药渡全球药物研发进展周报⸺创新药篇（2026/01/24-01/30）

⸺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.......................................................................................................61.1.2 BLA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..............................................................................................................131.3.2神经疾病领域......................................................................................................131.3.3感染领域..............................................................................................................141.3.4皮肤和结缔组织疾病领域..................................................................................151.3.5精神疾病领域......................................................................................................151.3.6免疫系统疾病领域..............................................................................................151.3.7呼吸系统疾病领域..............................................................................................16 药渡全球药物研发进展周报⸺创新药篇（2026/01/24-01/30） 1.3.8泌尿和生殖系统疾病领域..................................................................................161.3.9眼部疾病领域......................................................................................................161.3.10营养代谢病领域................................................................................................171.3.11内分泌系统疾病领域........................................................................................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...............................................................................................242.1国内新药批准情况......................................................................................................242.1.1 NDA批准情况.....................................................................................................252.1.2 BLA批准情况.......................................................................................................252.1.3疫苗批准情况......................................................................................................262.1.4新复方批准情况..................................................................................................262.1.5新适应症批准情况..............................................................................................262.1.6新制剂批准情况..................................................................................................262.1.7拒绝批准情况/主动撤回....................................................................................272.1.8国内新药临床默示许可进展..............................................................................272.2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.......................................................................................332.2.3国内新药申报临床情况.......................................................................................342.3国内新药研发进展......................................................................................................382.4国内新药研发领域政策法规动态..............................................................................402.5国内新药研发领域热点新闻......................................................................................41 ★本周渡选★ 1年长高超10厘米！维昇药业生长激素周制剂获NMPA批准上市 关注指数:★★★★★ 1月26日，维昇药业宣布，其核心产品——进口长效生长激素维臻高®（注射用隆培生长激素）正式获得中国国家药品监督管理局（NMPA）批准上市，用于治疗儿童生长激素缺乏症（PGHD）。该产品获批，标志着中国PGHD患儿迎来了一款基于全球