Lomustine

The clinical treatment of primary central nervous system tumors and metastatic brain cancer has long been confronted with the challenge of insufficient blood-brain barrier penetration. As an alkylating cell cycle non-specific anti-tumor drug, lomustine provides an important treatment option for such patients. Its mechanism of action is to induce apoptosis through alkylation cross-linking with DNA, which interferes with the DNA replication and transcription processes of tumor cells. Meanwhile, its high liposoluble molecular property enables it to penetrate the blood-brain barrier efficiently. Clinically, it is mainly used for the treatment of primary brain tumors (such as glioblastoma, anaplastic astrocytoma), Hodgkin's lymphoma and brain metastases of some solid tumors, and occupies an important position in the combined chemotherapy regimens for central nervous system tumors in both children and adults.

At present, the global market size of lomustine is approximately USD 120 million, with an annual compound growth rate maintained at around 4.7%. The core growth drivers come from the rising incidence of glioblastoma and the popularization of combination medication regimens. The competitive landscape is characterized by the dominance of the original research drug and a small number of generic enterprises. As this drug is a traditional old chemotherapeutic drug, there is a certain threshold for toxicity control in its production process. The global compliant production capacity is mainly concentrated in a small number of pharmaceutical enterprises in Europe, India and China. It has not yet been included in the national centralized volume-based procurement scope in China, and the overall market supply remains stable.

The original research enterprise of lomustine is Bristol-Myers Squibb, with the original brand name CeeNU. Its core compound patent in the US market expired in 1998. The main dosage form approved for the original research drug is capsules, with specifications including 10mg, 40mg and 100mg. It has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs (6th Batch)* of China. In terms of domestic API registration, currently a total of 3 enterprises have obtained A-status registration numbers for their lomustine APIs through the CDE associated review, and multiple domestic pharmaceutical enterprises have obtained approval for the marketing of lomustine capsule preparations. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of lomustine impurity reference standards, 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 the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of pharmaceutical enterprises in all stages from API R&D, quality research to marketing application.