A few days ago, according to the announcement on the official website of the NMPA, Shijiazhuang No. 4 Medicine submitted 4 generic drugsPropofol medium long-chain fat emulsion injectionThe listing application was approved and passed the consistency evaluation.
Screenshot**: NMPA
Propofol is listed in ChinaPropofol medium long-chain fat emulsion injectionwithPropofol emulsion injectionTwo kinds, the former has been selected by the country (the fourth batch), the latter originally developed from Fresenius Kabi, Germany, as a fast and short-acting intravenous *** is the most widely used in China, the largest market share *** has the characteristics of rapid onset, stable induction, short duration and rapid complete awakening. It can reduce injection pain, alleviate respiratory depression, reduce clinical adverse reactions, ensure safe and efficient application, and is an indispensable intravenous general anesthetic in clinical practice. According to the statistics of Yaorong Cloud, in 2022Propofol medium long-chain fat emulsion injectionThe sales volume in the hospital nationwide is nearly 600 million yuan.
Screenshot**: Yaorongyun National Hospital Sales Database.
At present, in addition to the original research enterprises, 14 domestic companies including Sichuan Kelun Pharmaceutical, Jiangsu Hengrui Pharmaceutical, Chongqing Yaoyou Pharmaceutical, Yichang Renfu Pharmaceutical, Yangtze River Pharmaceutical, and Liaoning Haisco Pharmaceutical have been approved and deemed to have passed the consistency evaluation.
Screenshot**: Yaorongyun China Drug Approval Database.
In terms of imitation layout, only one company in China, Yuanda Life Sciences, has also submittedPropofol medium long-chain fat emulsion injectionThe application for imitation is currently in the review and approval stage.
From 2024 to the present, in addition to the varieties approved this time, Shijiazhuang No. 4 Medicine has:Magnesium sulfate injection, vortioxetine hydrobromide tablets, ropivacaine hydrochloride sodium chloride injection, nifedipine sustained-release tabletsFour varieties were approved and deemed to have passed the consistency evaluation.
Screenshot**: Pharmaceutical Rongyun China Drug Evaluation Database.
In addition, at present, Shijiazhuang No. 4 Pharmaceutical has also submitted imitation applications for 64 varieties, including lidocaine hydrochloride injection, cefuroxime ester dry suspension, ozagrel sodium injection, vonora fumarate raw tablets, ondansetron hydrochloride injection, esmolol hydrochloride sodium chloride injection, sodium bicarbonate injection, etc., all of which are under review and approval.
February** Dynamic Incentive Program