After Pfizer, the first clinical approval of "azithromycin sustained release dry suspension" was obtained by domestic pharmaceutical companies

The indications of azithromycin sustained-release dry suspension in Jianmin Pharmaceutical Co., Ltd are acute bacterial sinusitis in adults caused by sensitive bacterial infection, pneumonia in children and adults over 6 months and community acquired pneumonia in adults The clinical trial application was submitted and accepted in February 2015, with acceptance number of cxhl1500515 (specification: 1g) and cxhl1500516 (specification: 2G) Up to now, the R & D investment is 5.29 million yuan According to the statistics of the World Health Organization, rhinitis has been listed as the highest incidence of the global residents, and sinusitis is one of the most common diseases in the clinical rhinology Adults can have 2-3 times of viral upper respiratory tract infection every year, about 0.5% - 2% of patients will form secondary acute bacterial sinusitis Community acquired pneumonia is a common community infection disease It is one of the common infectious diseases threatening human health Its incidence rate and mortality rate are very high In China, the prevalence rate of children over six months is 6.8%, and that of adults is 7.2% The total number of patients is tens of millions Azithromycin is a macrolide antibiotic developed and produced in recent years It is a broad-spectrum antibiotic obtained by modifying the chemical structure of erythromycin Its clinical application is relatively mature Azithromycin, as one of the best-selling antibiotics, is mainly used in tablets, capsules, dispersible tablets, dry suspensions and syrups in China, and there is no slow-release dry suspensions on the market Up to now, after Pfizer, Jianmin Pharmaceutical is the first domestic enterprise to obtain the clinical approval of azithromycin sustained-release dry suspension As a new dosage form of azithromycin, azithromycin sustained-release dry suspension only needs to be taken once in the whole course of treatment, which is convenient to use, greatly improving the compliance of patients with drugs, improving the stability of drug effects, reducing side effects The development of this product has a better market prospect Azithromycin preparation is a more mature variety in clinical application At present, it is approved to produce APIs, tablets, capsules, dispersible tablets, granules, injections, dry suspensions and syrups The specifications of oral preparations vary from 0.1g to 0.25g In August 1995, the former Ministry of Health approved the production of azithromycin for the first time in China So far, the State Food and drug administration has issued 25 API production numbers and hundreds of preparation production approval numbers, including 34 dry suspension approval numbers Azithromycin, as the first antibiotic in macrolide drugs, had a market scale of 6.49 billion yuan and a market share of 52.7% in 2015 At present, the three best selling dosage forms of azithromycin are injection, tablet and dry suspension Pfizer ranked first in the sales volume of dry suspension, followed by Ouyi Pharmaceutical Group and Nantong Jiuhe Pharmaceutical Group