2021年11月23日，国家药品监督管理局药品审评中心（CDE）受理了住友制药（苏州）有限公司（以下简称“住友制药”）拉法姆林（Lefamulin）的口服片剂和静脉注射液的新药上市申请（NDA），用于治疗成人社区获得性肺炎（CAP）。
拉法姆林是Nabriva Therapeutics Ireland DAC公司（总部位于爱尔兰都柏林）研发的截短侧耳素类抗生素，其作用机制不同于现有抗生素，是一种不易产生耐药及交叉耐药的新型抗感染药物。美国食品药品监督管理局（FDA）、加拿大卫生部（Health Canada）及欧洲药品管理局（EMA）已经批准该药用于成人社区获得性细菌性肺炎的治疗，目前在美国以“XENLETA® ”为商品名销售。拉法姆林也是住友制药在今年5月宣布获得中国大陆以及中国香港、中国台湾等地区独家研发和销售权的4款新产品之一。
住友制药自上世纪90年代引入第一个抗感染产品注射用美罗培南（商品名：美平® ）以来，一直将抗感染领域作为主要发力的领域之一。同时，我们注意到临床抗感染治疗正面临日益严重的细菌耐药问题。作为一家植根中国的跨国药企，住友制药一贯秉承“以患者为中心”的理念积极为中国患者寻找更多、更好、更可及的健康解决方案。我们期待这款拥有不同作用机制的新型抗生素能够为中国CAP患者的经验性单药治疗带来便利，同时也带来更多临床获益。
On November 23, 2021, Sumitomo Pharmaceuticals (Suzhou) Co., Ltd., (hereinafter referred as Sumitomo Pharmaceuticals) has officially submitted its new drug Lefamulin application (NDA) for treatment of community acquired pneumonia (CAP) to Chinese Center for Drug Evaluation (CDE).
Lefamulin is a pleuromutilin antimicrobial agent discovered and developed by Nabriva Therapeutics Ireland DAC (headquartered in Dublin, Ireland). It is a novel treatment for infectious diseases with a mechanism of action that differs from existing antibiotics. The drug has been approved for the indication of community-acquired bacterial pneumonia in adults by the U.S. Food and Drug Administration (FDA), Health Canada and the European Medicines Agency (EMA). The drug is currently being marketed in the United States under the brand name XENLETA®. Lefamulin is one of four new products that Sumitomo Pharmaceuticals had announced it has acquired exclusive R&D and marketing rights in mainland China, Hong Kong and Taiwan at May, 2021.
Since the first infectious disease product which is Meropenem for Injection (Trade name: Mepem® ) around 1990s, Sumitomo pharmaceuticals was focusing on infectious disease area many years. At the same time, the clinical infection disease therapy is facing an increasingly serious bacterial resistance problem. As a multinational pharmaceutical company with roots in China, Sumitomo Pharmaceuticals always adheres to the concept of “patient-centered” and actively seeks better and more accessible health solutions for Chinese patients. We expect that this new antibiotic drug with different mechanism of action can bring convenience to the monotherapy for CAP patients in China and bring more clinical benefits.
