Shanghai Pharmaceuticals Holding (02607): Nicardipine tablets pass the consistency evaluation of generic drugs.

Shanghai Pharmaceuticals Holding (02607) announced that recently, its subsidiary Shandong Xinyi Pharmaceutical Co., Ltd. (hereinafter referred to as "Shandong Xinyi") received the "Drug Supplementary Application Approval Notice" (Notice No.: 2025B04288) issued by the National Medical Products Administration (hereinafter referred to as the "NMPA") for its Nicorandil tablets (hereinafter referred to as the "drug"), which passed the generic drug quality and efficacy consistency evaluation. Nicorandil tablets are used to treat angina pectoris and were originally developed by Japan Yashima Pharmaceutical Co., Ltd. and launched in Japan in 1983. In November 2024, Shandong Xinyi applied for and was accepted for the generic drug consistency evaluation of the drug with the NMPA. As of the date of this announcement, the company has invested approximately RMB 5,535,200 in research and development expenses for the drug. As of the date of this announcement, the main manufacturers of the drug in China include Japan Yashima Pharmaceutical Co., Ltd., Xi'an Hanfeng Pharmaceutical Co., Ltd., Tianfang Pharmaceutical Co., Ltd., Shanxi Xinyu Pharmaceutical Co., Ltd., and others. According to IQVIA database, in 2024, the amount of Nicorandil tablets (5mg) purchased by hospitals in mainland China was RMB 727 million. In accordance with relevant national policies, varieties that pass consistency evaluation will receive greater support in areas such as medical insurance payment and medical institution procurement. Therefore, Shandong Xinyi's Nicorandil tablets passing the generic drug consistency evaluation will help expand the drug's market share, improve market competitiveness, and accumulate valuable experience for the company's future consistency evaluation work for other products.