By Fineline Cube 
Jiangsu Simcere Pharmaceutical Co., Ltd. (HKG: 2096) announced the nationwide launch of its first prescription drug in China: Quviviq (daridorexant), a next‑generation dual orexin receptor antagonist (DORA) for insomnia.
Product Overview
- Mechanism – Quviviq blocks orexin receptors, reducing arousal drive and promoting sleep without altering sleep architecture.
- Efficacy – Clinical trials show rapid onset of sleep onset and maintenance, with no residual next‑day effects.
- Safety – Favorable profile; no withdrawal or abuse risk reported in Phase III studies.
Licensing & Regulatory Milestones
| Milestone | Detail |
|---|---|
| License | Simcere acquired exclusive Greater China rights from Idorsia Pharma (Nov 2022). |
| NMPA Approval | Granted in June 2025 for adult insomnia (difficulty falling or maintaining sleep). |
| International Presence | Approved in 11 markets, including the US, UK, Switzerland, Canada, and Hong Kong SAR. |
| Guideline Recommendation | Strongly recommended in the 2025 edition of the Chinese Diagnostic and Therapeutic Guidelines for Insomnia Disorders (2nd Ed.). |
Market Implications
- First‑Mover Advantage – China’s largest market for insomnia therapies; Quviviq becomes the first DORA approved nationwide.
- Competitive Landscape – Positions Simcere against established hypnotics (benzodiazepines, Z‑drugs) and emerging non‑benzodiazepine agents.
- Revenue Potential – Expected to capture a significant share of the multi‑billion‑dollar insomnia market, driven by increasing prevalence and demand for non‑residual treatments.
Strategic Outlook
Simcere’s launch underscores its commitment to expanding its specialty‑pharma portfolio beyond traditional therapeutics. By partnering with Idorsia and leveraging robust clinical data, the company has secured a differentiated entry into a high‑growth therapeutic area.-Fineline Info & Tech