On July 15, Henan Zhenzhen Biotechnology Co., Ltd. announced that the results of the registration phase III clinical trial of Azivudine Tablets for the treatment of new coronavirus pneumonia indications met expectations. Recently, a marketing application has been officially submi

2024/06/2819:14:32 science 1252

Beijing Daily Client | Reporter Zhao Yuhan

The first domestic oral drug for COVID-19 is here! On July 15, Henan Real Biotechnology Co., Ltd. (hereinafter referred to as "Real Bio") announced that the results of the registration phase III clinical trial of Azivudine Tablets for the treatment of new coronavirus pneumonia indications met expectations. Recently, a marketing application has been officially submitted to State Food and Drug Administration .

On July 15, Henan Zhenzhen Biotechnology Co., Ltd. announced that the results of the registration phase III clinical trial of Azivudine Tablets for the treatment of new coronavirus pneumonia indications met expectations. Recently, a marketing application has been officially submi - DayDayNews

Related clinical trial results show that Azivudine tablets can significantly shorten the symptom improvement time of patients with moderate new coronavirus-infected pneumonia, increase the proportion of patients with improved clinical symptoms, and achieve clinical superior results.

In terms of significantly reducing 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 better results than the placebo group. For a greater reduction in viral load, the virus clearance time is about 5 days.

In terms of significantly improving clinical symptoms, Azivudine tablets can significantly shorten the hospitalization time of patients with moderately severe novel coronavirus-infected pneumonia, increase the proportion of clinical symptom improvement in patients, and achieve clinically superior results. The proportion of subjects whose clinical condition 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

In terms of safety, Azivudine tablets were generally well tolerated, The incidence of adverse events There is no statistical difference between the Azivudine group and the placebo group, and there is no increase in the risk of subjects

It is understood that Azivudine is the world's first dual-target innovative anti-AIDS drug and has been used in clinical trials. As an antiviral small molecule oral drug, Azivudine has applied for patents and been authorized in many countries such as China and the United States. It has the effect of broadly inhibiting the replication of RNA virus . The new coronavirus is also a virus with RNA as its genetic material. 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 contribute to domestic and even global epidemic prevention and control. "

According to the registration information of domestically produced drugs on the official website of the State Food and Drug Administration , Azivudine tablets have been registered on June 29 and are expected to become the first domestically produced COVID-19 oral drugs.

Image source: Real Bio

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