达卡巴嗪

Malignant melanoma is a skin tumor with extremely high malignancy, and there were very limited systemic treatment options in the past. The advent of dacarbazine has filled the core gap in chemotherapy for this type of disease. As a classic alkylating agent class of anti-tumor active pharmaceutical ingredient, it acts on the purine nucleoside synthesis process, interferes with the synthesis of DNA, RNA and proteins in tumor cells, and ultimately induces apoptosis. In clinical practice, in addition to being used as the first-line chemotherapeutic agent for malignant melanoma, it can also be used in the combination treatment regimens for soft tissue sarcoma and Hodgkin's lymphoma, and the applicable population covers adult patients with solid tumors and lymphoma who have no severe myelosuppression or abnormal liver and kidney function.

The global market size of dacarbazine has long been stable at around USD 230 million. In recent years, with the year-on-year increase in the incidence of malignant melanoma, the annual compound growth rate of the market has remained at 3.7%. In the domestic market, with the advancement of the centralized procurement policy, the price of preparations has dropped significantly, and the demand for upstream API has increased steadily. At present, the supply of domestic API accounts for more than 90%, and only a small amount of demand for high-end preparations relies on imported API. There is no obvious supply gap caused by patent restrictions.

The original research enterprise of dacarbazine is Bayer AG of Germany, and the original brand name is DTIC-Dome. The core compound patent expired worldwide in 1979, and there is no valid compound patent restriction at present. The marketed original dosage forms are mainly powder for injection, with two specifications of 100mg and 200mg. The original product has been included in the FDA Reference Listed Drug Catalog, but it has not yet been included in the Domestic Catalog of Reference Listed Drugs for Chemical Products. According to the domestic API registration platform, at present, 6 domestic enterprises have obtained A-status registration numbers for dacarbazine API, and there are 17 domestic approvals for the marketed dacarbazine for injection. No imported original preparation has been approved yet. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for dacarbazine API, and most products 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 fully meet the reference standard needs of pharmaceutical enterprises in the whole process of API R&D, quality research and production.