Shandong Xinhua Pharmaceutical Co., Ltd. (00719) obtained the drug registration certificate for dapoxetine hydrochloride tablets

According to the Zhitong Finance App, Shandong Xinhua Pharmaceutical Co., Ltd. (00719) issued an announcement. The company received the “Drug Registration Certificate” for dapoxetine hydrochloride tablets (hereinafter referred to as “this product”) approved and issued by the State Drug Administration.

In April 2025, Xinhua Pharmaceutical submitted marketing license registration data for the domestic production of dapoxetine hydrochloride tablets to the Drug Evaluation Center (CDE) of the State Drug Administration and was accepted. The “Drug Registration Certificate” was obtained in August 2026. The review concluded that registration was approved.

This product is suitable for treating male premature ejaculation (PE) patients aged 18 to 64 who meet all of the following conditions: Intravaginal ejaculation latency (IELT) of less than 2 minutes; continuous or repeated ejaculation of the penis before, during, or shortly after insertion, and before sexual satisfaction; significant personal distress or interpersonal disorder due to premature ejaculation (PE); poor ejaculation control ability; history of premature ejaculation during most sexual attempts over the past 6 months.

According to relevant statistics, the sales volume of dapoxetine in public medical institutions in China in 2025 is approximately RMB 1.03 billion.

Xinhua Pharmaceuticals' dapoxetine hydrochloride tablets obtained a drug registration certificate in August 2026, which will further enrich the company's formulation product line and enhance market competitiveness.