A variety of key drugs for new coronary pneumonia in my country enter clinical trials
Beijing, November 17, reporter Yang Shu
learned from the Ministry of Science and Technology recently that China has followed the three technical routes of inhibiting virus replication, blocking virus entry into cells, and regulating the human immune system. A variety of key drugs such as 196 and BRII-198 neutralizing antibody combination therapy, Azvudine, Prokrutamide, etc., have all entered the clinical trial stage.
According to the relevant person in charge of the Ministry of Science and Technology, since the outbreak of the new crown pneumonia epidemic, the State Council’s joint prevention and control mechanism scientific research team, in accordance with the decisions and deployment of the Party Central Committee and the State Council, immediately arranged drug research and development tasks on January 21, 2020. The scientific research team composed of the Ministry of Science and Technology, the Health Commission, the Ministry of Industry and Information Technology, the National Development and Reform Commission, the Food and Drug Administration, the Bureau of Traditional Chinese Medicine and other departments for drug research and development, organized a national team of superior experts to focus on clinical treatment needs, and fully promote the research and development of effective drugs and treatment technologies Work.
On the technical route, inhibiting virus replication refers to blocking the replication of the new coronavirus in the human body by inhibiting the key enzymes of virus replication.
The reporter learned that Azivudine, a key drug developed by Henan Normal University, is a new class 1 anti-AIDS drug.
However, for new coronary pneumonia, it has good anti-new coronavirus activity at the cellular level and animal level. Phase III clinical trials are being carried out in China, Brazil, and Russia, and it is expected to obtain emergency use authorization from Brazil in December.
Blocking the virus from entering the cell means blocking the virus from entering the cell by preventing the virus S protein from binding to the key receptor that mediates the virus into the human cell.
Chinese scientists have made many key drug achievements on this technical route.
The BRII-196 and BRII-198 neutralizing antibody combination therapy developed by the Tsinghua University and Tengsheng Huachuang team is currently undergoing phase II clinical trials in China. At the same time, phase III clinical trials are also being carried out abroad, and it has been launched on October 9 this year. Japan submitted a rolling application for conditional marketing to the National Food and Drug Administration, and submitted an emergency use authorization application to the US FDA.
According to reports, as of October 11, a total of about 575 patients have been treated with this drug. Preliminary clinical observations indicate that this drug has good safety and antiviral efficacy.
Prokalutamide, developed by Suzhou Kaifeng Pharmaceutical, is a new generation of androgen receptor antagonists under development.
Three clinical trials conducted in Brazil initially showed that this drug has a good effect on ambulatory and hospitalized patients with mild and moderate new coronary pneumonia, reducing the risk of death of severe patients by 78%, and has obtained emergency use authorization from Paraguay.
It has been approved by the State Food and Drug Administration for Phase III clinical trials, and is currently undergoing phase III clinical trials in the United States, Brazil and other countries.
The neutralizing antibody JS016, developed by the Institute of Microbiology of the Chinese Academy of Sciences and the Junshi Biology team, is also a drug that blocks the virus from entering cells. Currently, 60 patients have been enrolled in phase Ib and IIa clinical trials in China, the Philippines, and Ukraine. Work.
This drug is combined with the drug LY-CoV555 developed abroad to form a combination therapy. Its phase II and III clinical trial results show that this therapy can significantly reduce the hospitalization rate and mortality rate of patients with mild to moderate new coronary pneumonia who are at high risk of severe disease. At present, it has obtained emergency authorization for use in the United States, Italy, Europe, Brazil, India and other places, and the United States has also urgently authorized its use for post-exposure prevention.
In addition, the neutralizing antibody BGB-DXP-604, a drug developed by Peking University and Beijing Danxu, has been approved by the National Food and Drug Administration for clinical trials in February 2021, and has completed phase I clinical trials in Australia. Safety And well tolerated.
In addition, the two drugs FB2001 and VV116 developed by the Shanghai Institute of Materia Medica, Chinese Academy of Sciences also have good antiviral activity at the cellular level, and have good pharmacokinetic properties and lower toxicity at the animal level.
FB2001 has officially launched Phase I clinical trials in the United States in March 2021.
Preliminary results show that FB2001 exhibits good safety and human pharmacokinetic characteristics.
VV116 has already submitted clinical research applications to the National Medical Products Administration of China and the Uzbekistan Drug Evaluation Center in January and February 2021, respectively, and the clinical trial application in Uzbekistan has been approved.