Osecon (002755.SZ): Delafloxacin and methylamine for injection obtained drug registration certificate

According to Zhitong Finance App, Osecon (002755.SZ) issued an announcement. Jiangsu Aosaikang Pharmaceutical Co., Ltd. (hereinafter referred to as the “subsidiary”), a wholly-owned subsidiary of the company, recently received the approval and issuance of the “Drug Registration Certificate” for injectable delafloxacin methamine from the China Drug Administration (hereinafter referred to as the “Drug Administration”).

As a novel broad-spectrum antibiotic, delafloxacin shows broad and strong antimicrobial activity against gram-positive bacteria (G+), gram-negative bacteria (G-), and anaerobes. Compared with other fluoroquinolone antimicrobials, delafloxacin has anionic properties, can enhance antibacterial activity in an acidic environment, and the cumulative amount of the drug in an acidic environment can reach 10 times that of other fluoroquinolone drugs, and has stronger antibacterial activity against methicillin-resistant Staphylococcus aureus (MRSA) and other pathogens. Delafloxacin has novel structural characteristics, significantly enhanced antibacterial activity, and is not easily resistant. Its clinical efficacy and safety have been verified by clinical research practices at home and abroad. It is currently the only quinolone drug recommended for MRSA treatment by the American Society of Surgical Infectious Diseases (SIS) “Guidelines for the Management of Complex Skin and Soft Tissue Infections”, which is a significant difference from traditional quinolone drugs that are not recommended for MRSA infections. It is safe, and there are no reports of common risks with traditional quinolone drugs such as prolonged QT interval or phototoxicity in related treatments.