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江苏吉贝尔药业股份有限公司 自愿披露关于收到化学原料药上市申请批准通知书的公告
Group 1 - The company has received approval from the National Medical Products Administration for the marketing application of Gatifloxacin, a chemical raw material drug [1][2] - Gatifloxacin is a broad-spectrum antibacterial agent effective against various bacteria, including Gram-positive and Gram-negative bacteria, and is the main raw material for the company's Gatifloxacin eye drops [2] - The approval is valid until October 21, 2030, and the company is required to continue accumulating research data on nitrosamine impurities and improve control strategies as necessary [2] Group 2 - The approved Gatifloxacin raw material is primarily intended to meet the production needs of the company's Gatifloxacin eye drops, and it is not expected to have a significant impact on the company's recent operations [3]
江苏吉贝尔药业股份有限公司自愿披露关于收到化学原料药上市申请批准通知书的公告
Group 1 - The company, Jiangsu Jibeier Pharmaceutical Co., Ltd., has received the approval notice for the listing application of the chemical raw material drug Gatifloxacin from the National Medical Products Administration [1][2] - Gatifloxacin is a broad-spectrum antibacterial drug effective against various bacteria, including Gram-positive and Gram-negative bacteria, and is the main raw material for the company's Gatifloxacin eye drops [2] - The approval is valid until October 21, 2030, and the company is required to continue accumulating research data on nitrosamine impurities and improve control strategies as necessary [2] Group 2 - The approved Gatifloxacin raw material is primarily used to meet the production needs of the company's Gatifloxacin eye drops, and it is not expected to have a significant impact on the company's recent operations [3]
吉贝尔(688566.SH):加替沙星收到化学原料药上市申请批准通知书
Ge Long Hui A P P· 2025-10-23 08:24
Core Viewpoint - The company, Jibeier (688566.SH), has received the approval notice for the marketing application of its chemical raw material, gatifloxacin, from the National Medical Products Administration, indicating a significant advancement in its product pipeline [1]. Group 1: Product Information - Gatifloxacin is a quinolone antibiotic effective against various bacteria, including Gram-positive and Gram-negative bacteria, as well as Chlamydia trachomatis [1]. - The product gatifloxacin eye drops, which utilize gatifloxacin as the main raw material, are primarily used for treating acute bacterial conjunctivitis caused by sensitive bacteria [1]. - The antibacterial action of gatifloxacin is achieved by inhibiting bacterial DNA gyrase and topoisomerase IV, thereby blocking the processes of DNA replication, transcription, and repair [1].
吉贝尔:化学原料药加替沙星上市申请获批
Core Viewpoint - The company, Jibeier (688566), has received approval from the National Medical Products Administration for its chemical raw material, gatifloxacin, which is the main ingredient in its gatifloxacin eye drops used for treating acute bacterial conjunctivitis caused by sensitive bacteria [1] Group 1 - The approval notification is specifically for the chemical raw material drug application [1] - Gatifloxacin eye drops are primarily indicated for acute bacterial conjunctivitis [1]