Vismodegib

For rare skin tumors such as locally advanced or metastatic basal cell carcinoma that lack effective systemic treatment options, the advent of vismodegib has filled the clinical gap. As the first oral selective Hedgehog signaling pathway inhibitor, it precisely targets the SMO protein to block the abnormally activated Hedgehog pathway, thereby inhibiting the proliferation and differentiation of tumor cells. It is clinically indicated for patients with locally advanced basal cell carcinoma who are not suitable for surgery or radiotherapy, as well as patients with metastatic basal cell carcinoma, providing the possibility of significantly prolonging the survival cycle and improving the quality of life for this population who had no standard treatment regimen in the past.

The current global market size of vismodegib is approximately USD 210 million. Driven by factors such as the improvement of rare disease drug security policies and the increase in the detection rate of basal cell carcinoma, the compound annual growth rate of the market has maintained at around 6.2% in the past three years. In terms of the competitive landscape, only a small number of pharmaceutical companies have obtained approval for the marketing of generic preparations of this product globally, and the original research product still accounts for more than 85% of the market share. In China, no generic drug of this product has been approved so far, and the market demand is mainly met by imported original research products, so there is still much room for improvement in accessibility.

The original research enterprise of vismodegib is Genentech, a subsidiary of Roche, with the original brand name Erivedge. Its core compound patent in the United States expires in 2028, and the compound patent in China expires in 2026. The main dosage form approved for the original research product is capsules with a specification of 150mg, which has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the *China Catalog of Chemical Medicines*. There is no vismodegib API registration number that has been publicized by the Center for Drug Evaluation (CDE) in China. Only the original imported vismodegib capsules were approved for marketing by the National Medical Products Administration in 2021, and no generic preparations from domestic enterprises have been approved yet. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for vismodegib API, and most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the needs of pharmaceutical enterprises for impurity reference standards in all stages of API R&D, quality research and registration declaration.