By Fineline Cube 
Amgen Inc. (NASDAQ: AMGN) announced that China’s National Medical Products Administration (NMPA) has granted marketing approval for Evenity (romosozumab), a sclerostin (SOST)-targeted monoclonal antibody indicated for postmenopausal women with osteoporosis at high risk of fracture.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Approval Type | Full marketing approval |
| Product | Evenity (romosozumab) injection |
| Indication | Treatment of postmenopausal women with osteoporosis at high risk of fracture |
| Approval Date | 7 May 2026 |
| Next Steps | Commercial launch following pricing and reimbursement negotiations |
Drug Profile & Mechanism of Action
- Molecule: Humanized monoclonal antibody (subcutaneous injection)
- Target: Sclerostin (SOST) – a natural inhibitor of bone formation
- Innovation: Dual-action mechanism that simultaneously promotes bone formation and inhibits bone resorption, enabling rapid increases in bone mineral density (BMD)
- Intellectual Property: Global patents held by Amgen, covering the romosozumab molecule and therapeutic use
Clinical Evidence – Pivotal Phase III Trials
| Trial | Key Finding | Comparator | Benefit |
|---|---|---|---|
| FRAME | 73% reduction in new vertebral fractures at 12 months | Placebo | Statistically significant risk reduction |
| FRAME | BMD increase: 13.3% (lumbar spine), 6.8% (total hip), 5.2% (femoral neck) | Placebo | Rapid and substantial bone density gains |
| ARCH | ~50% reduction in vertebral fracture risk | Alendronate alone | Superior efficacy with sequential therapy |
| STRUCTURE | Approximately 2x greater BMD gains at all measured sites | Teriparatide | Enhanced bone-forming capacity |
The integrated clinical program demonstrated that romosozumab delivers robust efficacy in reducing fracture risk and increasing BMD with a generally favorable tolerability profile.
Market Impact & Outlook
- China Osteoporosis Landscape: With over 90 million people affected by osteoporosis in China and a rapidly aging population, effective treatments for high-risk patients represent a significant unmet need.
- Revenue Potential: Amgen projects strong uptake among the estimated 25-30 million postmenopausal women with osteoporosis in China, particularly those at high fracture risk.
- Competitive Position: Evenity’s dual-action mechanism differentiates it from antiresorptives (like bisphosphonates) and other bone-forming agents, offering a unique therapeutic option for appropriate patients.
- Commercial Strategy: Amgen will leverage its established presence in China’s biologics market and work with healthcare providers to identify high-risk patients who would benefit most from Evenity’s rapid bone-building effects.
Forward‑Looking Statements
This brief contains forward-looking statements regarding regulatory approvals, clinical outcomes, and commercial expectations for Evenity. Actual results may differ due to risks including market adoption, competitive dynamics, and reimbursement decisions.-Fineline Info & Tech