Pipeline
Through in-house discovery and strategic in-licensing with global best-in-class partners, we are accelerating the development and delivery of breakthrough medicines to patients around the world.
Brii Bio is building a pipeline of more than 10 novel therapeutic candidates that allows the Company to develop differentiated treatment options for patients based on two key methods:
The application of novel chemistry and extended-release formulation
Combination therapies to tackle the heterogeneity of complex diseases with a multi-prong approach
Infectious Disease Programs
Indication
Program
Preclinical
IND
Phase 1
Phase 2
Phase 3
NDA/BLA
Brii Rights
Partners
Hepatitis B
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Preclinical:
Hepatitis B
Program:
BRII-179 (VBI-2601)/BRII-835 (VIR-2218) Combination
BRII-179 (VBI-2601)/BRII-835 (VIR-2218) Combination
BRII-179 (VBI-2601)
- Phase 2 development in China.
- BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that is being evaluated as a potential functional cure for HBV.
- Based on a licensing agreement with VBI Vaccines, Brii Bio has the exclusive rights to develop and commercialize BRII-179 in Greater China.
BRII-835 (VIR-2218)
- Phase 2 development in China.
- BRII-835 is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV.
- Based on a licensing agreement with Vir Biotechnology, Brii Bio has the exclusive rights to develop and commercialize BRII-835 in Greater China.
Preclinical
IND
Phase 1
Phase 2
Phase 3
NDA/BLA
Brii Rights:
Greater China*
Partners:
Preclinical:
Hepatitis B
Program:
BRII-179 (VBI-2601)/PEG-IFN-α Combination
BRII-179 (VBI-2601)
- Phase 2 development in China.
- BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that is being evaluated as a potential functional cure for HBV.
- Based on a licensing agreement with VBI Vaccines, Brii Bio has the exclusive rights to develop and commercialize BRII-179 in Greater China.
Preclinical
IND
Phase 1
Phase 2
Phase 3
NDA/BLA
Brii Rights:
Greater China*
Partners:
Preclinical:
Hepatitis B
Program:
BRII-877 (VIR-3434)(1)
BRII-877 (VIR-3434)
- Phase 2 development in China.
- BRII-877 is an investigational subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and to reduce the level of virions and subviral particles in the blood.
- Based on a licensing agreement with Vir Biotechnology, Brii Bio has the exclusive rights to develop and commercialize BRII-877 in Greater China.
Preclinical
IND
Phase 1
Phase 2
Phase 3
NDA/BLA
Brii Rights:
Greater China*
Partners:
COVID-19
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Preclinical:
COVID-19
Program:
Amubarvimab/Romlusevimab Combination
Amubarvimab/Romlusevimab Combination
- Approved by the NMPA and commercially available in China.
- 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 a potentially more durable treatment effect. Live virus testing data, as well as pseudovirus testing data from multiple independent labs, have demonstrated that the amubarvimab / romlusevimab combination retains neutralizing activity against all major SARS-CoV-2 variants of concern.
Preclinical
IND
Phase 1
Phase 2
Phase 3
NDA/BLA
China BLA approved and commercially launched
Under US EUA review
Brii Rights:
Global
Partners:
HIV
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Preclinical:
HIV
Program:
BRII-732
BRII-732
- Phase 1 development in the U.S.
- BRII-732 is a new chemical entity (NCE) that, upon oral administration, is a proprietary prodrug that is metabolized into the active moiety islatravir, an investigational candidate being studied to treat and prevent HIV infection. BRII-732 is being developed as part of a potential once-weekly, combination therapy with BRII-778 to treat HIV-1.
- Internally discovered.
Preclinical
IND
Phase 1
Phase 2
Phase 3
NDA/BLA
Brii Rights:
Global
Partners:
Internally discovered
MDR/XDR Gram-negative Bacterial Infections
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Preclinical:
MDR/XDR Gram-negative Bacterial Infections
Program:
BRII-672 (ORAvance)(2)
BRII-672 (ORAvance)
- Phase 1 development in China.
- BRII-672, a prodrug of BRII-636, is an oral beta-lactamase inhibitor in development for the treatment of multidrug- and extensively drug-resistant (MDR/XDR) Gram-negative bacterial infections.
- Based on a licensing agreement with Qpex Biopharma, Brii Bio has the exclusive rights to develop and commercialize BRII-672 in Greater China.
Preclinical
IND
Phase 1
Phase 2
Phase 3
NDA/BLA
Brii Rights:
Greater China*
Partners:
Preclinical:
MDR/XDR Gram-negative Bacterial Infections
Program:
BRII-693 (QPX9003)(2)
BRII-693 (QPX9003)
- Phase 1 development in China.
- BRII-693 is a novel synthetic lipopeptide in development for the treatment of multidrug- and extensively drug-resistant (MDR/XDR) Gram-negative bacterial infections.
- Based on a licensing agreement with Qpex Biopharma, Brii Bio has the exclusive rights to develop and commercialize BRII-658 in Greater China.
Preclinical
IND
Phase 1
Phase 2
Phase 3
NDA/BLA
Brii Rights:
Greater China*
Partners:
Preclinical:
MDR/XDR Gram-negative Bacterial Infections
Program:
BRII-636 (OMNIvance)(2)
BRII-636 (OMNIvance)
- Phase 1 development in China.
- BRII-636 is novel cyclic boronic acid derived broad-spectrum inhibitor in development for the treatment of multidrug- and extensively drug-resistant (MDR/XDR) Gram-negative bacterial infections.
- Based on a licensing agreement with Qpex Biopharma, Brii Bio has the exclusive rights to develop and commercialize BRII-636 in Greater China.
Preclinical
IND
Phase 1
Phase 2
Phase 3
NDA/BLA
Brii Rights:
Greater China*
Partners:
NTM Lung Disease
More+
Preclinical:
NTM Lung Disease
Program:
BRII-658 (Epetraborole)(3)
BRII-658
- Phase 1 development in China.
- BRII-658 is in development as a once-daily oral treatment for patients with chronic nontuberculous mycobacterial (NTM) lung disease, with an initial focus on treatment of refractory mycobacterium avium complex (MAC) lung disease.
- Based on a licensing agreement with AN2 Therapeutics, Brii Bio has the exclusive rights to develop and commercialize BRII-658 in Greater China.
Preclinical
IND
Phase 1
Phase 2
Phase 3
NDA/BLA
Brii Rights:
Greater China*
Partners:
Central Nervous System Disease Programs
Indication
Program
Preclinical
IND
Phase 1
Phase 2
Phase 3
NDA/BLA
Brii Rights
Partners
PPD Treatment
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Preclinical:
PPD Treatment
Program:
BRII-296
BRII-296
PPD Treatment
- Phase 1 development in the U.S.
- BRII-296 is a novel, single injection therapeutic candidate in development for the treatment postpartum depression (PPD) . It acts as a gamma-aminobutyric acid A (GABAa) receptor positive allosteric modulator (PAM) and is designed to provide a rapid, profound and sustained reduction in depressive symptoms of PPD with the potential to lead to greater adherence, convenience and fewer side effects compared to the current standard of care.
- Internally discovered.
Preclinical
IND
Phase 1
Phase 2
Phase 3
NDA/BLA
Brii Rights:
Global
Partners:
Internally discovered
PPD Prevention
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Preclinical:
PPD Prevention
Program:
BRII-296
BRII-296
PPD Prevention
- Phase 1 development in the U.S.
- BRII-296 is a novel, single injection therapeutic candidate in development for the prevention postpartum depression (PPD) .
- Internally discovered.
Preclinical
IND
Phase 1
Phase 2
Phase 3
NDA/BLA
Brii Rights:
Global
Partners:
Internally discovered
Anxiety & Depressive Disorder
More+
Preclinical:
Anxiety & Depressive Disorder
Program:
BRII-297
BRII-297
- Preclinical in the U.S.
- BRII-297 is a new chemical entity under development for the treatment of various anxiety and depressive disorders.
- Internally discovered.
Preclinical
IND
Phase 1
Phase 2
Phase 3
NDA/BLA
Brii Rights:
Global
Partners:
Internally discovered *Greater China – Mainland China, Macau, Hong Kong and Taiwan
Source: Company information
(1) The Phase 2 clinical trials have been conducted by VIR
(2) To this date, the development and clinical trials have been conducted by Qpex
(3) To this date, the development and clinical trials have been conducted by AN2
Partners
Advancing innovation with a shared vision
We are working with global best-in-class partners to advance our shared vision of delivering innovative and meaningful treatment options to patients. Our strategic partnerships optimize the unique strengths and capabilities of each entity in order rapidly transform cutting-edge science and address patient needs.
Corporate Partners
AN2Therapeutics
Qpex Biopharma
VBI Vaccines
Vir Biotechnology
WuXi Biologics
WuXi AppTec
Academic Partners
Columbia University
Tsinghua Industrial R&D Institute
Shenzhen Third People’s Hospital
Tsinghua University School of Medicine