On December 8, the National Medical Products Administration of China urgently approved Tengsheng Huachuang Medical Technology (Beijing) Co., Ltd.'s new coronavirus neutralizing antibody combined therapy drug Ambavirimab Injection (BRII-196) and Romisvirdan Anti-injection solution (BRII-198) registration application. This is China's first approved new coronavirus neutralizing antibody combination therapy with independent intellectual property rights.

According to the relevant provisions of the "Drug Administration Law" and in accordance with the special drug approval procedures, the State Drug Administration will conduct emergency review and approval, and approve the combination of the above two drugs for the treatment of mild and common types with progress to severe (including hospitalization or death) ) Adults and adolescents (12-17 years old, weight ≥40kg) with high-risk factors, patients with novel coronavirus infection (COVID-19). Among them, adolescents (12-17 years old, weight ≥40kg) indication population are conditional approval.

Tengshengbo Pharmaceutical focuses on the research and development of innovative drugs for infectious diseases. The new crown monoclonal neutralizing antibody BRII-196/BRII-198 combined with "cocktail" therapy is the new drug with the fastest research progress of this company that has just been established for more than three years. At the beginning of 2020, Tengsheng Biopharmaceuticals, together with Tsinghua University and Shenzhen Third People's Hospital, jointly established Tengsheng Huachuang to jointly develop BRII-196 and BRII-198 new crown neutralizing antibodies.

The China National Medical Products Administration's marketing approval for the Ambasavirzumab/Romisvirzumab combination therapy is based on the interim and final results of Phase 3 of the ACTIV-2 trial (NCT04518410) supported by the National Institutes of Health (NIH). The final results showed that compared with placebo, this combination therapy reduced the composite endpoint of hospitalization and death of COVID-19 outpatients with a high risk of clinical progression by 80%, which was statistically significant. The data further proves that high-risk patients can benefit from the BRII-196/BRII-198 combination therapy within 10 days after the onset of symptoms.

As of the 28-day clinical endpoint, there were zero deaths in the treatment group and 9 deaths in the placebo group, and its clinical safety was better than that of the placebo group. At the same time, subjects who started treatment at an early stage (within 5 days after the onset of symptoms) or at a late stage (within 6 to 10 days after the onset of symptoms) had a significant reduction in hospitalization and mortality, which provided new coronary disease patients. Longer treatment window.

This approval marks that China has the first fully self-developed and effective anti-neovirus specific drug that has undergone strict randomized, double-blind, and placebo-controlled studies, and has made important contributions to global epidemic prevention and control.