Artemether

As an important derivative of artemisinin, artemether is a core component of artemisinin-based combination therapies among antimalarial drugs. It inhibits the surface membrane-mitochondrial function of Plasmodium, interferes with its glucose metabolism and nucleic acid synthesis, and exerts a potent and rapid killing effect on Plasmodium falciparum in the erythrocytic stage. It is clinically mainly used for the treatment of various types of malaria, including chloroquine-resistant falciparum malaria and severe falciparum malaria, and can also be used for the treatment of vivax malaria. It is a first-line antimalarial drug recommended by WHO, and is especially suitable for severe patients and children in malaria-endemic areas.

In the current global antimalarial drug market, artemisinin-based drugs account for more than 60% of the market share. The artemether-lumefantrine combination, which takes artemether as the core component, is one of the most widely used artemisinin-based combination preparations. In 2023, the global market size of artemether API was approximately USD 120 million. China is the core supplier of artemether API in the world, with its output accounting for more than 90% of the total global production capacity. Relying on mature artemisinin extraction and semi-synthesis processes, domestic enterprises have significant advantages in cost and quality, and their products are mainly supplied to malaria-prone regions such as Africa and Southeast Asia.

The original research enterprise of artemether is KPC Pharmaceuticals, Inc., and the original research trade name is "Artemether Injection". The core compound patent expired in 2005. The domestically marketed artemether preparations mainly include injections (specifications: 1ml:80mg, 1ml:100mg) and artemether-lumefantrine combination preparations, among which the original research artemether injection has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration. Up to now, the artemether APIs of 6 domestic enterprises have been registered with CDE and obtained A-status registration numbers, which can be used in association with domestic preparation declarations. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for artemether API. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most products are in stock, and orders placed before 16:00 can be shipped on the same day, which fully meets the needs of API enterprises for quality research, impurity control and declaration.