Product Description
Amubarvimab / Romlusevimab (BRII-196/BRII-198) Monoclonal Antibody Description
BRII-196 and BRII-198 are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients. The monoclonal antibodies have been specifically engineered to reduce the risk of antibody-dependent enhancement and prolong the plasma half-lives for potentially more durable treatment effect. In addition, their non-overlapping epitope binding regions provide a high degree of neutralization activity against the SARS-CoV-2 betacoronavirus.
The combination of BRII-196/BRII-198 was generally safe and well-tolerated in Phase 1 studies. In addition to the collaboration with NIAID, Brii Biosciences is conducting additional studies in China, evaluating the pharmacokinetics and safety of combination BRII-196/BRII-198 and a Phase 2 efficacy study of combination BRII-196/BRII-198 for the treatment of COVID-19.
The Company confirmed investigational New Drug applications had been submitted for the combination therapy to the U.S. Food and Drug Administration.
The China National Medical Products Administration (NMPA) granted approval on December 9, 2021, for the amubarvimab/romlusevimab combination (previously BRII-196/BRII-198 combination), for the treatment in adults and pediatric patients (age 12-17 weighing at least 40 kg) with the mild and normal type of COVID-19, at high risk for progression to severe disease, including hospitalization or death. The NMPA approval is based on the phase 3 study final results demonstrated a statistically significant 80% (78% in interim results) reduction of hospitalization and death with fewer deaths through 28 days in the treatment arm (0) relative to placebo (9), and improved safety outcome over placebo in non-hospitalized COVID-19 patients at high risk of clinical progression to severe disease. Similar efficacy rates were observed in participants initiating therapy early (0-5 days) and late (6-10 days), following symptom onset, providing critically needed clinical evidence in COVID-19 patients who were late for treatment.
Brii Bio (stock code: 2137. HK) is a multi-national company based in DURHAM, N.C., United States, and BEIJING, China, developing innovative therapies for diseases with significant unmet medical needs large public health burdens. Brii Biosciences Limited has been included as a constituent stock of the Hang Seng Composite Index. October 2021 corporate presentation. . On Dec. 5, 2021, Brii Biosciences Limited was added to the Hong Kong Stock Connect.
Amubarvimab / Romlusevimab (BRII-196/BRII-198) Monoclonal Antibody History
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. Amubarvimab and Romlusevimab are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients.
In less than 20 months, Brii Bio progressed the amubarvimab/romlusevimab combination from discovery to completion of Phase 3 development leading to this rapid approval by the NMPA. This approval represents the highly successful partnership with the best scientists and clinical investigators in China and around the globe on a shared mission, including the 3rd People’s Hospital of Shenzhen and Tsinghua University, who discovered these neutralizing antibody leads; the U.S. National Institute of Health, the AIDS Clinical Trial Group, who sponsored and led the ACTIV-2 trial.
Amubarvimab / Romlusevimab (BRII-196/BRII-198) Monoclonal Antibody Indication
BRII-196/BRII-198 Monoclonal Antibody is indicated to treat non-hospitalized COVID-19 patients at high risk of clinical progression. The indication of pediatric patients (age 12-17 weighing at least 40 kg) is under conditional approval in China.
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