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Overview of Brii Biosciences Limited
Brii Biosciences Limited is a biotechnology company committed to developing innovative therapeutic solutions that address critical public health challenges. With a core focus on chronic hepatitis B virus (HBV) infections and additional efforts in central nervous system and infectious diseases, the company is advancing a diversified pipeline that includes immunotherapeutics, siRNA-based treatments, and neutralizing monoclonal antibodies. With its operations spanning major biotech hubs such as Raleigh-Durham, the San Francisco Bay Area, Beijing, and Shanghai, Brii Biosciences leverages cutting-edge technologies and strategic collaborations to enhance patient care.
Core Therapeutic Modalities and Pipeline
The company has developed a robust portfolio of therapeutic candidates designed to achieve functional cures for chronic HBV infection. Among its lead programs are:
- BRII-877 (Tobevibart): An investigational monoclonal antibody engineered with extended half-life technology, designed to neutralize HBV and hepatitis D virus (HDV) by blocking viral entry into hepatocytes and reducing circulating virions.
- BRII-835 (Elebsiran): A novel siRNA therapeutic utilizing Enhanced Stabilization Chemistry Plus (ESC+) technology to directly target and degrade HBV RNA transcripts, thereby reducing the production of hepatitis B surface antigen (HBsAg).
- BRII-179: A recombinant protein-based immunotherapeutic that presents key HBV antigens to stimulate robust B-cell and T-cell responses. This candidate is designed to break immune tolerance and potentially enhance viral control when used in combination treatment regimens.
Market Position and Competitive Landscape
Brii Biosciences has carved out a unique technological niche by focusing on combination therapy regimens that integrate different therapeutic modalities to target HBV and HDV infections. Its innovation is underpinned by breakthrough designations granted in multiple clinical studies, underscoring the potential clinical impact of its therapies. The company differentiates itself through its strategic partnerships with established biotech players, thereby enhancing its research capabilities and bolstering its competitive positioning in the biotechnology sector.
Business Model and Revenue Streams
Operating within the high-stakes biotechnology environment, Brii Biosciences generates revenue opportunities primarily through licensing arrangements, milestone payments, and co-development partnerships. While direct product sales are not yet realized, its business model is focused on advancing clinical candidates through rigorous Phase 1 and Phase 2 studies with the aim of establishing a robust platform for future commercialization. This strategic emphasis on innovation and collaboration highlights a commitment to addressing significant unmet medical needs.
Research, Development, and Clinical Expertise
The company’s deep expertise in immunotherapy, siRNA technology, and combination treatment regimens is reflected in its methodical approach to research and development. By integrating early-phase clinical insights and leveraging comprehensive safety and efficacy data, Brii Biosciences is well-positioned to refine its therapeutic strategies. The use of advanced technologies such as Xencor's Xtend™ platform and Enhanced Stabilization Chemistry Plus (ESC+) further demonstrates the firm’s commitment to scientific excellence and innovation.
Infrastructure and Global Operations
Brii Biosciences maintains a global operational footprint with key centers in strategic biotech hubs around the world. This international presence not only facilitates access to diverse patient populations for clinical trials but also positions the company to navigate complex regulatory environments effectively. The international scope of its research and development efforts underscores its commitment to advancing therapeutic candidates that have the potential to impact millions of lives worldwide.
Significance in the Biotechnology Sector
In an industry driven by the need for innovative solutions to address chronic diseases, Brii Biosciences stands out with its targeted approach toward functional cures for HBV infections. By focusing on therapeutic combinations that stimulate effective immune responses and viral suppression, the company offers a scientifically grounded solution aimed at one of the world’s most pressing infectious diseases. This combination of targeted science, strategic partnerships, and global operational capability reinforces its role as a key player in the biotechnology space.
Summary
Overall, Brii Biosciences Limited represents an essential contributor to the evolving landscape of biotech therapeutics for infectious diseases. Its multi-modality pipeline, supported by breakthrough clinical data and meaningful partnerships, positions the company as an informed and methodically driven entity in the pursuit of innovative treatment strategies for chronic HBV infection and related conditions.
Brii Bio (BRIBY) has unveiled new data from its ongoing Phase 2 ENSURE study at APASL 2025, highlighting promising results in treating chronic HBV infection. The study's Cohort 4 data revealed that participants who previously responded to BRII-179 (therapeutic vaccine) achieved a 55.6% HBsAg seroclearance rate at Week 24, compared to only 10% in non-responders.
The 48-week data from Cohorts 1-3 demonstrated that the combination of elebsiran (siRNA) with PEG-IFNα achieved higher HBsAg loss rates of 26.3% (200mg) and 33.3% (100mg), significantly outperforming PEG-IFNα alone (5.6%). The combination therapy showed greater HBsAg reductions and was generally well-tolerated.
This data supports BRII-179's potential as a predictive tool for identifying patients more likely to respond to curative therapies, potentially improving treatment efficiency for the 254 million patients worldwide living with chronic HBV infection.
Brii Biosciences (BRIBY) has provided its full-year 2024 financial results and corporate update, highlighting significant progress in its hepatitis B virus (HBV) functional cure program. The company reported strong cash reserves of US$335.7 million, sufficient to fund operations into 2028.
Key developments include the strategic acquisition of BRII-179's intellectual property for $18 million and advancement of multiple Phase 2b studies. The ENHANCE study completed enrollment in January 2025, while the ENSURE study showed promising 48-week end-of-treatment data, demonstrating higher HBV surface antigen loss rates with elebsiran combination therapy.
Financial results showed a cash position of RMB2,413.4 million, down 9.3% year-over-year. Research and development expenses decreased by 38% to RMB249.8 million, while administrative expenses reduced by 22% to RMB153.2 million. The company reported an increased loss of RMB512.4 million for 2024, up 177.9% from 2023, primarily due to investment-related losses and impairment charges.
Brii Bio (2137.HK) has signed asset purchase agreements to acquire full intellectual property rights and assets related to BRII-179 from VBI Vaccines for US$18 million. This acquisition eliminates future milestone and royalty obligations to VBI and secures uninterrupted clinical supply of BRII-179. The company will also terminate previous agreements with VBI from February 14, 2024, canceling all payment obligations except for a US$2.5 million promissory note.
The company has initiated several BRII-179-containing combination studies targeting higher functional cure rates for chronic Hepatitis B Virus (HBV) infection. Notably, patient enrollment has been completed for the ENRICH study, a Phase 2b trial evaluating sequential treatment of BRII-179 followed by elebsiran and PEG-IFNα combination.
Brii Bio announced new data from its Phase 2 ENSURE study, comparing elebsiran (BRII-835) combined with PEG-IFNα versus PEG-IFNα alone in chronic HBV patients. The 48-week end-of-treatment results showed significantly higher HBsAg seroclearance rates in combination therapy groups: 26.3% (200mg elebsiran) and 33.3% (100mg elebsiran) versus 5.6% with PEG-IFNα alone. In patients with baseline HBsAg of 100-1,500 IU/mL, the combination achieved even higher rates: 31.3% (200mg) and 40.0% (100mg). The combination therapy demonstrated greater HBsAg reductions and was generally safe and well-tolerated.
Brii Bio presented new data from its ongoing Phase 2 trials at the EASL Congress 2024. The data revealed that BRII-179, a therapeutic vaccine, induced significant immune responses and high levels of HBsAg reduction in some participants with chronic HBV infection.
The trials evaluated BRII-179 either in combination with BRII-835 (elebsiran) or as an add-on to PEG-IFNa treatment. Findings included increased B and T cell responses, enhanced HBsAg loss post-treatment, and no need for NRTI retreatment.
The combination therapies were safe and well tolerated, supporting further evaluation for achieving a functional cure for chronic HBV infection.
Brii Biosciences announced that the National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designations for two of its investigational therapies: BRII-877 (tobevibart) and BRII-835 (elebsiran). These therapies target hepatitis B virus (HBV) and are supported by extensive Phase 1 and 2 studies. BRII-877 has treated over 350 patients, showing well-tolerated results and significant decreases in HBsAg levels. BRII-835, studied in over 570 patients, demonstrated robust antiviral activity against HBV. These designations bolster Brii Bio’s ongoing efforts to develop functional cures for chronic HBV and HDV infections, enhancing their therapeutic regimens to achieve higher cure rates in broader patient populations.
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