CSPC PHARMA (01093) announced that the new chemical drug category 1 product developed by the Group, the potent aldosterone synthase inhibitor (SYH2072 Tablets), has obtained approval from the U.S. Food and Drug Administration to commence clinical trials in the United States.
The product had also previously received approval in December 2025 from the National Medical Products Administration of China to initiate clinical trials within the country.
This product is a highly selective and potent aldosterone synthase inhibitor (ASI) capable of effectively reducing plasma aldosterone levels without impacting cortisol levels.
The clinical indications approved for this trial are uncontrolled hypertension and treatment-resistant hypertension.
Preclinical studies indicate that the product selectively inhibits the activity of aldosterone synthase, significantly lowers plasma aldosterone levels in animal disease models, and reduces blood pressure in hypertensive models in a dose-dependent manner, all while not affecting cortisol levels.
The product demonstrates favorable pharmacokinetic (PK) characteristics and a strong safety profile, giving it the potential to become a best-in-class drug.
Currently, the Group has submitted multiple patent applications for this product both in China and abroad.
Given the substantial clinical need for aldosterone synthase inhibitors, this product holds significant clinical development value and is expected to provide a new treatment option for patients with uncontrolled and treatment-resistant hypertension.
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