By Fineline Cube 
Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced that it has filed a New Drug Application (NDA) with China’s National Medical Products Administration (NMPA) for its proprietary Class 1 biologic, SAL003. The recombinant fully‑human anti‑PCSK9 monoclonal antibody is designed for the treatment of hypercholesterolemia and mixed dyslipidemia.
Why SAL003 Could Disrupt the PCSK9 Market
- Simplified Dosing – Administered via a single subcutaneous injection every four weeks, contrasting with existing PCSK9 agents that require two‑to‑three injections per month or sterile compounding.
- Cost‑Effective Delivery – A single‑dose regimen reduces pharmacy workload, improves patient adherence, and may lower overall treatment costs.
- Domestic Innovation – Represents one of the first fully human, Class 1 biologics from a Chinese manufacturer to target a globally competitive indication.
Development Highlights
- Origin – Developed entirely in‑house by Shenzhen Salubris, leveraging its advanced recombinant protein platform.
- Clinical Potential – Early phase data suggest comparable or superior LDL‑cholesterol lowering efficacy relative to current anti‑PCSK9 therapies.
- Regulatory Pathway – The NDA submission aligns with China’s accelerated approval framework for high‑impact biologics, positioning SAL003 for a potential market entry in 2026.
Market Implications
- Competitive Landscape – If approved, SAL003 could challenge established players such as Repatha and Praluent, especially within China’s growing lipid‑management market.
- Strategic Advantage – A once‑monthly dosing schedule aligns with patient preference trends and could drive broader adoption among clinicians.-Fineline Info & Tech