On May 14, Gelonghui | Tengshengbo Pharmaceutical-B (02137.HK) announced that the Drug Evaluation Center of the China State Drug Administration will include the hepatitis B virus (“HBV”) specific broad-spectrum neutralizing monoclonal antibody BRII-877 (tobevibart) and the HBV-targeted small-interfering ribonucleic acid BRII-835 (elebsiran) under development as breakthrough therapeutic varieties. This is another milestone achieved by the company in seeking a functional cure for HBV after the recombinant protein-based HBV immunotherapy BRII-179 was certified as a breakthrough treatment in November 2023.
Dr. Zhu Qing, head of research and development at the company in China, said, “BRII-835 and BRII-877 were certified as breakthrough treatment varieties, and BRII-179 was recognized as a breakthrough treatment type earlier, further supporting our long-term scientific basis for developing functional treatment combinations for patients with chronic HBV infection. Over the past five years, we have conducted numerous clinical trials with our partner Vir, from which we have obtained very comprehensive clinical safety and efficacy data, and a thorough understanding of our late-stage development plans and achieving a higher functional cure rate for HBV in a wider range of patient groups.”
Having three breakthrough treatments puts the company in a unique position to address a wider range of HBV infections, including co-HDV infections. As part of the company's development of functional curative therapies for HBV, the company and its partner Vir are advancing plans to launch multiple joint studies in 2024 to further optimize treatment plans and provide a basis for the company's registration strategy, thereby providing the best treatment plan for HBV patients.