Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-09-03 22:59Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the consistency evaluation of the quality and efficacy of injectable Cefotaxime [1][2] Drug Basic Information - The drug is injectable Cefotaxime with specifications of 0.5g and 1.0g, classified as a chemical drug [1] - The approval notification numbers are 2025B04013 and 2025B04015, with acceptance numbers CYHB2350966 and CYHB2350965 [1] - The drug is produced by Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., located at 808 Binhai East Road, Haizhu District, Guangzhou [1] Drug Related Information - Tianxin Pharmaceutical obtained the registration certificate for injectable Cefotaxime in September 2002 and submitted the consistency evaluation application in December 2023 [3] - Injectable Cefotaxime is a third-generation cephalosporin antibiotic used for treating various infections, including severe systemic infections and respiratory tract infections [3] - The sales revenue for injectable Cefotaxime in 2024 is projected to be RMB 1,431.78 million, with total sales in China expected to reach RMB 185,877 million [3] R&D Investment - As of the announcement date, Tianxin Pharmaceutical has invested approximately RMB 1,036 million in the R&D project for injectable Cefotaxime [4]