Baiyunshan (00874) issued an announcement. On July 11, 2024, the company's branch, Guangzhou Baiyunshan Pharmaceutical Group...
According to Zhitong Finance App, Baiyunshan (00874) announced that on July 11, 2024, the company's branch Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. Baiyunshan Pharmaceutical General Factory (hereinafter referred to as “Baiyunshan Pharmaceutical General Factory”) received the “Drug Supplement Application Approval Notice” issued by the State Drug Administration. Cefuroxime for injection has passed the consistent evaluation of the quality and efficacy of generic drugs.
Application content: Consistency evaluation of the quality and efficacy of generic drugs. Simultaneous application: 1. Change in drug quality standards (including changes in storage conditions and expiration dates); 2. Change packaging materials and containers in direct contact with drugs.
According to reports, Baiyunshan Pharmaceutical Factory officially launched cefuroxime sodium for injection in China in May 2006, and submitted a consistency evaluation application to the State Drug Administration on April 7, 2023, which was accepted on April 17, 2023.
Cefuroxime sodium is a second-generation cephalosporin. It is sensitive to most gram-negative bacteria and gram-positive bacteria. It has the advantages of broad antibacterial spectrum, low renal toxicity, and stability to beta-lactamase. It is widely used clinically to treat respiratory infections, urinary infections and surgical infections. Cefuroxime for injection was included in the National Essential Medicines List (2018) and belongs to the National Health Insurance Class A category (2023).
Currently, manufacturers of injectable cefuroxime sodium marketed in China include Shandong Runze Pharmaceutical Co., Ltd., Zhejiang Huidisen Pharmaceutical Co., Ltd., and Shenzhen Xinlitai Pharmaceutical Co., Ltd. According to data from the Mi Intranet, the sales volume of injectable cefuroxime sodium in Chinese public hospitals in 2023 was RMB 2.37 billion.
As of the date of this announcement, Baiyunshan Pharmaceutical General Factory has invested about RMB 9.015 million (unaudited) in research and development expenses for the drug's consistency evaluation. In 2023, Baiyunshan Pharmaceutical General Factory's sales revenue for this drug was RMB 0.