12月4日，据CDE官网显示，4类化学仿制药注射用甲苯磺酸奥马环素截至目前在国内尚无仿制药获批上市。 | CYHS2504162 | 注射用甲苯磺酸奥马环 蒙 | 化药 | 仿制 | A | 海南广升营制药有限公 司;海南灵康制药有限 | 2025-12-04 | | --- | --- | --- | --- | --- | --- | --- | | 슷庙号 | 药品名称 | 药品类型 | 申请类型 | 注册分类 | 企业名称 公司: | 承か日期 | 甲苯磺酸奥马环素属于30S subunit抑制剂，是四环素家族中脱颖而出的创新成员。2018年，这款药物在美国成功获批上市，为抗菌治疗领域注入新活力。该 品种它主要针对社区获得性细菌性肺炎（CABP）、急性细菌性皮肤及皮肤结构感染（ABSSSI）等病症，凭借独特的作用机制和良好的疗效，被视为应对 当下严峻抗生素耐药危机的"利器"。据数据显示，该品种在2024年实现了销售业绩的爆发式增长，在全终端医院市场的销售总额逼近3亿元，同比增长高达 128.84%；2025年上半年销售额近2亿元，同比增长44.08%，市场潜力可期。 | 约品饼友力程(国内) | | ...

Core Viewpoint - Hunan Kelun Pharmaceutical Co., Ltd. has had its application for the injection of tosilate omadacycline accepted, marking a significant step in the development of this antibiotic in China, where no generic versions have been approved yet [1][12]. Group 1: Product Overview - Tosilate omadacycline is a novel aminomethylcycline antibiotic belonging to the tetracycline family, primarily used for treating community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) [3]. - The global sales of omadacycline exceeded $200 million in 2022, indicating a strong market demand driven by the increasing antibiotic resistance crisis [4]. Group 2: Market Performance - Since its launch in 2021, the sales of injection tosilate omadacycline in China have surged, with a reported increase of 905% in 2023, surpassing 100 million yuan [6]. - The sales are projected to continue growing, with an expected increase of 85.26% in 2024, reaching approximately 223 million yuan [6][9]. Group 3: Regulatory and Competitive Landscape - Currently, there are no approved generic versions of tosilate omadacycline in China, although several companies, including Qilu Pharmaceutical and Sichuan Meida Kanghua Pharmaceutical, have submitted applications that are under review [12]. - The rapid approval process for omadacycline, taking only eight months from NDA submission to approval, reflects the benefits of China's innovative drug policies [10]. Group 4: Strategic Implications for Companies - Hunan Kelun's involvement in the first generic competition for tosilate omadacycline is expected to enhance its market presence in the anti-infection sector, which is critical given the rising demand for innovative antibiotics [18]. - The inclusion of omadacycline in the "Clinical Urgently Needed Overseas New Drug List" underscores its importance in addressing the urgent need for new antibiotics in China [10][16].