Henan Daily Client Reporter Ke Yang and Li Xiaomin Azivudine, which has been approved to conduct phase III clinical trials for more than two years, is expected to become my country's first oral anti-COVID-19 drug with completely independent intellectual property rights! On July 1

Henan Daily Client Reporters Ke Yang and Li Xiaomin

Azivudine , which has been approved to carry out phase III clinical trials for more than two years, is expected to become my country's first oral anti-COVID-19 drug with completely independent intellectual property rights!

On July 15, Henan Real Biotechnology Co., Ltd. (hereinafter referred to as "Real Bio") announced that it has recently officially submitted a marketing application for Azivudine for the treatment of new coronavirus indications to the National Medical Products Administration and has been accepted.

Since April 2020, Azivudine has been approved to conduct Phase III clinical trials at home and abroad. Clinical trial results show:

(1) significantly reduces viral load. Azivudine tablets can inhibit the activity of the new coronavirus. The higher the viral load, the more obvious the inhibitory effect. On the 3rd, 5th, and 7th days after administration, the test group showed a greater decrease in viral load than the placebo group. , the virus clearance time is about 5 days.

(2) significantly improves clinical symptoms. Azivudine tablets can significantly shorten the hospitalization time of patients with moderately severe new coronavirus-infected pneumonia, improve the proportion of clinical symptom improvement in patients, and achieve clinical excellent results. The proportion of subjects whose clinical condition improved on the 7th day after the first administration was 40.43% in the Azivudine group and 10.87% in the placebo group, (P value 0.001). The median time for the improvement of the clinical condition of the subjects in the experimental group and the control group There is a very significant statistical difference (P value 0.001).

(3) In terms of safety, Azivudine tablets are generally well tolerated. There is no statistical difference in the incidence of adverse events between the Azivudine group and the placebo group, and there is no increased risk to subjects.

It is understood that Azivudine is the world’s first dual-target innovative anti-AIDS drug. It has applied for patents and been authorized in many countries such as China and the United States. As an antiviral small molecule oral drug, Azivudine has a broad-spectrum inhibitory effect on the replication of the RNA virus . The new coronavirus is also a virus with RNA as its genetic material, so the drug has an inhibitory effect on the new coronavirus.

Dr. Du Jinfa, chief scientist of Real Biotechnology, said: "We are very happy to usher in this important moment and look forward to the early approval of Azivudine to provide a force for domestic and even global epidemic prevention and control."

Azivudine drug invention Professor Chang Junbiao, former president of Henan Normal University and now deputy secretary and vice president of Zhengzhou University, said: "We broke through traditional thinking and developed a new design strategy for nucleoside drugs, innovatively utilizing the virus replication process. The properties of RNA polymerase in the microenvironment allow the drug to be specifically activated in target cells and work in situ. In addition, further studies have proven that the half-life of azivudine in CD4T cells is greater than 120 hours. "

Jiang Jiandong, academician of the Chinese Academy of Engineering and director of the Institute of Pharmacy of the Chinese Academy of Medical Sciences and Peking Union Medical College, said: " Azivudine has obvious anti-coronavirus effects. , effective for clinical mild and severe patients, Azivudine treats new crown through a molecular mechanism that treats both symptoms and root causes, which is its unique biological feature. "

(Source: Henan Daily Client)

Editor: Wang Shidan | Reviewer: Li Zhen | Director: Wan Junwei