Favipiravir

During the COVID-19 pandemic, the clinical value of RNA polymerase inhibitor antiviral drugs has been widely verified, and favipiravir is a representative oral broad-spectrum anti-RNA virus drug among them. It selectively inhibits the activity of viral RNA-dependent RNA polymerase to block the replication process of the viral genome. Clinically, it can be used for the treatment of novel or recurrent influenza in adults, and also shows clear application potential in the clinical treatment of emerging and sudden infectious diseases such as SARS-CoV-2 infection and Ebola virus infection. It is one of the key antiviral drugs in the public health emergency reserve catalogue.

In 2023, the overall market size of domestic anti-influenza drugs exceeded 12 billion yuan, among which the growth rate of oral antiviral drugs reached 21%. As a second-line influenza treatment and public health reserve drug, favipiravir has an annual API demand of around 180 tons stably. At present, 8 domestic enterprises have obtained approval for the marketing of favipiravir generic drugs, and the localization rate of APIs has exceeded 95%. After the patent cliff, the price of APIs has dropped by 78% compared with that during the patent period of the original research drug. The winning of centralized procurement has driven the continuous release of downstream preparation capacity, and the demand for upstream APIs and supporting impurity reference standards has maintained a steady increase.

CATO can provide a full set of impurity reference standards for favipiravir API. All products are available in stock, and meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA at the same time. They can directly support the full-process needs of pharmaceutical enterprises in API quality research, stability study and registration declaration, helping enterprises shorten the R&D cycle and reduce compliance risks.