Elmustine

As an anti-tumor alkylating agent with a methylnitrosourea structure, eamustine belongs to the nitrosourea class of cytotoxic drugs. It exerts anti-tumor activity by inducing alkylation cross-linking in the DNA of tumor cells and interfering with DNA replication and transcription processes. Clinically, it is mainly used for the treatment of solid tumors such as glioblastoma and malignant melanoma. It has a particularly good penetration effect on central nervous system tumors, and is one of the optional drugs in chemotherapy regimens for patients with refractory brain tumors.

At present, the global market size of eamustine is relatively small, and there is no publicly verifiable large-scale sales data available. It is generally a niche anti-tumor drug category. In terms of the competitive landscape, the original research product has not been marketed and circulated on a large scale globally, and no generic drug manufacturer has achieved large-scale mass production. The market supply side is highly concentrated. It is only applied in the clinical stage in a small number of countries, has not been included in the medical insurance and centralized procurement catalogs of various countries, and has a low degree of commercialization.

The original research enterprise of eamustine is Servier (France), and the original research brand name is Emostin. The core compound patent expired around 2000. The main dosage form developed by the original research is injection, with a specification of 100 mg per vial. It has not yet been included in the *Catalogue of Reference Preparations of Chemical Medicines* of China and the FDA reference preparation catalogue. There is no registered DMF filing number for eamustine active pharmaceutical ingredient (API) in China, and no eamustine-related preparation has been approved for marketing in China. (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 eamustine API. Most of the products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards comply with the regulatory requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can meet the use needs of different scenarios such as drug research and development, quality research, and registration and declaration.