Intellectual Property of Antofloxacin Hydrochloride

Antofloxacin hydrochloride is the first innovative quinolone drug with independent intellectual property rights (patent number: ZL97 106728.7) developed by Shanghai Institute of Drugs for more than ten years. Antofloxacin hydrochloride is a new antibacterial drug, which has the characteristics of long biological half-life, broad antibacterial spectrum, strong antibacterial activity, wide tissue distribution, good absorption, high bioavailability, good safety and little toxic and side effects, and its comprehensive performance is better than that of similar drugs on the market at present. The medicine has obvious curative effect on treating skin system, respiratory system and urinary system infections.

In June 2004, SFDA approved Antofloxacin Hydrochloride and its tablets for clinical study of new drugs, and completed the first phase of clinical study. In June 2006, after the second and third clinical studies were completed, Antofloxacin Hydrochloride and its tablets applied to SFDA for new drug certificate and drug approval number.

Phase I clinical studies have proved that antofloxacin hydrochloride has good drug metabolism characteristics. Compared with the latest fourth-generation fluoroquinolones, the oral dosage is the lowest, the protein binding rate is the lowest, and the longest half-life is 20 hours, and it only needs to be taken 1 time every day. It is a real long-acting fluoroquinolone antibacterial drug.

Phase II/III clinical trials (involving 943 patients) proved that Antofloxacin Hydrochloride was effective in treating bacterial infectious diseases of respiratory tract, urinary tract and skin and soft tissue, with few adverse reactions, and the total effective rate was over 95%. For the same course of treatment and the same curative effect, the total dose of this product is only 1600 mg, which is less than the total dose of levofloxacin of 2,800 mg 1200 mg, showing higher curative effect and higher safety.