HENGRUI PHARMA (01276) has issued an announcement stating that Jiangsu Hengrui Pharmaceuticals Co.,Ltd. recently received notification from the National Medical Products Administration approving a new indication for the company's Class 1 innovative drug remimazolam tosilate for injection, for sedation during mechanical ventilation in intensive care.
Sedation management for critically ill patients on mechanical ventilation is a key component of ICU diagnosis and treatment. Standardized sedation can reduce stress responses, improve patient-ventilator synchrony, protect organ reserve function, shorten the duration of mechanical ventilation and ICU stay, lower the risk of delirium, and improve patient prognosis. However, traditional sedative drugs are prone to circulatory depression and respiratory depression risks, and long-term infusion can easily lead to drug accumulation and delayed emergence; elderly patients and those with hepatic or renal impairment have poor tolerance, making them more susceptible to prolonged mechanical ventilation, increased ICU stay, and impacts on weaning and long-term prognosis. Therefore, there remains a significant unmet clinical need in terms of efficacy and safety for ICU sedation treatment at the current stage.
Remimazolam tosilate belongs to the benzodiazepine class and is a short-acting GABAa receptor agonist. Remimazolam tosilate produces sedative and anesthetic effects by binding to GABAa receptors and inhibiting neuronal activity. The advantages of remimazolam tosilate lie in its rapid onset, short emergence time, and minimal impact on the respiratory and cardiovascular systems.
The remimazolam besylate developed by German company PAION AG was approved for marketing in Japan in January 2020, in the United States in October 2020, and in China in July 2020. According to available information, global sales of remimazolam besylate totaled approximately US$59.22 million in 2024. As of now, the cumulative R&D investment in projects related to remimazolam tosilate for injection is approximately RMB 222.5 million (unaudited).
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