Core Viewpoint - Heng Rui Medicine (01276) has received the acceptance notice from the National Medical Products Administration for the marketing authorization application of injectable toremifene, indicating progress in its product pipeline [1] Group 1: Product Development - The injectable toremifene has been approved for indications including sedation and anesthesia during non-tracheal intubation surgeries and for induction and maintenance of general anesthesia [1] - The application for market approval is based on two key studies focused on sedation for mechanically ventilated patients in the Intensive Care Unit (ICU) [1] Group 2: Clinical Research - The HR7056-302 study is a Phase III clinical trial evaluating toremifene compared to standard first-line treatments for short-term sedation during critical care, involving 214 patients across 43 centers, led by Professor Guan Xiangdong from Sun Yat-sen University First Affiliated Hospital [1] - The HR7056-206 study is a multi-center Phase II clinical trial assessing toremifene for long-term sedation in critical care, with 24 patients enrolled from 18 centers, led by Professor Shen Feng from Guizhou Medical University Affiliated Hospital [1] - Both studies achieved their primary endpoints as expected [1]
恒瑞医药(01276)注射用甲苯磺酸瑞马唑仑的药品上市许可申请获国家药监局受理