Xinlitai new drug xisataxing obtained clinical approval

The approval status of xisataxing (cxhl1000078yue) and xisataxing tablets (cxhl1000077yue) of Shenzhen xinlitai Pharmaceutical Co., Ltd changed to "approved - to be prepared" from December 26, and the CDE review conclusion was "approved clinical", which indicated that the clinical trial application of the drug was approved The drug is a broad-spectrum quinolones antibacterial drug, belonging to the national new drug 3.1 The original research drug was developed by Japanese enterprises, and no domestic varieties have been listed Antibiotics are widely used in clinical practice Although the management of antibiotic use in China has been gradually strict in recent years, antibiotics are still the most widely used drug Industry insiders said that the sales volume of the star antibiotic variety baifule in 2013 was still about 1.5 billion yuan It is reported that the daily treatment cost of cetifloxacin is lower than the current high-end quinolones product moxifloxacin, and the treatment effect and safety are also better than other quinolones competitive varieties The low price, safety and excellent treatment characteristics make the drug more suitable for the policy guidance of medical insurance control and encouraging the use of low-cost and high-quality drugs Therefore, some analysts said that the variety has the potential to become a billion yuan variety The original research drug of sitafloxacin is developed by No.1 Pharmaceutical Co., Ltd., which belongs to broad-spectrum quinolones In June 2008, sales of sitafloxacin increased rapidly after it was listed in Japan According to some data, from 2011 to 2012, the sales volume of xishataxin in Japan increased from $7.9 million to $18.6 million, an increase of 135.4% At present, there is no domestic product of xisataxing on the market It should be noted that there are risks in the development of new drugs.