Shanghai Pharmaceuticals Holding Co., Ltd. (SHA: 601607) announced that the National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for SPH3127 tablets, a new‑generation oral, non‑peptide, small‑molecule renin inhibitor for the treatment of primary hypertension.
Regulatory Milestone
Item
Details
Approval Date
10 Dec 2025
Agency
NMPA (China)
Product
SPH3127 tablets (oral, QD dosing)
Indication
Primary hypertension
Mechanism of Action
Direct renin inhibition, counteracting RAAS overactivation
Innovation:New‑generation renin inhibitor with enhanced potency vs. existing RAAS pathway agents
Mechanism: Directly inhibits renin activity, blocking downstream Angiotensin II generation and aldosterone release
Preclinical Profile: Demonstrated superior renin inhibition in vitro/vivo; activity shown in hypertension, chronic kidney disease, and inflammatory bowel disease models
Clinical Evidence
Study
Key Findings
Phase III Pivotal Trial
Definitive antihypertensive efficacy in primary hypertension patients
Safety Profile
Good overall tolerability; AE rates comparable to standard RAAS inhibitors
Differentiation
Stronger renin activity suppression vs. other RAAS‑targeting drugs
Market Opportunity
Metric
Value
Implication
China Hypertension Prevalence
>245 million patients (2024)
<30% achieve optimal control
China Antihypertensive Market
¥45 billion (≈ US$6.3 B)
RAAS inhibitors dominate with >40% share
SPH3127 Peak Sales Forecast
¥800‑1.0 billion (≈ US$112‑140 M) by 2030
Captures 2‑3% of RAAS class through differentiation
Competitive Landscape
ACE inhibitors, ARBs, direct renin inhibitors (aliskiren)
SPH3127 offers oral convenience and potentially better efficacy
Forward‑Looking Statements This brief includes forward‑looking statements regarding SPH3127’s commercial launch, market penetration, and sales forecasts. Actual results may differ due to pricing negotiations, competitive responses, and adoption rates among physicians.-Fineline Info & Tech
By Fineline Cube 