The drug market application for injection of Jiangsu Hengrui Pharmaceuticals' (01276) methylsulfonyl riamzolam has been accepted by the National Medical Products Administration.

Jiangsu Hengrui Pharmaceuticals (01276) announced that the company has recently received a "Notice of Acceptance" from the National Medical Products Administration regarding the application for market approval of the injectable form of remimazolam tosylate. The drug has been accepted for review by the National Medical Products Administration. The approved indications for the injectable form of remimazolam tosylate include sedation and anesthesia for non-tracheal intubation procedures/operations, as well as induction and maintenance of general anesthesia. The application for market approval is based on two key studies on sedation of critically ill patients in intensive care units (ICUs) when undergoing mechanical ventilation using the injectable form of remimazolam tosylate. These studies include the HR7056-302 study for short-term sedation and the HR7056-206 study for long-term sedation. The HR7056-302 study is a Phase III clinical trial evaluating the use of remimazolam tosylate for short-term sedation during ICU care compared to standard first-line treatments. It is led by Professor Guan Xiangdong from the First Affiliated Hospital of Sun Yat-sen University, with a total of 43 centers nationwide and 214 patients enrolled. The HR7056-206 study is a Phase II multicenter clinical trial assessing the use of remimazolam tosylate for long-term sedation during ICU care, led by Professor Shen Feng from the Affiliated Hospital of Guizhou Medical University. A total of 18 centers nationwide participated, with 24 patients enrolled. Both studies successfully met their primary endpoints.