By Fineline Cube 
Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced that its independently developed innovative small molecule drug, SAL0139 tablets, received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical trial for the treatment of hyperlipidemia (high cholesterol), advancing a potential new LDL‑C lowering therapy.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | SAL0139 tablets |
| Company | Shenzhen Salubris Pharmaceuticals (002294.SZ) |
| Agency | NMPA (China) |
| Approval Type | Clinical trial approval |
| Indication | Hyperlipidemia (high cholesterol) |
| Mechanism | LDL‑C lowering small molecule |
| Application Accepted | September 2025 |
| Next Step | Initiate Phase I study Q1 2026 |
Drug Profile
- Class: Innovative small molecule drug with novel mechanism
- Mechanism: Potential to lower low‑density lipoprotein cholesterol (LDL‑C) through a pathway distinct from statins
- Differentiation: Addresses unmet need in statin‑intolerant patients; oral administration
- Pipeline Status: First hyperlipidemia asset in Salubris’s cardiovascular portfolio
Market Context & Outlook
| Metric | Value |
|---|---|
| China Hyperlipidemia Patients | ~180 million (2024) |
| LDL‑C Market Size (China) | ¥28 billion (US$3.8 billion) |
| Current Standard of Care | Statins (85% share), PCSK9 inhibitors (15%) |
| Statin‑Intolerant Patients | ~20‑30% of diagnosed population (~54 million) |
| Peak Sales Forecast (SAL0139) | ¥1.5‑2.0 billion (US$200‑270 million) by 2032 |
| Market Share Target | 3‑5% of statin‑intolerant or refractory patients |
- Competitive Landscape: Dominated by Pfizer’s Lipitor generics and Amgen’s Repatha; SAL0139’s novel mechanism could capture the significant statin‑intolerant patient segment
- Reimbursement Path: Clinical trial design will align with NMPA cardiovascular drug guidelines; potential for priority review if Phase I shows superior safety profile
- Investment Rationale: Hyperlipidemia represents a large, stable market; successful development would diversify Salubris beyond its core cardiovascular and oncology franchises
Forward‑Looking Statements
This brief contains forward‑looking statements regarding SAL0139’s clinical development, regulatory pathway, and commercial potential. Actual results may differ materially due to risks including clinical trial outcomes, safety profiles, competitive dynamics, and market adoption rates.-Fineline Info & Tech