The safety and effectiveness of China's new crown antibody drug JS016 has been recognized worldwide

The safety and effectiveness of my country's new crown antibody drug JS016 has been recognized worldwide

This paper, Beijing, December 4, reporter Qi Fang

learned from the Institute of Microbiology, Chinese Academy of Sciences recently that a new drug JS016, a new coronary pneumonia therapeutic antibody with China’s independent intellectual property rights, has completed the international multi-center phase II clinical trial and is actively advancing phase III. Clinical Trials.

　　According to Yan Jinghua, the main researcher of the drug and a researcher at the Institute of Microbiology of the Chinese Academy of Sciences, JS016 is an injectable drug jointly developed by the institute and Shanghai Junshi Biology, and its generic name is "Etesvizumab."

　　Yan Jinghua introduced that this single-antibody drug is derived from the memory B cells of COVID-19 rehabilitation patients. "This memory B cell can produce antibodies to the new coronavirus. We use single-cell sequencing to obtain this antibody gene, and then perform in vitro cloning and The cells are expressed, purified, and then transferred back into the patient's body to have a therapeutic effect."

　　"For a virus to invade cells, a protein on its surface needs to interact with a protein on human cells. If we compare this process to'open the door and enter', then these two interacting proteins are the key and the lock." Yan Jinghua explained, "The antibody can block this interaction, as if the key is covered, and the virus can no longer invade the cell."

　　JS016 has also gained worldwide attention.

Junshi Biotech cooperated with Eli Lilly to authorize commercial development in markets outside of Greater China.

Eli Lilly has conducted multiple phase III clinical trials in combination with the JS016 antibody and another monoclonal antibody of its own. The results show that the combination therapy can be significant for patients with mild to moderate new coronary pneumonia who are at high risk of becoming severely ill. Reduce the risk of hospitalization and all-cause death (70%~84%), and protect death cases by 100%.

The combination therapy has been authorized for emergency use in 15 countries and regions including the United States, the European Union, India, and Brazil, and is currently one of the three new crown antibody therapies used internationally.

Recently, the US FDA has expanded the scope of use of this combination antibody and approved it for emergency prevention after exposure to new crowns. The US government has repeatedly purchased more than 900,000 doses, and the EU has purchased 220,000 doses for prevention and mild disease after exposure to new crowns. Treatment with ordinary patients.

At present, more than 500,000 people have received JS016's combination therapy. According to Our World in Data statistics, the current mortality rate of new coronary pneumonia is 2.01%. The use of 500,000 doses of drugs may have avoided nearly 10,000 deaths.

　　Yan Jinghua said: "At present, the global new crown drug research and development has made many important progress, and the combination of multiple targets will be an option for the treatment of patients with new crown virus in the future, until we finally defeat the virus."