By Fineline Cube 
Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276, HKG: 1276) announced that China’s National Medical Products Administration (NMPA) has accepted a new supplementary application for its injectable remimazolam tosylate for sedation during mechanical ventilation in the intensive care unit (ICU).
Regulatory Milestone & Drug Profile
| Attribute | Details |
|---|---|
| Company | Jiangsu Hengrui Pharmaceutical Co., Ltd (600276.SH) |
| Drug | Remimazolam tosylate injection |
| Application Type | Supplementary application (new indication) |
| New Indication | Sedation during mechanical ventilation in ICU |
| Drug Class | Short-acting GABAA receptor antagonist |
| First China Approval | December 2019 |
Existing Indications & Clinical Use
Remimazolam tosylate is currently approved in China for:
- Sedation and anesthesia during non‑intubated surgeries/procedures
- Induction and maintenance of general anesthesia
The new ICU sedation indication would expand its use into critical care settings, addressing a key unmet need for short‑acting sedatives that allow rapid awakening and neurological assessment.
Market Context & Competitive Landscape
| Sedative Agent | Mechanism | Key Advantage | Market Position |
|---|---|---|---|
| Remimazolam | GABAA receptor antagonist | Ultra‑short acting, rapid recovery | Emerging |
| Propofol | GABAA receptor agonist | Established standard of care | Market leader |
| Dexmedetomidine | Alpha‑2 adrenergic agonist | Analgesic properties | Strong competitor |
ICU Sedation Market: China ICU sedation market valued at ¥3.5 billion (≈ US$490 million), growing at 8% CAGR. Demand for short‑acting agents is increasing as ICUs adopt early mobilization protocols.
Strategic Outlook & Commercial Implications
- Differentiation: Remimazolam’s short half‑life (~40 minutes) offers faster recovery vs. propofol, potentially reducing ICU length of stay
- Reimbursement: ICU indication may command premium pricing if included in China’s National Reimbursement Drug List (NRDL)
- Pipeline Expansion: Strengthens Hengrui’s anesthesia/sedation franchise alongside existing portfolio
- Timeline: NMPA review typically takes 12‑18 months; potential launch H2 2027 if approved
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory review timelines, market potential, and commercial prospects for remimazolam tosylate. Actual results may differ due to regulatory, competitive, and market access uncertainties.-Fineline Info & Tech