Press Releases

October 28, 2022

October 19, 2022

Findings from two Phase 1 studies show both BRII-732 and BRII-778 are safe and well-tolerated

Results indicate potential for oral once-weekly, long-acting combination therapy for HIV infection, supporting continued clinical development

Additional data presented by Brii’s licensing partners at IDWeek 2022 showcase breadth of Company’s infectious disease program, spanning six therapeutic candidates and four potential disease indications

October 11, 2022

September 26, 2022

Data demonstrated that a single administration of BRII-296 at 600 mg delivered a favorable pharmacokinetic profile and is safe and well-tolerated in healthy subjects

Findings suggest BRII-296 has potential to provide a safe and effective, one-time injectable treatment option to people with PPD in an outpatient setting

Company has identified an optimal dose regimen for BRII-296 for the upcoming Phase 2 study expected to commence by end of 2022

September 02, 2022

Dr. Qing Zhu to become China R&D Head, Dr. Ankang Li to join the Board, Mr. Rico Liang to become China GM, and Mr. Yongqing (Rogers) Luo resigned from the Board and his current positions

September 01, 2022

Addition increases diversity of Board governance and supports further independent expertise

August 29, 2022

August 24, 2022

Additions to executive team strengthen global leadership and position Company for strategic long-term growth

First-ever product launch of long-acting amubarvimab/romlusevimab combination therapy for COVID-19 in China advances Brii Bio from clinical development to commercial stage biotechnology company

On track to advance clinical programs in HBV, CNS, HIV and MDR/XDR, and deliver key data read-outs in 2022

Ample funds to support operations through 2025

Company to host conference call today at 8:30 PM HKT / 8:30 AM ET

August 23, 2022

Building a leadership team with global and local experience and expertise to enable rapid execution across Company’s broad therapeutic strategy

July 27, 2022

Independent lab results demonstrate that the combination therapy retains neutralizing activity against currently dominant COVID-19 strains, as previously demonstrated with all variants of concern to date

The amubarvimab/romlusevimab combination is commercially available in China and is under review for Emergency Use Authorization by the U.S. Food and Drug Administration (FDA)

July 19, 2022

The partnership will accelerate stockpiling, channel distribution and hospital access for the amubarvimab/romlusevimab combination in China

The amubarvimab/romlusevimab combination is the first locally-discovered and approved SARS-CoV-2 target-specific treatment in China, evaluated through a randomized, double-blind, placebo-controlled trial

The amubarvimab/romlusevimab combination was commercially launched in China on July 7, 2022

July 13, 2022

Strategic executive hire adds to Company’s global leadership team and positions the Company for continued growth

July 07, 2022

The Company is working closely with its commercial partners to supply the combination therapy to patients in need

Brii Bio progressed the combination therapy from discovery to global Phase 3 data readout and first regulatory approval by the China NMPA in less than 20 months, validating the Company’s R&D expertise and capabilities

July 04, 2022

Exclusive development and commercialization rights to VIR-3434 in China strengthen Company’s leadership and robust clinical pipeline in HBV

Key partnership with Vir enables multitude of combination treatment options as part of Company’s strategic approach to developing a functional cure for HBV

June 30, 2022

June 09, 2022

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

May 31, 2022

May 27, 2022

May 25, 2022

DURHAM, N.C., United States and BEIJING, China – May 25 […]

May 09, 2022

Studies conducted by independent labs demonstrate the amubarvimab/romlusevimab combination retains neutralizing activity against COVID-19 Omicron variant

Review of the monoclonal antibody combination therapy is underway by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization

May 07, 2022

DURHAM, N.C., United States and BEIJING, China – May 7, […]

April 29, 2022

DURHAM, N.C., United States and BEIJING, China – April […]

April 01, 2022

March 31, 2022

New data demonstrate BRII-835 (VIR-2218) was well tolerated with notable reductions in serum HBsAg observed in the Chinese patients infected with chronic hepatitis B

March 30, 2022

The partnership will accelerate stockpiling, channel distribution and regional access of the amubarvimab/romlusevimab combination

The amubarvimab/romlusevimab combination is the first locally-discovered and approved SARS-CoV-2 target-specific treatment in China, through a randomized, double-blind and placebo-controlled trial

National Health Commission of China recently added the amubarvimab/romlusevimab combination to its COVID-19 Diagnosis and Treatment Guidelines (9th Pilot Edition)

March 23, 2022

– Advancing key programs in HBV, CNS, and HIV

– Received first BLA approval for COVID-19 Treatment in China and added to China’s latest COVID-19 Diagnosis and Treatment Guidelines

– Multiple clinical value drivers expected across the portfolio in 2022 and beyond

– Cash, bank balances, and potential revenue to support operations through 2025

– Brii Bio to host conference call today at 8:00 PM HKT / 8:00 AM ET

March 17, 2022

March 16, 2022

The amubarvimab/romlusevimab combination is the first locally-discovered and approved SARS-CoV-2 target-specific treatment in China, through a randomized, double-blind and placebo-controlled trial

In vitro tests shows that amubarvimab/romlusevimab combination retains neutralizing activity against the Omicron variant and other variants of concern such as Delta and Delta Plus

February 28, 2022

January 27, 2022

Senior hire strengthens Brii Bio’s leadership team and aligns with Company’s mission to tackle the world’s largest public health issues affecting everyday people

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.

December 17, 2020

- 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

September 18, 2020

- Rogers Yongqing Luo, B.M., MBA, President of Brii Bio and General Manager for Greater China, will lead acceleration of Brii Bio’s China strategy and expand the company’s capabilities in access and partnerships
- Ankang Li, Ph.D., J.D., CFA, Brii Bio’s Chief Financial Officer, will lead all financial and corporate development functions

March 31, 2020

-     Multiple highly potent, neutralizing antibodies already identified from convalesced patients
-     First-in-human trials planned for third quarter this year

March 11, 2020

- Brii Biosciences will provide funding and expertise in infectious disease treatment modalities for projects in development in Aaron Diamond AIDS Research Center and other Columbia Laboratories

December 03, 2019

- Dr. Kraus to lead newly-created Neurosciences Therapy Area
- Zhijian Chen, Ph.D., named Strategic Scientific Advisor

November 21, 2019

-Three partnerships focused on novel programs for treatment-resistant bacterial infections and diseases
-Company pipeline now includes up to 12 partnered assets, in addition to internal development programs
-Infectious disease focus will address disproportional unmet need in China and support global public health

November 14, 2019

-Novel recombinant, protein-based immuno-therapeutic for the treatment of chronic hepatitis B virus (HBV) infection
-Two-part, dose-escalation study expected to enroll up to 65 patients 
-Initial data expected in H2 2020

December 11, 2018

WuXi Biologics (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, announced today a strategic collaboration with Brii Biosciences…

December 06, 2018

Brii Biosciences, a company committed to serving patients’ needs and improving public health in China, today announced several research collaborations that significantly advance its efforts to develop innovative medicines to meet the unique needs of patients in China.

October 02, 2018

Beijing, China – October 2, 2018 – Brii Biosciences today was named by FierceBiotech as one of 2018’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry.

May 24, 2018

Brii Bio aims to accelerate the development and delivery of breakthrough medicines in China through partnerships, best-in-class research and development, and the disruptive application of digital and data insight.