China’s first anti COVID-19 specific drug was approved for sale, effective for many variants such as delta

China’s first anti COVID-19 specific drug was approved for sale, effective for many variants such as delta.

In December 8, 2021, Tsinghua University released the new crown monoclonal antibody neutralab, which was developed by Professor Zhang Linqi of China Medical College of Tsinghua University. The combination therapy of BRII-196/BRII-198 and NMPA was previously approved by the China Drug Administration (NMPA). Novel coronavirus pneumonia risk factors were also associated with adult and adolescent patients (over 12 years old, weighing 40 kg or more).

variants such as delta.


The approval marks China’s first fully developed and proven randomized, double-blind, placebo-controlled study to prove effective anti COVID-19.

In October 2021, the R & D team has completed the application for emergency use authorization (EUA) of ambacizumab / romisizumab combination therapy to the U.S. Food and Drug Administration (FDA). In addition, the R & D team is actively promoting the application for registration of ambacizumab / romisizumab combination therapy in other mature and emerging markets around the world, first ensuring market access in countries that have carried out clinical trials and countries that have a huge gap in access to efficient treatment. The R & D team will also carry out further research in China to evaluate the preventive immune enhancement effect of ambacizumab / romistuzumab combination therapy in immunosuppressed populations.

Professor Zhang Linqi of China Medical College of Tsinghua University

This approval is based on the phase 3 clinical trial of activ-2 supported by the National Institutes of Health (NIH), including the positive interim and final results of 847 enrolled patients. The final results showed that compared with placebo, ambacizumab / romisizumab combination therapy could reduce the risk of hospitalization and death in high-risk new crown outpatients by 80% (the interim result was 78%), which was statistically significant.

As of the clinical end point of 28 days, there were no deaths in the treatment group and 9 deaths in the placebo group, and its clinical safety was better than that in the placebo group. At the same time, there was a significant reduction in hospitalization and mortality in subjects who started treatment early (within 5 days after the onset of symptoms) or late (within 6 to 10 days after the onset of symptoms), which provided a longer treatment window for patients with new crowns.

相关文章

Leave a Reply

Your email address will not be published. Required fields are marked *