SHANDONG XINHUA (00719): Phenobarbital tablets pass the evaluation of generic drug consistency.

Shandong Xinhua (00719) announced that recently, the company received the approved notification letter for the supplementary application of phenobarbital tablets issued by the National Medical Products Administration (NMPA). This product has passed the evaluation of generic drug quality and efficacy consistency. In May 2025, Shandong Xinhua Pharmaceutical submitted the application materials for the consistency evaluation of phenobarbital tablets to the Center for Drug Evaluation (CDE) of the NMPA, and it was accepted. In May 2026, they received the "Drug Supplementary Application Approval Notice", and the evaluation conclusion was that this product passed the evaluation of generic drug quality and efficacy consistency. This product is mainly used to treat anxiety, insomnia (for patients with short sleep time and early awakening), and epilepsy, and is a medication for treating grand mal seizures and partial seizures. It belongs to the Class A varieties of the "National Essential Medicines List" and the "National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2025)". According to relevant statistics, the sales of phenobarbital in public medical institutions in China in 2025 were approximately 220 million yuan.