药渡全球药物研发进展周报——创新药篇（2026/01/10-2026/01/16）

⸺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........................................................................................................51.1.1 NDA批准情况.......................................................................................................71.1.2 BLA批准情况.........................................................................................................71.1.3疫苗批准情况........................................................................................................71.1.4新复方批准情况....................................................................................................71.1.5新适应症批准情况................................................................................................81.1.6新制剂批准情况....................................................................................................81.1.7拒绝批准/主动撤回/撤市情况.............................................................................81.2全球新药申报进展........................................................................................................81.2.1 NDA/BLA申报......................................................................................................81.2.2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感染领域..............................................................................................................131.3.4皮肤和结缔组织疾病领域..................................................................................131.3.5病理状态、体征和症状领域..............................................................................141.3.6精神疾病领域......................................................................................................141.3.7免疫系统疾病领域..............................................................................................141.3.8呼吸系统疾病领域..............................................................................................141.3.9血液和淋巴疾病领域..........................................................................................15 药渡全球药物研发进展周报⸺创新药篇（2026/01/10-2026/01/16） 1.3.10心血管疾病领域................................................................................................151.3.11肌肉和骨骼系统疾病领域................................................................................151.3.12先天性遗传性疾病和畸形领域........................................................................161.3.13营养代谢病领域................................................................................................161.3.14眼部疾病领域....................................................................................................161.3.1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...............................................................................................262.1国内新药批准情况......................................................................................................262.1.1 NDA批准情况.....................................................................................................272.1.2 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..................................................................................................272.1.7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..............................................................................................342.2.1药物特殊资格认定相关进展情况.......................................................................342.2.2国内新药申报上市情况.......................................................................................352.2.3国内新药申报临床情况.......................................................................................372.3国内新药研发进展.............................................................