格隆汇1月20日丨润都股份(002923.SZ)公布，近日收到国家药品监督管理局签发的关于沙库巴曲缬沙坦 钠《化学原料药上市申请批准通知书》。沙库巴曲缬沙坦钠片（商品名：诺欣妥®）原研为瑞士诺华公 司（以下简称"Novartis"），于2015年获得美国食品药品监督管理局（以下简称"FDA"）批准上市，是 一种新型心衰治疗药物，也是全球首个血管紧张素受体-脑啡肽酶抑制剂（ARNI）。该药品用于射血分 数降低的慢性心力衰竭（NYHAⅡ- Ⅳ级，LVEF≤40％）成人患者，降低心血管死亡和心力衰竭住院的 风险。沙库巴曲缬沙坦钠片可代替血管紧张素转化酶抑制剂（ACEI）或血管紧张素Ⅱ受体拮抗剂 （ARB），与其他心力衰竭治疗药物（例如：β受体阻断剂、利尿剂和盐皮质激素拮抗剂）合用。2017 年7月，国家药品监督管理局正式批准该药品在中国上市。 ...

Core Viewpoint - The company has successfully obtained GMP certification from Brazil's National Health Surveillance Agency (ANVISA) for four chemical raw materials, indicating compliance with international quality standards [1] Group 1: Certification Details - The GMP certification was conducted from March 17 to March 21, 2025, covering the following products: Candesartan Cilexetil, Sacubitril/Valsartan, Telmisartan, and Valsartan [1] - The certification is valid until May 26, 2027, and June 9, 2027, respectively, for the two certificates issued by ANVISA [1] - The on-site inspection by ANVISA concluded that the company’s facilities met the required standards, resulting in a qualified status for the four raw material products [1]

Core Viewpoint - The company successfully passed the FDA's cGMP inspection, which is a significant achievement that enhances its competitiveness and supports its expansion into the U.S. raw material drug market [1][2]. Group 1: FDA Inspection Details - The company underwent an FDA cGMP inspection from February 12 to February 17, 2025, focusing on the production of nine active pharmaceutical ingredients [1]. - The inspection covered various systems including quality, production, equipment, laboratory control, and material management [1]. - The company received the Establishment Inspection Report (EIR) confirming the successful completion of the inspection [1]. Group 2: Implications for the Company - Passing the FDA inspection establishes a solid foundation for the company's further expansion into the U.S. raw material drug market [2]. - This achievement is expected to inject momentum into the company's ongoing international market expansion efforts [2]. - The successful inspection is anticipated to enhance the company's overall competitiveness and promote future development [2].

Core Viewpoint - The company has received approval from the National Medical Products Administration for the marketing application of Sacubitril/Valsartan Sodium, which is indicated for adult patients with heart failure with reduced ejection fraction, aimed at reducing the risk of cardiovascular death and hospitalization due to heart failure [1] Company Summary - The approved drug, Sacubitril/Valsartan Sodium tablets, is specifically for adult patients suffering from chronic heart failure with reduced ejection fraction [1] - The anticipated sales revenue for Sacubitril/Valsartan Sodium tablets in Chinese public medical institutions is approximately RMB 4.9 billion in 2024 [1]