SHANDONG XINHUA (00719) has obtained the drug registration certificate for Dapoxetine Hydrochloride Tablets.

SHANDONG XINHUA (00719) announced that the company has received the drug registration certificate for Dapoxetine Hydrochloride Tablets (hereinafter referred to as "the product") issued by the National Medical Products Administration. In April 2025, Shandong Xinhua Pharmaceutical submitted the application materials for the domestic production listing license registration of Dapoxetine Hydrochloride Tablets to the Drug Evaluation Center (CDE) of the National Medical Products Administration and it was accepted. In August 2026, the product obtained the drug registration certificate, with the review conclusion being approved for registration. This product is indicated for the treatment of male patients aged 18 to 64 with premature ejaculation (PE) who meet all of the following conditions: intra-vaginal ejaculatory latency time (IELT) of less than 2 minutes; ejaculation occurs persistently or repeatedly due to minimal sexual stimulation, either before penetration, during the process, or shortly after penetration, prior to achieving sexual satisfaction; significant personal distress or interpersonal difficulty due to premature ejaculation (PE); poor ejaculatory control; and a history of premature ejaculation in the majority of sexual attempts over the past six months. According to relevant statistical data, the sales of Dapoxetine in Chinese public medical institutions in 2025 are approximately RMB 1.03 billion. The Dapoxetine Hydrochloride Tablets of Shandong Xinhua Pharmaceutical obtained the drug registration certificate in August 2026, which will further enrich the companys formulation product portfolio and enhance its market competitiveness.