就在今年5月，患者腹壁脓腔合并的肉芽肿已经突破了皮肤，再次手术也无法去除感染灶。绝望之 际，朱同玉教授噬菌体团队通过精准配型，找到裂解性噬菌体。 记者 顾泳 抗生素耐药已成为全球临床医学一大难题。数据统计，全球每年抗生素耐药相关死亡病例达400万 人，直接死亡病例达130万人。如何应对棘手的抗生素耐药？19日起在复旦大学附属中山医院召开的中 国生物工程学会噬菌体大会暨第八届中国噬菌体治疗大会传出消息，噬菌体疗法或成破解抗生素耐药的 全新突破口。 复旦大学医学院副院长朱同玉教授为记者介绍临床案例。56岁男性肾移植术后七年，两年前因移植 肾周和腹壁感染反复多次入院就医，髂窝移植肾周穿刺引流和腹壁脓肿分泌物培养均提示大肠埃希菌 （多重耐药），予以多种抗菌药物治疗后，细菌难以清除。患者前后进行了三次手术切除，效果也不 佳。 噬菌体治疗像剥洋葱一样，一步步摧毁患者体内的感染病灶。在经过多轮噬菌体局部治疗后，患者 伤口愈合，伤口下的感染灶已明显缩小好转。目前患者一般情况稳定，无需使用抗生素，体温正常，各 项感染指标持续好转中。 什么是噬菌体？朱同玉解释：生态环境可谓"一物降一物"，噬菌体是侵袭细菌的病毒，也是赋予宿 主菌 ...

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].