NMPA Approves Hengrui's Remimazolam Tosilate for ICU Ventilation Sedation
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China's NMPA has approved a new indication for Hengrui Medicine's remimazolam tosilate for injection, brand name Ruibening, for sedation of patients undergoing mechanical ventilation in the ICU. Remimazolam tosilate is a Class 1 innovative drug. The approval rests on two pivotal trials, HR7056-302 in short-term sedation and HR7056-206 in long-term sedation, both of which met their primary endpoints as expected. The decision adds an intensive-care use to the drug's approved indications. No further regulatory or commercial details were given in the announcement.
Written by a model from the reports · updated 2 hours ago
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- mp.weixin.qq.comHengrui's Remimazolam Tosilate for Injection Wins Approval for ICU Mechanical Ventilation Sedation
China's NMPA has approved a new indication for Hengrui Medicine's Class 1 innovative drug remimazolam tosilate for injection (brand name Ruibening) for sedation during mechanical ventilation in the ICU. The approval is based on two pivotal studies, HR7056-302 in short-term sedation and HR7056-206 in long-term sedation, both of which met their primary endpoints as expected.
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