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ArticleMedicine Guanlan
On November 17, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China announced that Yichang Renfu Pharmaceutical, a holding subsidiary of Renfu Medicine, has submitted a new indication for the listing of "remazolam besylate for injection".
Apply
.
Public information shows that this is the first Class 1 new drug approved for listing by Yichang Renfu Pharmaceutical.
Screenshot source: CDE official website
According to Renfu Medicine’s earlier announcement, remazolam besylate for injection (trade name: Ruima) is a new benzodiazepine drug jointly developed by Yichang Renfu Pharmaceutical and German PAION Company.
It is an ultra-short-acting drug.
GABAa receptor agonists can be metabolized by tissue esterase, and the metabolites are inactive
.
Currently, the product is being developed simultaneously in many countries and regions including China, the United States, Germany, and Japan
According to an earlier press release of Renfu Medicine, compared with similar products, remazolam has clinical advantages such as rapid onset of action, quicker awakening, lower respiratory/circulation inhibition, and specific antagonists
.
In clinical trials for procedural sedation indications, compared with the new generation of sedative drugs, remazolam besylate has comparable performance and recovery time, but has outstanding advantages in hemodynamics
In July 2020, remazolam besylate for injection was approved for marketing in China through the priority review process, and its indication is sedation for colonoscopy
.
Overseas, the application for the procedural sedation indication of remazolam besylate has been approved by the European Medicines Agency (EMA) and the US FDA, and the application for the indication for general anesthesia has been approved in Japan and South Korea
According to the Chinese drug clinical trial registration and information disclosure platform, in addition to colonoscopy sedation, Yichang Renfu Pharmaceutical has also registered and completed a number of clinical trials of remazolam besylate in China
.
Among them, it includes phase 3 clinical indications for sedation, induction and maintenance of anesthesia during treatment or diagnostic procedures
According to the official website of CDE, this is the third time that Yichang Renfu Pharmaceutical has submitted and accepted a listing application in China
.
It is hoped that remazolam besylate for injection will be approved as soon as possible for more indications and bring more treatment options to patients
Reference materials:
[1] The official website of the Center for Drug Evaluation of China National Medical Products Administration.
[3] Announcement of Renfu Pharmaceutical Group Co.
(The original text has been deleted)
