Shanghai Pharmaceuticals Holding (02607): Clevidipine Emulsion Injection Approved for Production

Shanghai Pharmaceuticals Holding (02607) has announced that recently, Shanghai Pharmaceuticals Holding Group Co., Ltd. (hereinafter referred to as the "Company")'s subsidiary Shanghai SPH First Biochemical Pharmaceutical Co., Ltd. (hereinafter referred to as "SPH First Biochemical") received the Drug Registration Certificate (Certificate Nos.: 2026S03524, 2026S03525) issued by the National Medical Products Administration (hereinafter referred to as the "NMPA") for Clevidipine Emulsion Injection (hereinafter referred to as "the Drug"), and the Drug has been approved for production. Clevidipine Emulsion Injection is mainly used for the treatment of hypertension in patients who are not suitable for oral therapy or whose expected response to oral therapy is inadequate. It was originally developed by AstraZeneca and approved for marketing in the United States in August 2008. In July 2024, SPH First Biochemical submitted a registration and marketing application for the Drug to the NMPA, which was accepted. As of the date of this announcement, the Company has invested approximately RMB 52.2 million in research and development expenses for the Drug. As of the date of this announcement, the major manufacturers of the Drug in China include Nanjing Youke Pharmaceutical Co., Ltd., Sichuan Kelun Pharmaceutical Co., Ltd., Qilu Pharmaceutical (Hainan) Co., Ltd., Yangzijiang Pharmaceutical Group Co., Ltd., and CSPC PHARMA Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. According to the IQVIA database, in 2025, the procurement amount of calcium channel blocker injections with the same mechanism as Clevidipine Emulsion Injection by hospitals in mainland China was RMB 911.39 million.