By Fineline Cube 
Novartis (NYSE: NVS) announced that Leqvio (inclisiran) has received an additional indication approval from the National Medical Products Administration (NMPA) in China, allowing its use as a monotherapy adjunct to diet for adult patients with primary hypercholesterolemia (non‑familial) or mixed dyslipidemia to lower LDL‑C. The siRNA therapy was previously approved only in combination with statins or other lipid‑lowering therapies.
Regulatory Milestone & Drug Profile
| Item | Detail |
|---|---|
| Company | Novartis AG (NYSE: NVS) |
| Drug | Leqvio (inclisiran) |
| Mechanism | Small interfering RNA (siRNA) targeting PCSK9 |
| New Indication | Monotherapy for primary hypercholesterolemia or mixed dyslipidemia |
| Previous Approval | Combination with statins/LLTs (August 2023) |
| Dosing | Twice‑yearly injection |
| Innovation | World’s first and only approved siRNA cholesterol‑lowering therapy |
Clinical Data & Market Context
- V‑MONO China Study: Phase III trial demonstrated clinically meaningful and statistically significant LDL‑C reduction with inclisiran monotherapy vs. placebo in low‑to‑moderate ASCVD risk patients not receiving prior lipid‑lowering therapy
- Adherence Advantage: Twice‑yearly dosing offers potential to improve treatment adherence and long‑term LDL‑C goal attainment compared to daily oral statins
- Market Need: ASCVD remains leading cause of mortality in China; ~180 million adults have hypercholesterolemia with many patients statin‑intolerant or uncontrolled
- Competitive Landscape: Competes with PCSK9 antibodies (alirocumab, evolocumab) and bempedoic acid; Leqvio’s siRNA mechanism and dosing convenience differentiate positioning
- Strategic Value: Monotherapy expansion broadens eligible patient population, potentially unlocking ¥2–3 billion (US$280–420 million) additional peak sales in China
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial expectations, market penetration, and revenue projections for Leqvio in China. Actual results may differ due to competitive dynamics, pricing negotiations, and market adoption rates.-Fineline Info & Tech