China’s Center for Drug Evaluation (CDE) website has indicated that Brii Biosciences Ltd (HKG: 2137), a China-based company, is poised to secure breakthrough therapy designation (BTD) status for its BRII-179 (VBI-2601), a first-in-class therapeutic vaccine targeting Pre-S1/Pre-S2/S for the treatment of chronic hepatitis B virus (HBV) infection. The potential designation highlights the vaccine’s significance in addressing the unmet medical needs for HBV patients.
Brii Biosciences’ Strategic Partnership and Global Expansion
Previous studies have demonstrated that BRII-179 can elicit a broad spectrum of antibodies and T cell responses against Pre S1, Pre S2, and S epitopes in chronic HBV patients. In 2018, Brii Bio entered into a licensing agreement with VBI Vaccines Inc., a US-based company listed on Nasdaq as VBIV, securing exclusive rights to the vaccine in Greater China, which includes Hong Kong, Taiwan, and Macau. This strategic move was further expanded in July 2023 when Brii Bio extended the BRII-179 (VBI-2601) license to cover global rights, underscoring the company’s commitment to advancing treatments for HBV on a worldwide scale.- Flcube.com
