Main Efficacy Endpoints in Phase III Clinical Trials for Registration of Azvudine Tablets for the Treatment of COVID-19 Have Met Expectations

Henan Genuine Biotech Co., Ltd. (hereinafter referred to as "Genuine Biotech") announced that the results of phase III clinical trial for registration of Azvudine tablets for the treatment of COVID-19 have met the expectations. Recently, a marketing application has been formally submitted to the National Medical Products Administration.

The pivotal phase III clinical trial for registration supporting the marketing application for this product was designed as multicenter, randomized, double-blind, and placebo-controlled, and the study results showed:

(1) Significant improvement in relieving clinical symptoms: Azvudine Tablets significantly shortened the time to relief symptom in patients with moderate COVID-19 and increased the proportion of patients with clinical symptom improvement, achieving clinically superior outcomes. The proportion of subjects whose clinical symptoms improved on day 7 after the first dose was 40.43% in the Azvudine group and 10.87% in the placebo group (P value < 0.001), and there was a highly significant statistical difference in the median time to the improvement of clinical symptoms between the Azvudine and placebo groups (P value < 0.001). (per protocol set, PPS)

(2) Effect of inhibiting novel coronavirus: Azvudine has the activity of inhibiting SARS-CoV-2, and the virus clearance time is about 5 days.

(3) Good safety: Azvudine tablets were generally well tolerated. The incidences of adverse events were not statistically different between the Azvudine and placebo groups, thus Azvudine did not increase the risk to the subjects.

Dr. Du Jinfa, Chief Scientific Officer of Genuine Biotech, said, "We are very happy to come to this important moment, and are looking forward to the approval of Azvudine tablets as soon as possible to contribute to the prevention and control of the domestic epidemic and even the global pandemic."

"As a nucleoside analogue that inhibits viral RNA-dependent RNA polymerase (RdRp), Azvudine specifically acts on the RdRp of novel coronavirus, thereby inhibiting the viral replication with strong drug targeting." said Professor Chang Junbiao, inventor of Azvudine, former president of Henan Normal University, and current deputy secretary and vice president of Zhengzhou University.

Jiang Jiandong, Academician of the Institute of Pharmaceutical Sciences, Chinese Academy of Medical Sciences, said, "Azvudine has a significant anti-novel coronavirus effect and is effective in patients with mild and severe clinical conditions. Azvudine treats COVID-19 through a molecular mechanism against both the symptoms and the root cause, which is its distinctive biological feature."