Icaritin

As an innovative traditional Chinese medicine monomer drug in the field of advanced hepatocellular carcinoma treatment, icaritin is a small molecule immunomodulatory anti-tumor drug. Its mechanism of action is to inhibit inflammatory pathways by binding to MyD88 and IKKα targets, meanwhile regulate the cell cycle progression of tumor cells and induce apoptosis. It can also improve the tumor immune microenvironment and enhance the killing activity of immune cells. This drug is mainly used for the treatment of patients with unresectable advanced hepatocellular carcinoma, especially for patients who have not received systemic treatment, it can significantly prolong the overall survival with a lower incidence of adverse events, providing a safer treatment option for patients who cannot tolerate chemotherapy.

The annual number of newly diagnosed hepatocellular carcinoma patients in China exceeds 400,000, most of whom are already at an advanced stage at the time of diagnosis, and there is a large gap in systemic treatment drugs. Data show that the domestic market size related to icaritin was approximately RMB 230 million in 2023, with an annual growth rate remaining above 45%. The current market is dominated by the original research product, and multiple pharmaceutical companies have already laid out the research and development of generic drugs. As the indications are expanded to other solid tumor fields in the future, the market growth space will be further expanded.

The original research enterprise of icaritin is Beijing Shenogen Pharma Group Co., Ltd., and the original brand name is "Akelading". The expiration date of its core compound patent is 2030. The dosage form that has been approved for marketing is soft capsule, with a specification of 150 mg icaritin per capsule, and it has been included in the *List of Chemical Drugs* as a reference listed drug. In terms of active pharmaceutical ingredients, the API of the original research enterprise registered with A status can be queried on the CDE platform at present. Only the icaritin soft capsule approved by the original research enterprise is marketed in China, and there are no preparation approval documents from other manufacturers. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for icaritin API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for links such as API R&D, quality research and consistency evaluation.