China’s Center for Drug Evaluation (CDE) has indicated that Hengrui Medicine Co., Ltd’s (SHA: 600276) dexmedetomidine hydrochloride nasal spray has been awarded priority review status. The drug is filed for approval as a preoperative sedation in children, such as for general anesthesia in pediatric patients.
Drug Overview and Market Context
Dexmedetomidine, a relatively selective alpha2-adrenoceptor agonist with a sedative effect, was originally developed by Hospira Inc. and first applied in clinical settings in the US in 1999. According to Fineline Info & Tech data, injectable and infusion versions of dexmedetomidine hydrochloride are approved for marketing in China. The product is manufactured by a total of 19 companies, including Hengrui Medicine, Brilliant Pharma, and Yangtze River Pharma, and was involved in the “4+7” drug centralized procurement. Currently, no exported version of the drug is available in the country.
Regulatory and Development Status
No hydrochloride nasal spray form of dexmedetomidine has been approved anywhere in the world. In China, Purity Pharma’s dexmedetomidine hydrochloride nasal spray is awaiting a regulatory decision, and Humanwell’s version obtained clinical approval in February this year. All three are Category 2.2 modified drugs, indicating their potential to offer improved formulations or delivery methods compared to existing products.
Future Outlook
The priority review status granted by the CDE underscores the potential of Hengrui Medicine’s dexmedetomidine hydrochloride nasal spray to address significant unmet needs in pediatric sedation. This move is expected to expedite the drug’s availability in the Chinese market, providing a new treatment option for preoperative sedation in children.-Fineline Info & Tech
