNewswire/-Brii Biosciences Limited（“Brii Bio”或“公司”，股票代码：2137。HK），一家开发治疗方法以改善患者健康和选择需求未得到满足的疾病的生物技术公司，今天宣布，国家医药产品管理局（NMPA）药物评估中心（CDE）批准了Brii-877（tobevibart）的突破性治疗名称，Brii-877是一种针对乙型肝炎病毒（HBV）的研究性广泛中和单克隆抗体，Brii-835（elebsiran）是一种针对小干扰核糖核酸（siRNA）的研究性HBV。

This represents another milestone in the Company's pursuit of a functional cure for HBV, following the Breakthrough Therapy Designation granted for BRII-179, a recombinant protein-based HBV immunotherapeutic, in November 2023..

这是继2023年11月BRII-179（一种基于重组蛋白的HBV免疫治疗剂）获得突破性治疗指定后，该公司追求HBV功能性治疗的另一个里程碑。。

The Breakthrough Therapy Designation for BRII-877 (tobevibart) was supported by Phase 1 and 2 studies conducted by Vir Biotechnology ('Vir', Nasdaq: VIR) and Brii Bio. As of September 2023, more than 350 people living with HBV have received treatment of BRII-877 (tobevibart). Data has shown BRII-877 (tobevibart) to be well-tolerated and to have resulted in marked decreases in HBsAg levels suggesting the potential for BRII-877 (tobevibart) to be an important part of a treatment regimen for people living with chronic HBV infection and chronic hepatitis D virus (HDV) infection.

BRII-877（tobevibart）的突破性治疗指定得到了Vir Biotechnology（'Vir'，Nasdaq:Vir）和BRII Bio进行的第一阶段和第二阶段研究的支持。截至2023年9月，超过350名HBV感染者接受了BRII-877（tobevibart）的治疗。数据显示BRII-877（tobevibart）具有良好的耐受性，并导致HBsAg水平显着降低，这表明BRII-877（tobevibart）可能成为慢性HBV感染者治疗方案的重要组成部分。慢性丁型肝炎病毒（HDV）感染。

The Breakthrough Therapy Designation for BRII-835 (elebsiran) was supported by Phase 1 and 2 studies conducted by Brii Bio and its partner Vir. As of September 2023, more than 570 people living with HBV have participated in clinical studies where BRII-835 (elebsiran) has been shown to be well-tolerated and has demonstrated direct antiviral activity against HBV in participants with chronic HBV and HDV infection..

BRII-835（elebsiran）的突破性治疗指定得到了BRII Bio及其合作伙伴Vir进行的第一阶段和第二阶段研究的支持。截至2023年9月，超过570名HBV感染者参加了临床研究，其中BRII-835（elebsiran）已被证明具有良好的耐受性，并在慢性HBV和HDV感染的参与者中显示出对HBV的直接抗病毒活性。。

'Receiving Breakthrough Therapy Designations for BRII-877 and BRII-835 as well as the earlier Breakthrough Therapy Designation for BRII-179 further supports our long-held scientific rationales in the development of functional cure combination regimens for patients with chronic HBV infection,' said Dr.

“接受BRII-877和BRII-835的突破性治疗指定以及BRII-179的早期突破性治疗指定进一步支持了我们长期以来为慢性HBV感染患者开发功能性治疗联合方案的科学依据，”Dr。

Qing Zhu, Head of China R&D, Brii Bio. 'Brii Bio and our partner Vir Biotechnology have conducted numerous clinical trials over the past five years, from which we have gained comprehensive clinical safety and efficacy data as well as critical insight towards our late-stage development plan and achieving potentially higher rates of HBV functional cure in broader patient populations.'.

Brii Bio中国研发负责人朱青表示：“Brii Bio和我们的合作伙伴Vir Biotechnology在过去五年中进行了大量临床试验，从中我们获得了全面的临床安全性和有效性数据，以及对我们的后期发展计划的重要见解，并在更广泛的患者人群中实现了潜在的更高的HBV功能治愈率。”。

Having three breakthrough therapeutic modalities puts the Company in a unique position to address the broader populations of HBV infections including co-infection with HDV. As part of Brii Bio's approach to developing a functional cure for HBV, the Company and its partner Vir are progressing plans to initiate multiple combination studies in 2024 to further optimize the curative regimens that will inform the Company's registration strategy to bring the best regimens to HBV patients..

拥有三种突破性的治疗方式，使该公司在解决更广泛的HBV感染人群（包括与HDV合并感染）方面处于独特地位。作为Brii Bio开发HBV功能性治疗方法的一部分，该公司及其合作伙伴Vir正在计划于2024年启动多项联合研究，以进一步优化治疗方案，为公司的注册策略提供信息，为HBV患者提供最佳治疗方案。。

About Hepatitis B

关于乙型肝炎

Hepatitis B viral infection (HBV) is one of the world's most significant infectious disease threats with more than 254 million people infected globally.1 Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV each year.1 HBV is of exceptional concern in China, where 87 million people are infected.2.

乙型肝炎病毒感染（HBV）是世界上最重要的传染病威胁之一，全球感染人数超过2.54亿。1慢性HBV感染是肝病的主要原因，估计每年有820000人死于慢性HBV并发症。1 HBV在中国受到特别关注，中国有8700万人感染。

About Hepatitis D

关于丁型肝炎

Hepatitis D is a liver inflammation caused by the hepatitis D virus (HDV), which relies on hepatitis B virus (HBV) for replication. This infection can only occur in the presence of HBV. The combination of HDV-HBV co-infection is considered the most severe form of chronic viral hepatitis, leading to a quicker progression towards hepatocellular carcinoma and liver-related death.

丁型肝炎是由丁型肝炎病毒（HDV）引起的肝脏炎症，其依赖于乙型肝炎病毒（HBV）进行复制。这种感染只能在HBV存在的情况下发生。HDV-HBV合并感染被认为是最严重的慢性病毒性肝炎，导致肝细胞癌和肝相关死亡的进展更快。

Globally, nearly 5% of individuals with chronic HBV infection are affected by HDV. HDV infection can occur through either simultaneous infection with both hepatitis B and D (co-infection) or acquiring hepatitis D after already having hepatitis B (super-infection).3.

在全球范围内，近5%的慢性HBV感染者受到HDV的影响。HDV感染可以通过同时感染乙型肝炎和丁型肝炎（合并感染）或在已经患有乙型肝炎（超级感染）后获得丁型肝炎来发生。

About BRII-877 (Tobevibart)

关于BRII-877（Tobeibart）

BRII-877 (tobevibart) is an investigational subcutaneously administered neutralizing monoclonal antibody designed to block entry of HBV and HDV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. BRII-877 (tobevibart), which incorporates Xencor's Xtend™ and other Fc technologies, has been engineered to potentially function as a T-cell vaccine against HBV and HDV, as well as to have an extended half-life.

BRII-877（tobevibart）是一种研究性皮下给药的中和单克隆抗体，旨在阻止HBV和HDV进入肝细胞，并降低血液中病毒粒子和亚病毒颗粒的水平。BRII-877（tobevibart）结合了Xencor的Xtend™和其他Fc技术，已被设计为潜在的针对HBV和HDV的T细胞疫苗，并具有延长的半衰期。

Brii Bio licensed exclusive rights to develop and commercialize BRII-877 (tobevibart) for the greater China territory from Vir Biotechnology, Inc. ('Vir') in 2022..

Brii Bio于2022年从Vir Biotechnology，Inc.（“Vir”）获得了在大中华区开发和商业化Brii-877（tobevibart）的专有权。。

About BRII-835 (Elebsiran)

关于BRII-835（Elebsiran）

BRII-835 (elebsiran) is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and has direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index.

BRII-835（elebsiran）是一种研究性皮下注射的HBV靶向siRNA，具有刺激有效免疫反应的潜力，并具有针对HBV和HDV的直接抗病毒活性。这是临床上第一个包括增强稳定化学加（ESC+）技术的siRNA，以增强稳定性并最大程度地降低脱靶活性，这可能会导致治疗指数增加。

Brii Bio licensed exclusive rights to develop and commercialize BRII-835 (elebsiran) for the greater China territory from Vir Biotechnology, Inc. ('Vir') in 2020..

Brii Bio于2020年获得Vir Biotechnology，Inc.（“Vir”）在大中华区开发和商业化Brii-835（elebsiran）的专有权。。

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, and is designed to induce enhanced and broad B-cell and T-cell immunity. Brii Bio licensed BRII-179 from VBI Vaccines, Inc. ('VBI') in December 2018 and has extended the exclusive license to global rights since July 2023..

BRII-179是一种新型的基于重组蛋白的HBV免疫治疗候选物，表达前S1，前S2和S HBV表面抗原，旨在诱导增强和广泛的B细胞和T细胞免疫。Brii Bio于2018年12月从VBI疫苗公司（“VBI”）获得Brii-179许可，并自2023年7月起将独家许可扩展至全球权利。。

About Brii Bio

关于Brii Bio

Brii Biosciences Limited ('Brii Bio', stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious and central nervous system diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B viral infection (HBV).

Brii Biosciences Limited（“Brii Bio”，股票代码：2137。HK）是一家生物技术公司，开发治疗方法，以应对患者面临的重大公共卫生挑战，其中患者的医疗需求未得到满足，选择有限，社会耻辱感严重。该公司专注于传染性和中枢神经系统疾病，正在推进一系列独特的治疗候选药物，并推出针对乙型肝炎病毒感染（HBV）的领先项目。

The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit www.briibio.com..

该公司由一支富有远见、经验丰富的领导团队领导，在罗利达勒姆、旧金山湾区、北京和上海等关键生物技术中心开展业务。有关更多信息，请访问www.briibio.com。。

[1] World Health Organization. (April 2024). Global hepatitis report 2024: action for access in low- and middle-income countries. World Health Organization. Retrieved from https://www.who.int/publications/i/item/9789240091672

[1] 世界卫生组织。（2024年4月）。2024年全球肝炎报告：中低收入国家获取行动。世界卫生组织。检索自https://www.who.int/publications/i/item/9789240091672

[2] World Health Organization. Hepatitis. World Health Organization. Retrieved from https://www.who.int/china/health-topics/hepatitis#:~:text=There%20are%2087%20million%20people,living%20with%20chronic%20hepatitis%20C.

[2] 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=2087%2000万人，生活在慢性肝炎患者中。

[3] World Health Organization. (July 2023). Hepatitis D. World Health Organization. Retrieved from https://www.who.int/news-room/fact-sheets/detail/hepatitis-d

[3] 世界卫生组织。（2023年7月）。丁型肝炎。世界卫生组织。检索自https://www.who.int/news-room/fact-sheets/detail/hepatitis-d

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SOURCE Brii Biosciences Limited

SOURCE Brii生物科学有限公司

Company Codes: HongKong:2137, OTC-PINK:BRIBY

公司代码：香港：2137，OTC-PINK：贿赂