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On November 8, Hengrui Medicine's application for the new indication of "Remazolam Tosylate for Injection" entered the approval stage and is expected to be approved in the near future
Remazolam is a short-acting GABAa receptor agonist designed by GSK company and developed by PaionAG company.
Due to the unstable free base of remazolam, Paion developed it as a besylate of remazolam
Remazolam tosylate is used by Hengrui Pharmaceuticals in the salt-type screening process.
The research and development history of Hengrui Remazolam Tosylate (Image source: corporate website)
In March 2018, the market application for the indication of remazolam tosylate for gastroscopy sedation was accepted by CDE and was subsequently included in the priority review range
On June 24, 2020, the second indication of remazolam tosylate for injection was approved for marketing for colonoscopy for diagnosis and treatment of sedation
Subsequently, in December 2020, February and May 2021, Hengrui submitted three applications for the marketing of remazolam for new indications of category 2.
Remazolam besylate project details (Insight)
From: Insight database (http://db.
Insight database shows that Hengrui has initiated 4 phase III clinical trials for remazolam tosylate, all of which have been completed
Phase II and Phase III clinical trials of remazolam tosylate (Insight)
From: Insight database (http://db.
In addition, remazolam tosylate has been approved for clinical applications for four other indications, namely, ICU mechanical ventilation sedation, and sedation before, during, and during non-intubation anesthesia operations
In last year's medical insurance negotiations, remazolam tosylate did not enter the medical insurance through negotiations, and this year, this new drug will again be negotiated in 2021
Not only remazolam tosylate, Hengrui will also seek to enter the medical insurance catalogue through negotiations with fluzoparil and trelopopag; apatinib and carrelizumab will participate this year with new indications Medical insurance negotiations
Note: The original text has been deleted
