药渡全球药物研发进展周报—创新药篇（2026/02/14-02/20）

⸺创新药篇 www.pharmacodia.com 目录 ★本周渡选★...........................................................................................................................3一、全球药物批准/研发动态.................................................................................................51.1全球新药批准情况........................................................................................................51.1.1NDA批准情况.................................................................................................61.1.2BLA批准情况...................................................................................................61.1.3疫苗批准情况...................................................................................................61.1.4新复方批准情况....................................................................................................61.1.5新适应症批准情况................................................................................................71.1.6新制剂批准情况....................................................................................................71.1.7拒绝批准/主动撤回/撤市情况.............................................................................71.2全球新药申报进展........................................................................................................71.2.1 NDA/BLA申报......................................................................................................71.2.2特殊资格认定........................................................................................................91.3全球新药研发进展......................................................................................................111.3.1肿瘤领域..............................................................................................................121.3.2神经疾病领域......................................................................................................131.3.3先天性遗传性疾病和畸形领域..........................................................................131.3.4皮肤和结缔组织疾病领域..................................................................................141.3.5免疫系统疾病领域..............................................................................................141.3.6肌肉和骨骼系统疾病领域..................................................................................141.3.7血液与淋巴系统疾病领域..................................................................................141.3.8病理状态、体征和症状......................................................................................151.3.9感染领域..............................................................................................................15 药渡全球药物研发进展周报⸺创新药篇（2026/02/14-02/20） 1.3.10精神疾病领域....................................................................................................161.3.11营养代谢病领域................................................................................................161.3.12眼部领域............................................................................................................161.3.13泌尿和生殖系统疾病领域................................................................................171.3.14心血管系统疾病领域........................................................................................171.3.15消化系统疾病领域............................................................................................171.4本周全球医药交易事件汇总表..................................................................................17二、国内药物批准/研发动态...............................................................................................222.1国内新药批准情况......................................................................................................222.1.1 NDA批准情况.....................................................................................................232.1.2 BLA批准情况.......................................................................................................232.1.3疫苗批准情况......................................................................................................232.1.4新复方批准情况..................................................................................................232.1.5新适应症批准情况..............................................................................................232.1.6新制剂批准情况..................................................................................................232.1.7拒绝批准情况/主动撤回....................................................................................232.1.8国内新药临床默示许可进展..............................................................................232.2国内新药申报最新进展..............................................................................................242.2.1药物特殊资格认定相关进展情况.......................................................................242.2.2国内新药申报上市情况.......................................................................................242.2.3国内新药申报临床情况.......................................................................................252.3国内新药研发进展...............................................................................................