Humanwell Healthcare’s Remimazolam Receives NMPA Approval for Bronchoscopy Use

China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its remimazolam (benzenesulfonate), a Category 1 chemical injectable. The drug is now approved for use as a sedative in support of bronchoscopy procedures.

Drug Overview and Development
Remimazolam (benzenesulfonate) is an ultra-short-acting GABAa receptor agonist co-developed by German firm Paion AG. The drug was first approved in China as a sedative for colonoscopy procedures in July 2020. It subsequently received market approval for general anesthesia induction and maintenance (25mg) in March 2022 and as a sedative for bronchoscopy procedures (25mg) in July 2022. Additionally, its 50mg specification was approved in June 2022.

Market and Reimbursement Status
Included on China’s National Reimbursement Drug List (NRDL) in late 2021, remimazolam continues to expand its indications, further solidifying its position in the market. The latest approval for bronchoscopy procedures underscores the drug’s versatility and potential to address diverse medical needs.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry