Brii Biosciences’ HBV Drug Candidates Receive NMPA’s Breakthrough Therapy Designations

Brii Biosciences Ltd (HKG: 2137) has announced that two of its hepatitis B virus (HBV) drug candidates, BRII-835 (elebsiran) and BRII-877 (tobevibart), have been granted breakthrough therapy designations (BTDs) by China’s National Medical Products Administration (NMPA).

BRII-877 (tobevibart) is a hepatitis B virus-specific broad-spectrum neutralizing monoclonal antibody (mAb) designed to block the entry of HBV and HDV into liver cells, thereby reducing the levels of viral particles and subviral particles in the bloodstream. On the other hand, BRII-835 (elebsiran) is a small interfering ribonucleic acid (siRNA) administered subcutaneously that targets HBV, with the potential for direct antiviral activity against HBV and HDV, as well as inducing effective immune responses.

Both BRII-877 and BRII-835 were obtained from Vir Biotechnology, Inc. (NASDAQ: VIR) through licensing deals secured in 2020 and 2022, respectively. They have demonstrated good tolerability and exhibited significant antiviral activities in HBV patients during Phase I/II clinical trials.- Flcube.com

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