Lepu Medical Technology (Beijing) Co., Ltd. (SHE: 300003) announced that MWX205 Injection, a dual‑target small interfering RNA (siRNA) drug independently developed by its controlled subsidiary Shanghai Minwei Biotechnology Co., Ltd. (“Minwei Biotech”), has been approved by China’s National Medical Products Administration (NMPA) to initiate clinical trials for dyslipidemia. MWX205 is currently the world’s first PCSK9/ANGPTL3 dual‑target siRNA to enter clinical development.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Approval Type | Clinical trial initiation (IND) |
| Product | MWX205 Injection – dual‑target siRNA |
| Indication | Dyslipidemia |
| Approval Date | 10 Nov 2026 |
| Prior Clearance | Phase I clinical trial approved in Australia, June 2026 |
| Sponsor | Shanghai Minwei Biotechnology Co., Ltd., controlled subsidiary of Lepu Medical Technology |
Drug Profile & Mechanism of Action
- Modality: siRNA therapeutic independently developed by Minwei Biotech, engineered to silence two key lipid‑regulation targets simultaneously — PCSK9 and ANGPTL3.
- PCSK9 Inhibition: By inhibiting PCSK9 expression, MWX205 increases the number of low‑density lipoprotein receptors (LDLR) on the surface of hepatocytes, potently reducing low‑density lipoprotein cholesterol (LDL‑C) levels in the blood.
- ANGPTL3 Inhibition: By inhibiting ANGPTL3 expression, the drug concurrently modulates the activity of lipoprotein lipase (LPL) and hepatic lipase (HL) — not only further reducing LDL‑C but also demonstrating excellent efficacy in lowering triglycerides (TG) and triglyceride‑rich lipoproteins (TRL).
- Differentiation: One molecule covering both the LDL‑C and TG/TRL axes, potentially delivering broader lipid control than single‑target siRNA or antibody therapies.
- First‑in‑Class Status: World’s first PCSK9/ANGPTL3 dual‑target siRNA to advance into clinical development — a global first‑mover position in RNA‑based cardiometabolic medicine.
Preclinical Evidence – Non‑Human Primate Study
| Parameter | Maximum Effect | Notes |
|---|---|---|
| PCSK9 Protein Inhibition | 82.21 % | Rhesus monkeys with spontaneous dyslipidemia |
| ANGPTL3 Protein Inhibition | 94.41 % | Same model |
| Durability | Persistent up to 12 weeks | Through the study endpoint |
| LDL‑C Reduction | 74.28 % | Significant vs. baseline |
| TG Reduction | 82.30 % | Significant vs. baseline |
| Total Cholesterol (TC) Reduction | 52.13 % | Significant vs. baseline |
Non‑clinical results showed that MWX205 significantly reduced both PCSK9 and ANGPTL3 protein levels in rhesus monkeys with spontaneous dyslipidemia, with inhibitory effects maintained through the full 12‑week study period — consistent with the prolonged‑action profile expected of hepatic siRNA therapeutics.
Market Impact & Outlook
- Dyslipidemia Burden: Elevated LDL‑C and TG are central drivers of atherosclerotic cardiovascular disease, and many patients remain inadequately controlled on statins and existing therapies — sustaining demand for potent, long‑acting alternatives.
- RNA Therapeutics Momentum: As siRNA lipid‑lowering agents gain global clinical validation, the dual‑target design positions MWX205 to compete on breadth of lipid control rather than single‑pathway potency.
- Dual‑Market Pathway: Australian Phase I clearance (June 2026) followed by NMPA trial approval (November 2026) reflects a coordinated international development strategy by Lepu Medical Technology and Minwei Biotech.
- Commercial Outlook: Clinical‑stage asset; human safety and efficacy data, trial design, timelines and partnering terms – not disclosed.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical trial initiation, development timelines, and the therapeutic potential of MWX205. Preclinical findings in non‑human primates are not predictive of human outcomes. Actual results may differ materially due to risks including early‑phase safety findings, clinical efficacy, regulatory requirements in China and other jurisdictions, and competitive dynamics in the lipid‑lowering field.-Fineline Info & Tech
