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A few days ago, Sinopharm Yinhu Pharmaceutical has entered the administrative examinationand approval stage with the imitation of dexmedetomidine hydrochloride injection for production of Category 3,and it is expected to be approved in the near future.According to data from Meinenet, in recent years, the sales of dexmedetomidine injections in public medical institutions in China have grown rapidly.After breaking through the 3 billion yuan mark in 2018, it reached a new high in 2019 and declined in the first half of 2020.There are 12 manufacturers of dexmedetomidine hydrochloride injection, and Yangtze River Pharmaceutical Group has the largest market share, exceeding 80%.
Dexmedetomidine hydrochloride is a relatively selective α2-adrenergic receptor agonist,suitable for tracheal intubation and sedation during mechanical ventilation in patients undergoing general anesthesia,and for intubation and use during intensive care treatment. Sedation of ventilator patients.Dexmedetomidine hydrochloride injection was jointly developed by Oricon Pharma and Abbott.It was approved for listing in the United States in 1999, and has since been marketed in the European Union, Japan and other countries and regions.
Sales of terminal dexmedetomidine injections in Chinese public medical institutions in recent years
According to data from Minai.com, in recent years, the sales of dexmedetomidine injections in China is urban public hospitals,county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions) have grown rapidly,breaking the 3 billion mark in 2018. After that, it reached a new high in 2019, with a year-on-year decline in the first half of 2020.There are 12 manufacturers of dexmedetomidine hydrochloride injection, including Yangzijiang Pharmaceutical Group, Jiangsu Hengrui Pharmaceutical,Jiangsu Enhua Pharmaceutical, and Hunan Kelun Pharmaceutical. Among them,Yangzijiang Pharmaceutical Group has the largest market share, exceeding 80%. .
In terms of consistency evaluation, 9 companies for dexmedetomidine hydrochloride injection have been approved for evaluation,
of which 7 companies including Jiangsu Hengrui Pharmaceutical, Yichang Renfu Pharmaceutical,
and Sichuan Guorui Pharmaceutical have been approved for supplementary applications.
; Yangtze River Pharmaceutical Group and Sinopharm Group Industry have been approved for imitation of category 3, which is regarded as over-evaluated.
Currently, Jiangsu Huatai Chenguang Pharmaceutical Co., Ltd.
and Chengdu Beite Pharmaceutical Co., Ltd. are under review and approval for the consistency evaluation supplement;
8 companies including Jiangsu Zhengda Qingjiang Pharmaceutical Co., Ltd., Shijiazhuang No. 4 Pharmaceutical Co., Ltd.,
and Sichuan Meidakang Huakang Pharmaceutical Co., Ltd. have used generic 3 types of applications.
The application for production is under review and approval, and it is deemed as over-evaluated after approval.
