China's first novel coronavirus specific drug
The marketing approval of ambavizumab/romisizumab combination therapy specific drug by China's National Food and Drug Administration marks the official launch of China's first independently developed and proven effective anti-novel Coronavirus antibody specific drug.
How to use China's first specific anti-Novel Coronavirus antibody? How effective is it?
Clinical trial data show that amberavizumab/romisizumab combination therapy can reduce hospitalization and mortality rates by 80% in patients at high risk of COVID-19 outpatients, with the primary effect being treatment. At the same time, antibodies can persist in the human body for 9 to 12 months, to prevent infection also has a role. These are the best therapeutic data of novel coronavirus agents in the world at present.
Linqi Zhang, a professor at Tsinghua University's School of Medicine and director of the Center for Global Health and Infectious Diseases, is leading the team developing the wonder drug. Zhang linqi said that antibodies are the natural weapon of the human body. They "searched for a needle in a haystack" to screen out two antibodies that are strong in blocking the Novel Coronavirus. "The drug is administered intravenously for 40 minutes.
Wonder drugs go abroad to undergo clinical trials around the world
After the development of specific drugs, when Zhang linqi's team wanted to carry out phase II and Phase III clinical studies, due to the proper epidemic prevention measures, it was difficult to find COVID-19 patients for research in China. In December 2020, based on the results of the previous phase I clinical study conducted in China, Zhang and his team applied to participate in a world-leading clinical trial sponsored by the National Institutes of Health (NIH) in the United States.
In accordance with international practice, the organizers divided novel Coronavirus patients into two groups, one receiving the ambavizumab/romisizumab specific for COVID-19 antibody, and the other receiving placebo drops, in strict randomized, double-blind, controlled international phase II and Iii trials of the specific for COVID-19 antibody. Hospitalizations and deaths were compared over a 28-day period.
On December 3, 2021, the National Institutes of Health (NIH) released full clinical data on the novel coronavirus antibody specific for ambayzumab/romizimab combination therapy following rigorous comparative testing. In a Phase iii trial, the combination of amberavizumab/romisizumab reduced the risk of hospitalization and death in high-risk COVID outpatients by 80% compared to placebo.
When will the wonder drug be on the market?
Although the new drug has been approved for marketing, there is no exact time frame for bringing it fully to market. Zhang said relevant departments and technical teams are working around the clock to push forward the process.
In the future, With the support of the Ministry of Science and Technology, Zhang linqi and his research team will further explore the interaction mechanism of the whole virus and antibody, the rule of virus variation, and the "spare antibody", so that the specific drug can play its role in effectiveness, broad spectrum and durability.