Gemifloxacin

As respiratory tract infection is a highly prevalent infectious disease in clinical practice, quinolones are one of the core options for its empirical treatment. Gemifloxacin is a fourth-generation fluoroquinolone antibacterial agent. It exerts its antibacterial effect by inhibiting the activities of bacterial DNA gyrase and topoisomerase IV, thereby blocking the processes of bacterial DNA replication and transcription. It has broad-spectrum antibacterial activity against Gram-positive bacteria, Gram-negative bacteria and atypical pathogens. In particular, its antibacterial activity against common respiratory pathogens such as Streptococcus pneumoniae is significantly superior to that of traditional quinolones. Clinically, it is mainly used for the treatment of respiratory tract infections in adults, such as acute exacerbation of chronic bronchitis, community-acquired pneumonia, acute sinusitis, etc. It is a first-line drug for respiratory tract infections recommended by domestic and foreign infectious disease guidelines.

The current global market size of gemifloxacin is approximately US$210 million, with a compound annual growth rate maintained at 3.2% in the past three years. The growth momentum mainly comes from the release of diagnosis and treatment demand for respiratory tract infections in primary medical institutions and the application expansion of combination therapy for drug-resistant bacterial infections. In terms of the domestic market, 4 enterprises have been approved to produce gemifloxacin oral preparations so far, among which the oral dosage forms have been included in the scope of local centralized procurement, and the winning bid price has decreased by about 78% compared with that of the original research product. With the implementation of centralized procurement, the clinical use volume of gemifloxacin in China has increased by 217% compared with that before centralized procurement, and the market demand for upstream API has also shown a rapid growth trend simultaneously.

The original research enterprise of gemifloxacin is LG Life Sciences of South Korea, and the original research trade name is "FACTIVE". The core compound patent of gemifloxacin expired in the United States in 2019, and the Chinese compound patent expired in 2021. The dosage form of the original research marketed product is tablet, with the specification including 320mg. This original research product has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalogue of Reference Preparations for Chemical Drugs (Third Batch)* of China. In terms of domestic API registration, 3 enterprises' gemifloxacin APIs have been registered with CDE and are in active status, and another 7 enterprises' API registration applications are under review. At present, 5 gemifloxacin oral preparation varieties have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for gemifloxacin API. Most of the products can be supplied from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in the whole process of API R&D, quality research and production.