奥赛康(002755.SZ)：注射用德拉沙星葡甲胺获得药品注册证书

Core Viewpoint - Aosaikang (002755.SZ) has received approval from the National Medical Products Administration for the registration of injectable Delafloxacin Mesylate, marking a significant advancement in its product portfolio [1] Group 1: Product Approval - Aosaikang's wholly-owned subsidiary, Jiangsu Aosaikang Pharmaceutical Co., Ltd., has recently obtained the drug registration certificate for injectable Delafloxacin Mesylate from the National Medical Products Administration [1] Group 2: Product Characteristics - Delafloxacin is a novel broad-spectrum antibiotic that exhibits strong antibacterial activity against both Gram-positive (G+) and Gram-negative (G-) bacteria, as well as anaerobic bacteria [1] - Compared to other fluoroquinolone antibiotics, Delafloxacin has anionic properties that enhance its antibacterial activity in acidic environments, with drug accumulation levels reaching up to ten times that of other fluoroquinolones in such conditions [1] - The drug demonstrates superior antibacterial activity against Methicillin-resistant Staphylococcus aureus (MRSA) and other pathogens, distinguishing it from traditional fluoroquinolones that are not recommended for MRSA infections [1] Group 3: Clinical Validation - Delafloxacin's clinical efficacy and safety have been validated through domestic and international clinical research practices, making it the only fluoroquinolone recommended by the American Surgical Infection Society (SIS) for the treatment of MRSA in its guidelines for managing complicated skin and soft tissue infections [1] - The safety profile of Delafloxacin is favorable, with no reported cases of QT interval prolongation or phototoxicity, which are common risks associated with traditional fluoroquinolone antibiotics [1]