奥马环素首仿战升级，短期遭10家药企争夺首仿资格！

Core Viewpoint - The injection of tobramycin sulfate is a novel antibiotic that has shown significant market potential in China, with no generic versions approved yet, but multiple companies are pursuing approvals, indicating a competitive landscape ahead [1][6]. Group 1: Product Overview - Tobramycin sulfate injection is a member of the 30S subunit inhibitors and has been recognized as an innovative product in the tetracycline family, approved in the U.S. in 2018 for treating community-acquired bacterial pneumonia and acute bacterial skin infections [2][4]. - The product achieved explosive sales growth in 2024, nearing 300 million yuan, with a year-on-year increase of 128.84%, and sales in the first half of 2025 reached nearly 200 million yuan, up 44.08% year-on-year, showcasing its market potential [2][4]. Group 2: Market Dynamics - Currently, there are no approved generic versions of tobramycin sulfate injection in China, but as of June this year, 10 companies have submitted applications for generic versions, indicating a growing competitive environment [1][6]. - The first generic application has sparked interest among various pharmaceutical companies, with the potential for significant economic benefits and enhanced brand influence for the first company to gain approval [6]. Group 3: Regulatory and Market Access - The injection form of tobramycin sulfate was successfully included in the Category B of the medical insurance directory in 2024, improving accessibility for patients and reducing their financial burden [4]. - The product is currently exclusively produced by a specific pharmaceutical company, which has enjoyed a significant market advantage since its approval in December 2021 [3].