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Brii Biosciences

Company Overview

A sino-American biotechnology company developing therapies for high-unmet-need infectious diseases and CNS conditions, with a dual US-China commercial and clinical footprint spanning hepatitis B, COVID-19, and beyond. Brii Biosciences focuses on diseases that carry not only significant clinical burden but also social stigma, a positioning that shapes both its therapeutic priorities and its geographic strategy. The company operates across North America and Asia, bridging Western drug development expertise with large patient populations in China.

Headquarters and Global Presence

Brii Biosciences is headquartered at One City Center, Durham, North Carolina, with significant operations in Beijing, China, and a presence in San Francisco, California. This dual-continent footprint allows the company to run clinical programs simultaneously in the US and Chinese markets.

Founding and History

Brii Biosciences was co-founded by Zhi Hong, who serves as President and CEO, and the company is listed on public markets under the OTC ticker BRIBF. The company built early momentum through its infectious disease pipeline, most visibly its COVID-19 neutralizing antibody combination therapy, which completed Phase III enrollment across five countries and was subsequently launched commercially in China. More recently, the company has deepened its hepatitis B portfolio through multiple licensing agreements with US vaccine developer VBI Vaccines, with a second deal announced in June 2024.

Therapy Areas and Focus

Infectious disease is the primary strategic pillar at Brii Biosciences, with hepatitis B virus and COVID-19 representing the most advanced clinical programs. Chronic HBV remains a major global health challenge, affecting an estimated 296 million people worldwide, with functional cure rates under current standard-of-care treatments remaining very low. Brii's CNS interests round out the pipeline, addressing neurological and psychiatric conditions where patient stigma and limited treatment options create parallel unmet needs to those seen in its infectious disease work.

Technology Platforms and Modalities

Brii Biosciences employs a diversified modality strategy spanning monoclonal antibodies, small molecules, prophylactic vaccines, and genetically engineered subunit vaccine constructs. Its COVID-19 program demonstrated the company's antibody engineering capabilities through the development of long-acting neutralizing antibody combinations. For hepatitis B, the company is advancing both immune-stimulating and direct-acting approaches, including assets in-licensed from VBI Vaccines that leverage the company's novel HBV antigen platforms. In December 2025, Brii announced an AI-driven collaboration with OpenBench, Inc. to advance proprietary molecular discovery capabilities.

Key Pipeline and Programs

Amubarvimab and romlusevimab, previously designated BRII-196 and BRII-198, form the company's COVID-19 neutralizing antibody combination. This long-acting monoclonal antibody therapy completed Phase III enrollment in the ACTIV-2 study across 846 participants at sites in the US, Brazil, South Africa, Mexico, and Argentina, and has since been commercially launched in China.

On the HBV side, BRII-835 is the company's internally developed therapeutic candidate targeting chronic hepatitis B. The program has generated notable clinical data, with Brii reporting durable hepatitis B surface antigen control in a Phase II analysis released in April 2026, a key surrogate endpoint on the path toward functional cure. VBI-2601, an in-licensed recombinant HBV antigen therapy from VBI Vaccines, complements BRII-835 by targeting immune reconstitution in chronic HBV patients and has been advancing through clinical evaluation as part of the expanded VBI collaboration announced in June 2024.

Recent Developments

In June 2024, Brii Biosciences entered into a second licensing agreement with VBI Vaccines, further broadening its HBV portfolio and sending VBI's shares up nearly 10% on the announcement. The commercial launch of amubarvimab/romlusevimab in China marked a significant milestone for the company's revenue trajectory. In April 2026, Brii reported durable HBV surface antigen control in a Phase II analysis, reinforcing the functional cure thesis underpinning its HBV strategy. In December 2025, the company announced an AI-driven molecular discovery collaboration with OpenBench, Inc. to strengthen its early-stage discovery engine.

Key Personnel

Zhi Hong serves as President, Co-Founder, and CEO. Hong brings deep biopharma experience bridging US and Chinese drug development ecosystems, having helped establish Brii's dual-continent operating model. Li Yan serves as Chief Medical Officer, overseeing the company's clinical development programs across infectious disease and CNS. Lianhong Xu leads medicinal chemistry as Senior Vice President, heading the internal discovery and optimization efforts that underpin Brii's small molecule pipeline.

Strategic Partnerships

Brii Biosciences has established a multi-agreement collaboration with VBI Vaccines covering HBV therapeutic and vaccine assets, with two deals in place as of mid-2024 spanning licensing and co-development. The December 2025 collaboration with OpenBench brings AI-powered molecular discovery capabilities to Brii's platform, targeting next-generation asset identification. These partnerships reflect a consistent in-licensing and co-development model that allows Brii to supplement internal programs with externally validated science.

FAQ Section

Brii's dual-continent model is central to its strategy: the company conducts drug development and regulatory work in the US while targeting commercial launch in China, where the HBV and infectious disease burden is among the highest globally. This allows Brii to access large patient populations for clinical trials and commercialization while leveraging US scientific infrastructure. The commercial launch of amubarvimab/romlusevimab in China is the clearest example of this model translating into revenue.

Chronic HBV is difficult to cure because the virus establishes a stable reservoir of covalently closed circular DNA (cccDNA) in hepatocytes, which persists even when viral replication is suppressed. Current nucleoside analogues and interferon therapies achieve functional cure — defined as sustained loss of HBV surface antigen — in fewer than 10% of patients. Brii's approach combines direct-acting agents with immune-activating therapies to simultaneously reduce viral reservoirs and restore host immune control, a dual-mechanism strategy increasingly favored in the HBV field.

Brii is pursuing a combination strategy that pairs its internal therapeutic candidate BRII-835 with VBI-2601, an antigen-based immune restorative asset in-licensed from VBI Vaccines. The April 2026 Phase II data showing durable HBsAg control is a meaningful differentiator, as this endpoint is considered the closest available surrogate for functional cure. The company's ability to run large-scale trials in both Western and Chinese patient populations also provides a clinical dataset breadth that many single-geography HBV programs lack.

Amubarvimab and romlusevimab (formerly BRII-196/BRII-198) are long-acting neutralizing monoclonal antibodies targeting SARS-CoV-2, evaluated in the NIH-sponsored ACTIV-2 adaptive Phase II/III trial. The Phase III portion enrolled 846 participants across the US, Brazil, South Africa, Mexico, and Argentina. The combination has since been commercially launched in China, marking one of the first approvals of a long-acting antibody COVID-19 therapy in that market.

Infectious disease — particularly HBV and COVID-19 — is the dominant pipeline pillar, reflecting the company's founding thesis around high-prevalence public health challenges carrying social stigma. Central nervous system diseases represent a secondary therapeutic interest, though CNS assets are at earlier stages than the infectious disease programs. This dual-disease focus gives Brii strategic diversification while keeping both franchises tied to underserved patient populations in markets where the company has operational expertise.

Brii has achieved late-stage and commercial proof of concept with amubarvimab/romlusevimab in China, while its HBV franchise is progressing through Phase II with BRII-835. The April 2026 HBsAg control data from the Phase II analysis represents the most recent major clinical readout. Next milestones center on longer-duration HBV follow-up data, potential Phase III design decisions for the HBV program, and early outputs from the OpenBench AI collaboration on next-generation discovery assets.

Brii is at an inflection point in its HBV program, with several key watchpoints ahead:

Phase II durability data for BRII-835 and VBI-2601 combination: sustained HBsAg loss rates will determine the case for Phase III investment.
Phase III design and regulatory feedback: clarity from Chinese and US regulators on functional cure endpoints and trial design is critical to the HBV program's timeline.
Commercial performance of amubarvimab/romlusevimab in China: revenue traction will signal the company's ability to monetize its approval and fund further R&D.
OpenBench AI collaboration outputs: early pipeline candidates emerging from this deal could broaden Brii's discovery engine materially.
Macroeconomic and geopolitical risk: as a sino-American company, Brii is exposed to regulatory and trade dynamics between the US and China that could affect operations, partnering, and funding.

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