Recently, Shanghai Pharma's subsidiary, Shanghai Shenyang Chinese-Western Medicine Co., Ltd., has received a "Notice of Approval for Drug Supplement Application" (Notice No.: 2025B04804, 2025B04815) issued by the National Medical Products Administration. The notice agrees to change the holder of the market authorization for Amisulpride Orally Disintegrating Tablets to Shanghai Shenyang Chinese-Western Medicine Co., Ltd.

Key Information: - Drug Name: Amisulpride Orally Disintegrating Tablets - Formulation: Tablet - Specification: 50mg, 0.2g - Registration Category: Chemical Drug - Drug Approval Numbers: National Drug Approval No. H20250041, H20250042 - Approval Conclusion: The market authorization holder for this product is changed from "Shanghai Zezheng Pharmaceutical Technology Co., Ltd." to "Shanghai Shenyang Chinese-Western Medicine Co., Ltd."

Additional Information: Amisulpride Orally Disintegrating Tablets are an improved formulation of Amisulpride tablets, which were launched by Sanofi in France in 1986 for the treatment of schizophrenia in adults. In September 2025, Shenyang Chinese-Western applied for the change of market authorization holder to the National Medical Products Administration and received acceptance.

Currently, there are no other companies in China marketing Amisulpride Orally Disintegrating Tablets. According to the IQVIA database, the hospital procurement amount for Amisulpride oral formulations in 2024 was approximately RMB 168.41 million.

The acquisition of the market authorization for Amisulpride Orally Disintegrating Tablets by Shanghai Shenyang significantly enriches the company's product line and enhances its market competitiveness.