Sitafloxacin

Respiratory and urinary tract infections, as clinically prevalent bacterial infectious diseases, have long been plagued by clinical pain points of increasing drug resistance of pathogenic bacteria and limited efficacy of conventional quinolone drugs. Sitafloxacin is a third-generation broad-spectrum quinolone antibacterial agent. By inhibiting the activities of bacterial DNA gyrase and topoisomerase IV, it blocks the process of bacterial DNA replication and transcription, and exhibits excellent antibacterial activity against Gram-positive bacteria, Gram-negative bacteria, anaerobes and atypical pathogens. Clinically, it is mainly used to treat infectious diseases such as community-acquired pneumonia, pyelonephritis, cystitis and prostatitis caused by sensitive bacteria, and is applicable to adult patients with infections, especially suitable for refractory infection scenarios with insufficient sensitivity to other quinolone drugs.

The global sitafloxacin market size exceeded USD 420 million in 2023, with a compound annual growth rate of 7.8% in the past five years. The core growth drivers come from the improvement of the diagnosis and treatment rate of respiratory and urinary tract infections in low- and middle-income countries, as well as the continuous release of demand for the treatment of drug-resistant bacterial infections. As the fastest growing region, the Chinese market reached RMB 1.27 billion in 2023. At present, the domestic preparation market has formed a pattern of joint competition between original research drugs and generic drugs, and generic drugs from more than 8 local enterprises have been approved for marketing. After the implementation of centralized procurement, the price of sitafloxacin oral dosage forms has dropped by more than 60%, further promoting the improvement of clinical accessibility.

The original research enterprise of sitafloxacin is Daiichi Sankyo Co., Ltd. of Japan, with the original brand name "Gracevit". Its core compound patent expired in Japan in 2024, and the core compound patent in China expired in 2022. At present, the main dosage forms of the original research drug marketed globally are tablets (50mg, 100mg) and injections (100mg/20ml). The original research tablets have been included in the China Listed Drugs Catalogue and are used as reference listed drugs. As of October 2024, there are more than 15 sitafloxacin API registration information on the API registration platform of China CDE, among which 10 have been marked as status A. In addition, sitafloxacin oral preparations from 12 enterprises and injections from 3 enterprises have been approved for marketing in China. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for sitafloxacin API, fully covering the requirements for synthesis process impurities, degradation impurities and reference standards. Most products are in 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 help enterprises successfully complete the whole process of API R&D, registration and declaration, and quality control.