Multiple Ongoing Phase 2b Studies Advancing HBV Functional Cure Strategy

Greater China Partnership with Joincare to Accelerate Development of Critical Care Antibiotic soralimixin

Strong Cash Position to Pursue New Discovery Opportunities and Partnership Strategy

Conference Calls Scheduled: 
English Session: August 21 at 9:00 p.m. HKT / 9:00 a.m. ET 
Chinese Session: August 22 at 9:00 a.m. HKT / August 21 at 9:00 p.m. ET

DURHAM, N.C., and BEIJING, Aug. 21, 2025 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," or the "Company," stock code: 2137.HK), a biotechnology company developing therapies to improve patient health across diseases with high unmet medical need, today provided a corporate update and reported its financial results for the six-month period ended June 30, 2025.

In the first half of 2025, Brii Bio rapidly advanced its core hepatitis B virus (HBV) functional cure program through multiple confirmatory Phase 2b trials, including ENRICH and ENHANCE studies, seeking combination regimens with higher HBV functional cure rates. Encouraged by promising data from Cohort 4 of the ENSURE study, presented at both the Asian Pacific Association for the Study of the Liver(APASL) and the European Association for the Study of the Liver (EASL) Congress 2025 supporting the potential of its patient enrichment strategy through BRII-179 induced anti-HBs response, the Company initiated a new cohort in an amended protocol within the ENHANCE study. This amendment evaluates a new triple regimen cohort with BRII-179 and elebsiran combination treatment followed by an added short-course pegylated interferon alpha (PEG-IFNα) treatment. This new cohort was fully enrolled in July 2025. Beyond its HBV pipeline, Brii Bio entered into a strategic license collaboration with Joincare Pharmaceutical Group Industry Co., Ltd ("Joincare Group") for the development of soralimixin (BRII-693) in the Greater China region. The Company has expanded its new discovery efforts to further broaden its portfolio and will continue to pursue partnership to extend the cash runway.  

With effective cost control measures in place, Brii Bio remains well-capitalized, maintaining a cash position of US$289.9 million, which is sufficient to support its late-stage development plans for its core HBV functional cure program and early discovery initiatives.

"We made significant strides in our HBV cure program during the first half of 2025, highlighted by encouraging data from Cohort 4 of the ENSURE study and the rapid advancement of ENRICH and ENHANCE studies." said Dr. Zhi Hong, Chairman and Chief Executive Officer of Brii Bio, "These achievements reflect Brii's experience and commitment to discovering innovative curative treatments for patients with chronic HBV infection. Meanwhile, the out-licensing of soralimixin in Greater China and our continued investment in early-stage discovery programs reinforce our strategy of combining internal innovation with strategic external collaborations to drive sustainable growth."

Corporate and Clinical Updates

HBV Program

Brii Bio continues to advance its HBV pipeline with a strong focus on achieving higher rates of HBV functional cure through novel combination regimens. The Company is progressing multiple ongoing Phase 2b combination studies (ENSURE, ENRICH and ENHANCE) with its differentiated HBV candidates, including elebsiran, an HBV-targeting siRNA, and BRII-179, a recombinant protein-based HBV immunotherapeutic. 

• BRII-179 demonstrated encouraging results in the Cohort 4 of ENSURE study, with key data presented at APASL and EASL 2025:
  • At Week 48 (end of treatment [EOT]), 61% (11/18) of patients who previously responded to BRII-179 achieved HBsAg seroclearance, compared to 10% (1/10) of non-responders. Among responders, 91% (10/11) developed anti-HBs titers ≥100 IU/L.
  • BRII-179-experienced participants achieved faster HBsAg loss, with 83% (10/12) achieving loss by Week 24, versus 55% (6/11) in BRII-179 naïve participants.

The ENSURE study results demonstrate that prior treatment with BRII-179 and elebsiran can induce robust anti-HBs responses and enrich for patients more likely to achieve HBsAg loss. These data also suggest that most HBsAg loss may be achievable with a shorter PEG-IFNα treatment duration (24 weeks).

The 24-week follow-up data of Cohort 4 of ENSURE study are expected in 2H 2025 and will be presented at a scientific conference.

• To further define BRII-179's role in HBV treatment and identify the optimal combination regimen for advancement into a registrational study, the Company is assessing BRII-179 in two additional Phase 2b trials:
  • ENRICH Study: Evaluates the role of BRII-179 in priming HBV-specific immunity and/or identifying immuno-responsive patients with a higher likelihood of achieving functional cure. We continue to believe that BRII-179 may play a unique role as part of the curative regimens.
  • ENHANCE Study:
    Evaluates a triple combination treatment regimen of BRII-179 and elebsiran plus PEG-IFNα to enhance the functional cure rate.
    Based on insight from ENSURE Cohort 4, we amended the protocol to evaluate a simplified triple combination regimen aimed at shortening PEG-IFNα treatment duration to 24 weeks.
    All studies have been fully enrolled. EOT data from ENRICH and ENHANCE are expected to be presented at a scientific conference in the first half of 2026.
• The Company has engaged with CDE of NMPA on potential Phase 3 study design and primary endpoints. The results from the ongoing ENRICH and ENHANCE studies will inform which final combination regimen will be taken forward to potential registrational studies.

Additional Clinical Programs

Brii Bio is actively seeking external partnerships to advance the development and commercialization of its therapeutic candidates for HIV and multidrug-resistant/extensively drug-resistant (MDR/XDR) infections.

• In July 2025, the Company announced the strategic out-licensing agreement with Joincare Group for the research, development, and commercialization of soralimixin (BRII-693) in Greater China region. This collaboration will leverage Joincare Group's strong capabilities in anti-infective therapeutics to accelerate the development and maximize the commercial potential of soralimixin (BRII-693). The Company will continue to seek non-dilutive funding or partnership opportunities for rights outside of Greater China.

Outlook

Looking ahead, Brii Bio remains committed to delivering innovative therapies for infectious diseases, with a continued focus on achieving a functional cure for HBV.

With key data readouts from its HBV functional cure program expected in the first half of 2026, the Company is well-positioned to make informed decisions that will shape the next phase of its HBV functional cure clinical strategy.

Following the appointment of its new CSO last year, Brii Bio has further expanded its internal discovery team and capabilities, complementing the continued advancement of its core HBV program. Brii Bio will continue to scale up its early discovery efforts to strengthen its innovation engine and reinforce its position at the forefront of biotech breakthroughs.

Interim 2025 Financial Results 

• The Company maintains a strong cash position to support its operations through 2028. Our bank deposits and cash and cash equivalents were RMB2,075.3 million as of June 30, 2025, representing a decrease of RMB338.1 million or 14.0% compared with RMB2,413.4 million as of December 31, 2024. The decrease was primarily due to payout of research and development activities and daily operations.
• Through pipeline prioritization, resource optimization, internalization of certain clinical development activities, and cost-saving measures of third-party contractors, we have effectively controlled our operational expenses. Research and development expenses were RMB117.0 million for the six months ended June 30, 2025, representing a decrease of RMB9.2 million or 7.3%, compared with RMB126.2 million for the six months ended June 30, 2024. The decrease reflected disciplined pipeline prioritization and organizational streamlining, while maintaining continued investment in core programs during the first half of 2025. 
• Administrative expenses were RMB58.2million for the six months ended June 30, 2025, representing a decrease of RMB20.4 million or 26.0%, compared with RMB78.6 million for the six months ended June 30, 2024. The decrease was primarily attributable to the decrease in employee cost of RMB9.5 million and the decrease in facility-related costs and professional service fees of RMB8.4 million, which was primarily attributable to organizational optimization and effective cost control. 
• Other income was RMB28.1 million for the six months ended June 30, 2025, representing a decrease of RMB42.8 million or 60.4%, compared with RMB70.9 million for the six months ended June 30, 2024. This was mainly due to the decrease in bank interest income of RMB21.6 million attributable to the declining interest rates on CNY and HKD time deposits, reallocation of short-term deposits to money market fund investments, and the decrease in income recognized from PRC government grants.

Conference Call Information

The Company will host two live conference calls. The English session will be held August 21 at 9:00 p.m. HKT (9:00 a.m. ET), For the registration link, please click here. Followed by a Chinese session on August 22 at 9:00 a.m. HKT (9:00 p.m. ET on August 21). For the registration link, please click here.

All participants shall use the link provided above to complete the online registration process prior to the conference call. A replay of the conference call will be available after the call and can be accessed by visiting the Company's website at www.briibio.com under the Investor Relations section.

This press release contains references to third-party information. Such information is not deemed to be incorporated by reference in this press release. Brii Bio disclaims responsibility for such third-party information.

About 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 diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. 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.

Forward-Looking Statement

 The information communicated in this press release contains certain statements that are or may be forward-looking. These statements typically contain words such as "will," "expects," "believes," "plans" and "anticipates," and words of similar import. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There may be additional material risks that are currently not considered to be material or of which the Company is unaware. These forward-looking statements are not a guarantee of future performance. Against the background of these uncertainties, readers should not rely on these forward-looking statements. The Company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.

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SOURCE Brii Biosciences Limited