药渡全球药物研发进展周报—创新药篇（2026/02/21-02/28）

⸺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......................................................................................................101.3全球新药研发进展......................................................................................................121.3.1肿瘤领域..............................................................................................................141.3.2神经疾病领域......................................................................................................161.3.3内分泌系统疾病领域..........................................................................................171.3.4皮肤和结缔组织疾病领域..................................................................................171.3.5免疫系统疾病领域..............................................................................................171.3.6病理状态、体征和症状......................................................................................171.3.7血液与淋巴系统疾病领域..................................................................................181.3.8呼吸系统系统疾病领域......................................................................................181.3.9感染领域..............................................................................................................18 药渡全球药物研发进展周报⸺创新药篇（2026/02/21-02/28） 1.3.10精神疾病领域....................................................................................................191.3.11营养代谢病领域................................................................................................191.3.12眼部领域............................................................................................................191.3.13消化系统疾病领域............................................................................................201.3.14心血管疾病领域................................................................................................201.4本周全球医药交易事件汇总表..................................................................................20二、国内药物批准/研发动态...............................................................................................262.1国内新药批准情况......................................................................................................262.1.1 NDA批准情况.....................................................................................................262.1.2 BLA批准情况.......................................................................................................272.1.3疫苗批准情况......................................................................................................272.1.4新复方批准情况..................................................................................................272.1.5新适应症批准情况..............................................................................................272.1.6新制剂批准情况..................................................................................................282.1.7拒绝批准情况/主动撤回....................................................................................282.1.8国内新药临床默示许可进展..............................................................................282.2国内新药申报最新进展..............................................................................................312.2.1药物特殊资格认定相关进展情况.......................................................................312.2.2国内新药申报上市情况.......................................................................................322.2.3国内新药申报临床情况.......................................................................................342.3国内新药研发进展......................................................................................................412.4国内新药研发领域政策法规动态........................................