Azivudine , which has been approved for 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 Biotechnology") 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.
Since April 2020, Azivudine has been approved to conduct Phase III clinical trials at home and abroad. Clinical trial results show that ▼
(1) significantly improves clinical symptoms: Azivudine tablets can significantly shorten the symptom improvement time of patients with moderate new coronavirus infection pneumonia, increase the proportion of patients with improved clinical symptoms, and achieve clinical superior results. The proportion of subjects whose clinical symptoms improved on the 7th day after the first dose was 40.43% in the Azivudine group and 10.87% in the placebo group (P value 0.001). The median time to improvement in the clinical status of the subjects was 40.43% in the Azivudine group and 10.87% in the placebo group. There was a very significant statistical difference in the placebo group (P value 0.001).
(2) Inhibiting the new coronavirus: Azivudine has the activity of inhibiting the new coronavirus, and the virus clearance time is about 5 days.
(3) 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 does not increase the risk to the 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 China, the United States and other countries.. 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 welcome this important moment and look forward to the early approval of Azivudine to provide a contribution to 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 and of Azivudine in CD4 T cells is greater than 120 hours. Its drug is highly targeted and long-acting."
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-COVID-19 effects and is very beneficial to clinical practice. It is effective in both mild and severe patients. Azivudine treats new coronavirus through a molecular mechanism that treats both symptoms and root causes. This is its unique biological feature. "
Source: Henan Daily WeChat public account (ID: hnrbxmtb)
.
