Nemonoxacin

In the clinical treatment of bacterial infectious diseases such as community-acquired pneumonia and skin and soft tissue infections, quinolones are commonly used antibacterial options. However, the pain points of traditional quinolones, including their tendency to induce drug resistance and limited activity against Gram-positive bacteria, have persisted for a long time. As a non-fluorinated quinolone antibacterial agent, nemonoxacin blocks bacterial DNA replication by inhibiting the activities of bacterial DNA gyrase and topoisomerase Ⅳ. It not only retains the favorable activity of traditional quinolones against Gram-negative bacteria, but also enhances the effect against Gram-positive bacteria such as Streptococcus pneumoniae and methicillin-resistant Staphylococcus aureus. Meanwhile, it covers atypical pathogens, and is indicated for adult community-acquired pneumonia, acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and other indications, providing a safer treatment option for patients with drug-resistant bacterial infections.

The current market size of quinolone antibacterial agents in China has exceeded RMB 15 billion, among which the annual compound growth rate of new quinolone varieties remains above 8%, which is significantly higher than the growth rate of traditional varieties. In terms of the competitive landscape, nemonoxacin is the first independently innovated non-fluorinated quinolone drug in China, and its domestic substitution process is currently accelerating. The advancement of the volume-based procurement policy has further reduced the medication burden on patients, and its market penetration space continues to expand.

The original research enterprise of nemonoxacin is Zhejiang Medicine Co., Ltd., and the original brand name is "Taijiexin". The core compound patent expired in 2023. At present, the main dosage forms approved in China are oral tablets and injections. The specification of the oral dosage form is 0.5g, and the specification of the injection dosage form is 250ml:0.5g. This product has been included in the China Listed Drug Catalogue, and is the reference preparation of this product in China. In terms of API registration, the nemonoxacin API of Zhejiang Medicine has completed registration with the CDE (registration number: Y20190000278) with the status of A, which can support associated declaration. At present, a number of domestic pharmaceutical companies have submitted marketing applications for generic nemonoxacin. (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 nemonoxacin API, which strictly comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations. Most products are in regular stock. Spot orders submitted before 16:00 can be shipped on the same day, fully meeting the reference standard supply needs of pharmaceutical enterprises in the process of R&D, quality research and production.