Micronomicin

For respiratory tract, urinary tract and abdominal infections caused by Gram-negative bacteria, clinical practice has long been faced with the dual challenges of otonephrotoxicity and drug resistance of aminoglycoside drugs. The emergence of micronomicin provides a safer option for the treatment of such infections. As a new generation of aminoglycoside antibiotics, its mechanism of action is to bind to the 30S subunit of bacterial ribosomes to block protein synthesis. Meanwhile, its stability against aminoglycoside inactivating enzymes produced by Gram-negative bacteria is significantly higher than that of gentamicin, with a lower clinical drug resistance rate. Its otonephrotoxicity is only 1/4 of that of gentamicin. It is mainly indicated for moderate to severe infections caused by sensitive bacteria in adults and children, and can also be topically used for the treatment of superficial infections of the eyes, ears, skin, etc.

In the domestic anti-infective drug market, the penetration rate of micronomicin in primary medical institutions continues to increase due to its safety advantages. Data show that the market size of domestic micronomicin preparations reached 870 million yuan in 2023, with a three-year compound annual growth rate of 6.2%, which is higher than the average growth rate of traditional aminoglycoside drugs. In terms of the competitive landscape, there are more than 15 domestic preparation manufacturers, and the supply of API is dominated by local enterprises, with no situation where imported original research drugs dominate for the time being. After the implementation of centralized procurement, the price of micronomicin injection dropped by 48%, further expanding the coverage of the primary market.

Micronomicin was originally developed by Kyowa Hakko Kogyo Co., Ltd. of Japan, with the trade name "Micronomicin", and the core compound patent expired globally in 1998. At present, the main dosage forms marketed in China include micronomicin sulfate injection, oral solution and eye drops. The mainstream specifications of the injection are 1ml:30mg and 2ml:60mg, and the specification of the eye drops is 8ml:24mg. This variety has been included in the National Medical Insurance Catalog (Class B), and preparations from multiple domestic manufacturers have been listed as reference listed drugs. As of July 2025, there are 11 registration records of micronomicin sulfate API on the CDE API registration platform, of which 8 have been approved for marketing through the associated review with preparations, and the number of domestic preparation approval documents exceeds 60. (Data as of July 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of micronomicin impurity reference standards, covering all research dimensions such as process impurities and degradation impurities. Most products are in stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable material basis support for pharmaceutical enterprises in API quality research, consistency evaluation and other work.