深圳信立泰药业股份有限公司 关于SAL0140 获得临床试验批准通知书的公告

Group 1 - The company has received clinical trial approval for its innovative small molecule drug SAL0140, aimed at treating primary hyperaldosteronism [1][2] - SAL0140 is a proprietary aldosterone synthase inhibitor, with potential indications including uncontrolled hypertension, primary hyperaldosteronism, and chronic kidney disease (CKD) [1] - The drug is expected to lower aldosterone levels in patients, potentially reducing blood pressure and organ damage, indicating significant development potential [1] Group 2 - The company’s drugs Xinchaotuo and Fulitan have been newly included in the National Medical Insurance Directory, while Ennaero has successfully renewed its inclusion [3][4] - Xinchaotuo is the first approved ARNI co-crystal drug in China, showing significant blood pressure reduction in clinical trials, with a notable average decrease of 25.07 mmHg to 28.22 mmHg after 12 weeks of treatment [7] - Fulitan is a compound formulation that effectively lowers blood pressure while minimizing adverse effects, making it suitable for salt-sensitive and elderly hypertensive patients [7][9] Group 3 - Ennaero is a new generation HIF-PHI drug approved for treating anemia in CKD patients, demonstrating high efficacy and safety [11][12] - The company has established an innovative product matrix in the cardiovascular chronic disease field, focusing on the heart-kidney metabolic syndrome [14] - The new medical insurance directory will be effective from January 1, 2026, and the company aims to enhance drug accessibility and meet unmet clinical needs [14]