Shandong Xinhua Pharmaceutical Company Limited (Xinhua Pharmaceutical) announced on 28 August 2026 that China’s National Medical Products Administration (NMPA) has granted a Drug Registration Certificate for the company’s Dapoxetine Hydrochloride Tablets.

The newly approved product is a 30 mg prescription tablet classified as a Class 4 chemical drug under domestic production. It is indicated for treating premature ejaculation (PE) in males aged 18-64 who meet defined clinical criteria, including an intravaginal ejaculation latency time of less than two minutes. The approved product carries drug approval number “H20265706” and certificate number “2026S03108.”

Xinhua Pharmaceutical submitted its registration dossier to the NMPA’s Center for Drug Evaluation in April 2025; the dossier was accepted, and the approval was issued in August 2026. The company must satisfy Good Manufacturing Practice requirements before commencing commercial production and sales.

Market data cited in the announcement show that sales of Dapoxetine in China’s public medical institutions reached approximately RMB 1.03 billion in 2025, underscoring the drug’s commercial potential.

Management stated that the approval expands the company’s finished-dosage portfolio and strengthens overall competitiveness. The announcement also notes that pharmaceutical sales remain sensitive to policy changes, procurement dynamics and broader market conditions, representing ongoing uncertainties for future performance.