药渡全球药物研发进展报告：仿制药篇.pptxVIP

2026年01月03日—2026年01月09日

药渡全球药物研发进展报告

-仿制药篇

目录

★本周渡选★.........................................................................................................................................2

一、国内仿制药研发批准动态......................................................................................................4

1.1首家仿制药品种批准上市情况..............................................................................................4

1.1.1新注册分类品种批准上市情况...................................................................................4

1.1.2一致性评价品种批准上市情况...................................................................................7

1.2其他仿制药品种批准上市情况..............................................................................................8

1.2.1新注册分类品种批准上市情况...................................................................................8

1.2.2一致性评价品种批准上市情况.................................................................................16

1.3仿制药品种批准临床情况....................................................................................................17

1.4仿制药品种拒绝批准/主动撤回情况...................................................................................17

二、国内仿制药研发申报动态....................................................................................................18

2.1新注册分类品种申报上市情况............................................................................................18

2.2一致性评价品种申报上市情况............................................................................................27

2.3仿制药补充申请情况............................................................................................................28

2.4仿制药申报上市专利声明信息............................................................................................29

三、国内仿制药研发领域热点聚焦............................................................................................36

3.1国内仿制药研发领域政策法规相关动态............................................................................36

3.2国内仿制药研发领域热点新闻..............