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.

In early 2020, the Company partnered with Tsinghua University and Shenzhen Third People’s Hospital to establish TSB Therapeutics for the development of BRII-196 and BRII-198, non-competing SARS-CoV-2 neutralizing antibodies derived from recovering coronavirus disease 2019 (“COVID-19”) patients. The two antibodies, BRII-196 and BRII-198, target distinct epitope regions in the receptor binding domain (RBD) in coronavirus spike glycoproteins non-competitively, and are being developed as a “cocktail”, or combination therapy, with a goal of retaining efficacy against current and future variants and preventing the generation and selection of resistant viruses.

BRII-196 and BRII-198 have completed Phase 1 clinical trials as individual monotherapies in China. The results showed that both BRII-196 and BRII-198 were safe and well-tolerated in healthy Chinese participants with predicted pharmacokinetic profiles. The BRII-196 and BRII-198 antibody “cocktail” is currently being evaluated in a Phase 1 combination study in healthy subjects in China and in  ACTIV-2 Phase 3 of the master trial protocols developed by the National Institutes of Health of United States of America as part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines program being conducted by the United States National Institute of Allergy and Infectious Diseases globally among ambulatory COVID-19 patients who are at high risk for disease progression. Recent preclinical studies have also shown that this cocktail combination therapy may maintain neutralizing activity against the SARS-CoV-2 variants, which continue to be of global concern, including Alpha (α), Beta (β) and Gamma (γ) variants. Evaluation of emerging variants is underway.

"The emergence of SARS-CoV-2 variants poses new global public health challenges. The Phase 3 clinical trial evaluating BRII-196 and BRII-198 is progressing well, with enrollment ongoing at multiple clinical study centers worldwide," commented Rogers Luo, President and General Manager for Greater China at Brii Biosciences and CEO of TSB Therapeutics. "With the initiation of this Phase 2 clinical trial in China, we will continue to collect extensive data to actively advance this important investigational antibody cocktail therapy in the fight against the COVID-19 pandemic around the world."

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About Brii Biosciences

Brii Biosciences Limited (“Brii Biosciences” or the “Company”, stock code: 2137.HK) is a biotechnology company based in China and the United States committed to advancing therapies for significant infectious diseases, such as hepatitis B virus (HBV), human immunodeficiency virus (HIV), multi-drug resistant (MDR) or extensive drug resistant (XDR) gram-negative infections and other illnesses, such as the central nervous system (CNS) diseases, which have significant public health burdens in China and worldwide. For more information, visit www.briibio.com.

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