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

Investment will enable the Company to accelerate regulatory filings and commercial launches in the U.S. and China, as well as in other markets Decision follows a positive and statistically significant Phase 3 data outcome demonstrating a high degree of clinical efficacy and improved safety over placebo in non-hospitalized COVID-19 patients DURHAM, N.C., United States and BEIJING, China – September 7, 2021 – 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, today announced that the Company is committing an additional US$100 million to advance global regulatory filings and commercial efforts for its investigational SARS-CoV-2 (virus that causes COVID-19) combination therapy, BRII-196/BRII-198 (“combination BRII-196/BRII-198”). “Following on the heels of a positive Phase 3 data readout from the ACTIV-2 trial, and as countries around the world continue to face a significant resurgence of COVID-19 cases, we are doubling down on our efforts to bring BRII-196/BRII-198 to a broad range of patients as a promising potential new treatment option for COVID-19,” said Zhi Hong, Ph.D., Chairman and CEO of Brii Biosciences. “This investment reinforces the Company’s mission, building on the highly effective clinical outcomes, as we accelerate our strategic efforts to pursue regulatory filings, expand manufacturing and supply capabilities and establish key collaborations in both established and emerging global markets to pave a clear and compelling path to commercialization.” BRII-196/BRII-198 is a SARS-CoV-2 neutralizing monoclonal antibody combination therapy. Interim results from Phase 3 of the NIH-sponsored ACTIV-2 trial recently demonstrated that the combination therapy achieved a statistically significant reduction, 78%, of relative risk in the combined endpoint of hospitalization and death in non-hospitalized COVID-19 patients at high risk of clinical progression (nominal one-sided p value = 0.00001) with significantly less frequent grade three or above adverse events compared with placebo. Following the clear demonstration of both clinical and safety outcomes, the independent data safety monitoring board (DSMB) permitted the early release of the interim results while the complete study follow-up remains ongoing. This study was conducted at clinical trial sites around the world, including the United States, Brazil, South Africa, Mexico, Argentina and the Philippines, with patients enrolled between January and July of 2021 – a period of rapid global emergence of novel SARS-CoV-2 variants. Data on the clinical efficacy of combination BRII-196/BRII-198 by variant type will also be evaluated as part of the study. Current in vitro pseudovirus testing data suggests that combination BRII-196/BRII-198 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), B.1.617.2 (Delta), B.1.429 (Epsilon), P.1 (Gamma), C.37 (Lambda), and B.1.621 (Mu). About BRII-196 and BRII-198 BRII-196 and BRII-198 are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients. They have been specifically engineered to reduce the risk of antibody-dependent enhancement, enhance antibody penetration to the lung and prolong the plasma half-lives for potentially more durable treatment effect. Their non-overlapping epitope binding regions provide a high degree of neutralization activity against SARS-CoV-2. Investigational New Drug (IND) applications have been submitted for the combination therapy to the U.S. Food and Drug Administration (FDA), the China National Medical Products Administration (NMPA) and the Department of Health in Hong Kong, China. The combination of BRII-196/BRII-198 was generally safe and well tolerated in Phase 1 studies, supporting evaluation in later stage studies. In addition to the collaboration with NIAID, Brii Biosciences is conducting additional studies in China, evaluating the pharmacokinetics and safety of combination BRII-196/BRII-198 as well as a Phase 2 efficacy study of combination BRII-196/BRII-198 for the treatment of COVID-19. About Brii Biosciences Brii Biosciences Limited (“Brii Biosciences”, or the “Company”, 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 virus (HBV), human immunodeficiency virus (HIV), 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 . Media Inquiry: [email protected] Summer Li (China) +86-135-2191-1607 Darcie Robinson (US) +1-203-919-7905 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 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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 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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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