By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its μ‑opioid receptor (MOR)‑biased small‑molecule agonist, tegileridine, has received clinical approval from China’s National Medical Products Administration (NMPA) for use in mechanically ventilated patients in intensive‑care units (ICUs).
What Is Tegileridine?
| Feature | Detail |
|---|---|
| Mechanism | MOR‑biased agonist that preferentially activates analgesic pathways while limiting β‑arrestin‑mediated side effects. |
| Category | China’s first home‑developed Category 1 opioid analgesic. |
| Original indication (Jan 2024) | Moderate‑to‑severe postoperative pain after abdominal surgery. |
| Expanded indication (Mar 2025) | Moderate‑to‑severe postoperative pain across all surgical specialties. |
| New ICU indication (Nov 2025) | Analgesia for mechanically ventilated patients in ICU settings. |
| Comparable product | Trevena’s Olinvyk (oliceridine) – licensed in China by Jiangsu Nhwa Pharmaceutical (002262.SZ) and approved in May 2023. |
Clinical & Market Significance
- First‑in‑class for ICU use – Tegileridine becomes the first domestically developed Category 1 opioid cleared for analgesia in ventilated ICU patients, a segment traditionally dominated by injectable opioids with higher respiratory‑depression risk.
- Safety profile – MOR‑bias is expected to reduce respiratory depression and gastrointestinal adverse events, addressing a key concern for sedated, ventilated patients.
- Revenue outlook – The Chinese ICU analgesia market is projected to exceed CNY 30 billion (~US$4.3 billion) by 2028. Assuming a 5 % market capture within three years at an average price of CNY 12,000 per treatment course, tegileridine could generate ≈ CNY 1.5 billion (~US$215 million) in annual sales.
- Strategic fit – The approval expands Jiangsu Hengrui’s opioid portfolio beyond postoperative pain, positioning the company for cross‑indication leverage and potential global development of MOR‑biased agents.
Timeline of Tegileridine Approvals
| Date | Regulatory Milestone | Indication |
|---|---|---|
| Jan 2024 | NMPA marketing authorization | Post‑abdominal surgery pain |
| Mar 2025 | NMPA label expansion | General postoperative pain |
| Nov 2025 | NMPA clinical approval | Mechanically ventilated ICU patients |
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory approvals, clinical benefits, and market potential for tegileridine. Actual results may differ due to clinical outcomes, regulatory actions, competitive dynamics, and other risk factors.-Fineline Info & Tech