Artesunate

In the global antimalarial treatment system, artesunate occupies a core position by virtue of its characteristics of quick effect and low toxicity, and it belongs to artemisinin derivative antimalarial drugs. It has a unique mechanism of action: it generates free radicals through activation in the plasmodium, destroys the cell membrane structure and protein synthesis pathways of the parasite, and has a potent killing effect on the asexual forms of plasmodium in the erythrocytic stage. Clinically, it is mainly used for the rescue of cerebral malaria and severe falciparum malaria, and is also applicable to patients with falciparum malaria who are resistant to traditional antimalarial drugs such as chloroquine. It is a first-line treatment drug for severe malaria recommended by WHO, covering applicable populations of all age groups including adults and children.

The global antimalarial drug market size was approximately USD 3.7 billion in 2023, among which artemisinin-based combination therapies account for more than 60%. As one of the core components, artesunate has an annual demand for its API of over 200 tons. China is the core supplier of artesunate API in the world, with production capacity accounting for more than 90% of the global total. With the improvement of primary diagnosis and treatment coverage in high malaria prevalence areas such as Africa and Southeast Asia, it is expected that the annual compound growth rate of artesunate API demand will remain at around 7% in the next three years. At present, a number of domestic enterprises have obtained WHO prequalification, the market competition is dominated by large-scale leading enterprises, and the price system remains relatively stable under the influence of public health procurement orders.

The original research enterprise of artesunate is Guilin Pharma Co., Ltd., and the original brand name is "Artesun". Its core compound patent has expired. At present, the main dosage forms approved in China include injections and tablets, among which the specification of injection is 60 mg per vial, and the specification of tablet is 50 mg per tablet. The original preparation of this variety has been included in the FDA Reference Listed Drug Catalog, and is also included in the *National Essential Medicine List of China*. According to the data of the domestic API registration platform, 6 enterprises including Guilin Pharma have obtained the A-status registration number of artesunate API, and the artesunate preparations of a number of domestic enterprises have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the quality research needs related to artesunate, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can directly support enterprises in the whole process of research work such as API registration and declaration, and quality control.