Tengsheng Pharmaceutical-B (02137) announced that the Drug Evaluation Center of China's State Drug Administration will be developing type B...
According to Zhitong Finance App, Tengsheng Pharmaceutical-B (02137) announced that the China National Drug Administration Drug Evaluation Center will include the hepatitis B virus (“HBV”) specific broad-spectrum neutralizing monoclonal antibody BRII-877 (tobevibart) and the HBV-targeted low-interfering ribonucleic acid BRII-835 (elebsiran) under development as breakthrough treatments. 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.
BRII-877 (tobevibart) was certified as a breakthrough therapeutic variety based on phase 1 and phase 2 studies conducted by Vir Biotechnology, Inc. (“Vir”) and the company. By the end of September 2023, more than 350 patients had been treated with BRII-877 (tobevibart). The data shows that BRII-877 (tobevibart) is well tolerated and can significantly reduce the level of hepatitis B surface antigen, which indicates that BRII-877 (tobevibart) has the potential to become an important part of the treatment regimen for chronic HBV infected people and chronic hepatitis D virus (“HDV”) infected people. BRII-835 (elebsiran) was recognized as a breakthrough therapeutic variety based on phase 1 and phase 2 studies conducted by the company and its partner Vir. By the end of September 2023, more than 570 cases of HBV infected people had participated in clinical studies. These findings showed that BRII-835 (elebsiran) was well tolerated and showed direct antiviral activity in chronic HBV and chronic HDV subjects.
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 curative combination therapies for patients with chronic HBV infection. Over the past five years, the company and our partner Vir have conducted numerous clinical trials, 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 of HBV in a wider range of patient groups.”
Having three breakthrough treatments puts the company in a unique position to tackle a wider range of HBV infections, including those complicated with HDV. 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.