Isepamicin

In response to the clinical treatment dilemma of multidrug-resistant Gram-negative bacterial infections, isepamicin, a semi-synthetic aminoglycoside antibiotic, has become an important option in the anti-infection field with its unique structural modification advantages. Its mechanism of action is to specifically bind to the 30S subunit of bacterial ribosomes, inhibit protein synthesis and destroy the integrity of cell membrane. It still maintains strong antibacterial activity against Enterobacteriaceae and Pseudomonas aeruginosa resistant to gentamicin and amikacin. It is mainly used clinically for lower respiratory tract infections, urinary tract infections, sepsis and abdominal infections caused by susceptible bacteria, especially for severe infection patients with low immunity and underlying diseases, and its ototoxicity and nephrotoxicity are significantly lower than those of traditional aminoglycoside drugs.

At present, the global market size of isepamicin is about USD 180 million, with China's market share accounting for more than 45%, and the compound annual growth rate in the past three years has remained at 7.2%, which is higher than that of the overall anti-infection drug market. The competitive landscape is characterized by the coexistence of original research drugs and generic drugs. Domestic clinical use is dominated by generic drugs. After the centralized drug procurement, the price of preparations has dropped by about 62%, driving the continuous expansion of the demand for active pharmaceutical ingredients (APIs). There are 7 domestic enterprises that have obtained the production approval for isepamicin APIs, with production capacity mainly concentrated in Jiangsu-Zhejiang region and Sichuan-Chongqing region, and there is no production capacity gap for the time being.

The original research enterprise of isepamicin is Meiji Seika Pharma Co., Ltd. of Japan, with the original brand name "Isepal". Its Japanese compound patent expired in 2012, and the core compound patent in China expired in 2013. The dosage form approved for the original research drug is injection, with specifications of 200mg/2ml and 400mg/4ml. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs (9th Batch)* of China, and is also included in the reference preparation catalogue of the FDA Orange Book. At present, there are 8 domestic isepamicin API registration numbers, among which 5 are in status A (can be used in marketed preparations), and another 11 enterprises have passed the quality and efficacy consistency evaluation of generic drugs for their isepamicin injections. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of isepamicin impurity reference standards, fully covering impurities from the synthesis process, degradation impurities and stereoisomers. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and the FDA. Most products have sufficient in-stock reserves. In-stock orders placed before 16:00 can be shipped on the same day, which can quickly meet the full-process needs of API R&D, quality research and compliance declaration.