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Dec 27, 2021

Brii Bio Doses First Patient in Phase 2a/2b Clinical Trial of BRII-179 (VBI-2601) for the Functional Cure of Chronic Hepatitis B

Two-part study taking place in China will investigate efficacy and safety of novel immunotherapeutic vaccine BRII-179 (VBI-2601) in 600 patients with chronic hepatitis B


Dec 12, 2021

Brii Bio Announces Amubarvimab/Romlusevimab Combination Retains Neutralizing Activity Against Omicron SARS-CoV-2 Variant

In vitro tests against the omicron pseudovirus show that Amubarvimab/Romlusevimab Combination retains neutralizing activity against the Omicron variant and other variants of concern such as Delta and Delta Plus

Data validate the amubarvimab/romlusevimab combination strategy to be an important line of defense against emerging variants

U.S. FDA Emergency Use Authorization review for the amubarvimab/romlusevimab combination is underway


Dec 12, 2021

Brii Biosciences Receives Clinical Hold Notification from US. FDA on BRII-732



Dec 09, 2021

Brii Bio Announces Amubarvimab/Romlusevimab Combination Received Approval from NMPA as First COVID-19 Neutralizing Antibody Combination Therapy in China

The approval marks the first locally-discovered and approved SARS-CoV-2 target-specific treatment in China, through a randomized, double-blind and placebo-controlled trial

Brii Bio is also seeking U.S. FDA Emergency Use Authorization for the amubarvimab/romlusevimab combination


Dec 06, 2021

Brii Biosciences Included in Hong Kong Stock Connect

Brii Biosciences listed on the Main Board of Hong Kong Stock Exchange on July 13, 2021 and was selected on November 19, 2021 as a constituent stock of the following Hang Seng Indexes. Its inclusion on the Hong Kong Stock Connect is also effective December 6, 2021.


Nov 19, 2021

Brii Biosciences Joins Hang Seng Composite Index

DURHAM, N.C., United States and BEIJING, China – Nov 19, 2021 – Brii Biosciences Limited (“Brii Bio” or the “Company”, stock code: 2137.HK), today announced that Brii Biosciences has been included as a constituent stock of the Hang Seng Composite Index.


Nov 17, 2021

Brii Bio Receives the BioCentury-BayHelix R&D Achievement of the Year Award at the 2021 BioCentury China Healthcare Summit

BEIJING, China and DURHAM, N.C., United States – November 17, 2021


Oct 14, 2021

Brii Biosciences Announces Upcoming Participation at November Conferences

DURHAM, N.C., United States and BEIJING, China – October 14, 2021


Oct 09, 2021

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

Data supporting the EUA filing will be submitted to the FDA on a rolling basis with the ultimate goal of securing regulatory approval as soon as possible

Submission is based on positive Phase 3 data from the NIH-sponsored ACTIV-2 study, which demonstrated a statistically significant reduction of hospitalization and death over placebo in COVID-19 outpatients treated within an early (up to 5 days) or late treatment window (6 to 10 days)


Oct 04, 2021

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

Data demonstrated a 78% reduction in the risk of hospitalization or death in patients receiving single dose treatment of BRII-196/BRII-198 with zero deaths, versus eight compared to placebo, through the 28-day primary endpoint

Results show significant benefits in non-hospitalized, high risk COVID-19 patients who received treatment early or late following symptom onset, extending a potential therapeutic option to patients with challenges to access care timely

An improved safety outcome in Grade 3/4 adverse events was observed with patients on BRII-196/BRII-198 versus placebo, including no drug related serious adverse events or infusion reactions


Sep 28, 2021

Brii Bio Appoints Coy Stout as Senior Vice President and Head of U.S. Market Access and Patient Advocacy

Strategic senior hire strengthens Brii Bio’ leadership team and positions the Company for U.S. market access and commercialization


Sep 07, 2021

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


Aug 25, 2021

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

The monoclonal antibody combination therapy reduced the combined endpoint of hospitalizations and death by 78% over placebo in 837 COVID-19 patients at high risk of clinical progression
These data demonstrate that high-risk outpatients may benefit from combination BRII-196/BRII-198 therapy up to 10 days following symptom onset


Aug 05, 2021

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 Combina

846 outpatients at high risk of clinical progression have been enrolled in the ACTIV-2 phase 2/3 clinical study, from sites in the United States, Brazil, South Africa, Mexico and Argentina.
The participants are being evaluated for the combined endpoint of hospitalizations and death relative to placebo, in the 28 days following treatment.


Jul 20, 2021

Brii Biosciences Initiates Phase 2 Clinical Trial in China for Neutralizing Antibodies, BRII-196 and BRII-198, in SARS-CoV-2

has initiated a Phase 2 clinical trial in China for its severe acute respiratory syndrome coronavirus 2 (“SARS-CoV-2”) neutralizing antibodies, BRII-196 and BRII-198. This study will be led by Dr. Nanshan Zhong, the Academician of the Chinese Academy of Engineering and Director of the National Clinical Medical Research Center for Respiratory Diseases at the First Affiliated Hospital of Guangzhou Medical University, and conducted at clinical centers in Beijing Ditan Hospital, Guangzhou Eighth People’s Hospital, and Shenzhen Third People’s Hospital.


Jul 13, 2021

Brii Biosciences Limited Successfully Listed on Main Board of Hong Kong Stock Exchange

BEIJING, China – July 13, 2021 – Brii Biosciences Limited (“Brii Biosciences” or the “Company”, stock code: 2137.HK), a biotechnology company based in China and the United States committed to advancing therapies for significant infectious diseases and other illnesses which have significant public health burdens, was officially listed on the Main Board of the Stock Exchange of Hong Kong Limited (“SEHK”) today.


Jun 23, 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

Data demonstrate that BRII-179 (VBI-2601) induced both B cell (antibody) and T cell responses in chronically-infected hepatitis B (HBV) patients, and was well-tolerated with no safety signals observed
Results support further clinical evaluation of BRII-179 (VBI-2601) as an immunomodulator in combination with other treatment modalities as a potential functional cure for chronic HBV infection
Abstract selected for inclusion in the ‘Best of ILC’ slide deck at EASL 2021


Jun 09, 2021

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

DURHAM, N.C., and BEIJING, China – June 9, 2021


May 17, 2021

Brii Biosciences Provides Update on Strategic Clinical Development Progress

- Company received US FDA clearance of Investigational New Drug Applications for four diverse pipeline candidates and advanced each into the clinic


Apr 29, 2021

Brii Biosciences Monoclonal Antibodies, BRII-196 and BRII-198, Progress to Phase 3 in NIH ACTIV-2 Trial in Ambulatory COVID-19 Patients

- Independent data safety monitoring board (DSMB) formally recommends investigational combination therapy advance to Phase 3 following Phase 2 pre-specified analysis for safety and efficacy
- Currently enrolling Phase 3 study enables expansion into a broad range of international trial sites


Apr 21, 2021

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

- New combination trial of an RNA-targeted therapeutic candidate and an HBV immunotherapeutic candidate aimed at delivering a functional cure for chronic hepatitis B infection


Mar 23, 2021

Brii Biosciences Closes US$155 Million Series C Financing

- Financing led by Invesco Developing Markets Fund, joined by a syndicate of new and current investors
- Proceeds will support accelerating clinical development programs in the United States and China


Mar 03, 2021

Brii Biosciences Antibody Combination Will Not Progress into a Phase 3 Study Evaluating the Treatment of SARS-CoV-2 in Hospitalized Patients

- The complete dataset from this study is evolving, including important sensitivity and sub-group analysis, which will help inform whether a treatment benefit can be observed in particular subgroups of hospitalized patients.
- Additional studies of the BRII-196 and BRII-198 combination are ongoing in ambulatory COVID-19 patients through ACTIV-2 clinical trial in collaboration with NIH-NIAID.


Dec 17, 2020

Brii Biosciences Provides Corporate Update on Progress Against Strategic R&D Priorities

- Initiated clinical research of investigational monoclonal antibodies BRII-196 and BRII-198 in combination for the treatment of COVID-19 in collaboration with the NIH-NIAID
- Continues to rapidly advance the development of potential therapeutics for the mitigation of serious infectious disease threats by HBV, multi-drug resistant gram-negative bacteria, and HIV
- Continues to advance CNS programs with IND for BRII-296 planned for January 2021
- Expanded U.S. Leadership Team with Executive Appointments