Tilorone

In the clinical diagnosis and treatment of viral infectious diseases, the research and development of broad-spectrum antiviral drugs has always been one of the core demands in the field of public health. As a small-molecule interferon inducer antiviral drug, tilorone belongs to aromatic ethyl ketone amine derivatives. Its mechanism of action is to induce the body to produce endogenous interferon by activating the intracellular nucleic acid recognition pathway, and at the same time, it can regulate the body's immune function and enhance the phagocytic activity of macrophages and the killing ability of NK cells. It can be clinically used for the treatment of a variety of viral infectious diseases such as herpes zoster, viral myocarditis and viral hepatitis, and can also be used as an adjuvant therapeutic drug for tumors, covering adult patients and pediatric patients who meet the medication indications.

The current global tilorone market size is approximately USD 230 million, with a compound annual growth rate of around 6.8% in the past three years. The growth momentum mainly comes from the release of demand for antiviral drugs in primary medical institutions and the expansion of clinical scenarios related to immunomodulation. The domestic market has long been dominated by the supply of generic drugs, and the original research product has not entered the Chinese market. At present, 7 domestic enterprises have obtained preparation approvals, the supply of active pharmaceutical ingredients has basically been localized, and there is no relevant record of national centralized procurement, so the competitive landscape of the segmented track is relatively stable.

The original research enterprise of tilorone is Farmak, a Ukrainian pharmaceutical company, and the original research trade name is Tiloron. Its core compound patent expired in Ukraine and the Commonwealth of Independent States in 2015, and the core patent in the European Union expired in 2018. The main dosage forms of the original research product are oral tablets, with specifications of 125mg and 150mg, which have been included in the national drug catalogues and local reference preparation lists of Ukraine, Russia and other regions. At present, no original research preparation has been approved for marketing in China. No valid tilorone registration number in status A under review or approved has been found in the CDE API registration database, and only the API registration application submitted by one enterprise is in status I. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for tilorone API, and can provide customized synthesis services on demand during the R&D stage. The full series of products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most of the products are in regular stock, and spot orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard supply needs of pharmaceutical enterprises in the whole process of R&D, quality research and production.