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

Data are consistent with the results of the global Phase 3 ACTIV-2 trial, demonstrating a favorable safety and tolerability profile in people with both severe and non-severe SARS-CoV-2 infections in China Clinical benefits were observed in efficacy indicators such as RNA conversion rate, resolution of COVID-19 symptoms, and risk of progressing to severe disease DURHAM, N.C., United States and BEIJING, China – June 9 , 2022 – Brii Biosciences Limited (“Brii Bio” or the “Company”, stock code: 2137.HK) a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, and TSB Therapeutics (Beijing) Co., Ltd. (“TSB Therapeutics”), a joint venture majority-owned by the Company, today announced, positive data from a randomized, single-blind clinical study ( NCT04787211 ) of its long-acting COVID-19 neutralizing antibody therapy, the amubarvimab/romlusevimab combination, in China. In June 2021, in parallel with the National Institutes of Health (NIH)-sponsored global ACTIV-2 Phase 3 clinical trial of the amubarvimab/romlusevimab combination, TSB Therapeutics initiated a clinical study in China to evaluate the safety, tolerability, and preliminary clinical efficacy of the combination treatment in people infected with SARS-CoV-2 (virus that causes COVID-19). Under the leadership of Prof. Nanshan Zhong, the leading principal investigator of the study, and the Guangzhou National Laboratory, the clinical centers successfully completed the enrollment of 48 subjects as planned, marking the combination therapy’s first study in China. The results of the study in China show that the amubarvimab/romlusevimab combination was generally safe and well-tolerated in both severe and non-severe SARS-CoV-2 infected subjects. No drug-related serious adverse events (SAEs), infusion reactions, dose discontinuation, or reduction due to adverse events were observed. All eight subjects with severe SARS-CoV-2 infections were enrolled and treated with the combination therapy, and their viral loads were significantly reduced from baseline levels with no subjects experiencing exacerbations that required mechanical ventilation or led to death. Among the 40 subjects with non-severe SARS-CoV-2 infections treated with the combination therapy, there were several clinical benefits observed, including RNA conversion rate (93% in treatment arm vs. 64% in placebo arm), median time to symptom resolution (8 days in treatment arm vs. 10 days in placebo arm), and proportion of progression to severe cases (0% in treatment arm vs. 5% in placebo arm). These findings are consistent with the results of the global ACTIV-2 Phase 3 trial conducted in 837 subjects. “This is the first study of our long-acting COVID-19 neutralizing antibody therapy, the amubarvimab/romlusevimab combination, in COVID-19 patients in China. We are pleased to see that the study results further enrich the safety and efficacy of the combination therapy, providing important data for its clinical application. These data alongside the real-world data of the nearly 1,000 patients who received emergency treatment in China last year further support the currently approved indications and dosing regimen of the combination therapy in China,” said Rogers Luo, President and General Manager, Greater China of Brii Bio, and Chief Executive Officer of TSB Therapeutics. “As the pandemic continues to affect the health of Chinese people, 20 Healthcare Security Administrations of provinces and cities in China have included the amubarvimab/romlusevimab combination for reimbursement under local health insurance funds. In addition, we have received purchase orders and stockpiling requests from over 20 provincial Health Commissions as well as more than 100 healthcare institutions and commercial organizations. We are rapidly advancing the preparation of our production to ensure we are in a position to provide the combination therapy to patients in need as soon as possible.” Previously, the live virus and pseudovirus testing data from multiple independent labs demonstrate that amubarvimab/romlusevimab combination retains neutralizing activity against Omicron BA.2 subvariant and all previous variants of concern. In addition, according to the preprint article posted on bioRxiv on May 26, 2022, by Prof. David Ho’s team from Columbia University, in vitro pseudovirus testing data demonstrate that the IC 50 of amubarvimab/romlusevimab combination against Omicron BA.4/5 subvariant is 2.445ug/ml. Based on the PK/PD model, the serum concentration of intravenous amubarvimab 1000mg and romlusevimab 1000mg on day 7 is 126-fold of the IC 50 against BA.4/5 subvariant. Additional testings including live virus assays are being conducted to confirm the neutralizing activity against BA.4/5 and BA.2.12.1. About Long-Acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination Amubarvimab and Romlusevimab are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients developed in collaboration with the 3rd People’s Hospital of Shenzhen and Tsinghua University. They have been specifically engineered to reduce the risk of antibody-dependent enhancement and prolong the plasma half-lives for potentially more durable treatment effect. Based on the final results from the U.S. National Institutes of Health (NIH)-sponsored ACTIV-2 Phase 3 clinical trial with 837 enrolled outpatients, the amubarvimab/romlusevimab combination demonstrates a statistically significant 80% reduction of hospitalization and death with fewer deaths through 28 days in the treatment arm (0) relative to placebo (9), and improved safety outcome over placebo in non-hospitalized COVID-19 patients at high risk of clinical progression to severe disease. Similar efficacy rates were observed in participants initiating therapy early (0-5 days) and late (6-10 days), following symptom onset, providing critically needed clinical evidence in COVID-19 patients who were late for treatment. The live virus testing data as well as pseudovirus testing data from multiple independent labs demonstrate that the amubarvimab/romlusevimab combination retains activity against major SARS-CoV-2 variants of concern, including the following commonly identified variants, B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.429 (Epsilon), B.1.617.2 (Delta), AY.4.2 (Delta Plus), C.37 (Lambda), B.1.621 (Mu), B.1.1.529-BA.1 (Omicron), and BA.1.1 and BA.2 (Omicron subvariants). About Brii Bio Brii Biosciences Limited (“Brii Bio”, stock code: 2137.HK) is a biotechnology company based in China and the United States committed to advancing therapies for significant infectious diseases, such as hepatitis B, COVID-19, human immunodeficiency virus (HIV) infection, multi-drug resistant (MDR) or extensive drug resistant (XDR) gram-negative infections, and other illnesses, such as the central nervous system (CNS) diseases, which have significant public health burdens in China and worldwide. For more information, visit www.briibio.com . About TSB Therapeutics TSB Therapeutics (Beijing) Co., Ltd. (“TSB Therapeutics”, or the “Company”) is a holding company of Brii Bio. TSB Therapeutics was jointly established in Beijing in May 2020 by Brii Bio, the 3rd People's Hospital of Shenzhen and Tsinghua University. The Company is committed to developing the amubarvimab/romlusevimab combination. TSB Therapeutics holds exclusive rights to develop and commercialize the amubarvimab/romlusevimab combination in Greater China. Media Inquiry: [email protected] Summer Li (China) +86-135-2191-1607 Ben Shannon (U.S.) +1-919-360-3039 Investor Inquiry: [email protected] Chris Fang +86-139-1692-8049 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 ↗