The Center for Drug Evaluation (CDE) website has indicated that Brii Biosciences Ltd (HKG: 2137), a biopharmaceutical company based in China, is poised to secure breakthrough therapy designation (BTD) for its drug BRII-835 (VIR-2218) from the National Medical Products Administration (NMPA). The drug is intended for the treatment of chronic hepatitis B virus (HBV) infection and the co-infection of chronic HBV/hepatitis D virus (HDV).
BRII-835, developed by Vir Biotechnology (NASDAQ: VIR), is an investigational subcutaneous small interfering RNA (siRNA) therapy specifically designed to treat HBV. It incorporates enhanced stable chemical potentiation (ESC+) technology, which aims to enhance the drug’s stability and reduce off-target effects, potentially leading to an improved treatment profile. Brii Bio secured exclusive rights to develop and commercialize BRII-835 in Greater China through a licensing agreement with Vir Biotechnology in 2020. The company previously reported positive results from a Phase II study of the drug in February of the previous year.- Flcube.com
