药渡全球药物研发进展周报⸺创新药篇（2026/02/07-02/13）
⸺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................................................................................................61.1.6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........................................................................................................81.3全球新药研发进展........................................................................................................91.3.1肿瘤领域..............................................................................................................111.3.2神经疾病领域......................................................................................................121.3.3先天性遗传性疾病和畸形领域..........................................................................121.3.4皮肤和结缔组织疾病领域..................................................................................121.3.5免疫系统疾病领域..............................................................................................131.3.6肌肉和骨骼系统疾病领域..................................................................................131.3.7血液与淋巴系统疾病领域..................................................................................131.3.8呼吸系统系统疾病领域......................................................................................13 药渡全球药物研发进展周报⸺创新药篇（2026/02/07-02/13） 1.3.9感染领域..............................................................................................................141.3.10精神疾病领域....................................................................................................141.3.11营养代谢病领域................................................................................................141.3.12眼部领域............................................................................................................151.4本周全球医药交易事件汇总表..................................................................................15二、国内药物批准/研发动态...............................................................................................212.1国内新药批准情况......................................................................................................212.1.1 NDA批准情况.....................................................................................................222.1.2 BLA批准情况.......................................................................................................222.1.3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..................................................................................................242.1.7拒绝批准情况/主动撤回....................................................................................242.1.8国内新药临床默示许可进展..............................................................................242.2国内新药申报最新进展..............................................................................................302.2.1药物特殊资格认定相关进展情况.......................................................................302.2.2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......................................................................................................402.4国内新药研发领域政策法规动态..............................................................................422.5国内新药研发领域热点新闻......................................................................................43 ★本周渡选★ 每年两次维持治疗！欧盟批准安进抗体疗法新适应症 关注指数:★★★★★ 2月13日，安进（Amgen）宣布，欧盟委员会（EC）已批准抗体Uplizna（Inebilizum
