Shanghai Pharma's SPH3127 tablets approved for hypertension treatment

Shanghai Pharmaceuticals Holding Co., Ltd. announced that its subsidiary, Shanghai Sine Pharmaceutical Laboratories Co., Ltd., has received approval from the National Medical Products Administration for the marketing authorization of setoglutam maleate tablets (SPH3127 tablets). The drug is classified as a Class 1 chemical drug, intended for the treatment of essential hypertension.

SPH3127 tablets are a novel oral non-peptide small molecule renin inhibitor designed to counteract blood pressure increases caused by overactivation of the renin-angiotensin-aldosterone system. Clinical studies confirmed its efficacy and good safety profile in hypertensive patients.

The company has invested approximately RMB 296 million in the development of SPH3127 tablets. The approval grants Shanghai Sine Pharmaceutical Laboratories the right to manufacture and sell this product in the domestic market, though future sales remain subject to market, policy, and competitive factors.