By Fineline Cube 
Everest Medicines Limited (HKG: 1952) announced that the U.S. FDA has approved the Biologics License Application (BLA) for LEROCHOL (lerodalcibep-liga), a novel third‑generation PCSK9 inhibitor from LIB Therapeutics, for lowering LDL‑C in adults with hypercholesterolemia. This approval accelerates the path for Everest to bring the first PCSK9 fusion protein to the Greater China market.
Partnership Structure & Regional Rights
| Partner | Role | Territory | Rights Acquired |
|---|---|---|---|
| LIB Therapeutics | Original developer | Global | US/EU development |
| Hasten Biopharm | China licensee | Greater China | Development & commercialization rights (acquired Sept 2023) |
| Everest Medicines | Strategic collaborator | Greater China | Multi‑drug partnership including lerodalcibep (signed Dec 2025) |
Drug Profile & Mechanism
- Drug Class: Third‑generation PCSK9 inhibitor fusion protein
- Mechanism: Small‑molecule protein‑binding technology reduces LDL‑C by blocking PCSK9‑mediated LDL receptor degradation
- Differentiation: Low immunogenicity and outstanding safety vs. monoclonal antibody PCSK9 inhibitors
- Dosing: Designed for long‑term maintenance of LDL‑C control goals
Global Regulatory Timeline
| Region | Status | Timeline |
|---|---|---|
| United States | BLA approved | Dec 2025 |
| European Union | Marketing authorization submitted | Under review |
| Greater China | BLA submission planned | H1 2026 |
| China Launch | Earliest possible approval & launch | 2027 |
Market Opportunity & Strategic Outlook
- Patient Population: 180 million adults with hypercholesterolemia in China; 2 million with HeFH
- PCSK9 Market: China PCSK9 inhibitor market projected to exceed $2 billion by 2028
- Competitive Advantage: Lerodalcibep is the first PCSK9 fusion protein; offers potential for improved safety and patient compliance
- Reimbursement Path: FDA approval strengthens case for priority review in China; may accelerate national insurance listing
- Investment Thesis: Everest’s strategic collaboration positions it to capture premium share of China’s growing lipid‑lowering market
Forward‑Looking Statements
This brief contains forward‑looking statements regarding lerodalcibep’s regulatory submissions, commercial launch timelines, and market potential. Actual results may differ due to regulatory, competitive, and market access uncertainties.-Fineline Info & Tech