Core Viewpoint - The company has received approval from the U.S. Food and Drug Administration (FDA) for its novel drug SYH2072, a potent aldosterone synthase inhibitor, to conduct clinical trials in the U.S. This product has also been approved by the National Medical Products Administration (NMPA) in China for clinical trials starting in December 2025 [1][1]. Group 1 - The product is a highly selective and potent aldosterone synthase inhibitor (ASI) that effectively lowers plasma aldosterone levels without affecting cortisol levels [1][1]. - The approved clinical indications for SYH2072 are uncontrolled hypertension and resistant hypertension [1][1]. - Preclinical studies have shown that the product selectively inhibits aldosterone synthase activity, significantly reducing plasma aldosterone levels in animal disease models and dose-dependently lowering blood pressure in hypertension models, while not affecting cortisol levels [1][1]. Group 2 - The product exhibits favorable pharmacokinetic (PK) characteristics and safety, positioning it as a potential best-in-class drug [1][1]. - The company has submitted multiple patent applications for this product both domestically and internationally [1][1]. - Given the broad clinical demand for aldosterone synthase inhibitors, the product holds significant clinical development value and is expected to provide new treatment options for patients with uncontrolled and resistant hypertension [1][1].
石药集团(01093)：强效醛固酮合成酶抑制剂( SYH2072片)在美国获临床试验批准