Brii Biosciences Announces First Subject Dosed in Phase 1 Clinical Trial of BRII-297, Long-Acting Injectable for the Treatment of Anxiety and Depressive Disorders

BRII-297, a first-of-its-kind treatment option for anxiety and depressive disorders, has the potential to enable greater therapeutic adherence and convenience for patients DURHAM, N.C., - May 31, 2023 and BEIJING, China - June 1, 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 announced the first subject has been dosed in a Phase 1 clinical trial evaluating BRII-297, a first-of-its-kind long-acting injectable (LAI), in development for the treatment of various anxiety and depressive disorders. This Phase 1 study is examining the safety, tolerability and pharmacokinetics of BRII-297 in healthy volunteers in Australia. “We are eager to continue advancing BRII-297 through the Phase 1 clinical trial and evaluate the potential of our long-acting technology to provide a differentiated treatment option for patients as they navigate their mental health journeys,” said Lianhong Xu, Ph.D., Head of Discovery at Brii Bio. “We believe psychiatric conditions such as anxiety and depressive disorders require treatment options that take into consideration of patient insights and preferences, so that patients can get the care they need in a timely and convenient way. Through our in-house discovery, we are thoughtfully designing BRII-297 and other long-acting therapies across our pipeline with the aim of improving outcomes and eliminating social stigma.” BRII-297 is a new chemical entity (NCE) discovered internally. It acts as a novel gamma-aminobutyric acid A (GABA A ) receptor positive allosteric modulator (PAM) with a LAI formulation, designed to provide rapid, profound and sustained reduction of symptoms, which has the potential to enable therapeutic adherence and convenience for patients living with anxiety and depressive disorders. About Anxiety and Depressive Disorders In 2019, nearly one billion people were living with a mental health disorder. Since the emergence of the COVID-19 pandemic, anxiety and depressive disorders have increased by a staggering 25%. Despite the high prevalence of mental health conditions and scientific innovations that have opened the door to developing more effective therapeutics, social stigma and discrimination remain significant barriers to accessing and receiving care for psychiatric conditions. About BRII-297 BRII-297 is a first-of-its-kind long-acting injectable (LAI) therapeutic candidate in development for the treatment of various anxiety and depressive disorders. Discovered internally, BRII-297 acts as a gamma-aminobutyric acid A (GABA A ) receptor positive allosteric modulator (PAM), a proven mechanism of action that is known to potentially restore “normal” levels GABA A receptor function for various depressive and anxiety central nervous system disorders. 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 a first-of-its-kind treatment for postpartum depression (PPD). 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] 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. All Rights Reserved. | Developed by Euroland IR Recruitment Scam Warning Privacy Statement Terms of Use This website uses cookies and similar technologies, to enhance your browsing experience and provide personalized recommendations. By continuing to use this website, you agree to the use of cookies and similar technologies as described in our Privacy Policy Accept

The release as fetched from its publisher. briibio.com ↗