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On May 13th, the CDE official website showed that Hengrui had submitted a new indication of "remazolam tosylate for injection" for the marketing application and was undertaken by CDE.
Remazolam is a short-acting GABAa receptor agonist designed by GSK and developed by Paion AG.
Because the free base of remazolam is unstable, Paion company 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 for remazolam tosylate for injection was approved for marketing for colonoscopy for diagnosis and treatment of sedation.
Subsequently, in December 2020, February and May 2021 (that is, today), Hengrui submitted three more category 2.
The Insight database shows that Hengrui has initiated 4 phase III clinical trials for remazolam tosylate, all of which have been completed.
From: Insight database (http://db.
In addition, remazolam tosylate has also been approved for clinical applications for two other indications, namely, ICU mechanical ventilation sedation, and sedation before, during, and during non-intubation anesthesia operations.
