恒瑞医药(600276.SH)：注射用达托霉素简略新药申请获美国FDA批准文号
格隆汇8月29日丨恒瑞医药(600276.SH)公布，公司近日收到美国食品药品监督管理局(“FDA”)通知，恒瑞医药向FDA申报的注射用达托霉素简略新药申请(ANDA，即美国仿制药申请，申请获得美国FDA审评批准意味着申请者可以生产并在美国市场销售该产品)已获得批准。
达托霉素为环脂肽类抗生素，经玫瑰孢链霉菌发酵得来，其适应症为治疗成人复杂性皮肤和皮肤组织感染（cSSSI）、成人血液金黄色葡萄球菌感染；作用机制为达托霉素与细菌细胞膜结合，并引起细胞膜电位的快速去极化，细胞膜电位的这种降低抑制了蛋白质、DNA和RNA的合成，最终导致细菌细胞死亡。
达托霉素是由Lilly（礼来）公司最初研究，Cubist制药公司开发的环脂肽类抗生达托霉素，是近四十年来继恶唑烷酮类抗生素后应用到临床的唯一新结构类别抗生素，临床主要用于治疗复杂性皮肤及皮肤软组织感染与金黄色葡萄球菌引起的菌血症。应病人对新型耐药抗生素的迫切需求，2003年9月，美国FDA经过优先审批程序首次批准注射用达托霉素（商品名为Cubicin®），目前注射用达托霉素已在全球广泛上市销售。经查询，国外除Cubist制药公司外，包括恒瑞医药已有12个公司的注射用达托霉素产品获批上市。国内已有Cubist制药公司的注射用达托霉素获准进口，商品名为Cubicin®，规格为0.5g。另，华东医药、海正药业及恒瑞医药的达托霉素原料药及注射用达托霉素已获批上市。
经查询IMS数据库，2018年达托霉素全球销售额约为8.7亿美元，美国销售额约为6.8亿美元。
截至目前，公司在该产品研发项目上已投入研发费用约3007万元人民币。
此次注射用达托霉素获得美国FDA批准文号标志着恒瑞医药具备了在美国市场销售该药品的资格，将对公司拓展市场带来积极影响。公司将积极推动该药品的上市销售。
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