山东新华制药股份(00719.HK):获得枸橼酸西地那非口崩片药品注册证书
Ge Long Hui·2025-09-16 08:54

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received the drug registration certificate for Sildenafil Citrate Orally Disintegrating Tablets from the National Medical Products Administration, indicating compliance with drug registration requirements [1] Group 1: Company Developments - The company submitted the registration application for Sildenafil Citrate Orally Disintegrating Tablets to the Center for Drug Evaluation (CDE) in April 2024, which was accepted [1] - The drug registration certificate was granted in September 2025, with the evaluation conclusion being approval for registration [1] Group 2: Market Context - Sildenafil Citrate Orally Disintegrating Tablets are indicated for the treatment of erectile dysfunction [1] - In 2024, the sales revenue of Sildenafil-related formulations in public medical institutions in China is estimated to be approximately RMB 5.2 billion [1]