Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Sildenafil Citrate Orally Disintegrating Tablets, which is expected to enhance the company's market competitiveness and open new market opportunities [1]. Company Summary - The company submitted the registration application for Sildenafil Citrate Orally Disintegrating Tablets to the Center for Drug Evaluation (CDE) in April 2024, and the application was accepted [1]. - The drug received its registration certificate in September 2025, with the evaluation conclusion being approval for registration [1]. - The product is indicated for the treatment of erectile dysfunction, a market segment with significant sales potential [1]. Industry Summary - In 2024, the sales revenue of Sildenafil-related formulations in Chinese public medical institutions is estimated to be approximately RMB 5.2 billion [1]. - The approval of this new formulation is expected to contribute positively to the overall market dynamics for erectile dysfunction treatments in China [1].
山东新华制药股份(00719)获得枸橼酸西地那非口崩片药品注册证书