Press Releases

December 27, 2021

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

December 12, 2021

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

December 12, 2021

December 09, 2021

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

December 06, 2021

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.

November 19, 2021

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.

November 17, 2021

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

October 14, 2021

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

October 09, 2021

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)

October 04, 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

September 28, 2021

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

September 07, 2021

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

August 25, 2021

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

August 05, 2021

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.

July 20, 2021

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.

July 13, 2021

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.

June 23, 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

June 09, 2021

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

May 17, 2021

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

April 29, 2021

- 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

April 21, 2021

- 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

March 23, 2021

- 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

March 03, 2021

- 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.