Shanghai Pharma's Nicorandil tablets pass generic consistency evaluation

Shanghai Pharmaceuticals Holding Co. Ltd. announced that its subsidiary, Shandong Sincere Pharmaceutical Co. Ltd., has received approval from the National Medical Products Administration for its Nicorandil Tablets (5mg) to pass the generic drug quality and efficacy consistency evaluation. The drug is used for treating angina.

Nicorandil Tablets were originally developed by Japan's Chugai Pharmaceutical Co. Ltd. and launched in Japan in 1983. Shandong Sincere filed the application for consistency evaluation in November 2024. The company has invested approximately RMB 5.54 million in research and development expenses for this drug.

According to the IQVIA database, the procurement amount for Nicorandil Tablets (5mg) in mainland China hospitals in 2024 was RMB 726.82 million. This approval is expected to enhance the drug's market share and competitiveness, while also providing valuable experience for the company's future consistency evaluation efforts for other products.