Imiquimod

For skin diseases such as external genital warts and basal cell carcinoma that have a high incidence among immunocompromised populations, topical immunomodulatory therapy has become one of the clinically preferred options due to its advantages of precision and low systemic adverse reactions. Imiquimod is an imidazoquinoline amine immunomodulator. It does not directly kill viruses or tumor cells, but induces the production of cytokines such as interferon and tumor necrosis factor by activating TLR7 receptors, enhances local innate immunity and adaptive immune responses, and thus exerts antiviral and anti-tumor activities. In addition to the approved indications of external genital and perianal warts, actinic keratosis, and superficial basal cell carcinoma, its off-label use in viral skin diseases such as molluscum contagiosum and verruca plana is also being explored in clinical practice, and the applicable population covers adult patients and some special groups with immune insufficiency.

At present, the global imiquimod market size has maintained a steady growth trend in recent years. In 2023, the overall market size exceeded 1.2 billion US dollars, with a compound annual growth rate of approximately 4.2%. The growth momentum mainly comes from the release of demand for early intervention of skin cancer in non-medical aesthetic fields. In terms of competitive landscape, the original research product accounts for about 32% of the global market share. Generic drug manufacturers seize primary care and chronic disease management scenarios with higher cost performance, among which Indian and Chinese manufacturers are the main suppliers of generic drugs. In 2023, the sales of imiquimod preparations at the terminal of Chinese public medical institutions exceeded 300 million yuan. After the centralized procurement, the price was more than 70% lower than that of the original research product, and the penetration rate of local enterprises continues to increase.

The original research enterprise of imiquimod is 3M Company, and the original research trade name is Aldara™. The core compound patent of it expired in the United States in 2007, and the Chinese compound patent expired in 2004. The main dosage form approved for the original research product is 5% cream, with a specification of 250mg per bag, and each bag contains 12.5mg of imiquimod. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the Chinese Catalog of Reference Preparations for Chemical Drugs. At present, 12 entries of imiquimod APIs from domestic API manufacturers have been publicized on the CDE API registration platform in China, among which 8 are in Status A and can be directly used for associated preparation declaration. A number of domestic enterprises have obtained approval for the marketing of 5% imiquimod cream. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for imiquimod API. The products fully cover all impurities that may be generated during the synthesis process and degradation impurities, and meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day, which can fully meet the reference substance use needs of drug research and development, quality research, and quality control links. It saves enterprises from customized services and can quickly respond to customers' customized delivery needs.