Company News

Azvudine was included in the latest version of Clinical Pharmacy Guideline for Antiviral Treatment of COVID-19 published by Guangdong Pharmaceutical Association.

Time:2022-12-09

On Dec. 7, 2022, Guangdong Pharmaceutical Association published the Clinical Pharmacy Guideline for Antiviral Treatment of COVID-19 (Updated Version), which aims to provide detailed guidance for rational and safe clinical use of drugs. Azvudine, the new oral antiviral COVID-19 treatment developed in China, was included in the latest guideline.

Since Dec. 2019, the outbreak of COVID-19 has taken place all over the world. To date, COVID-19 is still an ongoing global pandemic and a threat to human health. As of Dec. 2, 2022, there had been over 640 million confirmed cases of COVID-19 infection and more than 6.62 million related deaths worldwide.

So far, over a thousand of mutant strains of the novel coronavirus (SARS-CoV-2) have been identified in humans. As the virus mutates, Omicron strains have replaced Delta strains and become the new "variants of concern", including BA.1, BA.2, BA.3, BA.4, BA.5 and the descendant lineages. Compared to Delta variants, Omicron variants have higher infectiousness, decreased pathogenicity, and enhanced immune evasion. Studies have shown that people infected with Omicron variants are less likely to develop severe diseases than if they are infected with other variants. In addition, Omicron may escape from the immunity, thus reducing or even eliminating the efficacy of some monoclonal antibodies.

Azvudine is the first oral small-molecule antiviral drug independently developed in China.On Jul. 25, 2022, Azvudine was conditionally approved by the NMPA for the treatment of common COVID-19 in adults.On Aug. 9, 2022, the General Office of the National Health Commission and the Office of the National Administration of Traditional Chinese Medicine included Azvudine tablets in the Diagnosis and Treatment Guideline for COVID-19 (9th Edition) for the first time. In Sep. 2022, Azvudine was included in the List of Drugs that Passed the Preliminary Formal Review in the Adjustment of the National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance Drug Catalog in 2022.Up to now, Azvudine tablets have been included in the basic medical insurance networks of 31 provinces, autonomous regions and municipalities of China. The price is RMB 270 per bottle (1 mg/tablet, 35 tablets/bottle).

In terms of mechanism of action and clinical efficacy, Azvudine is a broad-spectrum RNA virus inhibitor. As a synthetic nucleoside analogue of the viral RNA-dependent RNA polymerase (RdRp), it is metabolized intracellularly into an active metabolite 5'-triphosphate (Azvudine triphosphate) that specifically targets the SARS-CoV-2 RdRp.It is incorporated into the viral RNA chain during SARS-CoV-2 virus RNA synthesis, thereby terminating the replication of SARS-CoV-2 and exerting therapeutic effects against COVID-19.

Regarding the dosage regimen, 1 mg of Azvudine is indicated for the treatment of common COVID-19 in adults.5mg of Azvudine should be administered once a day for a maximum of 14 days. Azvudine should be administered on an empty stomach as taking the drug after meal may increase drug exposure. Tablets should be swallowed whole and not crushed.