Domestic anti-new crown special drugs are coming!

On December 8, China's first anti-new coronavirus specific drug, ampavivir monoclonal antibody / romimab combination therapy drug, was approved by the China Food and Drug Administration, which marked the official appearance of the first anti-new coronavirus antibody special drug that China has fully independently developed and proved effective.

How to use China's first anti-new coronavirus antibody drug? How effective is it?

Clinical trial data show that the combination of amphavir monoclonal antibody/romizumab can reduce the hospitalization rate and mortality rate of high-risk COVID-19 outpatients by 80%, and the main role is treatment. At the same time, antibodies can remain in the human body for 9 to 12 months, which also has a certain effect on preventing infection. This is currently the best treatment data among the anti-coronavirus drugs in the world.

Zhang Linqi, a professor at Tsinghua University School of Medicine and director of the Global Health and Infectious Diseases Research Center, is the leader of the research and development team of this special drug. Zhang Linqi said that antibodies are the natural weapons of the human body, they "find a needle in a haystack", screen out two antibodies with strong blocking power against the new crown virus, let them play a combination of punches, "the drug takes the way of intravenous infusion, the whole process is 40 minutes before and after, and it takes effect immediately after injection."

Special drugs go abroad to receive clinical trials around the world

After the development of the specific drug, when Zhang Linqi's team wanted to further do phase II and phase III clinical research, due to the appropriate epidemic prevention measures, it was difficult to find new coronavirus patients in China that could be used for research. In December 2020, based on the results of a phase of clinical research previously conducted in China, Zhang Linqi applied to participate in a world-leading clinical trial sponsored by the National Institutes of Health (NIH).

In accordance with international practice, the organizers divided the new crown virus patients into two groups, one group received the treatment of this ampavirinumab /romimab new crown antibody specific drug, and the other group was only insimulated with placebo, and in strict accordance with the principle of randomization, double blindness and control, the special drug was carried out in international clinical phase II and PHASE III trials. Over a period of 28 days, the patient's hospitalization and death were compared.

On December 3, 2021, after rigorous comparative testing, the National Institutes of Health (NIH) released all clinical data on the combination of ampavirinumab/romizumab antibody for COVID-19 antibody drugs. In phase III clinical trials, the combination of amphavir monoclonal antibody/romizumab reduced the risk of hospitalization and death in high-risk COVID-19 outpatients by 80% compared with placebo.

Linqi Zhang: The results are actually very exciting. In the case of multi-ethnic and multi-variant strains in many parts of the world, it is not easy to achieve 80% of the effect.

Can a miracle drug cope with TheOmerick?

With the development of special drugs by scientists around the world, the mutation of the new crown virus is also continuing. Since November this year, the new crown virus variant Ofmicron has attracted strong attention. In the face of the menacing Aomi Kerong, can This special drug in China be effectively dealt with?

Zhang Linqi: Our evaluation found that one of the antibodies remained active and the other antibody lost part of its activity, but because we were a combination punch, the two antibodies added together still maintained the neutralization ability of the Omikejong variant strain. So we have great confidence in the ability of our antibody drugs to suppress emerging viruses.

When will the special drug be fully launched to the market?

While the new drug has been approved for marketing, there is no exact time to bring it fully to market. Zhang Linqi said that the relevant departments and the corresponding technical teams are working day and night to promote the process.

In the future, Zhang Linqi and the R&D team will further excavate the entire virus and antibody interaction mechanism and virus mutation law with the support of the Ministry of Science and Technology, and excavate the "spare tire antibody" so that the special drug can play its role in terms of effectiveness, broad spectrum and durability.

Source: CCTV News (ID: cctvnewscenter) comprehensive "Face to Face"