Brii Biosciences Provides Latest Clinical Development and Corporate Updates

Company extends BRII-179 license to global rights and introduces preventive vaccine, PreHevbri ® in Greater China and Asia Pacific markets New data from BRII-835 + PEG-IFN-α study have demonstrated that robust anti-HBs antibody responses at the end of treatment are associated with sustained HBsAg loss 24 weeks post treatment Company owns exclusive global rights of BRII-693 in development for difficult-to-treat carbapenem-resistant Gram-negative bacterial infections Dr. David Margolis appointed as Chief Medical Officer to lead organization’s late-stage clinical programs towards commercialization DURHAM, N.C., – July 5, 2023 and BEIJING, China – July 6, 2023 – 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 provided updates on its diverse pipeline of infectious disease (ID) and central nervous system (CNS) disease candidates and announced a pivotal leadership transition that will further advance its strategic priorities. "We are proud to announce our latest achievements in advancing our mission to improve patient health and address critical public health issues. With expanded collaborations and acquisitions, including the worldwide license extension of BRII-179, the introduction of PreHevbri ® vaccine in Greater China and Asia Pacific markets, and the acquisition of global rights for BRII-693, we are making remarkable progress in our infectious disease portfolio,” said Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio. “Additionally, it is with great pleasure that I introduce Dr. David Margolis as our new Chief Medical Officer. With his extensive experience and expertise both as a licensed ID specialist and a drug developer, Dr. Margolis will play a pivotal role in leading the successful execution of our late-stage clinical programs towards commercialization. Together, these strategic moves align seamlessly with our growth plans and represent important progress for our broader global strategy.” Core Clinical Development Updates Hepatitis B Virus (HBV) Led by Brii Bio’s team in China and partners, Vir Biotechnology, Inc. (“Vir,” NASDAQ: VIR) and VBI Vaccines, Inc. (“VBI,” NASDAQ: VBIV), the Company is addressing the full range of disease impact for HBV by progressing multiple combination studies to achieve a best-in-class functional cure in broad patient populations, as well as to commercialize a prevention vaccine in Greater China and Asia Pacific region. China and many Asia Pacific countries have the highest prevalence of HBV globally, with over 150 million people impacted by this disease (China ~86 million, Southeast Asia ~69 million HBsAg positive population 1 ). Currently, there is no effective HBV functional cure available, highlighting the urgent need for a better prophylactic vaccine. In July 2023, Brii Bio announced substantial expansion of its HBV portfolio in collaboration with VBI. Under the terms of the agreements, Brii Bio extends its exclusive license to worldwide markets for BRII-179 (VBI-2601). Additionally, Brii Bio also acquires exclusive rights to develop and commercialize PreHevbri ® in Greater China and Asia Pacific countries including Australia, Indonesia, Malaysia, New Zealand, Philippines, Singapore, South Korea, Thailand and Vietnam, among others. PreHevbri ® is a clinically differentiated 3-antigen adult HBV prophylactic vaccine recently approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel. In June 2023, Vir and VBI presented multiple clinical study results at the European Association for the Study of the Liver (EASL) Congress™ 2023: In follow-up data from Vir’s Phase 2 trial of combination 24 or 48 weeks of VIR-2218 (BRII-835) on top of a course of up to 48 weeks of pegylated interferon alpha (PEG-IFN-α), 16% (5/31) of participants demonstrated sustained HBsAg loss 24 weeks after end of treatment. Anti-HBs titers greater than 500 mIU/mL at the end of treatment were associated with sustained HBsAg loss at 24 weeks after the end of treatment. Data from Part A of Vir’s Phase 2 MARCH trial evaluating short treatment duration of combinations of VIR-2218 (BRII-835) and VIR-3434 (BRII-877) in chronic HBV participants demonstrated a 2.7-3.1 log 10 IU/mL decline in HBsAg levels and 90% of participants achieved HBsAg reduction below 10 IU/mL at the end of treatment. VBI presented follow-up data in a subset of participants from the pivotal Phase 3 study, PROTECT, up to 3.5 years after completion of immunization with PreHevbrio ® (also known as PreHevbri ® in the European Union/European Economic Area and United Kingdom, and Sci-B-Vac ® in Israel), a prophylactic 3-antigen HBV vaccine. The mean anti-HBs titers in participants vaccinated with PreHevbrio ® were more than 5x higher than those vaccinated with Engerix-B (1287 vs. 254 mIU/mL) suggesting that T-cell responses of PreHevbrio ® may contribute to long lasting and strong humoral immune responses and greater durability compared with Engerix-B. In May 2023, Brii Bio submitted an IND application to the NMPA of China for the development of BRII-877 (VIR-3434), and a Phase 1 clinical study is expected to start by the end of 2023. In the second half of 2023, the Company expects data readouts from two Phase 2 trials: Additional data from the Phase 2 study evaluating BRII-835 (VIR-2218) and BRII-179 (VBI-2601) combination. Topline results from the Phase 2 study evaluating BRII-179 (VBI-2601) in combination with PEG-IFN-α. Brii Bio plans for additional combination studies with the earliest to start in 2H 2023. Postpartum Depression (PPD) and Major Depressive Disorder (MDD)/Other CNS Disorders Brii Bio is developing its internally-discovered BRII-296 therapeutic candidate as a first-of-its-kind one-time injection treatment with the potential to expand the PPD and MDD treatment landscapes for patients in the U.S. In June 2023, Brii Bio announced the dosing of the first subject in a Phase 1 clinical trial for BRII-297, a long-acting injectable (LAI) being developed to treat anxiety and depressive disorders. The study, currently underway, aims to evaluate the safety, tolerability, and pharmacokinetics of BRII-297 in healthy volunteers. Brii Bio is working closely with the U.S. Food and Drug Administration (FDA) to align and agree on a PPD treatment protocol in preparation for its Phase 2 proof-of-concept (POC) study to be initiated in the second half of 2023. Brii Bio is actively working to expand the clinical indications for BRII-296 and plans to initiate additional studies in the U.S. in 2024. Additional Pre-Clinical and Clinical Development Updates Human Immunodeficiency Virus (HIV) Infection In December 2022, Brii Bio successfully lifted the U.S. FDA clinical hold, enabling the conduct of the Company’s planned Phase 1 study to investigate a lower oral dose of once-weekly BRII-732, with dosing initiated in 2Q 2023. The Company is exploring partnership opportunities to continue developing BRII-732 as part of a potential oral, once-weekly, long-acting combination treatment option for HIV patients. The Company is pursuing partnership opportunities for BRII-753 as part of a long-acting, subcutaneous injection with potential for dosing once monthly, once quarterly, or twice-yearly combination treatment option for HIV patients. MDR/XDR Gram-Negative Bacteria Infections In June 2023, Brii Bio announced definitive agreements with Qpex Biopharma (“Qpex”) to acquire exclusive global rights of BRII-693 (QPX-9003), expanding its existing rights in Greater China. The Company returns its exclusive rights of BRII-636 (QPX-7728 or OMNIvance) and BRII-672 (QPX-7831 or ORAvance) in Greater China to Qpex in connection with the acquisition of Qpex by Shionogi. In April 2023, Brii Bio submitted a pre-IND to the NMPA of China for the development of BRII-693 in China. BRII-693 has a highly differentiated safety and efficacy profile to address the most difficult-to-treat Acinetobacter baumannii and Pseudomonas aeruginosa infections resistant to carbapenem. Nontuberculosis Mycobacteria (NTM) Lung Disease Brii Bio’s partner, AN2 Therapeutics, Inc. (“AN2,” NASDAQ: ANTX) is enrolling its Phase 2/3 pivotal trial evaluating once-daily, oral epetraborole (BRII-658) for treatment-refractory MAC lung disease. AN2 reported in May that there were nearly 80 sites active in its pivotal Phase 2/3 trial of epetraborole in treatment-refractory MAC lung disease. Corporate Update Dr. David Margolis has been appointed Chief Medical Officer (CMO) after serving as Brii Bio’s Head of Infectious Diseases Therapy Area for nearly three years. As the CMO, Dr. Margolis will play a critical role in the Company’s late-stage clinical development towards commercial growth across the pipeline. In addition, he will continue to fulfill existing responsibilities that he previously held as Head of Infectious Diseases Therapy Area. Meanwhile, Dr. Li Yan will leave the company to pursue other interests. Brii Bio expresses sincere gratitude to Dr. Yan for his contributions to the Company in the past 5 years. About Brii Bio Brii Biosciences is a biotechnology company developing therapies to address some of the world’s most common diseases 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 to develop a novel functional cure for hepatitis B viral infection (HBV) and first-of-its-kind treatment options for postpartum depression (PPD) and major depressive disorder (MDD). 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 . Media Inquiry: [email protected] Investor Inquiry: [email protected] ---------------------------------- 1 Lancet Gastroenterol Hepatol. 2018; 3(6): 383-403 Previous Next [email protected] Home Company Back About Us Back Leadership Back Corporate Executive Team Back Board Of Directors Back Strategic Advisors Back Science Back Our Focus Pipeline Back Infectious Disease Programs Back Literature Archive Back Publications Back Conferences Back Media Back Press Release Back Brii Biosciences Announces Upcoming Conference Participation in November Brii Biosciences Presents Promising Clinical Data to Support Ongoing Development of Novel HIV Therapeutic Candidates at IDWeek 2022 Brii Biosciences to Present New Phase 1 Data from HIV Program at IDWeek 2022 Brii Biosciences Announces Top-line Results from Phase 1 Study of BRII-296, A Long-Acting Therapy in Development for Postpartum Depression Brii Biosciences Announces China Leadership Team Changes Brii Biosciences Appoints Taiyin Yang to Board of Directors, Strengthening Product Quality Oversight to Support Company Momentum Brii Biosciences Announces Upcoming Conference Participation in September Brii Biosciences Provides Corporate Update and Reports 2022 Interim Results WuXi Biologics Announced Exclusive Discovery Research with Brii Biosciences for Novel Bispecific Antibody Immunotherapeutics Brii Biosciences Builds Innovative Pipeline, Forges Public-Private Partnerships to Bring Novel Medicines to Chinese Patients FierceBiotech names Brii Biosciences as one of its “Fierce 15” Biotech Companies of 2018 Brii Biosciences Launches to Bring Innovative Medicines to Chinese Patients VBI Vaccines and Brii Biosciences Initiate Phase 1b/2a Study of BRII-179 (VBI-2601) in Patients with Chronic Hepatitis B Infection Brii Biosciences Expands Infectious Disease Pipeline Brii Biosciences Expands Therapeutic Focus to Include Neurosciences with Addition of John Kraus, M.D., Ph.D. Brii Biosciences Provides Corporate Update on Progress Against Strategic R&D Priorities Brii Biosciences Appoints Rogers Luo, Ankang Li To Leadership Positions Tsinghua University, 3rd People’s Hospital of Shenzhen and Brii Biosciences Establish Partnership to Develop Neutralizing Antibodies Against COVID-19 Brii Biosciences Provides Funding to Columbia University for Research on COVID-19 and Other Coronaviruses Brii Biosciences Antibody Combination Will Not Progress into a Phase 3 Study Evaluating the Treatment of SARS-CoV-2 in Hospitalized Patients Brii Biosciences Closes US$155 Million Series C Financing Brii Biosciences, Vir Biotechnology, and VBI Vaccines Announce Initiation of Phase 2 Clinical Trial of BRII-835 (VIR-2218) in Combination with BRII-179 (VBI-2601) for the Treatment of Hepatitis B Brii Biosciences Monoclonal Antibodies, BRII-196 and BRII-198, Progress to Phase 3 in NIH ACTIV-2 Trial in Ambulatory COVID-19 Patients Brii Biosciences Provides Update on Strategic Clinical Development Progress Brii Biosciences to Present Updated Phase 1b/2a Data on BRII-179 (VBI-2601) in Patients with Chronic Hepatitis B at the International Liver Congress 2021 Brii Biosciences and VBI Vaccines Present Positive Data from Completed Phase 1b/2a Study on BRII-179 (VBI-2601) in Patients with Chronic Hepatitis B at the International Liver Congress 2021 Brii Biosciences Limited Successfully Listed on Main Board of Hong Kong Stock Exchange Brii Biosciences Initiates Phase 2 Clinical Trial in China for Neutralizing Antibodies, BRII-196 and BRII-198, in SARS-CoV-2 Brii Biosciences Announces the Completion of Enrollment in the Phase 3 National Institutes of Health (NIH) ACTIV-2 Trial, Evaluating the BRII-196 and BRII-198 Monoclonal Neutralizing Antibody Combination for the Treatment of COVID-19 Brii Biosciences Announces Positive Data from the Phase 3 ACTIV-2 Trial Evaluating Combination BRII-196 and BRII-198 in Non-Hospitalized COVID-19 Patients Brii Biosciences Adds US$100 Million to Advance its Late-Stage Monoclonal Antibody Combination Therapy, BRII-196/BRII-198, for Non-Hospitalized COVID-19 Patients Brii Bio Appoints Coy Stout as Senior Vice President and Head of U.S. Market Access and Patient Advocacy Brii Bio Initiates Submission of Emergency Use Authorization Filing to U.S. FDA for BRII-196/BRII-198, its Monoclonal Antibody Combination Therapy for Non-Hospitalized COVID-19 Patients at High Risk of Clinical Progression to Severe Disease Brii Bio Presents Positive Phase 3 Data on BRII-196/BRII-198, the Company’s SARS-CoV-2 Monoclonal Neutralizing Antibody Combination Therapy, in an Oral Late-Breaker Presentation at IDWeek 2021 Brii Biosciences Announces Upcoming Participation at November Conferences Brii Bio Receives the BioCentury-BayHelix R&D Achievement of the Year Award at the 2021 BioCentury China Healthcare Summit Brii Biosciences Joins Hang Seng Composite Index Brii Biosciences Included in Hong Kong Stock Connect Brii Bio Announces Amubarvimab/Romlusevimab Combination Received Approval from NMPA as First COVID-19 Neutralizing Antibody Combination Therapy in China Brii Biosciences Receives Clinical Hold Notification from US. FDA on BRII-732 Brii Bio Announces Amubarvimab/Romlusevimab Combination Retains Neutralizing Activity Against Omicron SARS-CoV-2 Variant Brii Bio Doses First Patient in Phase 2a/2b Clinical Trial of BRII-179 (VBI-2601) for the Functional Cure of Chronic Hepatitis B Brii Biosciences Appoints Eleanor de Groot as Chief Technology Officer and Aleksandar Skuban as Central Nervous System Diseases Therapy Area Head Brii Biosciences Announces Positive Data Demonstrating its Long-Acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination, Retains Neutralizing Activity Against Live Omicron Virus BA.4/5 and BA.2.12.1 Subvariants Brii Bio Announces Strategic Partnership with China Resources Pharmaceutical Commercial Group to Advance the Commercialization of Long-acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination, in China Brii Biosciences Appoints Dr. Susannah Cantrell as Chief Business Officer Brii Biosciences Announces Commercial Launch of its Amubarvimab/Romlusevimab Combination Therapy for COVID-19 in China Brii Biosciences Exercises Option for Vir Biotechnology’s VIR-3434, a Broadly Neutralizing Monoclonal Antibody Targeting Hepatitis B in Greater China Brii Biosciences Announces Upcoming Conference Participation in July Brii Biosciences Announces Positive Data from a Randomized, Single-Blind Study of its Long-Acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination, in China Brii Bio Announces GMP Compliance Inspection Result for the Amubarvimab Injection and Romlusevimab Injection Brii Biosciences Announces Upcoming Conference Participation in June Brii Biosciences to be Added to MSCI China Small Cap Index Brii Bio Announces Positive Data Demonstrating its Long-Acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination, Retains Neutralizing Activity Against Omicron BA.2 Subvariant Brii Bio Reports Progress on ESG Commitments in Its Inaugural ESG Report Brii Biosciences Announces Upcoming Participation at May Conference Brii Biosciences Announces Upcoming Participation at April Conferences Brii Bio Presents New Data on BRII-835 (VIR-2218) in Chinese Patients with Chronic Hepatitis B at APASL 2022 Brii Bio Announces Strategic Partnership with Sinopharm to Advance Commercialization of Long-Acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination, in China Brii Biosciences Provides Corporate Update and Reports Full Year 2021 Financial Results Brii Bio to Present Phase 2 Data on Two Monthly Doses of BRII-835 (VIR-2218) in Chinese Patients with Chronic Hepatitis B at APASL 2022 Brii Bio Announces that National Health Commission of China Adds Amubarvimab/Romlusevimab Combination to its COVID-19 Diagnosis and Treatment Guidelines (9th Pilot Edition) Brii Biosciences Announces Upcoming Participation at March Conferences Brii Bio Appoints Karen D. Neuendorff as Chief People Officer and Head of Human Resources Brii Biosciences Announces Upcoming Conference Participation in January Brii Biosciences Provides Update on Strategic Clinical Development Progress Brii Biosciences Announces Interim Results from Phase 2 Study Evaluating Combination BRII-835 and BRII-179 in Development for HBV Functional Cure Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Press Release Media Reports Back Investor Relations Back Fact Sheet Corporate Governance Back Board of Directors Back Committee Composition Back Corporate Governance Documents Back Listing Documents Back Announcements & Circulars Share Graph Financial Calendar Presentation & Webcast Back Webcasts Back Presentations Back Financial Reports IR Enquiries & Email Alert Replacement of Lost Share Certificates Back People Back Culture Benefits Back Meet Our Team Opportunities Contact Us © 2026 Brii Biosciences. 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