According to the latest announcement on the official website of CDE, the listing application of the 3-class chemical drug "levosabutamol hydrochloride nebulized inhalation solution" submitted by #Kelun Pharmaceutical was accepted. Since 2022, 5 companies have successively evaluated #generic drugs and listed intensively.
Screenshot source: CDE official website
Levalsalbutamol is an adrenaline β receptor agonist, salbutamol, which is an asthmatic drug clinically used to treat or prevent bronchospasm caused by reversible airway obstructive disease. Levosabutamol inhaled solution was originally developed as Theracor Inc. of the United States and was approved for marketing by the FDA in March 1999. Compared with ordinary salbutamol, levalsalamine hydrochloride nebulized inhalation solution has the characteristics of small side effects, good efficacy and small dose.
In September 2019, #HealthYuan # listed the first new Class 3 registered levalbutamine hydrochloride nebulized inhalation solution (Lishutong ®) in China, becoming the first levosabutamol inhalation preparation listed in China. According to the pharmaceutical rong cloud database, the market of this variety will open rapidly in 2021, and the sales volume in the hospital in the first three quarters has reached 98 million, and it will exceed the mark of 100 million yuan throughout the year, and the market potential is unlimited.
Sales of levosabutamol hydrochloride nebulized inhalation solution in the hospital
Screenshot source: Yaorongyun National Hospital Sales Database
According to The Drug Rongyun inquiry, in the two years after the listing of the healthy yuan levalamine hydrochloride nebulized inhalation solution, no other enterprises have been approved for production, until 2022, there have been a number of companies evaluated. Since 2022, there have been 5 enterprises such as Nanjing Hengdao Pharmaceutical, Yangzhou Zhongbao, Ruiduoshi (Wuhan) Pharmaceutical, Sichuan Praite Pharmaceutical and Jiangsu Changtai Pharmaceutical, which have been approved to produce this variety, which is regarded as the consistency evaluation of generic drugs through levosabutamol hydrochloride nebulization inhalation solution, and the trend of getting together has begun to appear.
Levosabutamol hydrochloride nebulized inhalation solution generic drugs have been evaluated by enterprises
Screenshot source: Drug Rong Cloud Consistency Evaluation Database
In addition, in addition to Kelun Pharmaceutical, there are also Yangtze River Pharmaceutical, Renhe Yikang Group, Shenzhen Dafo Pharmaceutical/Zhejiang Thermo Pharmaceutical, Jiangxi Ashte Pharmaceutical and other enterprises have also submitted applications for the listing of generic drugs with levalbutyl alcohol nebulized inhalation solution.
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