SHANDONG XINHUA (00719) announced that it has recently received a Drug Registration Certificate for sildenafil citrate orally disintegrating tablets from the National Medical Products Administration.

In April 2024, Xinhua Pharmaceutical submitted registration application materials for the domestic production and marketing authorization of sildenafil citrate orally disintegrating tablets to the Center for Drug Evaluation (CDE) under the National Medical Products Administration, which was accepted for review. The company obtained the Drug Registration Certificate in September 2025, with the evaluation conclusion being approval for registration.

Sildenafil citrate orally disintegrating tablets are used for the treatment of erectile dysfunction. According to relevant statistical data, sales of sildenafil-related preparations in China's public medical institutions reached approximately RMB 5.2 billion in 2024.

Xinhua Pharmaceutical's receipt of the drug registration certificate for sildenafil citrate orally disintegrating tablets in September 2025 will be beneficial for the company to explore new market segments and enhance its market competitiveness.