Lumefantrine

In response to the clinical challenge of the spread of chloroquine-resistant malaria strains in malaria prevention and control, lumefantrine, a synthetic arylmethanol antimalarial compound, exerts its effect by inhibiting the nucleic acid synthesis and heme detoxification pathway of Plasmodium. It is mainly used in clinical practice as a compound preparation combined with artemether for the treatment of uncomplicated malaria caused by Plasmodium falciparum. It still maintains good activity against chloroquine-resistant Plasmodium falciparum strains, and the applicable population covers adults and children weighing more than 5 kg. It is a core component of the first-line malaria treatment regimen recommended by the WHO.

The size of the global antimalarial drug market in 2023 was approximately USD 4.2 billion, among which the compound artemether-lumefantrine preparation accounts for about 30% of the overall antimalarial drug market share, with an average annual demand growth rate remaining at 4%-6%. The core driver of demand comes from public procurement in high malaria prevalence regions such as Africa and Southeast Asia. At present, the production capacity of lumefantrine API is mainly concentrated in China and India, and the top 3 enterprises account for more than 70% of the global supply share. With the increase of the threshold of WHO prequalification, the industry concentration shows a further upward trend.

The original research enterprise of lumefantrine is Novartis, and the trade name of the original research compound preparation is Coartem (Compound Artemether and Lumefantrine Tablets). Its core compound patent expired globally in 2007. The core specification of the original research compound preparation is that each tablet contains 20 mg of artemether and 120 mg of lumefantrine, which has been included in the FDA Reference Listed Drug Catalog and the *Catalog of Reference Preparations for Chemical Drugs* of China. At present in China, 6 enterprises have completed the registration of lumefantrine API in CDE and obtained the A status label, and more than 10 enterprises have obtained the marketing approval for compound artemether and lumefantrine tablets. (Data as of July 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of lumefantrine 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 Chinese Pharmacopoeia and FDA, and can fully meet the R&D and production needs of various scenarios such as API quality research and preparation consistency evaluation.