Huahai Pharmaceutical secures approval for Nicorandil Injection

Zhejiang Huahai Pharmaceutical Co., Ltd. announced on November 17, 2025, that it has obtained a drug registration certificate for Nicorandil Injection (12mg) from the National Medical Products Administration. This approval, classified as a Class 3 chemical drug for domestic production, is expected to enhance the company's product line and market competitiveness.

Nicorandil Injection is indicated for unstable angina. The original drug was developed by Chugai Pharmaceutical Co., Ltd. and launched in Japan in September 1993, but it was not previously imported into China. Other domestic manufacturers with registration certificates for this drug include Beijing Sihuan Keba Pharmaceutical Co., Ltd., Yangtze River Pharmaceutical Group Co., Ltd., and Tianjin Tasly Diyi Pharmaceutical Co., Ltd.

Market data projects the domestic sales of Nicorandil Injection to reach approximately RMB 620 million in 2024. Zhejiang Huahai Pharmaceutical has invested approximately RMB 6.78 million in the research and development of this product. The company cautions investors that product manufacturing and sales are subject to national policies and market conditions.