By Fineline Cube Sanofi (NASDAQ: SNY) announced that Redemplo (plozasiran sodium injection), the world’s first small interfering RNA (siRNA) therapeutic targeting APOC3, has been approved by China’s National Medical Products Administration (NMPA) as an adjunct to diet to reduce triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS). The approval marks the first siRNA therapy for FCS in China, offering 80% triglyceride reduction and convenient quarterly dosing.
Product & Regulatory Milestone
| Item | Detail |
|---|---|
| Product | Redemplo (plozasiran sodium injection) |
| Company | Sanofi (NASDAQ: SNY) |
| Regulatory Status | NMPA approved (06 Jan 2026) |
| Indication | Adjunct to diet for triglyceride reduction in adult FCS patients |
| Mechanism | siRNA targeting APOC3 mRNA |
| Significance | World’s first APOC3‑targeting siRNA |
Clinical Efficacy & Safety Profile
Efficacy Results:
- 80% reduction in fasting triglyceride levels from baseline
- 80% reduction in acute pancreatitis incidence vs. placebo
- Convenient dosing: Four times per year (once every three months)
Safety Profile:
- Overall adverse event risk no significant difference vs. placebo
- Lower rates of serious adverse events and treatment discontinuation vs. placebo
- High patient compliance due to Q3M subcutaneous injection regimen
Market Context & Acquisition History
FCS Disease Burden:
- Rare genetic disorder with severely elevated triglyceride levels
- China Prevalence: ~5,000‑8,000 diagnosed patients
- Market Size: China severe hypertriglyceridemia market ¥800 million (2025), growing at 18% CAGR
Sanofi’s Strategic Moves:
- August 1 2025: Signed asset purchase agreement with Visirna Therapeutics (Arrowhead subsidiary) for Greater China rights
- December 2025: FDA granted Breakthrough Therapy Designation for severe hypertriglyceridemia (sHTG), expanding treatment scope
Commercial Strategy
Launch Timeline: Q2 2026 via Sanofi’s established rare disease infrastructure (1,200+ specialty pharmacies) in China.
Pricing Strategy: Projected ¥180,000‑220,000 annual cost, with patient assistance program to reduce out‑of‑pocket burden.
Reimbursement Pathway: Targeting NRDL inclusion via rare disease priority review in 2027, which could triple patient access.
Manufacturing: Imported from Sanofi’s Germany facility initially; tech transfer to Suzhou site planned for 2027‑2028.
Competitive Landscape
| Drug | Company | Mechanism | Stage (China) | Limitations |
|---|---|---|---|---|
| Onpattro | Alnylam | siRNA (TTR) | Marketed (different indication) | Not for FCS |
| Volanesorsen | Ionis | ASO (APOC3) | Not approved (safety concerns) | Injection weekly, thrombocytopenia risk |
| Redemplo | Sanofi | siRNA (APOC3) | Approved | Q3M dosing, superior safety |
| Gemcabene | Pfizer/Lilly | ApoC‑III inhibitor | Phase III | Small molecule, less potent |
Differentiation: Redemplo’s Q3M dosing and clean safety profile provide clear competitive advantage.
Financial Projections
| Metric | 2026E | 2027E | 2028E |
|---|---|---|---|
| China FCS Patients Treated | 1,200 | 2,500 | 4,000 |
| Market Share | 60% | 75% | 85% |
| Revenue (¥ million) | 216 | 450 | 756 |
| Gross Margin | 88% | 90% | 91% |
Peak Sales Potential: ¥1.8 billion (US$250 million) by 2032, assuming sHTG indication expansion.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Redemplo’s commercial launch, market penetration, and revenue forecasts. Actual results may differ materially due to pricing negotiations, reimbursement approvals, and competitive responses.Future Prospects
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