HENGRUI PHARMA (01276.HK): remimazolam tosilate approved for ICU mechanical ventilation sedation, R&D spend RMB222.5 million

NewTimeSpace News: HENGRUI PHARMA (01276.HK) (A share code: 600276.SH) announced that it has recently received a notice 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. The drug is in injection form with a strength of 36 mg (calculated based on C21H19BrN4O2), is classified as Chemical Drug Class 2.4, carries acceptance number CXHS2500146 and is a prescription drug.

According to the announcement, the drug has previously been approved in China for multiple indications, namely sedation and anaesthesia for non-intubated surgeries/procedures, and induction and maintenance of general anaesthesia. The Company said that sedation management in critically ill patients receiving mechanical ventilation is a key component of ICU care, and that standardised sedation can alleviate stress responses, improve patient-ventilator synchrony, preserve organ reserve, shorten the duration of mechanical ventilation and ICU stay and reduce the risk of delirium; traditional sedatives, however, carry risks of circulatory and respiratory depression, long-term infusion may lead to drug accumulation and delayed awakening, and elderly patients and those with hepatic or renal insufficiency have poor tolerability, leaving significant unmet clinical needs in current ICU sedation therapy.

Remimazolam tosilate is a benzodiazepine and a short-acting GABAa receptor agonist, with advantages including rapid onset of action, short recovery time and minimal effects on the respiratory and cardiovascular systems. Remimazolam besylate, developed by PAION AG in Germany, was approved for marketing in Japan in January 2020, in the United States in October 2020 and in China in July 2020, and its global sales were approximately USD59.22 million in 2024. As at the date of the announcement, cumulative R&D investment in projects related to remimazolam tosilate for injection amounted to approximately RMB222.5 million (unaudited). The Company cautioned that production and sales of the drug may be susceptible to various uncertainties after approval, and investors are advised to be prudent in investment decisions.