Pyronaridine

Malaria is a major long-standing challenge in the global public health field. In response to the treatment demand for chloroquine-resistant Plasmodium strains, the iterative research and development of antimalarial drugs has always been the core of clinical attention. Malaridine is a benzonaphthyridine class of antimalarial drug, which exerts its parasiticidal effect by destroying the composite membrane structure of Plasmodium and interfering with its nucleic acid metabolism. It has a good killing effect on both Plasmodium vivax and Plasmodium falciparum, and is especially suitable for patients infected with chloroquine-resistant strains, and can also be used for the treatment of severe cerebral malaria. It is one of the representative achievements of independent research and development in the field of antimalarial in China.

At present, the annual scale of the global antimalarial drug market exceeds 30 billion US dollars, among which the demand for antimalarial API is steadily above 4,000 tons per year. As a core variety of the new generation of antimalarial drugs, malaridine has maintained a compound annual market growth rate of 8.2% in the past five years, with demand mainly coming from high malaria endemic areas such as Africa and Southeast Asia, as well as international public health procurement projects. At present, only a small number of domestic enterprises have the large-scale production capacity of malaridine API. Against the background of the restructuring of the global antimalarial drug supply chain, the export share of domestic malaridine is increasing year by year.

Malaridine was originally developed by the Institute of Parasitic Diseases of the Chinese Academy of Medical Sciences, and the domestically approved preparation has the trade name "Malaniding". The core compound patent has expired. The main currently approved dosage forms include enteric-coated tablets (specification 0.1g) and injections (2ml:80mg, calculated as malaridine). Relevant preparations have been included in the National Essential Medicine List and are first-line recommended drugs for antimalarial treatment. According to the CDE API registration database, 2 domestic enterprises have completed the A-status registration of malaridine API so far, which can be used in association with domestic preparation declaration applications. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for malaridine API. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for API and preparation manufacturers in quality research, registration declaration, and release testing.