Zhitong Finance App News, Hengrui Pharmaceutical (01276) issued an announcement. Recently, Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”) received a notice from the State Drug Administration (hereinafter referred to as the “State Drug Administration”) to approve the addition of the company's Class 1 innovative drug remazolam toluene sulfonate for injection for sedation during mechanical ventilation during intensive care.
Sedation management for patients with severe mechanical ventilation is a key part of ICU diagnosis and treatment. Standardized sedation can reduce stress response, improve human-computer synchronization, protect organ reserve function, shorten mechanical ventilation and ICU hospitalization time, reduce the risk of delirium, and improve patient prognosis. However, traditional sedatives are prone to the risk of circulatory depression and respiratory depression, and long-term infusion can easily cause drug accumulation and delayed wake-up; older people with poor liver and kidney dysfunction are more likely to cause prolonged mechanical ventilation and increased ICU stay, which affects offline and long-term prognosis. Therefore, there are still significant unmet clinical requirements for ICU sedation treatment in terms of efficacy and safety at this stage.
Rimazolam toluene sulfonate is a benzodiazepine drug and is a short-acting GABAa receptor agonist. Rimazolam toluene sulfonate binds to GABAa receptors and inhibits neuronal activity, thereby producing a sedative anesthetic effect. The advantages of rimazolam toluene sulfonate are that it works quickly, has a short wake-up time, and has little effect on the respiratory and cardiovascular systems. Rimazolam benzenesulfonate developed by PAION AG in Germany was approved for marketing in Japan in January 2020, approved for listing in the US in October 2020, and approved for listing in China in July 2020. According to inquiries, the total global sales of rimazolam benzenesulfonate in 2024 was approximately US$59.22 million. Up to now, the total R&D investment in rimazolam related projects for injectable toluene sulfonate is about 22.5 million yuan (unaudited).